Peak Se, Model 5135
FDA 510(k) K063558 · Ultradent Products, Inc.
510(k) numberK063558
Submission
- Device name
- Peak Se, Model 5135
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- November 27, 2006
- Decision date
- December 14, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Peak Se, Model 5135 cleared by the FDA?
Peak Se, Model 5135 (K063558) received a 510(k) decision of Substantially Equivalent on December 14, 2006, 17 days after the submission was received.
What is the product code of K063558?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.