EIH · Class II · 21 CFR 872.6660

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
385–408 of 488
Cleared Aug 27, 2001
ERIS LAYERING MATERIALS
K012174
Ivoclar North America, Inc.
Dental · 46d
Cleared Aug 23, 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231
Jeneric/Pentron, Inc.
Dental · 38d
Cleared Aug 20, 2001
CERCON CERAM
K011333
Degussa - Ney Dental, Inc.
Dental · 110d
Cleared Aug 16, 2001
IMAGINE H.E.
K012156
Wieland Edelmetalle GmbH & Co.
Dental · 36d
Cleared Jun 29, 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
K011394
Espe Dental AG
Dental · 53d
Cleared Jun 05, 2001
CARMEN
K011425
Dentaurum, Inc.
Dental · 27d
Cleared Jun 05, 2001
TRICERAM
K011428
Dentaurum, Inc.
Dental · 27d
Cleared Apr 17, 2001
Y-TZP POWDER AND PROCERA ALLZIRKON
K010630
Procera Sandvik, Inc.
Dental · 46d
Cleared Nov 28, 2000
PROCAD ADD-ON
K003373
Ivoclar North America, Inc.
Dental · 29d
Cleared Nov 16, 2000
HERACERAM
K002993
J.F. Jelenko & Co., Inc.
Dental · 52d
Cleared Nov 06, 2000
WILLI GELLER CREATION AND LF PORCELAIN
K002904
Jensen Industries, Inc.
Dental · 49d
Cleared Aug 26, 2000
CERAMIX PORCELAIN SYSTEM
K000983
C-Mix
Dental · 152d
Cleared Aug 16, 2000
WILLI GELLER CREATION & AV PORCELAIN
K002041
Jensen Industries, Inc.
Dental · 42d
Cleared Aug 10, 2000
DC ZIRKON
K001815
Austenal, Inc.
Dental · 56d
Cleared Jul 05, 2000
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
K001418
Procera Sandvik, Inc.
Dental · 61d
Cleared May 25, 2000
VISION ESTHETIC PORCELAIN SYSTEM
K000680
Midatlantic Division of Dentrex, Inc.
Dental · 86d
Cleared May 17, 2000
VITA RESPONSE
K000597
Vident
Dental · 85d
Cleared Feb 10, 2000
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
K994435
Jeneric/Pentron, Inc.
Dental · 42d
Cleared Jan 11, 2000
3M TR SYSTEM
K992489
3M Company
Dental · 169d
Cleared Jan 10, 2000
CERGOGOLD
K993897
Degussa - Ney Dental, Inc.
Dental · 55d
Cleared Nov 29, 1999
OPC LOW WEAR OPAQUE PORCELAIN
K993249
Jeneric/Pentron, Inc.
Dental · 62d
Cleared Sep 29, 1999
DENZIR
K984201
Dentronic AB
Dental · 309d
Cleared Sep 22, 1999
CERANA
K992161
Nordiska Dental AB
Dental · 89d
Cleared Sep 03, 1999
GRAND CERAM
K992023
Noritake Co., Inc.
Dental · 79d