# K964867: Hybrid Resin Composite

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Apr 11, 1997 after 127 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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) Prisma-Fil: named in the summary without a submission number
- (no number) Estilux Posterior XR: named in the summary without a submission number
- (no number) Bisfil-1: named in the summary without a submission number
- (no number) Occlusin: named in the summary without a submission number
- (no number) Herculite: named in the summary without a submission number
- (no number) P-50: named in the summary without a submission number
- (no number) Pertac Hybrid: named in the summary without a submission number
- (no number) Z100: named in the summary without a submission number
- (no number) Tetric: named in the summary without a submission number

## Indications for use
May be described as a radiopaque, light-cured, hybrid composite resin for use as a tooth colored dental restorative in Class I, II, III, IV and V cavities. It is contoured and polished using currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as indicated, the material is recommended for restoring proper form and function of restored teeth.

Source page: https://510kreport.com/device/K964867
Methodology: https://510kreport.com/methodology