PLASDENT CORPORATION

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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, Accessories (NRD) (10)

Premarket Exempt

No Yes

Clear

Plasdent - D832VP2H1 Catalog Number : VP-2H

Device Description : VP Film Mount - 2H, 2 5/8" X 3 1/2"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP4C1 Catalog Number : VP-4C

Device Description : VP Film Mount - 4C, 3 1/8" X 7 1/4"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP4H1 Catalog Number : VP-4H

Device Description : VP Film Mount - 4H, 3 1/4" X 4 5/8"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP4H2V1 Catalog Number : VP-4H2V

Device Description : VP Film Mount - 4H2V, 2 1/16" X 10"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP4H3V1 Catalog Number : VP-4H3V

Device Description : VP Film Mount - 4H3V, 2 1/2" X 11 1/4"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP6H1 Catalog Number : VP-6H

Device Description : VP Film Mount - 6H, 3 1/4" X 6 3/8"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP8C1 Catalog Number : VP-8C

Device Description : VP Film Mount - 8C, 4" X 8"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP8H61 Catalog Number : VP-8H6V

Device Description : VP Film Mount - 8H6V, 4" X 11 1/4"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832VP8P1 Catalog Number : VP-8P

Device Description : VP Film Mount - 8P, 3 7/8" X 5 7/8"

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

ACUWEDGE - D832WG101 Catalog Number : WG-10

Device Description : Plastic Wedge, 10mm (XS), Blue, Disposable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

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