|
Device |
material, impression |
Product Code | ELW |
Regulation Number |
872.3660
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3M DEUTSCHLAND GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
3M ESPE AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARGES IMAGING, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B&E KOREA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLACKWELL DEVICE CONSULTING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CASCADES DEVICE CONSULTING ASSOCIATES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAVEX HOLLAND B.V |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAVEX HOLLAND BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTRIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHEMOMENT MATERIALS CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLTÈNE/WHALEDENT AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANVILLE MATERIALS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANVILLE MATERIALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTKIST, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTPLY INTERNATIONAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DMP LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DREVE DENTAMID GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GC AMERICA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GC AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENOSS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HDI, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS KULZER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS KULZER, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
HRS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HYGEDENT INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HYGEDENT INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IMICRYL DIS MALZEMELERI SAN. VE TIC. A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVATIVE PRODUCT BRANDS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IOS TECHNNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVOCLAR VIVADENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KERR CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KERR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KETTENBACH GMBH & CO KG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LASCOD SPA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
META BIOMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MILLENNIUM COMPANY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANCHANG DENTAL BRIGHT TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOSIL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NO STRESS IMPRESS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM GERMANY GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OSSTEM IMPLANT CO., LTD.. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAC-DENT INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTRON CLINICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PREVEST DENPRO LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RIZHAO HUGE DENTAL INDUSTRY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEILGLOBAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG HUGE DENTAL MATERIAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHERPA KOREA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPIDENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPOFADENTAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYBRON DENTAL SPECIALTIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VERICOM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERICOM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
VOCO GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHENGZHOU HUAER ELECTRO OPTICS TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHERMACK S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|