|
Device |
cement, dental |
Product Code | EMA |
Regulation Number |
872.3275
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3M COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M DEUTSCHLAND GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
3M ESPE AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M ESPE AG DENTAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
3M ESPE DENTAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BISCO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COLTENE/WHALEDENT AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CROWN DELTA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENALI CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENALI R&D CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSCARE LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DETAX GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DFL INDUSTRIA E COMERCIO S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIADENT GROUP INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DMG USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DOXA AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOXA DENTAL AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ESSENTIAL DENTAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ESSENTIAL DENTAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTA DENTAL DIRECT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GAIA DENTAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GC AMERICA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GC AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HARRY J. BOSWORTH CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ITENA CLINICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
IVOCLAR VIVADENT AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IVOCLAR VIVADENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KERR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KETTENBACH GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KURARAY MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KURARAY NORITAKE DENTAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KURARAY NORITAKE DENTAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
META BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVOCOL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OROSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARKELL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARKELL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PREMIER DENTAL COMPANY PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PREVEST DENPRO LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRIME DENTAL MANUFACTURING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULPDENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RIZHAO HUGE BIOMATERIALS COMPANY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S & C POLYMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SDI LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG HUGE DENTAL MATERIAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHOFU DENTAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHOFU DENTAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SILMET LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPIDENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STEINER LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYBRON DENTAL SPECIALTIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TEMREX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOKUYAMA DENTAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRADENT PRODUCTS INC. / ORATECH LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRADENT PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VERICOM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOCO GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
|
|
|
|