# K222435: Renamel® Microhybrid ;Renamel® Flowable Microhybrid

- Pathway: 510(k) (Traditional)
- Applicant: Cosmedent, Inc.
- Decided: Oct 11, 2022 after 60 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
Renamel Microhybrid * Anterior restorations (Class III and IV) * Deep Class V restorations (cervical caries, root erosion, wedge-shaped defects) * Restorations in the posterior region (Class I and II) * Veneering of discolored teeth * Closing of diastemas by vestibular veneering * Repair of composite and ceramic veneers Renamel Flowable Microhybrid * Class V restorations * Sealing margins * Repairing pitted areas in hybrid restorations * Small occlusal and lingual repairs * In deep Class V restorations to block out shine through prior to overlay with Renamel Microfill or Renamel Microhybrid

Source page: https://510kreport.com/device/K222435
Methodology: https://510kreport.com/methodology