Contra-Angle Handpiece Komet OS30
FDA 510(k) K090548 · W&H Dentalwerk Buermoos GmbH
510(k) numberK090548
Submission
- Device name
- Contra-Angle Handpiece Komet OS30
- Applicant
- W&H Dentalwerk Buermoos GmbH
Buermoos, AT - Received
- March 2, 2009
- Decision date
- June 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Contra-Angle Handpiece Komet OS30 cleared by the FDA?
Contra-Angle Handpiece Komet OS30 (K090548) received a 510(k) decision of Substantially Equivalent on June 30, 2009, 120 days after the submission was received.
What is the product code of K090548?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.