# K111431: B1P Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Clinical
- Decided: Aug 1, 2011 after 70 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 K973388 (1997). 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)
- K973388: Dentin Conditioning and Adhesive (Bond 1), Jeneric/Pentron, Inc. (1997) Summary page 1.
- K991808: Optibond Solo Plus 2, Sybron Dental Specialties, Inc. (1999) Summary page 1.
- K083652: Ibond Total Etch, Heraeus Kulzer,GmbH (2009) Summary page 1.

## Indications for use
SiP Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following: Direct Applications * Direct bonding to dentin and/ or enamel * Bonding composite to composite, porcelain and/ or metal * Opaquing metal (used in conjunction with an opaque resin stain or cement) * Bonding with dual cure and self cure composite resins, such as cements and core build up materials * Amalgam sealing * Dentin sealing Indirect applications * Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, onlays and veneers (used in conjunction with resin luting agents) * Bonding of fiber and metal posts (in conjunction with resin luting agents)

Source page: https://510kreport.com/device/K111431
Methodology: https://510kreport.com/methodology