Great Lakes Dental Technologies, Ltd.

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

5LB KIT SPLINT RESIN CLEAR *O - D7750400010 Catalog Number : 040-001

Device Description : 5LB KIT SPLINT RESIN CLEAR *O

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

1QT SPLINT MONOMER - D7750400020 Catalog Number : 040-002

Device Description : 1QT SPLINT MONOMER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

5LB SPLINT POLYMER - D7750400030 Catalog Number : 040-003

Device Description : 5LB SPLINT POLYMER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

FAST-WHITE RESIN KIT - D7750400040 Catalog Number : 040-004

Device Description : FAST-WHITE RESIN KIT

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

25LB SPLINT POLYMER CLEAR - D7750400050 Catalog Number : 040-005

Device Description : 25LB SPLINT POLYMER CLEAR

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

1LB FAST WHITE POLYMER - D7750400060 Catalog Number : 040-006

Device Description : 1LB FAST WHITE POLYMER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

1LB KIT SPLINT RESIN *O - D7750400080 Catalog Number : 040-008

Device Description : 1LB KIT SPLINT RESIN *O

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

8OZ SPLINT (CLEAR) MONOMER - D7750400090 Catalog Number : 040-009

Device Description : 8OZ SPLINT (CLEAR) MONOMER

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

1LB SPLINT POLYMER CLEAR - D7750400100 Catalog Number : 040-010

Device Description : 1LB SPLINT POLYMER CLEAR

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

#62 TOOTH SHADE 1# (ACRYLIC) - D7750400120 Catalog Number : 040-012

Device Description : #62 TOOTH SHADE 1# (ACRYLIC)

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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