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 - D832400BX440 Catalog Number : 400BX-44

Device Description : Large Round Bur Box, 44 FG Burs

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400BX720 Catalog Number : 400BX-72

Device Description : Rectangular Bur Box, 72 FG Burs

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400ES10 Catalog Number : 400ES-1

Device Description : Endo Clean Stand, White, Autoclavable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400ES10N0 Catalog Number : 400ES-10N

Device Description : Endo Clean Stand, Neon Purple, Autoclavable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400ES110 Catalog Number : 400ES-11

Device Description : Endo Clean Stand, Black, Autoclavable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400ES12N0 Catalog Number : 400ES-12N

Device Description : Endo Clean Stand, Neon Tangerine, Autoclavable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400ES20 Catalog Number : 400ES-2

Device Description : Endo Clean Stand, Blue, Autoclavable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832400ES2N0 Catalog Number : 400ES-2N

Device Description : Endo Clean Stand, Neon Blue, Autoclavable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D8324040CT1 Catalog Number : 4040-CT

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

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 2000

Plasdent - D8324040NW1 Catalog Number : 4040-NW

Device Description : 4" X 4" Non-Woven Gauze Sponge

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 2000

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