# K081200: Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4

- Pathway: 510(k) (Traditional)
- Applicant: Global Top, Inc.
- Decided: Aug 8, 2008 after 102 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
Longest line of descent: 3 generations back to K871808 (1987). 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)
- K062504: Ceramax, Alphadent Co., Ltd. (2006) Summary page 1.

## Indications for use
The device is intended to manufacture crown and bridge porcelain-fused-to-metal prostheses and dental cores

Source page: https://510kreport.com/device/K081200
Methodology: https://510kreport.com/methodology