# K160483: Burn-out Cylinder and Angled Screw Abutments

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium Co., Ltd.
- Decided: Aug 5, 2016 after 165 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K944964 (1995). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141457: Dentium Implantium and Superline Abutments, Dentium Co., Ltd. (2014) Summary page 4.

## Indications for use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K160483
Methodology: https://510kreport.com/methodology
