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

Unit, Operative Dental (EIA) (5) Light, Operating, Dental (EAZ) (3) Chair, Dental, Without Operative Unit (NRU) (2)

Premarket Exempt

Yes No

Clear

Bel-Nova LED - 04952195372416 Catalog Number : AL-D108G-NA-P

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

CLESTA LED DENTAL LIGHT - 04952195379798 Catalog Number : AL-320XV

Device Description : CLESTA LED DENTAL LIGHT 320X UNIT MOUNT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

CLESTA LED DENTAL LIGHT - 04952195379804 Catalog Number : AL-320XNV

Device Description : CLESTA LED DENTAL LIGHT 320X UNIT MOUNT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

Belmont X-Calibur Unit - 04952195383276 Catalog Number : AU-XV2500DV

Device Description : Belmont X-Calibur Unit CMOP DOCTOR TABLE

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Belmont X-Calibur Unit - 04952195383283 Catalog Number : AU-XV2570DV

Device Description : Belmont X-Calibur Unit SWING MOUNT DR TABLE

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Belmont X-Calibur Unit - 04952195383313 Catalog Number : AU-XV2510CV

Device Description : Belmont X-Calibur Unit PMU WITH ASSISTANT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Belmont Equipment (Chair) - 04952195385539 Catalog Number : AC-B50-V120V

Device Description : Belmont Equipment, CHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : NRU

Prescription Use : Yes

Device Count : 1

Evogue Chair - 04952195392889 Catalog Number : AC-Q33-CD36US

Device Description : Evogue Chair

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : NRU

Prescription Use : Yes

Device Count : 1

Belmont X-Calibur Unit - 04952195393558 Catalog Number : AU-XV2570DV-SE

Device Description : Belmont X-Calibur Unit SWING MOUNT DR TABLE

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Belmont X-Calibur Unit - 04952195393572 Catalog Number : AU-XV2510CV-SE

Device Description : Belmont X-Calibur Unit PMU WITH ASSISTANT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

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