Dentin Conditioning and Adhesive System (BOND-1)
FDA 510(k) K013542 · Jeneric/Pentron, Inc.
510(k) numberK013542
Submission
- Device name
- Dentin Conditioning and Adhesive System (BOND-1)
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- October 17, 2001
- Decision date
- February 14, 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 Dentin Conditioning and Adhesive System (BOND-1) cleared by the FDA?
Dentin Conditioning and Adhesive System (BOND-1) (K013542) received a 510(k) decision of Substantially Equivalent on February 14, 2002, 120 days after the submission was received.
What is the product code of K013542?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.