FDA.report

Sterngold Dental LLC

Matched from indexed company URL: STERNGOLD DENTAL LLC

FDA Registration(s)

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 GUDIDProductPhoneEmail
00841549115783Hader Bar® - Hader Bar® Starter Kit. A Hader Bar is a type of denture attachment that improves the retention and stability of a denture, particularly overdentures (dentures supported by implants). It involves a metal bar placed on the implants, with a plastic or metal bar fitting over it within the denture. The kit includes 2 bars, 6 yellow riders, 6 fabricating riders, 1 seating tool.5082265660laura.greige@sterngold.com
00841549115790Hader Bar® - Hader Bar® Nylon Ret. Riders, White, 6. A Hader bar nylon retention rider is a plastic clip that snaps onto a metal bar, providing retention and stabilization for a denture. The Hader bar is attached to implants or teeth, and the nylon rider clicks onto it to hold the denture in place. These riders come in different colors (white, yellow, red) to indicate varying levels of retention.5082265660laura.greige@sterngold.com

Registered Device Listings

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 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

Stern Snap One Piece Abutment 1mm Cuff (BK) - The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

2024-06-24

Stern Snap One Piece Abutment 2mm Cuff (BK) - The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

2024-06-24

Stern Snap One Piece Abutment 3mm Cuff (BK) - The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

2024-06-24

Stern Snap One Piece Abutment 4mm Cuff (BK) - The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

2024-06-24

Stern Snap One Piece Abutment 5mm Cuff (BK) - The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

2024-06-24

ORA Implant Abutment 1.0mm Cuff (BK) - Implant Interface design varies, dependent upon implant type. The ORA System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

STERNGOLD DENTAL LLC

2024-06-24

ORA Implant Abutment 2.0mm Cuff (BK) - Implant Interface design varies, dependent upon implant type. The ORA System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

STERNGOLD DENTAL LLC

2024-06-24

ORA Implant Abutment 3.0mm Cuff (BK) - Implant Interface design varies, dependent upon implant type. The ORA System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

STERNGOLD DENTAL LLC

2024-06-24

ORA Implant Abutment 4.0mm Cuff (BK) - Implant Interface design varies, dependent upon implant type. The ORA System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

STERNGOLD DENTAL LLC

2024-06-24

ORA Implant Abutment 5.0mm Cuff (BK) - Implant Interface design varies, dependent upon implant type. The ORA System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants. The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

STERNGOLD DENTAL LLC

2024-06-24

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