CROWN DELTA CORPORATION

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

PERFECTO - 00818524020004 Catalog Number : DW60

Device Description : PERFECTO HEAVY BODY SHM FAST SET 2 PACK CARTRIDGE KIT

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020011 Catalog Number : DW57

Device Description : PERFECTO MONOPHASE SHM REGULAR/SET 2 PACK CARTRIDGE KIT

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020028 Catalog Number : DW58

Device Description : PERFECTO HEAVY BODY SHM TUBE KIT

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020035 Catalog Number : DW55

Device Description : PERFECTO MONOPHASE SHM TUBE KIT

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020042 Catalog Number : DW07

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

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROOT LABS - PUTTY - 00818524020059 Catalog Number : RL320

Device Description : ROOT LABS, AUTO-ZONED, VINYL PUTTY, ECONO SIZE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROOT LABS - PUTTY - 00818524020066 Catalog Number : RL300

Device Description : ROOT LABS, AUTO-ZONED, VINYL PUTTY, REG SIZE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ROOT LABS - TIPS - 00818524020080 Catalog Number : RL500

Device Description : ROOT LABS INTRA-ORAL TIPS CLEAR -- (100/BAG)

Device Class : 1

Duns Number: 030479000

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

ROOT LABS - MIXING TIPS - 00818524020097 Catalog Number : RL510

Device Description : ROOT LABS RIBBON TIPS -- (100/BAG)

Device Class : 1

Duns Number: 030479000

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

ROOT LABS - VPS - 00818524020103 Catalog Number : RL700

Device Description : ROOT LABS INJECTION REG/SET HP

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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