FDA Inspection
Denttio, Inc.Denttio, Inc. – FDA Inspection, Oct 25, 2017
Record Details
This FDA Inspection record concerns Denttio, Inc., with an inspection on October 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8c05c0ea-3bcd-41df-b95c-f376a6f300ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029765
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Denttio, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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