LED Pro Seal
FDA 510(k) K073243 · Reliance Orthodontic Products, Inc.
510(k) numberK073243
Submission
- Device name
- LED Pro Seal
- Applicant
- Reliance Orthodontic Products, Inc.
Itasca, IL, US - Received
- November 19, 2007
- Decision date
- February 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was LED Pro Seal cleared by the FDA?
LED Pro Seal (K073243) received a 510(k) decision of Substantially Equivalent on February 8, 2008, 81 days after the submission was received.
What is the product code of K073243?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.