# K022974: Microhybrid 12

- Pathway: 510(k) (Traditional)
- Applicant: Ab Ardent
- Decided: Nov 22, 2002 after 77 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 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, 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 Contraindications: The placement of Microhybrid 12 is contraindicated If a dry working field cannot be established or if the stipulated technique cannot be applied. If the patient is known to be allergic to the components of Microhybrid 12. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Source page: https://510kreport.com/device/K022974
Methodology: https://510kreport.com/methodology