# K012882: Bitem Angel Reline Kit, Bitem Laboratory Kit, Models 120110, 120060

- Pathway: 510(k) (Traditional)
- Applicant: Thermoelastic Technologies, Inc.
- Decided: Nov 14, 2001 after 78 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.

Source page: https://510kreport.com/device/K012882
Methodology: https://510kreport.com/methodology