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

CEMENT, DENTAL (EMA) (4) CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (4) Mask, surgical (FXX) (2)

Premarket Exempt

No Yes

Clear

Com-Fit® - D687203561 Catalog Number :

Device Description : Com-Fit Plush™ Natural Fit Masks ASTM #2 Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Com-Fit® - D687203571 Catalog Number :

Device Description : Com-Fit Plush™ Natural Fit Masks ASTM #3 Box of 40

Device Class :

Duns Number: 056296981

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 40

Sensi Temp® - D687700101 Catalog Number :

Device Description : Sensi Temp® Non-Eugenol Temporary Cement Resin 5ml Cartridge 10 Mixing Tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Sensi Temp® - D687700201 Catalog Number :

Device Description : Sensi Temp® Non-Eugenol Temporary Cement Resin 25ml Cartridge 15 Mix Tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Sensi Temp® - D687700501 Catalog Number :

Device Description : Sensi Temp® Non-Eugenol Zinc Oxide Temporary Cement NEZO 5ml Syringe 10 Mix Tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Sensi Temp® - D687700551 Catalog Number :

Device Description : Sensi Temp® Non-Eugenol Zinc Oxide Temporary Cement NEZO 25ml Cartridge 15 Mix Tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Versa-Temp® - D687720151 Catalog Number :

Device Description : Versa-Temp® Shade A-1 Crown & Bridge Resin Refill, 25 ml, dispenser gun, 40 tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Versa-Temp® - D687720201 Catalog Number :

Device Description : Versa-Temp® Shade A-2 Crown & Bridge Resin-Refill, 25 ml, dispenser gun, 40 tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Versa-Temp® - D687720251 Catalog Number :

Device Description : Versa-Temp® Shade A-3.5 Crown & Bridge Resin Refill, 25ml, dispenser gun, 40 tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Versa-Temp® - D687720301 Catalog Number :

Device Description : Versa-Temp® Shade B-1 Crown & Bridge Resin Refill, 25 ml, dispenser gun, 40 tips

Device Class : 2

Duns Number: 056296981

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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