Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
FDA 510(k) K172977 · Nanova Biomaterials, Inc.
510(k) numberK172977
Submission
- Device name
- Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
- Applicant
- Nanova Biomaterials, Inc.
Columbia, MO, US - Received
- September 27, 2017
- Decision date
- January 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel cleared by the FDA?
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel (K172977) received a 510(k) decision of Substantially Equivalent on January 16, 2018, 111 days after the submission was received.
What is the product code of K172977?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.