# K073395: Gilb-2, Glass Ionomer Protective Coating

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: Jan 17, 2008 after 45 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K011200 (2001). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011200: Gilb, Model 8010, 3M Company (2001) Summary page 1.
- K013198: Fuji Vii Capsule, GC America, Inc. (2001) Summary page 1.
- K052281: Embrace Wetbond Clear Sealant, Pulpdent Corporation (2006) Summary page 1.

## Most influential descendants
- K091632: SPK Sealant (2009), 2 descendants of its own
- K100062: Infiltration Kit (2010), 1 descendant of its own
- K251124: G-Bond Universal (2025), 0 descendants of its own

## Indications for use
1. Lining and basing applications under composite, amalgam, ceramic or metal restorations. 2. Treatment of exposed root surface sensitivity 3. Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions

Source page: https://510kreport.com/device/K073395
Methodology: https://510kreport.com/methodology