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) (10)

Premarket Exempt

No Yes

Clear

Plasdent - D832PS46601 Catalog Number : PS4660

Device Description : Complete Curing Light Cover, 12" X 3 1/4"

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 250

Plasdent - D832PS47001 Catalog Number : PS4700

Device Description : Cordless Curing Light Cover, 1 3/4" X 9 3/4"

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS47011 Catalog Number : PS4701

Device Description : Cordless Curing Light Cover, 2" X 12 3/4"

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS47071 Catalog Number : PS4707

Device Description : Cordless Curing Light Cover, 4" X 12 1/2"

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 250

Plasdent - D832PS47081 Catalog Number : PS4708

Device Description : Cordless Curing Light Cover, 3 1/4" X 13"

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS5001 Catalog Number : PS500

Device Description : Bite Block Covers, 1" X 2"

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1000

Plasdent - D832PS5101 Catalog Number : PS510

Device Description : Bite Block Covers, 2" X 3"

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1000

Plasdent - D832PS5201 Catalog Number : PS520

Device Description : Sensor Covers, #2, 1 5/8"W X 8 3/8"L

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS5301 Catalog Number : PS530

Device Description : Sensor Covers, #0/#1, 1 3/8"W X 8 3/8"L

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS5401 Catalog Number : PS540

Device Description : Large Sensor Covers, 2 1/2"W X 9"L

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

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