Fluor Protector
FDA 510(k) K946032 · Ivoclar North America, Inc.
510(k) numberK946032
Submission
- Device name
- Fluor Protector
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- December 9, 1994
- Decision date
- March 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Fluor Protector cleared by the FDA?
Fluor Protector (K946032) received a 510(k) decision of Substantially Equivalent on March 7, 1995, 88 days after the submission was received.
What is the product code of K946032?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.