|
Device |
handpiece, air-powered, dental |
Product Code | EFB |
Regulation Number |
872.4200
|
Device Class |
1
|
Premarket Reviews |
Manufacturer | Decision |
A-DEC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AEROBINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING DONGBO DENTAL HANDPIECE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEYES DENTAL CANADA INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CODENT TECHNICAL INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAL SAVINGS CLUB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTALEZ GROUP, STARDENTAL DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTALEZ, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
EMS ELECTRO MEDICAL SYSTEMS SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANDPIECE CLUB, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANDPIECE HEADQUARTERS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HANDPIECE HEADQUARTERS INC. - HPR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARRY J. BOSWORTH CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
J. MORITA USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JAINTEK CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALTENBACH & VOIGT GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LARES RESEARCH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRON CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROP TECHNOLOGY (TAIWAN), INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MODERN KOREA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAKANISHI INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NAKANISHI, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NINGBO HPDOVE DENTAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NSK AMERICA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOMATICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSPRAY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAC-DENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PALM BEACH DENTAL SUPPLY D/B/A TEK USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PREMIUM PLUS INTERNATIONAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRODRIVE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REDENT-NOVA LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROLENCE ENT. INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SABLE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAESHIN PRECISION CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SATELEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CAREJOY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIRONA DENTAL SYSTEMS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYBRON DENTAL SPECIALTIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THUNDER TIGER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TTBIO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
W & H DENTALWERK BUERMOOS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
W&H DENTALWERK BURMOOS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|