|
Device |
unit, operative dental |
Product Code | EIA |
Regulation Number |
872.6640
|
Device Class |
1
|
Premarket Reviews |
Manufacturer | Decision |
A-DEC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AIOBIO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASEPTICO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASI MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CEFLA S.C. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIPLOMAT DENTAL S.R.O. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ERGONOMIC PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOREST DENTAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBAL DENTAL DIRECT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HALLIM DENTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEKA DENTAL A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALTENBACH & VOIGT GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LARES RESEARCH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEGAGEN IMPLANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MGNEWTON LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIDMARK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLSEN INDUSTRIA E COMERCIO S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLSEN INDÚSTRIA E COMÉRCIO S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PELTON & CRANE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRO DENTAL SERVICES LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROGENY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RITTER CONCEPT GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAFARI DENTAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI DYNAMIC INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINHUNG COMPANY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIRONA DENTAL SYSTEMS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TAKARA BELMONT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEROZONE USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI SIGER MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|