Dentin Protector
FDA 510(k) K901915 · Ivoclar North America, Inc.
510(k) numberK901915
Submission
- Device name
- Dentin Protector
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- April 26, 1990
- Decision date
- June 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Dentin Protector cleared by the FDA?
Dentin Protector (K901915) received a 510(k) decision of Substantially Equivalent on June 27, 1990, 62 days after the submission was received.
What is the product code of K901915?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.