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, Operative Dental (EIA) (5)

Premarket Exempt

No Yes

Clear

Evogue Dental Unit - 04952195254842 Catalog Number : AU-HV3410

Device Description : Evogue Dental Unit VACPAC

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

CLESTA LED DENTAL LIGHT - 04952195255849 Catalog Number : AL-301C-NA

Device Description : CLESTA LED DENTAL LIGHT 301 POLE MOUNT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

CLESTA LED DENTAL LIGHT - 04952195255856 Catalog Number : AL-302C-NA-PN

Device Description : CLESTA LED DENTAL LIGHT 302 CEILING MOUNT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

CLESTA LED DENTAL LIGHT - 04952195255863 Catalog Number : AL-305C-NA-H

Device Description : CLESTA LED DENTAL LIGHT 305 TRACK MOUNT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

CLESTA LED DENTAL LIGHT - 04952195255887 Catalog Number : AL-320XC

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

Bel-Halo LED - 04952195257232 Catalog Number : AL-920XC

Device Description : LIGHT, OPERATING, DENTAL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : Yes

Device Count : 1

Evogue Dental Unit - 04952195257577 Catalog Number : AU-HV3000D

Device Description : Evogue Dental Unit DR TABLE PMU OVERARM

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Evogue Dental Unit - 04952195257683 Catalog Number : AU-HV3100C

Device Description : Evogue Dental Unit PMU WITH CUSPIDOR BOWL AND ASSISTANT

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Evogue Dental Unit - 04952195257690 Catalog Number : AU-HV3010D

Device Description : Evogue Dental Unit DR TABLE PMU OVERARM TYPE

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Evogue Dental Unit - 04952195257706 Catalog Number : AU-HV3105C

Device Description : Evogue Dental Unit PMU WITH CUSPIDOR BOWL

Device Class : 1

Duns Number: 690540349

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

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