|
Device |
system, x-ray, extraoral source, digital |
Product Code | MUH |
Regulation Number |
872.1800
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3DISC AMERICAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AFP IMAGING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIR TECHNIQUES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLIAGE S/A INDUSTRIAS MEDICA ODONTOLÓGICO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APIXIA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATHLOS OY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CEFLA DENTAL GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CEFLA S.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CEFLA S.C. CEFLA DENTAL GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CND GLOBAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CRUXELL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DE GOTZEN S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DE GÖTZEN S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAL IMAGING TECHNOLOGIES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTERPRISE INTERNATIONAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTERPRISE INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTIMAX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTIMAX, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTTIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEXCOWIN CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEXCOWIN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEXIS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DUERR DENTAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DURR DENTAL SE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DÜRR DENTAL SE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
E-WOO TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDLEN IMAGING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FONA S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FONA SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FSUSEN TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENORAY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HDX WILL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEFEI DENTAFILM MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IRAY IMAGING TECHNOLOGY (HAINING) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IRAY TECHNOLOGY TAICANG LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
JAZZ IMAGING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JAZZ IMAGING LLC DBA JAZZ IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU DYNAMIC MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAVO DENTAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MASTERLINK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIC INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIDMARK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIDMARK CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NICAL SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OWANDY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PALODEX GROUP OY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANORAMIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PICOPACK INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PLANMECA OY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
POINTNIX CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QPIX SOLUTIONS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
RAY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAYENCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
REALCLOUD IMAGING INC. DBA REALCLOUD IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REMEDI CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RF CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROLENCE ENTERPRISE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHICK TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN XPECTVISION TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SODIUM SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOPRO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOPRO - ACTEON GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SOTA PRECISION OPTICS, INC. DBA SOTA IMAGING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNI MEDICAL IMAGING, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAKARA BELMONT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TAKARA BELMONT USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAKARA-BELMONT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEVERE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE YOSHIDA DENTAL MFG. CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIDENT S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRIDENT S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TROPHY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TUXEDO IMAGING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VATECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VATECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
VILLA SISTEMI MEDICALI S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VIVI S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZINNOVI INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZUMA DENTAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|