# FDA 483 - Dentlight Inc - June 01, 2026

Source: https://www.keypedia.com/records/483/dentlight-inc/46e85b92-48ad-42bc-806f-1625c4b1eab1

> FDA 483 for Dentlight Inc on June 01, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dentlight Inc
- Inspection Date: 2026-06-01
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Dentlight Inc in Plano, TX, a manufacturer of Class IV devices, identified two significant observations. The firm failed to submit required product reports and annual reports for its devices prior to commercial introduction. Additionally, Dentlight Inc did not adequately analyze service records to determine if the information should be handled as a complaint, indicating issues with their complaint handling procedures.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/dentlight-inc/b3ab6acb-ff47-4dee-9bec-705b92ed6285)
- [483 - 2023-08-23](https://www.keypedia.com/records/483/dentlight-inc/bad0da5e-647e-4d6b-b74c-f346517a6d72)

## Related Officers

- [Katherine M. Thames](https://www.keypedia.com/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)

Company: https://www.keypedia.com/companies/dentlight-inc/545221f5-e0ed-408a-b31f-5927f5e686de

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9