# K070956: SEA2 Self Etch Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: May 22, 2007 after 47 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: 8 generations back to K931812 (1993). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962785: 3M Dent System, 3M Company (1996) Summary page 1.
- K060684: Adper Prompt, Adper Prompt L-Pop, 3M Espe AG Dental Products (2006) Summary page 1.
- K040857: Modification to Adper Prompt, 3M Espe AG Dental Products (2004) Summary page 1.
- K020946: Adper Prompt, 3M Espe AG Dental Products (2002) Summary page 1.
- K023842: Clearfil SE Bond Plus, Kuraray Medical, Inc. (2003) Summary page 1.
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001) Summary page 1.
- K990040: Clearfil SE Bond, Kuraray Co. (1999) Summary page 1.

## Indications for use
1. Bonding between dentin/enamel and composite filling materials 2. Bonding between dentin/enamel and compomer filling materials 3. Intraoral repair of porcelain, composite, and metal using light-cure composite resin. 4. Desensitization of hypersensitive teeth, root surface desensitization

Source page: https://510kreport.com/device/K070956
Methodology: https://510kreport.com/methodology