# K982729: RENEW

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Sep 15, 1998 after 41 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 its predicate without a number.
- (no number) Aelitefil: named in the summary without a submission number

## Most influential descendants
- K080305: Nexcomp and Meta Etchant (2008), 1 descendant of its own
- K181689: Nexcomp (2018), 0 descendants of its own

## Indications for use
1. Class I, II, III, IV, V and VI restorations. 2. Direct aesthetic veneers for masking stains and developmental anomalies. 3. Core build ups to replace missing tooth structure. 4. Composite and porcelain repairs.

Source page: https://510kreport.com/device/K982729
Methodology: https://510kreport.com/methodology