# K060860: Turkom-Cera

- Pathway: 510(k) (Traditional)
- Applicant: Dental Suppliers of America, Inc.
- Decided: May 19, 2006 after 51 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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. The FDA summary names no predicate by number.

## Indications for use
Turkom-Cera fused alumina copings are indicated for use as core structures of an artificial prosthesis, i.e., a three unit bridge, long bridges, full mouth bridges, for partially endentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The copings are also indicated for use as single crowns that will be cemented to a natural or an artificial tooth abutment in the treatment of partially endentulous patients in order to restore chewing function.

Source page: https://510kreport.com/device/K060860
Methodology: https://510kreport.com/methodology