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) (10)

Premarket Exempt

No Yes

Clear

IMPRESS-RITE - 00818524020226 Catalog Number : IMP-9009

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

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

IMPRESS-RITE - 00818524020233 Catalog Number : IMP-9004

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

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020240 Catalog Number : DW62

Device Description : PERFECTO LIGHT BODY SHM YELLOW REGULAR SET - 50 mL CARTRIDGE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020257 Catalog Number : DW63

Device Description : PERFECTO LIGHT BODY SHM YELLOW FAST SET - 50 mL CARTRIDGE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

IMPRESS-RITE - 00818524020264 Catalog Number : IMP-9007

Device Description : M&S DENTAL IMPRESS-RITE SHM MONOPHASE REGULAR SET - 50 mL CART

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020271 Catalog Number : DW59

Device Description : PERFECTO HEAVY BODY SHM REGULAR SET

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

BITE-RITE - 00818524020288 Catalog Number : BIT-9002

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

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020295 Catalog Number : DW61

Device Description : PERFECTO LIGHT BODY SHM YELLOW TUBE KIT

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

IMPRESS-RITE - 00818524020301 Catalog Number : IMP-9010

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

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

PERFECTO - 00818524020318 Catalog Number : DW99

Device Description : PERFECTO CAD-CAM FAST SET CARTRIDGE

Device Class : 2

Duns Number: 030479000

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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