Dentin Desensitizer Agent
FDA 510(k) K073117 · Dentsply Intl., Inc.
510(k) numberK073117
Submission
- Device name
- Dentin Desensitizer Agent
- Applicant
- Dentsply Intl., Inc.
York, PA, US - Received
- November 5, 2007
- Decision date
- December 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dentin Desensitizer Agent cleared by the FDA?
Dentin Desensitizer Agent (K073117) received a 510(k) decision of Substantially Equivalent on December 19, 2007, 44 days after the submission was received.
What is the product code of K073117?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.