DARBY DENTAL SUPPLY, LLC

Address:NE INDUS. PARK, VAN BUREN BLVD,GUILDERLAND CENTER,NY,12085,US

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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) Indicator, physical/chemical sterilization process (JOJ) (4) MATERIAL, TOOTH SHADE, RESIN (EBF) (2)

Premarket Exempt

No Yes

Clear

Darby Dental Supply, LLC - 00889813001004 Catalog Number : 9520997

Device Description : Zinc Phosphate Cement Liquid 56ml

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Darby Dental Supply, LLC - 00889813001011 Catalog Number : 9520985

Device Description : Zinc Phosphate Cement Powder Light Yellow 1lb

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Darby Dental Supply, LLC - 00889813001028 Catalog Number : 9520991

Device Description : Zinc Phosphate Cement Powder Snow White 1lb

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Darby Dental Supply, LLC - 00889813001035 Catalog Number : 9521060

Device Description : Zinc Phosphate Cement Liquid 15 ml

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Darby Dental Supply, LLC - 00889813001097 Catalog Number : 9519192

Device Description : ETCH GEL 12ML

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Darby Dental Supply, LLC - 00889813001127 Catalog Number : 9509030

Device Description : COMPOLITE ACID ETCH LIQUID

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Darby Dental Supply, LLC - 00889813001257 Catalog Number : 9514754

Device Description : STERILIZATION TAPE 3/4"X60Y

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Darby Dental Supply, LLC - 00889813001264 Catalog Number : 9514756

Device Description : STERILIZATION TAPE 1"X60YD

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Darby Dental Supply, LLC - 00889813001271 Catalog Number : 9514752

Device Description : STERILIZATION TAPE 1/2"X60Y

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Darby Dental Supply, LLC - 00889813001288 Catalog Number : 9500043

Device Description : AUTOCLAVE INDICATOR TAPE 1/2" 60 yds

Device Class : 2

Duns Number: 825137818

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

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