# K070698: Coe Comfort

- Pathway: 510(k) (Special)
- Applicant: GC America, Inc.
- Decided: Mar 29, 2007 after 16 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K252035: DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) (2025), 0 descendants of its own

## Indications for use
Lining of ill fitting dentures Functional impression material for full dentures Impression material for construction of obturators Lining of surgical and periodontal splints Diagnostic aid to locate pressure areas on denture.

Source page: https://510kreport.com/device/K070698
Methodology: https://510kreport.com/methodology