Ivoclar Vivadent Manufacturing GmbH FDA Record
Ivoclar Vivadent Manufacturing GmbH has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ivoclar Vivadent Manufacturing GmbH" is on file.
- Latest inspection
- Sep 20, 2017 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | 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 20, 2017 | Somerset, NJ | Devices | Voluntary Action Indicated (VAI) | 2244842 |
| Aug 26, 2016 | Burs, Austria | Devices | No Action Indicated (NAI) | 1000493628 |
| Jun 23, 2016 | Naturno, Italy | Devices | No Action Indicated (NAI) | 3003310824 |
| Nov 22, 2011 | Somerset, NJ | Devices | No Action Indicated (NAI) | 2244842 |
| Aug 5, 2010 | Burs, Austria | Devices | Voluntary Action Indicated (VAI) | 1000493628 |
| Jan 21, 2009 | Somerset, NJ | Devices | No Action Indicated (NAI) | 2244842 |
- 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 2244842 | Somerset, NJ | 3 | Sep 20, 2017 |
| FEI 1000493628 | Burs, Austria | 2 | Aug 26, 2016 |
| FEI 3003310824 | Naturno, Italy | 1 | Jun 23, 2016 |
Ivoclar Vivadent Manufacturing GmbH and the FDA: common questions
Has Ivoclar Vivadent Manufacturing GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Ivoclar Vivadent Manufacturing 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 Ivoclar Vivadent Manufacturing GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Ivoclar Vivadent Manufacturing GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Ivoclar Vivadent Manufacturing GmbH?
The most recent FDA inspection on file ended Sep 20, 2017 at Somerset, NJ and was classified VAI. FDA has 6 inspections of Ivoclar Vivadent Manufacturing GmbH on file.
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