510(k) K172977
K172977 is an FDA 510(k) premarket notification submitted by Nanova Biomaterials, Inc. for the device "Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel". The FDA issued a decision of Substantially Equivalent on January 16, 2018. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Nanova Biomaterials, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2018
- Date Received
- September 27, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type