Ultradent Universal Dentin Sealant
FDA 510(k) K963979 · Ultradent Products, Inc.
510(k) numberK963979
Submission
- Device name
- Ultradent Universal Dentin Sealant
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- October 3, 1996
- Decision date
- December 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ultradent Universal Dentin Sealant cleared by the FDA?
Ultradent Universal Dentin Sealant (K963979) received a 510(k) decision of Substantially Equivalent on December 12, 1996, 70 days after the submission was received.
What is the product code of K963979?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.