# K022971: Microhybrid 11

- Pathway: 510(k) (Traditional)
- Applicant: Ab Ardent
- Decided: Nov 25, 2002 after 80 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
MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class 111, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Posterior restorations, Class I, II. Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Inlays/onlays with extra-oral post tempering

Source page: https://510kreport.com/device/K022971
Methodology: https://510kreport.com/methodology