XR Primer 2
FDA 510(k) K020303 · Kerr Dental Materials Center
510(k) numberK020303
Submission
- Device name
- XR Primer 2
- Applicant
- Kerr Dental Materials Center
Orange, CA, US - Received
- January 29, 2002
- Decision date
- April 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was XR Primer 2 cleared by the FDA?
XR Primer 2 (K020303) received a 510(k) decision of Substantially Equivalent on April 19, 2002, 80 days after the submission was received.
What is the product code of K020303?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.