Coltene A.R.T. Bond
FDA 510(k) K922615 · Coltene/Whaledent, Inc.
510(k) numberK922615
Submission
- Device name
- Coltene A.R.T. Bond
- Applicant
- Coltene/Whaledent, Inc.
New York, NY, US - Received
- June 2, 1992
- Decision date
- August 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Coltene A.R.T. Bond cleared by the FDA?
Coltene A.R.T. Bond (K922615) received a 510(k) decision of Substantially Equivalent on August 3, 1992, 62 days after the submission was received.
What is the product code of K922615?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.