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

Accessories, Retractor, Dental (EIF) (5) Cord, Retraction (MVL) (5)

Premarket Exempt

No Yes

Clear

Racord Two Retraction Cord 10/2 - 00310866000596 Catalog Number : 07820

Device Description : Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 i Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, size 10/2

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Retrax Retraction Cord 7/00 - 00310866000602 Catalog Number : 07897

Device Description : Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 7/00

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : No

Device Count : 1

Retrax Retraction Cord 8/0 - 00310866000619 Catalog Number : 07900

Device Description : Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 8/0

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : No

Device Count : 1

Retrax Retraction Cord 9/1 - 00310866000626 Catalog Number : 07910

Device Description : Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 9/1

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : No

Device Count : 1

Retrax Retraction Cord 10/2 - 00310866000633 Catalog Number : 07920

Device Description : Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 10/2

Device Class : U

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : MVL

Prescription Use : No

Device Count : 1

R-101 Standard Packing Instrument, Plain - 00310866000640 Catalog Number : 26100

Device Description : Retraction Cord Packing Instrument standard with plain tip

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

R-11 Standard Packing Instrument Serrated - 00310866000657 Catalog Number : 26110

Device Description : Retraction Cord Packing Instrument standard with serrated tip

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

R-50 Circlet Packing Instrument Plain - 00310866000664 Catalog Number : 26120

Device Description : Retraction Cord Packing Instrument Circlet with Plain tip

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

R-55 Circlet Packing Instrument Serrated - 00310866000671 Catalog Number : 26130

Device Description : Retraction Cord Packing Instrument Circlet with Serrated tip

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

R-55A Circlet Packing Instrument - 00310866000688 Catalog Number : 26140

Device Description : Retraction Cord Packing Instrument, Circlet off Angle, Serrated Tip

Device Class : 1

Duns Number: 009260217

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

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