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

Mouthpiece, Saliva Ejector (DYN) (5) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (5)

Premarket Exempt

No Yes

Clear

Plasdent - D832700811 Catalog Number : 7008-1

Device Description : White Frame Face Visors, 1 Frame + 12 Visors

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 13

Plasdent - D8327008111 Catalog Number : 7008-11

Device Description : Black Frame Face Visors, 1 Frame + 12 Visors

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 13

Plasdent - D832700821 Catalog Number : 7008-2

Device Description : Blue Frame Face Visors, 1 Frame + 12 Visors

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 13

Plasdent - D832700841 Catalog Number : 7008-4

Device Description : Green Frame Face Visors, 1 Frame + 12 Visors

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 13

Plasdent - D832700861 Catalog Number : 7008-6

Device Description : Pink Frame Face Visors, 1 Frame + 12 Visors

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 13

FLEXJET - D8328000CL1 Catalog Number : 8000-CL

Device Description : Saliva Ejector - Clear, White Tip

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

FLEXJET - D8328000CL21 Catalog Number : 8000-CL2

Device Description : Saliva Ejector - Transparent Blue, Blue Tip

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

FLEXJET - D8328000CL41 Catalog Number : 8000-CL4

Device Description : Saliva Ejector - Transparent Green, Green Tip

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

FLEXJET - D8328000CLB1 Catalog Number : 8000-CLB

Device Description : Saliva Ejector - Clear, Light Blue Tip

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

FLEXJET - D8328000CLM1 Catalog Number : 8000-CLM

Device Description : Saliva Ejector - Clear, Multi-Colored Tip

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

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