PLASDENT CORPORATION

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) (8) Gauze / Sponge,Nonresorbable For External Use (NAB) (2)

Premarket Exempt

No Yes

Clear

Plasdent - D8322020CT1 Catalog Number : 2020-CT

Device Description : Pure Cotton Spunlace Sponges, 2" X 2", Non-Sterile, 4-Ply, 40g, Non-Woven

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 5000

Plasdent - D8322020NW1 Catalog Number : 2020-NW

Device Description : 2" X 2" Non-Woven Gauze Sponge

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 5000

ACUWELL - D832400AW10P0 Catalog Number : 400AW-10P

Device Description : Universal Material Well, Purple Gala

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

ACUWELL - D832400AW110 Catalog Number : 400AW-11

Device Description : Universal Material Well, Black Knight

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

ACUWELL - D832400AW2P0 Catalog Number : 400AW-2P

Device Description : Universal Material Well, Blue Ocean

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

ACUWELL - D832400AW4X0 Catalog Number : 400AW-4X

Device Description : Universal Material Well, Green Grass

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

ACUWELL - D832400AW7X0 Catalog Number : 400AW-7X

Device Description : Universal Material Well, Orange Yellow

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

ACUWELL - D832400AW9L0 Catalog Number : 400AW-9L

Device Description : Universal Material Well, Light Gray

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400BX260 Catalog Number : 400BX-26

Device Description : Small Round Bur Box, 26 FG Burs

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400BX360 Catalog Number : 400BX-36

Device Description : Square Bur Box, 36 FG Burs

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

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