# K091632: SPK Sealant

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Sep 3, 2009 after 91 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011200 (2001). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992326: 3M Clinpro Sealant, 3M Company (1999). Our OCR of the scanned summary read K092326, FDA’s number for Smoothcool (Jeisys Medical, Inc.), decided Mar 5, 2010, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Clinpro Sealant”. Summary page 1.
- K011491: Helioseal Clear Chroma, Ivoclar North America, Inc. (2001)
- K062344: Grandio Seal, Voco GmbH (2006) Summary page 1.
- K061997: Premier Self-Etching Enamel Sealant, Premier Dental Products Co. (2006) Summary page 1.
- K073395: Gilb-2, Glass Ionomer Protective Coating, 3M Espe Dental Products (2008) Summary page 1.

## Most influential descendants
- K100062: Infiltration Kit (2010), 1 descendant of its own
- K251124: G-Bond Universal (2025), 0 descendants of its own

## Indications for use
Sealing pits-and-fissures, damaged-enamel surfaces and exposed dentin surfaces of teeth to prevent caries Protective coating for tooth surfaces predisposed to caries or non-cavitated lesions (e.g. including use in tooth brush-abrasion and root surfaces) Covering of caries predilection sites during orthodontic treatment

Source page: https://510kreport.com/device/K091632
Methodology: https://510kreport.com/methodology