Permaquick Se Bonding System
FDA 510(k) K032626 · Ultradent Products, Inc.
510(k) numberK032626
Submission
- Device name
- Permaquick Se Bonding System
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- August 26, 2003
- Decision date
- December 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Permaquick Se Bonding System cleared by the FDA?
Permaquick Se Bonding System (K032626) received a 510(k) decision of Substantially Equivalent on December 3, 2003, 99 days after the submission was received.
What is the product code of K032626?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.