# K153253: GC Reline II

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Mar 3, 2016 after 114 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
Longest line of descent: 1 generation back to K990736 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990736: GC Reline Soft/Extra Soft, GC America, Inc. (1999). Our reading of the summary gave K990376, FDA’s number for Ballard Medical Products Faciletome Bow String Papillotome (Ballard Medical Products). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “GC Reline Soft/Extra Soft”. Summary page 6.

## Indications for use
GC RELINE II is a resilient material for making soft relining of dentures.

Source page: https://510kreport.com/device/K153253
Methodology: https://510kreport.com/methodology