# FDA 483 - Boca Dental Regenerative LLC - June 05, 2023

Source: https://www.keypedia.com/records/483/boca-dental-regenerative-llc/1077d122-e5df-4859-a1ac-49d44c2c3b7e

> FDA 483 for Boca Dental Regenerative LLC on June 05, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boca Dental Regenerative LLC
- Inspection Date: 2023-06-05
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Boca Dental Regenerative LLC, a manufacturer in Boca Raton, FL, was inspected by the FDA from May 22 to June 5, 2023. The inspection resulted in one observation regarding incomplete complaint investigation records. Specifically, four out of five complaints received between 2021 and 2023 lacked a unique device identifier (UDI).

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Company: https://www.keypedia.com/companies/boca-dental-regenerative-llc/a1ff341b-d920-452c-a417-1ca8672e2b02

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6