# K090391: Pulpdent Micro-Hybrid Composite

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: May 11, 2009 after 83 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) Ivoclar Vivadent 4 Seasons: named in the summary without a submission number
- (no number) Dentsply/Caulk Esthet*X: named in the summary without a submission number
- (no number) GC Gradia, Direct: named in the summary without a submission number

## Indications for use
Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite used for esthetic, direct resin restorations including all cavity classifications (I-VI), anterior and posterior restorations, Class V restorations and direct veneering.

Source page: https://510kreport.com/device/K090391
Methodology: https://510kreport.com/methodology