J. MORITA U.S.A., INC

Address:9 MASON,IRVINE,CA,92618,US

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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

Material, Impression (ELW) (8) Post, Root Canal (ELR) (2)

Premarket Exempt

No Yes

Clear

Perfectim Putty Type Kit - 00852253006090 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

CF Carbon Fiber Post Kit - 00852253006274 Catalog Number :

Device Description : Carbon Fiber Post used for core build up

Device Class : 1

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELR

Prescription Use : Yes

Device Count : 1

GF Glass Fiber Post Kit - 00852253006328 Catalog Number :

Device Description : Root canal post for core build up

Device Class : 1

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Perfectim 30 Second Blue Velvet - 10852253006011 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Perfectim 90 Second Blue Velvet - 10852253006028 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Perfectim 30 Second SnoWhite - 10852253006035 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Perfectim 90 Second SnoWhite - 10852253006042 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Perfectim 30 Second Flexi-Velvet - 10852253006059 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Perfectim 90 Second Flexi-Velvet - 10852253006066 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Perfectim Single Phase Body - 10852253006073 Catalog Number :

Device Description : PVS Dental Impression Material

Device Class : 2

Duns Number: 021866033

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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