# K011200: Gilb, Model 8010

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jun 14, 2001 after 56 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
No predicates in its family tree.
6 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K073395: Gilb-2, Glass Ionomer Protective Coating (2008), 3 descendants of its own
- K091632: SPK Sealant (2009), 2 descendants of its own
- K230270: 3M™ VitCal Liner/Base (2023), 1 descendant of its own
- K100062: Infiltration Kit (2010), 1 descendant of its own
- K261728: One-Fil LC (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K011200
Methodology: https://510kreport.com/methodology