Data / Medical devices / Germany / Sirona Dental Systems GmbH
Sirona Dental Systems GmbH: FDA-registered device maker in Bensheim Hesse, Germany, 48 510(k) clearances
Sirona Dental Systems GmbH is registered with the FDA (registration 9681851) in Bensheim Hesse, Germany. It lists 11 device types. The FDA files 48 510(k) clearances under its listings, the newest dated September 4, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681851
- FEI number
- 3002807009
- Address
- Fabrikstrasse 31, Bensheim Hesse, Germany, 64625
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Specification developer
- First device listed
- August 15, 1984
- Registered through
- 2027
- Brand names listed
- Ankylos Temporary Abutment Balance, Dental Abutment/Implant, EsthetiCap, Implant, PrimeTaper, XiVe TG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Specification developer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Specification developer | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Specification developer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Operative | EKD | 1 | Specification developer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Specification developer | accessdata.fda.gov |
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 4, 2026 | K261935 | Surgical and Prosthetic Trays | KCT | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| January 16, 2024 | K231144 | Washtrays | KCT | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| November 16, 2022 | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | DZE | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| November 16, 2022 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | DZE | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| May 3, 2022 | K220791 | Surgical and Prosthetic Trays | KCT | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| March 4, 2022 | K212281 | Surgical Trays | KCT | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| November 15, 2021 | K213449 | DS Implants abutments provided with the EV connection | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 27, 2021 | K210610 | PrimeTaper EV Dental Implant | DZE | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| July 10, 2019 | K183079 | Conometric Abutments | NHA | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| March 31, 2017 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 20, 2014 | K140347 | ANKYLOS C/X IMPLANT SYSTEM | DZE | Substantially Equivalent | Dentsply Intl., Inc. | accessdata.fda.gov |
| January 22, 2014 | K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | NHA | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| October 25, 2013 | K130999 | OSSEOSPEED PROFILE EV | DZE | Substantially Equivalent | Dentsply Implants Manufacturing GmbH | accessdata.fda.gov |
| January 23, 2013 | K121810 | OSSEOSPEED ANGLED ABUTMENT EV | NHA | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
| December 11, 2012 | K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS | NHA | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| July 31, 2012 | K120414 | OSSEOSPEED PLUS | DZE | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
| June 21, 2011 | K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | NHA | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
| February 23, 2011 | K101732 | ASTRA TECH IMPLANT SYSTEM | DZE | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
| May 22, 2009 | K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Dentsply Intl., Inc. | accessdata.fda.gov |
| September 17, 2008 | K080156 | OSSEOSPEED TM PROFILE SYSTEM | DZE | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
| April 30, 2008 | K080396 | OSSEOSPEED NARROW | DZE | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
| February 15, 2008 | K073067 | ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS | DZE | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| February 12, 2008 | K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE | NHA | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| October 1, 2007 | K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | NHA | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
| April 27, 2007 | K063779 | OSSEOSPEED 4.0S-6MM, MODEL 24619 | DZE | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
| May 3, 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| March 24, 2006 | K053384 | FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM | DZE | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
| June 14, 2005 | K050208 | FRIADENT ESTHETICAP | NHA | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| August 26, 2004 | K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| October 2, 2003 | K032302 | XIVE TG ABUTMENTS | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| August 12, 2003 | K030639 | XIVE 3.0 DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Friandent GmbH | accessdata.fda.gov |
| March 3, 2003 | K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| November 7, 2002 | K023631 | ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS | NHA | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
| July 2, 2002 | K021318 | XIVE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| April 9, 2002 | K013067 | FRIALOC DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| March 15, 2002 | K013867 | XIVE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| December 20, 2001 | K013438 | FRIALIT-2 ESTHETICBASE ABUTMENT | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| June 28, 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | EGS | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| April 20, 2000 | K994174 | FRIALIT-2 MH-2 ABUTMENT | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| March 24, 2000 | K994376 | FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA | DZE | Substantially Equivalent | Friadent GmbH | accessdata.fda.gov |
| July 15, 1999 | K990304 | MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM | DZE | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
| November 19, 1998 | K974738 | ASTRA TECH IMPLANT DENTAL SYSTEM | DZE | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
| October 22, 1998 | K982576 | FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476 | DZE | Substantially Equivalent | Friatec AG | accessdata.fda.gov |
| September 4, 1998 | K980630 | FRIALIT-2 CORABASE | DZE | Substantially Equivalent | Friatec AG | accessdata.fda.gov |
| May 7, 1998 | K973924 | FRIOS BONESHIELD | JEY | Substantially Equivalent | Friatec AG | accessdata.fda.gov |
| March 19, 1998 | K980698 | ASTRA TECH IMPLANTS - DENTAL SYSTEM | DZE | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
| March 15, 1996 | K945847 | FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE | DZE | Substantially Equivalent | Friatec Medical Inc., USA | accessdata.fda.gov |
| February 8, 1994 | K931767 | ASTRA TECH IMPLANTS-DENTAL SYSTEM | DZE | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Chisel, Osteotome, Surgical
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Controller, Foot, Handpiece And Cord
Updated September 4, 2026. 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.