FDA Product Code EIH: Powder, Porcelain
FDA product code EIH covers dental porcelain powders used in the fabrication of ceramic restorations.
These materials are used by dental technicians to build up layered porcelain restorations — including crowns, bridges, and veneers — that match the optical properties of natural tooth enamel. They are fired in a dental furnace to achieve the desired strength and translucency.
EIH devices are Class II medical devices, regulated under 21 CFR 872.6660 and reviewed by the FDA Dental panel.
Leading manufacturers include Dentsply Intl., Prismatik Dentalcraft, Inc. and Aidite (Qinhuangdao) Technology Co., Ltd..
480
Total
480
Cleared
111d
Avg days
1977
Since
480 devices
Cleared
Dec 02, 2003
PFZ PORCELAIN SYSTEM
Dentsply Intl.
Dental
22d
Cleared
Sep 06, 2002
CERCON CERAM S PORCELAIN
Dentsply Intl.
Dental
14d
Cleared
Jan 11, 2000
3M TR SYSTEM
3M Company
Dental
169d
Cleared
Sep 11, 1997
FINESSE ALL-CERAMIC SYSTEM
Dentsply Intl.
Dental
113d
Cleared
May 28, 1996
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
Dentsply Intl.
Dental
54d
Cleared
Nov 02, 1995
FINESSE LOW-FUSING PORCELAIN SYSTEM
Dentsply Intl.
Dental
16d
Cleared
Aug 29, 1994
SOFTWEAR PORCELAIN SYSTEM
Dentsply Intl.
Dental
38d
Cleared
Mar 01, 1994
FINESSE PORCELAIN SYSTEM
Dentsply Intl.
Dental
39d
Cleared
Jul 02, 1992
DENTAL PORCELAIN
Dentsply Intl.
Dental
87d
Cleared
Mar 19, 1992
NEW OPAQUE PORCELAIN
Dentsply Intl.
Dental
100d
Cleared
Apr 16, 1990
OPAQUE PORCELAIN
Dentsply Intl.
Dental
77d
Cleared
Nov 19, 1985
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
Dentsply Intl.
Dental
76d
Cleared
Nov 14, 1985
SCOTCHPRIME CERAMIC PRIMER
3M Company
Dental
71d
Cleared
May 09, 1983
DENTAL CERAMIC FOR FABRICATION OF CROWN
Dentsply Intl.
Dental
45d
Cleared
Apr 06, 1983
DENTAL PORCELAIN POWDER
Dentsply Intl.
Dental
42d
Cleared
Mar 04, 1981
PORCELAIN POWDER FOR CLINICAL USE
Dentsply Intl.
Dental
49d
Cleared
Sep 26, 1980
MICRO-BOND HI-LIFE PROCELAIN & VIVERE
Howmedica Corp.
Dental
11d