FDA Inspection
DentSply SironaDentSply Sirona – FDA Inspection, Feb 10, 2014
Record Details
This FDA Inspection record concerns DentSply Sirona, with an inspection on February 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DentSply Sirona
- Inspection Date
- February 10, 2014
- Product Type
- Devices
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ID · 31f276c0-e612-42ca-9068-c94a63678130
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866891
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of DentSply Sirona
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 17, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 22, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DentSply Sirona
- FDA Inspection 1014987 - 2017-05-05
- FDA Inspection 822901 - 2013-01-17
- FDA Inspection 579647 - 2009-04-22
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