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 - D832PS55001 Catalog Number : PS-5500

Device Description : Perforated Bite Block Covers, 1"W X 2"L

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS55011 Catalog Number : PS-5501

Device Description : Perforated Bite Block Covers, 1 1/2"W X 3"L

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS55021 Catalog Number : PS-5502

Device Description : Large Dig Sensor Covers, 2 3/4"W X 8"L

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 250

Plasdent - D832PS55051 Catalog Number : PS-5505

Device Description : Universal Dig Sensor Covers, 1 1/2"W X 7"L

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS55111 Catalog Number : PS-5511

Device Description : Large Comfort Sensor Covers, 2"W X 4 1/2"L

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS55221 Catalog Number : PS-5522

Device Description : Comfort Sensor Covers, #2, 1 5/8"W X 4 1/8"L

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS55331 Catalog Number : PS-5533

Device Description : Comfort Sensor Covers, #0/#1, 1 3/8"W X 4 1/4"L

Device Class : 2

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS610001 Catalog Number : PS-6100-0

Device Description : Digital Sensor Sleeves for Kodak 6100 #0

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS610011 Catalog Number : PS-6100-1

Device Description : Digital Sensor Sleeves for Kodak 6100 #1

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

Plasdent - D832PS610021 Catalog Number : PS-6100-2

Device Description : Digital Sensor Sleeves for Kodak 6100 #2

Device Class :

Duns Number: 190377184

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 500

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