Great Lakes Dental Technologies, Ltd.

Address:200 COOPER AVENUE,TONAWANDA,NY,14150,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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (10)

Premarket Exempt

No Yes

Clear

2OZ NEON BLUE POWDER - D7750450240 Catalog Number : 045-024

Device Description : 2OZ NEON BLUE POWDER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

2OZ NEON YELLOW POWDER - D7750450250 Catalog Number : 045-025

Device Description : 2OZ NEON YELLOW POWDER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

2OZ NEON GREEN POWDER - D7750450260 Catalog Number : 045-026

Device Description : 2OZ NEON GREEN POWDER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

1LB NEON BLUE POWDER - D7750450270 Catalog Number : 045-027

Device Description : 1LB NEON BLUE POWDER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

NEON YELLOW POWDER ONLY 1LB - D7750450280 Catalog Number : 045-028

Device Description : NEON YELLOW POWDER ONLY 1LB

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

1LB NEON GREEN POWDER - D7750450290 Catalog Number : 045-029

Device Description : 1LB NEON GREEN POWDER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

4OZ RED DYE CONCENTRATE - D7750450300 Catalog Number : 045-030

Device Description : 4OZ RED DYE CONCENTRATE

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

4OZ BLUE DYE CONCENTRATE - D7750450310 Catalog Number : 045-031

Device Description : 4OZ BLUE DYE CONCENTRATE

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

2oz YELLOW DYE CONCENTRATE - D7750450320 Catalog Number : 045-032

Device Description : 2oz YELLOW DYE CONCENTRATE

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

2oz GREEN DYE CONCENTRATE - D7750450330 Catalog Number : 045-033

Device Description : 2oz GREEN DYE CONCENTRATE

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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