Data / Medical devices / United States / Sterngold Dental LLC
Sterngold Dental LLC: FDA-registered device maker in Attleboro, MA, United States, 54 510(k) clearances
Sterngold Dental LLC is registered with the FDA (registration 2921595) in Attleboro, MA, United States. It lists 15 device types. The FDA files 54 510(k) clearances under its listings, the newest dated September 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2921595
- Address
- 23 Frank Mossberg Drive, Attleboro, MA, United States, 02703
- Owner or operator
- Sterngold (10023675)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 4, 2009
- Registered through
- 2026
- Brand names listed
- 2.2mm Angled Micro ERA Dental Implant System, 23 Deg and 30 Deg ERA Female Abutment, 3340104 Red Friction Sleeves, 3340108 TDI Yellow Pins, 3340109 Blue Friction Sleeves, 6AL-4V Dental Implants, Abutments and Components, Acid Etch Implant System, Apollo and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 28, 2017 | K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | DZE | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| February 5, 2016 | K153173 | MOR Implant System | DZE | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| November 6, 2015 | K151928 | PUR Dental Implant System | DZE | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| July 24, 2015 | K150968 | TRU Dental Implant System | DZE | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| June 11, 2015 | K150250 | SternSnap Angled Attachment | NHA | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| January 7, 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 | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| December 24, 2014 | K142407 | Straight Stud Attachment | NHA | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| April 16, 2014 | K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] | NHA | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| February 25, 2014 | K132814 | SFI-BAR IMPLANT ABUTMENTS | NHA | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| July 7, 2013 | K130183 | SFI BAR ABUTMENTS | NHA | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| July 1, 2013 | K130408 | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT | NHA | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| June 1, 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 | Substantially Equivalent | Sterngold Dental, LLC | accessdata.fda.gov |
| November 10, 2009 | K092434 | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| October 28, 2004 | K041271 | STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| January 17, 2003 | K023580 | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| September 19, 2002 | K022252 | STERNGOLD 1, MODEL 1127781 | EJS | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| June 26, 2002 | K021741 | CRITERTION, MODEL #1067511 | EJT | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| June 26, 2002 | K021045 | ERA IMPLANT | DZE | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| May 16, 2002 | K021367 | STERNGOLD 66, MODEL #1180230 | EJS | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| April 4, 2002 | K020949 | APOLLO, MODEL 1124525 | EJT | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| March 8, 2002 | K020391 | STERN MICRO ERA ATTACHMENT SYSTEM | DZE | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| January 24, 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| November 17, 2000 | K003007 | GALAXY | EJT | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| August 17, 2000 | K002086 | PRIMAFLOW | EBF | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| September 22, 1999 | K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | EBI | Substantially Equivalent | Kay See Dental Mfg. Co. | accessdata.fda.gov |
| May 7, 1999 | K991436 | STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION | DZE | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| January 8, 1999 | K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | EBI | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| January 8, 1999 | K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | EMA | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| November 13, 1998 | K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | DZE | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| October 22, 1998 | K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | EBF | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| May 11, 1998 | K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | DZE | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| July 24, 1996 | K962326 | STERNGOLD BIO-5 (1127210) | EJT | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| July 24, 1996 | K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | EJS | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| July 23, 1996 | K962304 | STERNGOLD BIO-4 | EJS | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| July 18, 1996 | K962303 | STERNGOLD CF | EJT | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| July 18, 1996 | K962302 | PEGASUS DENTAL ALLOY | EJT | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| July 18, 1996 | K962301 | STERNGOLD G-HARD METAL ALLOY | EJS | Substantially Equivalent | The Stern Metals Co., Inc. | accessdata.fda.gov |
| May 29, 1996 | K960956 | STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 | EJT | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| June 14, 1995 | K946198 | IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR | DZE | Substantially Equivalent | Sterngold | accessdata.fda.gov |
| March 23, 1995 | K950213 | THE STERN ROOT ANCHOR SYSTEM | ELR | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| April 29, 1994 | K924830 | LUXATEMP AUTOMIX | EBG | Substantially Equivalent | Dmg Chemisch Pharmazeutische Fabrik GmbH | accessdata.fda.gov |
| March 7, 1994 | K933193 | IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L | DZE | Substantially Equivalent | The Stern Metals Co., Inc. | accessdata.fda.gov |
| March 1, 1994 | K926305 | IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER | DZE | Substantially Equivalent | The Stern Metals Co., Inc. | accessdata.fda.gov |
| February 14, 1994 | K924219 | ENDOSSEOUS IMPLANTS | DZE | Substantially Equivalent | The Stern Metals Co., Inc. | accessdata.fda.gov |
| October 20, 1993 | K933459 | RESIMENT WITH FLUORIDE | EMA | Substantially Equivalent | J.L. Blosser, Inc. | accessdata.fda.gov |
| October 27, 1992 | K921854 | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM | DZE | Substantially Equivalent | Impla-Med | accessdata.fda.gov |
| September 1, 1992 | K921010 | STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT | DZE | Substantially Equivalent | Apm Stern Gold | accessdata.fda.gov |
| January 30, 1992 | K913348 | THE STERN ERA SYSTEM | DZE | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| January 17, 1992 | K914764 | STERN ERA IMPLANT ABUTMENT | DZE | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| September 6, 1990 | K902911 | TITANIUM/STAINLESS STEEL INSTRUMENTS | DZE | Substantially Equivalent | Impla-Med | accessdata.fda.gov |
| August 9, 1990 | K902158 | TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP | DZE | Substantially Equivalent | Impla-Med | accessdata.fda.gov |
| October 20, 1989 | K892124 | IMPLA-MED IMPLANT SYSTEM | DZE | Substantially Equivalent | Impla-Med | accessdata.fda.gov |
| February 13, 1989 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL | EBC | Substantially Equivalent | Foremost Dental Mfg., Inc. | accessdata.fda.gov |
| April 14, 1981 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Dental-Material Gesellschaft | accessdata.fda.gov |
Compare with other makers
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- All makers of Attachment, Precision, All
Updated September 28, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.