# K984112: Advent

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Dec 22, 1998 after 35 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) belleGlas™ HP: named in the summary without a submission number

## Indications for use
1. Direct or indirect class I, II, III, IV, V, and VI restorations. 2. Core build-up material to replace missing tooth structure. 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.

Source page: https://510kreport.com/device/K984112
Methodology: https://510kreport.com/methodology