# K140537: TENURE4G

- Pathway: 510(k) (Traditional)
- Applicant: Den-Mat Holdings, LLC
- Decided: Aug 20, 2014 after 169 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: 1 generation back to K872510 (1987). 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)
- K910860: All-Bond 2, Bisco, Inc. (1991) Summary page 4.
- K872510: Den-Mat Tenure, Den-Mat Corp. (1987) Summary page 4.

## Indications for use
tenure®4G is recommended for the following types of applications: 1) All routine direct and indirect resin composite bonding 2) Porcelain, ceramic veneers, amalgams, precious and semi-precious metals bonding 3) Indirect gold, porcelain and ceramic inlays and onlays bonding 4) Desensitization of root or dentin prior to impressions or temporaries 5) Preparation desensitization of crown prior to impressions or temporaries

Source page: https://510kreport.com/device/K140537
Methodology: https://510kreport.com/methodology