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

Non-Surgical Isolation Gown (OEA) (7) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (3)

Premarket Exempt

No Yes

Clear

Plasdent - D8327004C110 Catalog Number : 7004C-11

Device Description : Supreme Reusable Gown, Black

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Plasdent - D8327004C20 Catalog Number : 7004C-2

Device Description : Supreme Reusable Gown, Blue

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Plasdent - D8327004C2X0 Catalog Number : 7004C-2X

Device Description : Supreme Reusable Gown, Navy

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Plasdent - D8327004C30 Catalog Number : 7004C-3

Device Description : Supreme Reusable Gown, Yellow

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Plasdent - D8327004C40 Catalog Number : 7004C-4

Device Description : Supreme Reusable Gown, Green

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Plasdent - D8327004C5P0 Catalog Number : 7004C-5P

Device Description : Supreme Reusable Gown, Burgundy

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Plasdent - D8327004C60 Catalog Number : 7004C-6

Device Description : Supreme Reusable Gown, Pink

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Plasdent - D83270051 Catalog Number : 7005

Device Description : Disposable Face Shields, 13"W X 8"L

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 24

Plasdent - D83270061 Catalog Number : 7006

Device Description : Disposable Eyeglass Side Shields

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 250

Plasdent - D83270071 Catalog Number : 7007

Device Description : Face Shields, 1 Frame + 10 Replaceable Shields

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 11

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