CROWN DELTA CORPORATION

Address:1520 FRONT ST.,Yorktown,NY,10598,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

Material, Impression (ELW) (8) Syringe, Restorative And Impression Material (EID) (2)

Premarket Exempt

No Yes

Clear

ROOT LABS - VPS - 00818524020110 Catalog Number : RL710

Device Description : ROOT LABS INJECTION FAST/SET HP - 50 ML CARTRIDGE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROOT LABS - VPS - 00818524020127 Catalog Number : RL750

Device Description : ROOT LABS REGULAR BODY REG/SET HP - 50 ML CARTRIDGE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROOT LABS - VPS - 00818524020134 Catalog Number : RL760

Device Description : ROOT LABS REGULAR BODY FAST/SET HP - 50 ML CARTRIDGE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROOT LABS - BITE REGISTRATION - 00818524020141 Catalog Number : RL800

Device Description : ROOT LABS BITE REGISTRATION FAST/SET HP - 50 ML CARTRIDGE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROOT LABS - MIXING TIPS - 00818524020158 Catalog Number : RL850

Device Description : ROOT LABS HP GREEN MIXERS -- (100/BAG)

Device Class : 1

Duns Number: 030479000

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

ROOT LABS - DISPENSER - 00818524020165 Catalog Number : RL762

Device Description : ROOT LABS HP CARTRIDGE DISPENSER

Device Class : 1

Duns Number: 030479000

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

BITE-RITE - 00818524020172 Catalog Number : BIT-9001

Device Description : M&S DENTAL BITE-RITE BITE REGULAR SET 50 mL CART

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

IMPRESS-RITE - 00818524020189 Catalog Number : IMP-9011

Device Description : M&S DENTAL IMPRESS-RITE SHM HEAVY BODY FAST SET 50 mL CART

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020196 Catalog Number : DW15

Device Description : PERFECTO VINYL PUTTY FAST SET (A & B) KIT

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

BITE-RITE - 00818524020202 Catalog Number : BIT-9003

Device Description : M&S DENTAL BITE-RITE BITE SUPER FAST SET - 50 mL CART

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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