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FDA Inspection
•Dental Evolutions, Inc.•February 9, 2024

Dental Evolutions, Inc. – FDA Inspection, Feb 9, 2024

Record Details

This FDA Inspection record concerns Dental Evolutions, Inc., with an inspection on February 9, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company
Dental Evolutions, Inc.
Inspection Date
February 9, 2024
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Sarah A. Hassas (Company Rep)
View Company Profile

ID · a96645f8-0728-4b38-afc6-0803b5314b25

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1229090
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

3
  1. 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
  2. 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
  3. 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Dental Evolutions, Inc.

2
DateClassificationOfficeProject area
October 11, 2019NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
July 30, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Dental Evolutions, Inc.
  • FDA Inspection 1106717 - 2019-10-11
  • FDA Inspection 1061601 - 2018-07-30

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