# K012180: A-WEAR

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Sep 5, 2001 after 55 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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. The FDA summary names its predicate without a number.
- (no number) Micronew™: named in the summary without a submission number

## Indications for use
1. Direct or indirect class III, IV, and V restorations. 2. Diastema closures. 3. Composite restorations bonded to tooth structure. 4. Composite restorations bonded to metal. 5. Composite restorations bonded to composite or fiber-reinforced substructure. 6. Composite restorations bonded to porcelain. 7. Direct or indirect veneers.

Source page: https://510kreport.com/device/K012180
Methodology: https://510kreport.com/methodology