Ez Connect Resin
FDA 510(k) K000357 · Kerr Dental Materials Center
510(k) numberK000357
Submission
- Device name
- Ez Connect Resin
- Applicant
- Kerr Dental Materials Center
Orange, CA, US - Received
- February 4, 2000
- Decision date
- April 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ez Connect Resin cleared by the FDA?
Ez Connect Resin (K000357) received a 510(k) decision of Substantially Equivalent on April 28, 2000, 84 days after the submission was received.
What is the product code of K000357?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.