# K183424: Ambar, Ambar APS, Ambar Universal APS

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Dec 13, 2019 after 367 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942493 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962785: 3M Dent System, 3M Company (1996) Summary page 5.

## Indications for use
- All classes of direct restoration with composites (class I, II, III, IV and V); - Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal; - Adhesive repairs in ceramic and composites. *Only for Ambar Universal APS: Use as metallic or ceramic primer.

Source page: https://510kreport.com/device/K183424
Methodology: https://510kreport.com/methodology