Light-Cured Orthodontic Band Cement
FDA 510(k) K001446 · Scientific Pharmaceuticals, Inc.
510(k) numberK001446
Submission
- Device name
- Light-Cured Orthodontic Band Cement
- Applicant
- Scientific Pharmaceuticals, Inc.
Pomona, CA, US - Received
- May 8, 2000
- Decision date
- July 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Light-Cured Orthodontic Band Cement cleared by the FDA?
Light-Cured Orthodontic Band Cement (K001446) received a 510(k) decision of Substantially Equivalent on July 21, 2000, 74 days after the submission was received.
What is the product code of K001446?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.