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) (8) Holder, Film, X-Ray (EGZ) (2)

Premarket Exempt

No Yes

Clear

ACUWEDGE - D832WG121 Catalog Number : WG-12

Device Description : Plastic Wedge, 12mm (S), Green, Disposable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

ACUWEDGE - D832WG141 Catalog Number : WG-14

Device Description : Plastic Wedge, 14mm (M), Yellow, Disposable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

ACUWEDGE - D832WG161 Catalog Number : WG-16

Device Description : Plastic Wedge, 16mm (L), Purple, Disposable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

ACUWEDGE - D832WGA1 Catalog Number : WG-A

Device Description : ACUWEDGE/Assorted, 4 Assorted Sizes, Disposable

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 100

Plasdent - D832WGDL1 Catalog Number : WGD-L

Device Description : Wedge w/ Guard, Large

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 10

Plasdent - D832WGDM1 Catalog Number : WGD-M

Device Description : Wedge w/ Guard, Medium

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 10

Plasdent - D832WGDS1 Catalog Number : WGD-S

Device Description : Wedge w/ Guard, Small

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 10

Plasdent - D832XR0001 Catalog Number : XR-000

Device Description : Film Carrier #0 & #00, White

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : EGZ

Prescription Use : No

Device Count : 5

Plasdent - D832XR0011 Catalog Number : XR-001

Device Description : Film Carrier #1, Black

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : EGZ

Prescription Use : No

Device Count : 5

Plasdent - D832XR07750 Catalog Number : XR-0775

Device Description : Universal Alignment Arm

Device Class : 1

Duns Number: 190377184

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

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