Manufacturer registered with FDA
Sterngold
Attleboro, MA, United States. Lists 15 dental device types with FDA across 1 registered establishment, and holds 24 510(k) clearances as applicant.
- Device types listed
- 15
- Brands and models
- 65
- 510(k) clearances
- 241995–2017
- Markets registered in
- 8124 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 8 markets
Where regulators' registries name Sterngold as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sterngold | 24 clearances | 1995–2017 | Below |
| Canada | Health Canada | Registration holder | STERNGOLD DENTAL, LLC | 67 | 1999–2017 | Pure Global AI |
| Colombia | INVIMA | Registration holder | STERNGOLD DENTAL LLC.STERNGOLD DENTAL, LLC. · STERNGOLD DENTAL LLC | 20 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sterngold Dental LLCSterngold | 14 | 1999–2015 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | STERNGOLD DENTAL LLCSTERNGOLD | 10 | 2004–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | STERNGOLD DENTAL LLCSTERNGOLD | 7 | 2000–2019 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Sterngold Dental, LLCSterngold Dental LLC | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Sterngold Dental LLC | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Sterngold currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Acid Etch Implant SystemERA Dental Implant SystemERA ImplantERA Implant AbutmentImplamed Hex Screw Implants, 18mm and 20mmImplamed Hex Screw Implants, 4.5mm and 6mm DiameterImplamed Implant SystemImplamed Low Margin AbutmentsImplamed UCLA Type Abutments and AccessoriesMicro ERA System 15 moreMOR 3mm and PUR 3.2mm Implant Systems, Mor 2.1x18mm and MOR 2.4x18mm ImplantsMOR Dental Implant SystemPUR Dental Implant SystemSern IC Dental Implant SystemStern AC Dental Implant SystemStern ERA Alignment Correction Implant AbutmentStern ERA Resilient Dental SystemSterngold Dental Narrow Platform Dental Implants, Related Prosthetics & InstrumentsSterngold Implamed Hex Screw Implant TPS and HA CoatedSterngold Implamed Wide Platform Dental Implants, Prosthetics and InstrumentsTitanium & Stainless Steel Dental Implant Drill, Countersinks, Bone Taps, Marking bursTitanium & Stainless Steel Instruments Screw Drivers, Hex Drivers, Seating Tools, Implant Mount, Depth Probe, Ratchet WrTRU Dental Implant2.2mm Angled Micro ERA Dental Implant System6AL-4V Dental Implants, Abutments and Components | 2009 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | MOR 3mm and PUR 3.2mm Implant Systems, Mor 2.1x18mm and MOR 2.4x18mm ImplantsMOR Dental Implant SystemORA Implant AbutmentsSern IC Dental Implant SystemSFI Abutments Platforms BD BE BF AE AN AP AY AJ AKSFI Bar Implant AbutmentStern Snap 0 Degree AttachmentStern Snap Angled Abutment23 Deg and 30 Deg ERA Female Abutment | 2012 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | ApolloCriterionGalaxyPegasusPegasus Dental AlloySterngold Bio-H & Bio-CSterngold M-PF | 2009 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | Phoenix & 2713Stern 1Stern 66Sterngold Bio-4Sterngold G-Hard | 2009 |
| Dental CementEMA · Class 2 | Dental cements | Maker | SternOmegaTempolock | 2009 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | OmegafloSternOmega | 2009 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | EZ Pickup MaterialInstatemp Max | 2009 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Quickline/InstagumsStern Vantage | 2009 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Stern Omega | 2009 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Stern Tek Duplicating MaterialSternTek Custom Tray Impression Material | 2011 |
| All Precision AttachmentEGG · Class 1 | — | Maker | 3340104 Red Friction Sleeves3340108 TDI Yellow Pins3340109 Blue Friction Sleeves | 2015 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | ERA Pickup Mixing Tips | 2014 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Stern Root Anchor System | 2009 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Stern Vantage | 2009 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Sterngold Dental AccessoriesSterngold Dental Instruments | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Sterngold as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Sep 2017 | K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | DZE Root-Form Endosseous Implant |
| 5 Feb 2016 | K153173 | MOR Implant System | DZE Root-Form Endosseous Implant |
| 6 Nov 2015 | K151928 | PUR Dental Implant System | DZE Root-Form Endosseous Implant |
| 24 Jul 2015 | K150968 | TRU Dental Implant System | DZE Root-Form Endosseous Implant |
| 11 Jun 2015 | K150250 | SternSnap Angled Attachment | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2015 | K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm | DZE Root-Form Endosseous Implant |
| 24 Dec 2014 | K142407 | Straight Stud Attachment | NHA Endosseous Dental Implant Abutment |
| 16 Apr 2014 | K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] | NHA Endosseous Dental Implant Abutment |
| 25 Feb 2014 | K132814 | SFI-BAR IMPLANT ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 7 Jul 2013 | K130183 | SFI BAR ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 1 Jul 2013 | K130408 | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 1 Jun 2012 | 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 Root-Form Endosseous Implant |
| 10 Nov 2009 | K092434 | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 28 Oct 2004 | K041271 | STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Jan 2003 | K023580 | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 19 Sep 2002 | K022252 | STERNGOLD 1, MODEL 1127781 | EJS Alloy Other Noble Metal |
| 26 Jun 2002 | K021741 | CRITERTION, MODEL #1067511 | EJT Gold-Based Noble Metal Alloy |
| 26 Jun 2002 | K021045 | ERA IMPLANT | DZE Root-Form Endosseous Implant |
| 16 May 2002 | K021367 | STERNGOLD 66, MODEL #1180230 | EJS Alloy Other Noble Metal |
| 4 Apr 2002 | K020949 | APOLLO, MODEL 1124525 | EJT Gold-Based Noble Metal Alloy |
| 8 Mar 2002 | K020391 | STERN MICRO ERA ATTACHMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Nov 2000 | K003007 | GALAXY | EJT Gold-Based Noble Metal Alloy |
| 7 May 1999 | K991436 | STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION | DZE Root-Form Endosseous Implant |
| 14 Jun 1995 | K946198 | IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (1).
