American Dental Products HG 35 Desensitizer with Fluoride
FDA 510(k) K964133 · American Dental Products, Inc.
510(k) numberK964133
Submission
- Device name
- American Dental Products HG 35 Desensitizer with Fluoride
- Applicant
- American Dental Products, Inc.
Medinah, IL, US - Received
- October 15, 1996
- Decision date
- January 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was American Dental Products HG 35 Desensitizer with Fluoride cleared by the FDA?
American Dental Products HG 35 Desensitizer with Fluoride (K964133) received a 510(k) decision of Substantially Equivalent on January 9, 1997, 86 days after the submission was received.
What is the product code of K964133?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.