# K081493: Infiltration Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Sep 18, 2008 after 113 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: 1 generation back to K891536 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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) Summary page 1.
- K021842: Admira Seal, Voco GmbH (2002) Summary page 1.
- K062344: Grandio Seal, Voco GmbH (2006) Summary page 1.
- K891536: Enamel Microabrasion Compound, Premier Dental Products Co. (1989) Summary page 1.

## 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 The HCI Etching Gel is indicated for etching of enamel.

Source page: https://510kreport.com/device/K081493
Methodology: https://510kreport.com/methodology