# K063558: Peak SE, Model 5135

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Dec 14, 2006 after 17 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931812 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032626: Permaquick SE Bonding System, Ultradent Products, Inc. (2003) Summary page 1.
- K990040: Clearfil SE Bond, Kuraray Co. (1999) Summary page 1.

## Recalls of this device
- Jun 1, 2022 · Class II · Z-1368-2022: SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
- May 24, 2012 · Class II · Z-1822-2012: Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products a

## Indications for use
Use for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: o Dentin and enamel o Porcelain o Metal o Composite

Source page: https://510kreport.com/device/K063558
Methodology: https://510kreport.com/methodology