# K172977: Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel

- Pathway: 510(k) (Traditional)
- Applicant: Nanova Biomaterials, Inc.
- Decided: Jan 16, 2018 after 111 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942493 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962785: 3M Dent System, 3M Company (1996) Summary page 4.

## Indications for use
Nanova 2 Step Etch and Rinse Dental Adhesive is indicated for use in: • All direct restorations • All indirect restorations • Intra-oral repairs • Desensitizing/sealing of tooth structure • Priming of enamel for orthodontic use

Source page: https://510kreport.com/device/K172977
Methodology: https://510kreport.com/methodology