PASCAL COMPANY, INC.

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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

Cord, Retraction (MVL) (10)

Premarket Exempt

No Yes

Clear

KnitTrax Plain Retraction Cord 0 - 00310866000299 Catalog Number : 07575

Device Description : Knitted Non Medicated Gingival Retraction Cord, 100 inches, Size: 0

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : No

Device Count : 1

KnitTrax Plain Retraction Cord 1 - 00310866000305 Catalog Number : 07580

Device Description : Knitted Non Medicated Gingival Retraction Cord, 100 inches, Size: 1

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : No

Device Count : 1

KnitTrax Plain Retraction Cord 2 - 00310866000312 Catalog Number : 07585

Device Description : Knitted Non Medicated Gingival Retraction Cord, 100 inches, Size:2

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : No

Device Count : 1

SilTrax AS Retraction Cord 7/00 - 00310866000329 Catalog Number : 07097

Device Description : Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size 7/00

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

SilTrax AS Retraction Cord 8/0 - 00310866000336 Catalog Number : 07100

Device Description : Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 8/0

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

SilTrax AS Retraction Cord 9/1 - 00310866000343 Catalog Number : 07110

Device Description : Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 9/1

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

SilTrax AS Retraction Cord 10/2 - 00310866000350 Catalog Number : 07120

Device Description : Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 10/2

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

SilTrax EPI Retraction Cord 7/00 - 00310866000367 Catalog Number : 07197

Device Description : Braided gingival retraction cord with epinephrine, 72 inches, size 7/00

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

SilTrax EPI Retraction Cord 8/0 - 00310866000374 Catalog Number : 07200

Device Description : Braided gingival retraction cord with epinephrine, 72 inches, size 8/0

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

SilTrax EPI Retraction Cord 9/1 - 00310866000381 Catalog Number : 07210

Device Description : Braided gingival retraction cord with epinephrine, 72 inches, size 9/1

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

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