Pulpdent Copal Varnish with Fluoride
FDA 510(k) K100503 · Pulpdent Corporation
510(k) numberK100503
Submission
- Device name
- Pulpdent Copal Varnish with Fluoride
- Applicant
- Pulpdent Corporation
Watertown, MA, US - Received
- February 22, 2010
- Decision date
- May 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pulpdent Copal Varnish with Fluoride cleared by the FDA?
Pulpdent Copal Varnish with Fluoride (K100503) received a 510(k) decision of Substantially Equivalent on May 12, 2010, 79 days after the submission was received.
What is the product code of K100503?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.