# K100062: Infiltration Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Mar 26, 2010 after 74 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: 3 generations back to K011200 (2001). 9 ancestors in all.
1 later device descends 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)
- K091632: SPK Sealant, 3M Company (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute, Orthovita, Inc. (2008). Our reading of the summary gave K081439, FDA’s number for Vitoss Bioactive Foam Pack Bone Graft Substitute (Orthovita, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Infiltration Kit”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K251124: G-Bond Universal (2025), 0 descendants of its own

## Indications for use
The Sealant (Infiltrant) is indicated for: - Sealing of pits and fissures - Sealing/facing of damaged enamel surfaces - Covering of caries predilection sites during orthodontic treatment - Sealing of secondary teeth - Sealing of deciduous teeth - Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries - Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces) HCI-Etching-Gel is indicated for: - Etching of enamel

Source page: https://510kreport.com/device/K100062
Methodology: https://510kreport.com/methodology