FDA Inspection
Ultradent Products, Inc.Ultradent Products, Inc. – FDA Inspection, Nov 8, 2013
Record Details
This FDA Inspection record concerns Ultradent Products, Inc., with an inspection on November 8, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ultradent Products, Inc.
- Inspection Date
- November 8, 2013
- Product Type
- Devices
View Company Profile
ID · 9ea95e2a-6a6c-4de8-a98c-40a5b36047ff
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 854539
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Ultradent Products, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | VAI | Denver District Office | Drug Quality Assurance |
| January 17, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 25, 2018 | Not classified | Denver District Office | |
| September 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ultradent Products, Inc.
- FDA Inspection 1272589 - 2025-06-13
- FDA Inspection 1115289 - 2020-01-17
- FDA Inspection 1086182 - 2019-03-28
- FDA Inspection 1121811 - 2018-09-25
- FDA Inspection 1025250 - 2017-09-15
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