|
Device |
powder, porcelain |
Product Code | EIH |
Regulation Number |
872.6660
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
1DERFUL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3DBIOCAD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M DEUTSCHLAND GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M ESPE AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
3M ESPE AG DENTAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
A & D DENTAL INNOVATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
A&E BIOCERAMIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADAMANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESTHETIC-PRESS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIBODENT BIOTECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
AMANN GIRRBACH AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI MIISEN INTELLIGENCE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AON CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARDENT INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARUMDENTISTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B&D DENTAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAOT BIOLOGICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BESORAH DENTAL SOLUTIONS NZ LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BETTINI S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIODEN CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIODENTA SWISS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLOOMDEN BIOCERAMICS (HUNAN) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLUE SKY BIO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON MICRO FABRICATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CCRI, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CENDRES+METAUX SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CERAMAY GMBH & CO.KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGSHA HONCHON TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COHO TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTINENTAL DENTAL CERAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROWN PORCELAIN DENTAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DE COREMATRIX CO.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENKEN-HIGHDENTAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAIM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAL DIREKT GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAL MILLING LABORATORY SUPPLIES (DLMS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTALMAX CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTALMAX CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DENTSPLY INTL. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
DIGITAL AGE DENTAL LAB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DMAX CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOCERAM MEDICAL CERAMICS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOCTUS GLOBAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN XIANGTONG CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DR SARAH POLLINGTON |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMERGO EUROPE CONSULTING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FINE ADVANCED COMPOUND CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUZHOU RICK BROWN BIOMATERIALS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GC AMERICA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GENOSS |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GENOSS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENOSS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
H.C. STARCK CERAMICS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HANGZHOU ERRAN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU IVISTA MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARVEST DENTAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HASS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
HEANY INDUSTRIES INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HILLA TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOCHENG CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN CERAMASTER MATERIAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN HUALIAN SPECIAL CERAMICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN QINGHAO PUZHONG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN VSMILE BIOTECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTITUT STRAUMANN AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IVOCLAR VIVADENT AG |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
IVOCLAR VIVADENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JENSEN INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KEROX LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KURARAY NORITAKE DENTAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
KURARAY NORITAKE DENTAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KUWOTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIAONING UPCERA CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIAONING UPCERA CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MAXX DIGM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
METOXIT AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEO GROUP LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NISSIN-METEC CHINA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOBEL BIOCARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORITAKE CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OPERART LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISMATIK DENTALCRAFT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
17
|
PRITIDENTA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINHUANGDAO AUDENTAL METAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINHUANGDAO SILIDE CERAMIC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REFRACTRON TECHNOLOGIES CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RHONDIUM, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RIZHAO HUGE DENTAL INDUSTRY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAGEMAX BIOCERAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI NEW CENTURY DENTAL MATERIALS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENYANG UPCERA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN UP3D TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN XIANGTONG CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHOFU DENTAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHOFU DENTAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SIRONA DENTAL SYSTEMS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SOMERSET DENTAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TALLADIUM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
TANAKA DENTAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE ARGEN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TOPZIR BIOTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&C INTERNATIONAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED DENTAL RESOURCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VATECH ACUCERA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
VATECH MCIS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERICOM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITA ZAHNFABRIK GMBH H RAUTER & CO |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITA ZAHNFABRIK H.RAUTER GMBH CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WHIP MIX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WHIP MIX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WHITEPEAKS DENTAL SOLUTIONS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
XCERAMUSA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YETI DENTALPRODUKTE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YILINK (TIANJIN) BIOTECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZENCERA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIRDENT NEW MATERIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIRKONZAHN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIRKONZAHN SRL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZMAXX BIOCERAMICS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZXTGY (BEIJING) TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|