Sirona Dental Systems GmbH FDA Record
Sirona Dental Systems GmbH has 0 FDA recalls, 2 inspections, 42 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sirona Dental Systems GmbH" is on file.
- Latest inspection
- Sep 17, 2010 · NAI
- Latest 510(k)
- Jun 2, 2016
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 42 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 17, 2010 | Bensheim, Germany | Devices | No Action Indicated (NAI) | 3003719498 |
| May 7, 2010 | Bensheim, Germany | Devices | No Action Indicated (NAI) | 3002807009 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003719498 | Bensheim, Germany | 1 | Sep 17, 2010 |
| FEI 3002807009 | Bensheim, Germany | 1 | May 7, 2010 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K160099 | CEREC SpeedGlaze | Jun 2, 2016 |
| K151045 | TENEO Dental Treatment Unit and Accessories | Jul 24, 2015 |
| K150909 | INTEGO Family and Accesories | Jul 17, 2015 |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Jul 2, 2015 |
| K150217 | ORTHOPHOS SL | May 8, 2015 |
| K131319 | T1/T2/T3 TURBINE FAMILY | May 30, 2014 |
| K132773 | SIDEXIS 4 | Dec 11, 2013 |
| K123664 | INCORIS ZI | Apr 8, 2013 |
| K123952 | CEREC BLOCS C IN | Mar 20, 2013 |
| K123070 | GALILEOS FAMILY | Mar 15, 2013 |
| K123545 | INCORIS TZI | Feb 1, 2013 |
| K111421 | SIRONA DENTAL CAD/CAM SYSTEM | Feb 17, 2012 |
| K103711 | ORTHOPHOS XG 3D / CEPH | Mar 22, 2011 |
| K103753 | SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER | Feb 15, 2011 |
| K100152 | SIRONA CAD/CAM SYSTEM | Oct 22, 2010 |
| K092660 | SIROLASER ADVANCE | Dec 3, 2009 |
| K083344 | HELIODENT PLUS | Dec 23, 2008 |
| K081903 | XIOS PLUS WALL-MODULE | Aug 26, 2008 |
| K080882 | CEREC OPTI SPRAY | Apr 11, 2008 |
| K072107 | PERIOSCAN, MODEL: D 3496 | Feb 14, 2008 |
Sirona Dental Systems GmbH and the FDA: common questions
Has Sirona Dental Systems GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Sirona Dental Systems GmbH" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Sirona Dental Systems GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Sirona Dental Systems GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sirona Dental Systems GmbH?
The most recent FDA inspection on file ended Sep 17, 2010 at Bensheim, Germany and was classified NAI. FDA has 2 inspections of Sirona Dental Systems GmbH on file.
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