Sultan Tooth Root Desensitizer
FDA 510(k) K072342 · Dentsply International, Inc.
510(k) numberK072342
Submission
- Device name
- Sultan Tooth Root Desensitizer
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- August 21, 2007
- Decision date
- October 3, 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 Sultan Tooth Root Desensitizer cleared by the FDA?
Sultan Tooth Root Desensitizer (K072342) received a 510(k) decision of Substantially Equivalent on October 3, 2007, 43 days after the submission was received.
What is the product code of K072342?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.