Clear Aligner Adhesive
FDA 510(k) K123348 · Reliance Orthodontic Products, Inc.
510(k) numberK123348
Submission
- Device name
- Clear Aligner Adhesive
- Applicant
- Reliance Orthodontic Products, Inc.
Itasca, IL, US - Received
- October 31, 2012
- Decision date
- February 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Clear Aligner Adhesive cleared by the FDA?
Clear Aligner Adhesive (K123348) received a 510(k) decision of Substantially Equivalent on February 28, 2013, 120 days after the submission was received.
What is the product code of K123348?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.