Light Cure Retainer
FDA 510(k) K101951 · Reliance Orthodontic Products, Inc.
510(k) numberK101951
Submission
- Device name
- Light Cure Retainer
- Applicant
- Reliance Orthodontic Products, Inc.
Itasca, IL, US - Received
- July 12, 2010
- Decision date
- October 26, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Light Cure Retainer cleared by the FDA?
Light Cure Retainer (K101951) received a 510(k) decision of Substantially Equivalent on October 26, 2010, 106 days after the submission was received.
What is the product code of K101951?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.