Enamelast
FDA 510(k) K132109 · Ultradent Products Inc. / Oratech, LLC
510(k) numberK132109
Submission
- Device name
- Enamelast
- Applicant
- Ultradent Products Inc. / Oratech, LLC
Salt Lake City, UT, US - Received
- July 8, 2013
- Decision date
- November 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K132255 | UltracemEMA · Traditional | 10/24/2013SE |
Questions and answers
When was Enamelast cleared by the FDA?
Enamelast (K132109) received a 510(k) decision of Substantially Equivalent on November 1, 2013, 116 days after the submission was received.
What is the product code of K132109?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.