GC Fuji Ortho Band Paste Pak
FDA 510(k) K020578 · GC America, Inc.
510(k) numberK020578
Submission
- Device name
- GC Fuji Ortho Band Paste Pak
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- February 21, 2002
- Decision date
- April 26, 2002
- 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 Fuji Ortho Band Paste Pak cleared by the FDA?
GC Fuji Ortho Band Paste Pak (K020578) received a 510(k) decision of Substantially Equivalent on April 26, 2002, 64 days after the submission was received.
What is the product code of K020578?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.