# FDA 483 - Sun Dental Laboratories, LLC - September 20, 2023

Source: https://www.keypedia.com/records/483/sun-dental-laboratories-llc/20cbe95e-c1f3-4d16-af88-c481476d391d

> FDA 483 for Sun Dental Laboratories, LLC on September 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Dental Laboratories, LLC
- Inspection Date: 2023-09-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Sun Dental Laboratories, LLC in Saint Petersburg, FL, a manufacturer of dental devices, identified three significant quality system deficiencies. The firm lacked written Medical Device Reporting procedures, failed to establish quality agreements with suppliers for product change notifications, and did not ensure proper examination of labeling for accuracy, specifically regarding Unique Device Identifier (UDI) information for SunClear Aligners.

## Related Documents

- [483 - 2023-09-20](https://www.keypedia.com/records/483/sun-dental-laboratories-llc/59ce16ab-ae92-489e-ba40-52ecdaef9e03)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.keypedia.com/companies/sun-dental-laboratories-llc/8636b656-af45-4399-83f7-b85306cd84d4

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