American Dental Products (Adp), Fluoride Releasing Glass Ionomer Band Cement
FDA 510(k) K950512 · American Dental Products, Inc.
510(k) numberK950512
Submission
- Device name
- American Dental Products (Adp), Fluoride Releasing Glass Ionomer Band Cement
- Applicant
- American Dental Products, Inc.
Medinah, IL, US - Received
- February 6, 1995
- Decision date
- March 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was American Dental Products (Adp), Fluoride Releasing Glass Ionomer Band Cement cleared by the FDA?
American Dental Products (Adp), Fluoride Releasing Glass Ionomer Band Cement (K950512) received a 510(k) decision of Substantially Equivalent on March 7, 1995, 29 days after the submission was received.
What is the product code of K950512?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.