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

Unit, Operative Dental, Accessories (NRD) (10)

Premarket Exempt

No Yes

Clear

Plasdent - D832XR08570 Catalog Number : XR-0857

Device Description : Anterior Arm, Blue

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832XR08580 Catalog Number : XR-0858

Device Description : Posterior Arm, Yellow

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832XR08600 Catalog Number : XR-0860

Device Description : Posterior Ring, Yellow

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832XR08611 Catalog Number : XR-0861

Device Description : Anterior Bite Blocks, Blue

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 25

Plasdent - D832XR08621 Catalog Number : XR-0862

Device Description : Anterior Bite Blocks, Yellow

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 25

Plasdent - D832XR08650 Catalog Number : XR-0865

Device Description : Anterior Ring, Blue

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832XR09221 Catalog Number : XR-0922

Device Description : Bitewing Bite Blocks, Red, V1

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 25

Plasdent - D832XR09270 Catalog Number : XR-0927

Device Description : Bitewing Arm, Red

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Plasdent - D832XR09291 Catalog Number : XR-0929

Device Description : Bitewing Bite Blocks, Red, H2

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 25

Plasdent - D832XR09331 Catalog Number : XR-0933

Device Description : Bitewing Bite Blocks, Red, H0/1

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 25

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