# K974465: Synergy

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Mar 9, 1998 after 103 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SYNERGY Shades (enamel) A1/D2, A2/B2, A3/D3, A4/M5, A3.5/B3, C2/C3 is indicated for: direct filling of class I, II, III, IV and V cavities reconstruction of natural enamel and dentine reconstruction of fractured anteriors sealing of extended fissure in molars and premolars stabilization of mobile anteriors repair of veneer facings fixation of splints banded bridges esthetic Synergy Compact (dentin) A2/B2, A3/D3, A3.5/B3 is specifically indicated for: core reconstruction in highly esthetic class I, II, III restorations, which are subsequently covered with a more translucent material direct class V fillings direct filling of opaque teeth palatinal of class IV restorations core build-ups Shape and color corrections to improve esthetics SYNERGY Transparent is specifically indicated for: reconstruction of incisal edges in class IV fillings translucent surface layers in all classes covering characterizations Super White is especially indicated for: restoration of whitened teeth restoration of deciduous teeth characterization of chalk spots veneering of anteriors

Source page: https://510kreport.com/device/K974465
Methodology: https://510kreport.com/methodology