GC OPB-100
FDA 510(k) K080724 · GC America, Inc.
510(k) numberK080724
Submission
- Device name
- GC OPB-100
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- March 14, 2008
- Decision date
- June 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was GC OPB-100 cleared by the FDA?
GC OPB-100 (K080724) received a 510(k) decision of Substantially Equivalent on June 11, 2008, 89 days after the submission was received.
What is the product code of K080724?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.