# K022972: Microfill 13

- 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
MICROFILL 13 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 III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth Contra indications: The placement of Microfill 13 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 Microfill 13. For use only by dental professional such as DDS or DMD. Not for use by qeneral public or OTC.

Source page: https://510kreport.com/device/K022972
Methodology: https://510kreport.com/methodology