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 Vident.
488
Total
488
Cleared
110d
Avg days
1977
Since
488 devices
Cleared
Aug 27, 2001
ERIS LAYERING MATERIALS
Ivoclar North America, Inc.
Dental
46d
Cleared
Aug 23, 2001
AVANTE MICRO CRYSTAL SYSTEM
Jeneric/Pentron, Inc.
Dental
38d
Cleared
Aug 20, 2001
CERCON CERAM
Degussa - Ney Dental, Inc.
Dental
110d
Cleared
Aug 16, 2001
IMAGINE H.E.
Wieland Edelmetalle GmbH & Co.
Dental
36d
Cleared
Jun 29, 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
Espe Dental AG
Dental
53d
Cleared
Jun 05, 2001
CARMEN
Dentaurum, Inc.
Dental
27d
Cleared
Jun 05, 2001
TRICERAM
Dentaurum, Inc.
Dental
27d
Cleared
Apr 17, 2001
Y-TZP POWDER AND PROCERA ALLZIRKON
Procera Sandvik, Inc.
Dental
46d
Cleared
Nov 28, 2000
PROCAD ADD-ON
Ivoclar North America, Inc.
Dental
29d
Cleared
Nov 16, 2000
HERACERAM
J.F. Jelenko & Co., Inc.
Dental
52d
Cleared
Nov 06, 2000
WILLI GELLER CREATION AND LF PORCELAIN
Jensen Industries, Inc.
Dental
49d
Cleared
Aug 26, 2000
CERAMIX PORCELAIN SYSTEM
C-Mix
Dental
152d
Cleared
Aug 16, 2000
WILLI GELLER CREATION & AV PORCELAIN
Jensen Industries, Inc.
Dental
42d
Cleared
Aug 10, 2000
DC ZIRKON
Austenal, Inc.
Dental
56d
Cleared
Jul 05, 2000
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
Procera Sandvik, Inc.
Dental
61d
Cleared
May 25, 2000
VISION ESTHETIC PORCELAIN SYSTEM
Midatlantic Division of Dentrex, Inc.
Dental
86d
Cleared
May 17, 2000
VITA RESPONSE
Vident
Dental
85d
Cleared
Feb 10, 2000
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
Jeneric/Pentron, Inc.
Dental
42d
Cleared
Jan 11, 2000
3M TR SYSTEM
3M Company
Dental
169d
Cleared
Jan 10, 2000
CERGOGOLD
Degussa - Ney Dental, Inc.
Dental
55d
Cleared
Nov 29, 1999
OPC LOW WEAR OPAQUE PORCELAIN
Jeneric/Pentron, Inc.
Dental
62d
Cleared
Sep 29, 1999
DENZIR
Dentronic AB
Dental
309d
Cleared
Sep 22, 1999
CERANA
Nordiska Dental AB
Dental
89d
Cleared
Sep 03, 1999
GRAND CERAM
Noritake Co., Inc.
Dental
79d