# K063557: Peak Bond, Model 5133

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Dec 12, 2006 after 15 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 K023042 (2002). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023042: PQ1, Ultradent Products, Inc. (2002) Summary page 1.

## Most influential descendants
- K100752: Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine) (2010), 7 descendants of its own
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K230465: Hi-Bond Universal (2023), 2 descendants of its own
- K240743: Peak Universal Bond (2024), 1 descendant of its own

## Indications for use
Use for most bonding needs in restorative dentistry. PeakTM Bond is formulated to work well with flowable composite for light cure luting. Ultradent recommends the PermaFlow® DC system using chemical cure PermaFlow® DC primer for chemical cure/dual core bonding (e.g., non-translucent veners, inlays, and post bonding). Peak MT Bond bonds to the following materials: o Dentin and enamel o Porcelain o Metal o Composite

Source page: https://510kreport.com/device/K063557
Methodology: https://510kreport.com/methodology