# K071500: Nano-Bond II Adhesive System

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Clinical Technologies
- Decided: Aug 10, 2007 after 71 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 K936222 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020499: Bond-3 Adhesive, Jeneric/Pentron, Inc. (2002) Summary page 2.

## Indications for use
Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.

Source page: https://510kreport.com/device/K071500
Methodology: https://510kreport.com/methodology