# K993344: P10 Special

- Pathway: 510(k) (Traditional)
- Applicant: North American Alloys, Inc.
- Decided: Nov 15, 1999 after 41 days
- Product code: EJH (Alloy, Metal, Base)
- Device class: 2
- Regulation: 21 CFR 872.3710
- 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 its predicate without a number.
- (no number) Austenal "Advantage": named in the summary without a submission number
- (no number) Jeneric "RX Biocast": named in the summary without a submission number
- (no number) CMP “Vulcan”: named in the summary without a submission number

## Indications for use
For the fabrication of a custom crown or bridge prosthesis by a dental laboratory. It is to be offered as an alternative to nickel-based crown and bridge alloys for nickel sensitive patients, as well as for international markets which prefer cobalt-based alloys.

Source page: https://510kreport.com/device/K993344
Methodology: https://510kreport.com/methodology