# FDA 483 - Dental Engineering Laboratories, LLC - May 21, 2019

Source: https://www.keypedia.com/records/483/dental-engineering-laboratories-llc/4efc2fe0-571e-4362-ab80-c5f45343b9ab

> FDA 483 for Dental Engineering Laboratories, LLC on May 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dental Engineering Laboratories, LLC
- Inspection Date: 2019-05-21
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Dental Engineering Laboratories, LLC in Santa Barbara, CA, revealed a significant quality system deficiency. The firm failed to establish a design history file for its Class II Terauchi File Retrieval Kit, a product that has been on the market since 2016. This indicates a lack of proper design control documentation for a medical device.

## Related Officers

- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/dental-engineering-laboratories-llc/7a1cd6d2-628e-4719-aca4-290201ca006c

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face