Multiple (Tooth Desensitizer)
FDA 510(k) K052263 · Cosmedent, Inc.
510(k) numberK052263
Submission
- Device name
- Multiple (Tooth Desensitizer)
- Applicant
- Cosmedent, Inc.
Chicago, IL, US - Received
- August 19, 2005
- Decision date
- December 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Multiple (Tooth Desensitizer) cleared by the FDA?
Multiple (Tooth Desensitizer) (K052263) received a 510(k) decision of Substantially Equivalent on December 16, 2005, 119 days after the submission was received.
What is the product code of K052263?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.