sterngold.comORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
STERNGOLD DENTAL LLC
Sterngold Dental LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2921595 | 2921595 | Sterngold Dental LLC | 1 | N | 2026-01-01 | 23 Frank Mossberg Drive Attleboro MA US 02703 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00841549101823 | ERA® DO LP Basic Kit w/ Tools SS - Resilient precision attachment. Kit contains: Three large post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange) 2 metal jackets, 2 Alignment handles, 2 blockout spacers, 1 of each Pilot drill, countersink bur, core cutter bur and seating tool. | 5082265660 | laura.greige@sterngold.com |
| 00841549103841 | ERA® Implant Abutment Micro 0°, 4mm Cuff (AX) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant). | 401-871-3489 | maria.rao@sterngold.com |
| 00841549103889 | ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant). | 401-871-3489 | maria.rao@sterngold.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 77161 | 1853345014 | K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | EBI | 1999-09-22 |
| 77161 | 1258432353 | K991436 | STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION | DZE | 1999-05-07 |
| 77161 | 1703420583 | K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | EBI | 1999-01-08 |
| 77161 | 1237884941 | K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | EMA | 1999-01-08 |
| 77161 | 1318114744 | K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | EMA | 1999-01-08 |
| 77161 | 1122926743 | K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | DZE | 1998-11-13 |
| 77161 | 1292922343 | K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | EBF | 1998-10-22 |
| 77161 | 1556950317 | K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | DZE | 1998-05-11 |
| 77161 | 1986813585 | K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | DZE | 1998-05-11 |
| 77161 | 1944351922 | K962326 | STERNGOLD BIO-5 (1127210) | EJT | 1996-07-24 |
| 77161 | 1877906495 | K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | EJS | 1996-07-24 |
| 77161 | 1781360099 | K962304 | STERNGOLD BIO-4 | EJS | 1996-07-23 |
| 77161 | 1332760081 | K962303 | STERNGOLD CF | EJT | 1996-07-18 |
| 77161 | 1462495292 | K962302 | PEGASUS DENTAL ALLOY | EJT | 1996-07-18 |
| 77161 | 1749041330 | K962301 | STERNGOLD G-HARD METAL ALLOY | EJS | 1996-07-18 |
| 77161 | 1744846042 | K960956 | STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 | EJT | 1996-05-29 |
| 77161 | 1236458876 | K950213 | THE STERN ROOT ANCHOR SYSTEM | ELR | 1995-03-23 |
| 77161 | 1241658190 | K946198 | IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR | DZE | 1995-06-14 |
| 77161 | 1163216876 | K933459 | RESIMENT WITH FLUORIDE | EMA | 1993-10-20 |
| 77161 | 1877419121 | K933193 | IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L | DZE | 1994-03-07 |
| 77161 | 1651295420 | K926305 | IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER | DZE | 1994-03-01 |
| 77161 | 1624205695 | K924830 | LUXATEMP AUTOMIX | EBG | 1994-04-29 |
| 77161 | 1835080975 | K924219 | ENDOSSEOUS IMPLANTS | DZE | 1994-02-14 |
| 77161 | 1004675358 | K921854 | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM | DZE | 1992-10-27 |
| 77161 | 1912487270 | K921854 | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM | DZE | 1992-10-27 |
| 77161 | 1448599359 | K921010 | STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT | DZE | 1992-09-01 |
| 77161 | 1638517310 | K914764 | STERN ERA IMPLANT ABUTMENT | DZE | 1992-01-17 |
| 77161 | 1308565661 | K913348 | THE STERN ERA SYSTEM | DZE | 1992-01-30 |
| 77161 | 2018004402 | K902911 | TITANIUM/STAINLESS STEEL INSTRUMENTS | DZE | 1990-09-06 |
| 77161 | 1804239823 | K902158 | TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP | DZE | 1990-08-09 |
| 77161 | 1029267753 | K892124 | IMPLA-MED IMPLANT SYSTEM | DZE | 1989-10-20 |
| 77161 | 1654306396 | K892124 | IMPLA-MED IMPLANT SYSTEM | DZE | 1989-10-20 |
| 77161 | 1424038119 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL | EBC | 1989-02-13 |
| 77161 | 1050511771 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | 1981-04-14 |
| 77161 | 1197162345 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | 1981-04-14 |
| 77161 | 2006198939 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | 1981-04-14 |
