Pre-Cemented Orthodontic Bracket System Extension
FDA 510(k) K081291 · Dentsply Interntional
510(k) numberK081291
Submission
- Device name
- Pre-Cemented Orthodontic Bracket System Extension
- Applicant
- Dentsply Interntional
York, PA, US - Received
- May 7, 2008
- Decision date
- May 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pre-Cemented Orthodontic Bracket System Extension cleared by the FDA?
Pre-Cemented Orthodontic Bracket System Extension (K081291) received a 510(k) decision of Substantially Equivalent on May 22, 2008, 15 days after the submission was received.
What is the product code of K081291?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.