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

Dental Barriers And Sleeves (PEM) (8) Unit, Operative Dental, Accessories (NRD) (2)

Premarket Exempt

No Yes

Clear

Plasdent - D832PS6501 Catalog Number : PS650

Device Description : Plastic Headrest Covers 9 1/2"L X 11"W

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 250

Plasdent - D832PS6601 Catalog Number : PS660

Device Description : LG Plastic Headrest Cover 10"L X 14"W

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 250

Plasdent - D832PS6701 Catalog Number : PS670

Device Description : Chair Armrest Covers

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 250

Plasdent - D832PS7001 Catalog Number : PS700

Device Description : Low Speed Long H.P. Cover 1 1/2" X 7 1/2"

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS7101 Catalog Number : PS710

Device Description : Low Speed Contra-Angle Cover, 8"L, 3 1/2" Opening

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS7201 Catalog Number : PS720

Device Description : High Speed Cover, 1 1/16" X 7 3/4"

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS7301 Catalog Number : PS730

Device Description : Scaler Sleeves - Stick Hold, 1 1/2" X 7"

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS7351 Catalog Number : PS735

Device Description : Scaler Sleeves, 1 5/8" X 8"

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS8501 Catalog Number : PS850

Device Description : Biohazard Bags, Stick-On, Red, 9" X 10"

Device Class :

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 200

Plasdent - D832PS850S1 Catalog Number : PS850S

Device Description : Biohazard Bags, Stick-On, Red, 6" X 6"

Device Class :

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 200

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