Resin Tooth Bonding Agent
FDA 510(k) K994302 · Parkell, Inc.
510(k) numberK994302
Submission
- Device name
- Resin Tooth Bonding Agent
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- December 21, 1999
- Decision date
- February 7, 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 Resin Tooth Bonding Agent cleared by the FDA?
Resin Tooth Bonding Agent (K994302) received a 510(k) decision of Substantially Equivalent on February 7, 2000, 48 days after the submission was received.
What is the product code of K994302?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.