Sultan Healthcare 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

CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (6) RESIN, DENTURE, RELINING, REPAIRING, REBASING (EBI) (3) Sterilant, medical devices (MED) (1)

Premarket Exempt

No Yes

Clear

Versa-Temp® - D687720711 Catalog Number :

Device Description : Versa-Temp® 2 Temporary Crown & Bridge Material - A2 3x50ml

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 3

Versa-Temp® - D687720751 Catalog Number :

Device Description : Versa-Temp® A3 Crown and Bridge Resin 50ml, Bulk (3 x 50ml)

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Versa-Temp® - D687720761 Catalog Number :

Device Description : Versa-Temp® 2 Temporary Crown & Bridge Material - A3 3x50ml

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 3

Versa-Temp® - D687720801 Catalog Number :

Device Description : Versa-Temp® Temporary Crown and Bridge Resin A1 5ml syringe 5 tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Versa-Temp® - D687720851 Catalog Number :

Device Description : Versa-Temp® A2 Crown and Bridge Resin 5ml syringe - 5 tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Versa-Temp® - D687720901 Catalog Number :

Device Description : Versa-Temp® A3 Crown and Bridge Resin 5ml syringe - 5 tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Hydro-Cast® - D687730101 Catalog Number :

Device Description : Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL Bottle Liquid, 1x130g Bottle Powder, 1x8mL Flow Replenisher

Device Class : 2

Duns Number: 056296981

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Hydro-Cast® - D687730151 Catalog Number :

Device Description : Hydro-Cast® Tissue Treatment and Functional Impression Material 1x115mL Bottle Liquid

Device Class : 2

Duns Number: 056296981

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Hydro-Cast® - D687730201 Catalog Number :

Device Description : Hydro-Cast® Tissue Treatment 130g bottle Powder Only

Device Class : 2

Duns Number: 056296981

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

SPOROX® II - D687751561 Catalog Number :

Device Description : Sporox® II Sterilizing & Disinfecting Solution 1 Gallon (3.8L)

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : MED

Prescription Use : Yes

Device Count : 1

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