TAKARA-BELMONT CO., LTD.

Address:2-1-1, HIGASHISHINSAIBASHI,OSAKA,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System,x-ray,extraoral source,digital (MUH) (6) Light, Operating, Dental (EAZ) (2) UNIT, X-RAY, EXTRAORAL WITH TIMER (EHD) (2) Unit, Operative Dental (EIA) (1) Unit, Operative Dental, Accessories (NRD) (1)

Premarket Exempt

No Yes

Clear

BELMAX CM - 04560217093616 Catalog Number : BELMAX CM-US

Device Description : BELMAX CM DIGITAL PANORAMIC AND CEPHALOMETRIC X-RAY(R)

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

BELCYPHER-N - 04560217093692 Catalog Number : BELCYPHER-N

Device Description : BELCYPHER-N CMOS 120V/60HZ

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

BELMAX CM - 04560217094552 Catalog Number : BELMAX CM-US

Device Description : BELMAX CM DIGITAL PANORAMIC AND CEPHALOMETRIC X-RAY(L)

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

BELCYPHER PRO - 04560217095634 Catalog Number : BELCYPHER PRO

Device Description : BELCYPHER-PRO 120V/60HZ

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Bel-Halo LED - 04952195078288 Catalog Number : AL-907C-NA

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

Quolis - 04952195089406 Catalog Number : AU-BDS5170

Device Description : QUOLIS PMU WITH ASSISTANT ARM

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : NRD

Prescription Use : Yes

Device Count : 1

Quolis 5000 Series Dental Unit - 04952195089413 Catalog Number : AU-BDS5180

Device Description : BELMONT QUOLIS 5000 SERIES DENTAL UNIT CUSPIDOR WITHOUT ASSISTANT INSTRUMENTS

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Bel-Halo LED - 04952195093557 Catalog Number : AL-920Q

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

BELRAY II - 04952195093809 Catalog Number : AR-97WKCNJ8

Device Description : 097 X-RAY WK with 31"Arm

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : EHD, MUH

Prescription Use : Yes

Device Count : 1

BELRAY II - 04952195093908 Catalog Number : AR-97WKCNJ6

Device Description : 097 X-RAY WK with 26"Arm

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : EHD, MUH

Prescription Use : Yes

Device Count : 1

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