| 77161 | 1691287537 | K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | DZE | 2017-09-28 |
| 77161 | 1784364435 | K153173 | MOR Implant System | DZE | 2016-02-05 |
| 77161 | 1747392634 | K151928 | PUR Dental Implant System | DZE | 2015-11-06 |
| 77161 | 2043686495 | K150968 | TRU Dental Implant System | DZE | 2015-07-24 |
| 77161 | 1672424129 | K150250 | SternSnap Angled Attachment | NHA | 2015-06-11 |
| 77161 | 1186504259 | K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm | DZE | 2015-01-07 |
| 77161 | 1409287071 | K142407 | Straight Stud Attachment | NHA | 2014-12-24 |
| 77161 | 1058388147 | K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] | NHA | 2014-04-16 |
| 77161 | 1536767155 | K132814 | SFI-BAR IMPLANT ABUTMENTS | NHA | 2014-02-25 |
| 77161 | 1335876318 | K130408 | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT | NHA | 2013-07-01 |
| 77161 | 1351669870 | K130183 | SFI BAR ABUTMENTS | NHA | 2013-07-07 |
| 77161 | 1898341282 | K111798 | STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... | DZE | 2012-06-01 |
| 77161 | 2015718928 | K092434 | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM | DZE | 2009-11-10 |
| 77161 | 1413211005 | K041271 | STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM | DZE | 2004-10-28 |
| 77161 | 1935457896 | K023580 | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM | DZE | 2003-01-17 |
| 77161 | 1391860617 | K022252 | STERNGOLD 1, MODEL 1127781 | EJS | 2002-09-19 |
| 77161 | 1017390759 | K021741 | CRITERTION, MODEL #1067511 | EJT | 2002-06-26 |
| 77161 | 1653319382 | K021367 | STERNGOLD 66, MODEL #1180230 | EJS | 2002-05-16 |
| 77161 | 1454233200 | K021045 | ERA IMPLANT | DZE | 2002-06-26 |
| 77161 | 1589326338 | K020949 | APOLLO, MODEL 1124525 | EJT | 2002-04-04 |
| 77161 | 2071769966 | K020391 | STERN MICRO ERA ATTACHMENT SYSTEM | DZE | 2002-03-08 |
| 77161 | 1393170993 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | EBG | 2002-01-24 |
| 77161 | 1573184975 | K003007 | GALAXY | EJT | 2000-11-17 |
| 77161 | 1406367931 | K002086 | PRIMAFLOW | EBF | 2000-08-17 |
| 77161 | 1170660502 | ||||
| 77161 | 1675991749 | ||||
| 77161 | 1824873401 | ||||
| 77161 | 1909548061 | ||||
| 77161 | 2060968049 |
Product Codes Associated With Registrations#
PMN#
SFI-BAR IMPLANT ABUTMENTS
STERNGOLD DENTAL LLC
SFI BAR ABUTMENTS
STERNGOLD DENTAL LLC
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
STERNGOLD DENTAL LLC
GUDID#
SternTek Duplicating Material - Reg. Set, Base&catalyst, 5L ea.
2023-10-04
ERA® DO LP Basic Kit w/ Tools SS - Resilient precision attachment. Kit contains: Three large post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange) 2 metal jackets, 2 Alignment handles, 2 blockout spacers, 1 of each Pilot drill, countersink bur, core cutter bur and seating tool.
2020-07-07
Sterngold Implant System Cortical Bone Drill 3.2mm - A metal device used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into.
2020-07-07
ERA® Implant Abutment Micro 0°, 4mm Cuff (AX) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro 0°, 2mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro 0°, 3mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro 0°, 4mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-21
ERA® Implant Abutment Micro 0°, 6mm Cuff (BD) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro 0°, 2mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro 0°, 3mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro 0°, 4mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro 0°, 5mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro 0°, 6mm Cuff (BE) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA® abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-22
ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro 0°, 0.5mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro 0°, 2mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro 0°, 3mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro 0°, 4mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro 0°, 5mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro 0°, 6mm Cuff (AH) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro Ang. Base, 0.5mm Cuff (AJ) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23
ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (AJ) - Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
2017-03-23