FDA Device Intelligence
HomeDevice types › NQA

Biologic Material, Dental

FDA product code NQA · Class 3 · Dental

11
Registered devices
10
Adverse events
7
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-10-17Straumann USA LLCThe possibility for this product that is intended for demonstration purposes only to be placed in patients.
2018-03-23Straumann Manufacturing, Inc.A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the produc
2018-03-23Straumann Manufacturing, Inc.A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the produc
2018-03-23Straumann Manufacturing, Inc.A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the produc
2018-03-23Straumann Manufacturing, Inc.A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the produc
2018-03-23Straumann Manufacturing, Inc.A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the produc
2018-03-23Straumann Manufacturing, Inc.A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the produc

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.