# K993659: Renamel Pack

- Pathway: 510(k) (Traditional)
- Applicant: Cosmedent, Inc.
- Decided: Jan 18, 2000 after 81 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 Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to ovetlay of a finishing material. Use for: 1. Posterior composite restoration. 2. Contact development in posterior restoration prior to occlusal overlay of more polishable materials.

Source page: https://510kreport.com/device/K993659
Methodology: https://510kreport.com/methodology