Also lists devices cleared under other names
Sterngold lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sterngold/Implamed (14), The Stern Metals Co., Inc. (4), Impla-Med (4), Dmg USA, Inc. (2), Kay See Dental Mfg. Co. (1), DMG Chemisch-Pharmazeutische Fabrik GmbH (1), J.L. Blosser, Inc. (1), Apm Stern Gold (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 17 Aug 2000 | K002086 | PRIMAFLOW | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 22 Sep 1999 | K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | Kay See Dental Mfg. Co. | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jan 1999 | K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | Sterngold/Implamed | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jan 1999 | K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | Sterngold/Implamed | EMA Dental Cement |
| 13 Nov 1998 | K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | Sterngold/Implamed | DZE Root-Form Endosseous Implant |
| 22 Oct 1998 | K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | Sterngold/Implamed | EBF Resin Tooth Shade Material |
| 11 May 1998 | K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | Sterngold/Implamed | DZE Root-Form Endosseous Implant |
| 24 Jul 1996 | K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | Sterngold/Implamed | EJS Alloy Other Noble Metal |
| 24 Jul 1996 | K962326 | STERNGOLD BIO-5 (1127210) | Sterngold/Implamed | EJT Gold-Based Noble Metal Alloy |
| 23 Jul 1996 | K962304 | STERNGOLD BIO-4 | Sterngold/Implamed | EJS Alloy Other Noble Metal |
| 18 Jul 1996 | K962302 | PEGASUS DENTAL ALLOY | Sterngold/Implamed | EJT Gold-Based Noble Metal Alloy |
| 18 Jul 1996 | K962303 | STERNGOLD CF | Sterngold/Implamed | EJT Gold-Based Noble Metal Alloy |
| 18 Jul 1996 | K962301 | STERNGOLD G-HARD METAL ALLOY | The Stern Metals Co., Inc. | EJS Alloy Other Noble Metal |
| 29 May 1996 | K960956 | STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 | Sterngold/Implamed | EJT Gold-Based Noble Metal Alloy |
| 23 Mar 1995 | K950213 | THE STERN ROOT ANCHOR SYSTEM | Sterngold/Implamed | ELR Root Canal Post |
| 29 Apr 1994 | K924830 | LUXATEMP AUTOMIX | DMG Chemisch-Pharmazeutische Fabrik GmbH | EBG Resin Temporary Crown and Bridge |
| 7 Mar 1994 | K933193 | IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L | The Stern Metals Co., Inc. | DZE Root-Form Endosseous Implant |
| 1 Mar 1994 | K926305 | IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER | The Stern Metals Co., Inc. | DZE Root-Form Endosseous Implant |
| 14 Feb 1994 | K924219 | ENDOSSEOUS IMPLANTS | The Stern Metals Co., Inc. | DZE Root-Form Endosseous Implant |
| 20 Oct 1993 | K933459 | RESIMENT WITH FLUORIDE | J.L. Blosser, Inc. | EMA Dental Cement |
| 27 Oct 1992 | K921854 | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM | Impla-Med | DZE Root-Form Endosseous Implant |
| 1 Sep 1992 | K921010 | STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT | Apm Stern Gold | DZE Root-Form Endosseous Implant |
| 30 Jan 1992 | K913348 | THE STERN ERA SYSTEM | Sterngold/Implamed | DZE Root-Form Endosseous Implant |
| 17 Jan 1992 | K914764 | STERN ERA IMPLANT ABUTMENT | Sterngold/Implamed | DZE Root-Form Endosseous Implant |
| 6 Sep 1990 | K902911 | TITANIUM/STAINLESS STEEL INSTRUMENTS | Impla-Med | DZE Root-Form Endosseous Implant |
| 9 Aug 1990 | K902158 | TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP | Impla-Med | DZE Root-Form Endosseous Implant |
| 20 Oct 1989 | K892124 | IMPLA-MED IMPLANT SYSTEM | Impla-Med | DZE Root-Form Endosseous Implant |
| 13 Feb 1989 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL | Foremost Dental Mfg., Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 14 Apr 1981 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | Dental-Material Gesellschaft | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Sterngold Dental LLCFDA reg. 2921595 | Attleboro, MA, United States | Manufacturer, Repacker / relabeler |
Other names on FDA records
Sterngold Dental LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023675). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.