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
457–480 of 488
Cleared Oct 05, 1990
VITA HI-CERAM
K902200
Vident
Dental · 142d
Cleared Aug 03, 1990
DEN-MAT CERINATE PORCELAIN
K895731
Den-Mat Corp.
Dental · 311d
Cleared Jun 26, 1990
PV-CERAMIC, CERAMINIQUE
K901261
Ivoclar North America, Inc.
Dental · 103d
Cleared Apr 16, 1990
OPAQUE PORCELAIN
K900393
Dentsply Intl.
Dental · 77d
Cleared Apr 10, 1990
SILHOUETTE PORCELAIN
K895888
Leach and Dillon Co., Inc.
Dental · 187d
Cleared Apr 09, 1990
WILLI GELLER CERAMIC CREATION & SURPRISE
K900209
Creation North America, Inc.
Dental · 82d
Cleared Apr 04, 1990
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K895889
Leach and Dillon Co., Inc.
Dental · 181d
Cleared Jan 10, 1989
NORITAKE SUPER PORCELAIN EX-3
K884356
Noritake Co., Inc.
Dental · 85d
Cleared Nov 24, 1986
PENTRON HIGH STRENGTH PORCELAIN
K864404
Pentron Corp.
Dental · 14d
Cleared Mar 06, 1986
TRU-COLOR
K855037
Veritas Dental Co., Inc.
Dental · 83d
Cleared Feb 21, 1986
CERAPEARL
K854763
Kyocera International, Inc.
Dental · 86d
Cleared Nov 19, 1985
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
K853707
Dentsply Intl.
Dental · 76d
Cleared Nov 14, 1985
SCOTCHPRIME CERAMIC PRIMER
K853698
3M Company
Dental · 71d
Cleared Jul 31, 1985
PORCELAIN VENEER SYSTEM LABORATORY KIT
K852743
The S. S. White Co.
Dental · 34d
Cleared Apr 08, 1985
CERESTORE DENTIN PORCELAIN
K850821
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Apr 25, 1984
CRYSTAR PORCELAIN MARGIN POWDER/LIQUID
K840873
Shofu Dental Corp.
Dental · 58d
Cleared Mar 06, 1984
SHOFU PORCELAIN STAIN
K834497
Shofu Dental Corp.
Dental · 77d
Cleared Dec 29, 1983
CRYSTAR PORCELAIN
K833643
Shofu Dental Corp.
Dental · 73d
Cleared Sep 26, 1983
CERESTORE CORE MATERIAL
K832286
Johnson & Johnson Professionals, Inc.
Dental · 75d
Cleared Jul 28, 1983
SAVE-A-BAKE PORCELAIN POLISH
K831483
Denpac Corp.
Dental · 80d
Cleared May 09, 1983
DENTAL CERAMIC FOR FABRICATION OF CROWN
K830955
Dentsply Intl.
Dental · 45d
Cleared Apr 06, 1983
DENTAL PORCELAIN POWDER
K830553
Dentsply Intl.
Dental · 42d
Cleared Dec 03, 1982
CERA 8
K823377
Cer-Met, Inc.
Dental · 21d
Cleared Dec 03, 1982
CERA COLOR
K823378
Cer-Met, Inc.
Dental · 21d