# K992838: Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC Activator, Adhere Cylanate

- Pathway: 510(k) (Traditional)
- Applicant: Biomat Sciences, Inc.
- Decided: Nov 15, 1999 after 84 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 K896659 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923546: Optibond, Kerr Corporation (Danbury) (1992) Summary page 1.
- K910860: All-Bond 2, Bisco, Inc. (1991) Summary page 1.
- K945604: Ecliptomer, Bisco, Inc. (1995) Summary page 1.
- K896659: Silane, Pulpdent Corp. (1990) Summary page 1.

## Indications for use
to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns. to seal dentinal tubules to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth to promote bonds between incremental layers of composite resins when building a composite restoration to bond composite resins repairs to ceramics and metals

Source page: https://510kreport.com/device/K992838
Methodology: https://510kreport.com/methodology