STERNGOLD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29215952921595Sterngold Dental LLC1N2026-01-0123 Frank Mossberg Drive Attleboro MA US 02703

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00841549101823ERA® 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.5082265660laura.greige@sterngold.com
00841549102219ERA® Micro DE Female Ti - Micro ERA distal extension attachment where the female is made of a titanium alloy and is coated using titanium nitride. Designed to be only welded to the end of a titanium bar to retain an overdenture. 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).401-871-3489maria.rao@sterngold.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
771611853345014K992609HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400EBI1999-09-22
771611258432353K991436STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATIONDZE1999-05-07
771611703420583K984341STERNVANTAGE VARNISH LC, MODEL 221001EBI1999-01-08
771611237884941K984340STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281EMA1999-01-08
771611318114744K984340STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281EMA1999-01-08
771611122926743K983786STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATIONDZE1998-11-13
771611292922343K982692STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LCEBF1998-10-22
771611556950317K981516STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUBDZE1998-05-11
771611986813585K981516STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUBDZE1998-05-11
771611944351922K962326STERNGOLD BIO-5 (1127210)EJT1996-07-24
771611877906495K962324STERNGOLD U-CPF METAL ALLOY (1067800)EJS1996-07-24
771611781360099K962304STERNGOLD BIO-4EJS1996-07-23
771611332760081K962303STERNGOLD CFEJT1996-07-18
771611462495292K962302PEGASUS DENTAL ALLOYEJT1996-07-18
771611749041330K962301STERNGOLD G-HARD METAL ALLOYEJS1996-07-18
771611744846042K960956STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200EJT1996-05-29
771611236458876K950213THE STERN ROOT ANCHOR SYSTEMELR1995-03-23
771611241658190K946198IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTORDZE1995-06-14
771611163216876K933459RESIMENT WITH FLUORIDEEMA1993-10-20
771611877419121K933193IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,LDZE1994-03-07
771611651295420K926305IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETERDZE1994-03-01
771611624205695K924830LUXATEMP AUTOMIXEBG1994-04-29
771611835080975K924219ENDOSSEOUS IMPLANTSDZE1994-02-14
771611004675358K921854IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MMDZE1992-10-27
771611912487270K921854IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MMDZE1992-10-27
771611448599359K921010STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENTDZE1992-09-01
771611638517310K914764STERN ERA IMPLANT ABUTMENTDZE1992-01-17
771611308565661K913348THE STERN ERA SYSTEMDZE1992-01-30
771612018004402K902911TITANIUM/STAINLESS STEEL INSTRUMENTSDZE1990-09-06
771611804239823K902158TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMPDZE1990-08-09
771611029267753K892124IMPLA-MED IMPLANT SYSTEMDZE1989-10-20
771611654306396K892124IMPLA-MED IMPLANT SYSTEMDZE1989-10-20
771611424038119K890464ZENITH 40% PHOSPHORIC ACID GELEBC1989-02-13
771611050511771K810825POLYVINYL SILICONE IMPRESSION MATERIALELW1981-04-14
771611197162345K810825POLYVINYL SILICONE IMPRESSION MATERIALELW1981-04-14
771612006198939K810825POLYVINYL SILICONE IMPRESSION MATERIALELW1981-04-14
771611691287537K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmDZE2017-09-28
771611784364435K153173MOR Implant SystemDZE2016-02-05
771611747392634K151928PUR Dental Implant SystemDZE2015-11-06
771612043686495K150968TRU Dental Implant SystemDZE2015-07-24
771611672424129K150250SternSnap Angled AttachmentNHA2015-06-11
771611186504259K142667Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mmDZE2015-01-07
771611409287071K142407Straight Stud AttachmentNHA2014-12-24
771611058388147K133791ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]NHA2014-04-16
771611536767155K132814SFI-BAR IMPLANT ABUTMENTSNHA2014-02-25
771611335876318K130408ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENTNHA2013-07-01
771611351669870K130183SFI BAR ABUTMENTSNHA2013-07-07
771611898341282K111798STERNIC 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 ...DZE2012-06-01
771612015718928K092434STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEMDZE2009-11-10
771611413211005K041271STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEMDZE2004-10-28
771611935457896K023580STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEMDZE2003-01-17
771611391860617K022252STERNGOLD 1, MODEL 1127781EJS2002-09-19
771611017390759K021741CRITERTION, MODEL #1067511EJT2002-06-26
771611653319382K021367STERNGOLD 66, MODEL #1180230EJS2002-05-16
771611454233200K021045ERA IMPLANTDZE2002-06-26
771611589326338K020949APOLLO, MODEL 1124525EJT2002-04-04
771612071769966K020391STERN MICRO ERA ATTACHMENT SYSTEMDZE2002-03-08
771611393170993K013674LUXATEMP/LUXATEMP SOLAR/INSTATEMPEBG2002-01-24
771611573184975K003007GALAXYEJT2000-11-17
771611406367931K002086PRIMAFLOWEBF2000-08-17
771611170660502
771611675991749
771611824873401
771611909548061
771612060968049

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE282017-09-28
EJT72002-06-26
NHA62015-06-11
EJS52002-09-19
EMA31999-01-08
ELW31981-04-14
EBG22002-01-24
EBF22000-08-17
EBI21999-09-22
ELR11995-03-23
EBC11989-02-13

PMN#

GUDID#

ERA® Micro DE Female Ti - Micro ERA distal extension attachment where the female is made of a titanium alloy and is coated using titanium nitride. Designed to be only welded to the end of a titanium bar to retain an overdenture. 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).

STERNGOLD DENTAL LLC

2017-03-13

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