Peak Z
FDA 510(k) K131357 · Ultradent Products, Inc.
510(k) numberK131357
Submission
- Device name
- Peak Z
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- May 10, 2013
- Decision date
- September 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Peak Z cleared by the FDA?
Peak Z (K131357) received a 510(k) decision of Substantially Equivalent on September 6, 2013, 119 days after the submission was received.
What is the product code of K131357?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.