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

Light, Operating, Dental (EAZ) (5) UNIT, X-RAY, EXTRAORAL WITH TIMER (EHD) (5) System,x-ray,extraoral source,digital (MUH) (3)

Premarket Exempt

Yes No

Clear

BELRAY II - 04952195093915 Catalog Number : AR-97WKCNJ5

Device Description : 097 X-RAY WK with 20"Arm

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : MUH, EHD

Prescription Use : Yes

Device Count : 1

BELRAY II - 04952195093922 Catalog Number : AR-97WKCNJ3

Device Description : 097 X-RAY WK with 12"Arm

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : MUH, EHD

Prescription Use : Yes

Device Count : 1

BELRAY II - 04952195093939 Catalog Number : AR-97WKCNJ1

Device Description : 097 X-RAY WK with 40"Arm

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : MUH, EHD

Prescription Use : Yes

Device Count : 1

PHOT-X IIs Model 505 - 04952195142248 Catalog Number : AR-55WKCNJ3

Device Description : PHOT-X IIS 505 WK with 12"Arm

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Bel-Halo LED - 04952195195329 Catalog Number : AL-901C-NA

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

Bel-Halo LED - 04952195195336 Catalog Number : AL-902C-NA-PN

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

Bel-Halo LED - 04952195195343 Catalog Number : AL-905C-NA-H

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

PHOT-X IIs Model 505 - 04952195196258 Catalog Number : AR-55WKCNJ6

Device Description : PHOT-X IIS 505 WK with 26"Arm

Device Class : 2

Duns Number: 690540349

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Bel-Halo LED - 04952195196685 Catalog Number : AL-920X

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

Bel-Halo LED - 04952195197866 Catalog Number : AL-901R-NA

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

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