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

Headgear, Extraoral, Orthodontic (DZB) (5) Mouthpiece, Saliva Ejector (DYN) (4) Accessories, Retractor, Dental (EIF) (1)

Premarket Exempt

No Yes

Clear

CHIN CUP SM-ORTHOPEDIC CHIN *O - D7753003040 Catalog Number : 300-304

Device Description : CHIN CUP SM-ORTHOPEDIC CHIN *O

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DZB

Prescription Use : Yes

Device Count : 1

SM FACE MASK PROTRACTION *O - D7753003060 Catalog Number : 300-306

Device Description : SM FACE MASK PROTRACTION *O

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DZB

Prescription Use : Yes

Device Count : 1

LG FACE MASK PROTRACTION *O - D7753003070 Catalog Number : 300-307

Device Description : LG FACE MASK PROTRACTION *O

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DZB

Prescription Use : Yes

Device Count : 1

SM HICKHAM PROTRACTION *O - D7753003080 Catalog Number : 300-308

Device Description : SM HICKHAM PROTRACTION *O

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DZB

Prescription Use : Yes

Device Count : 1

LG HICKHAM PROTRACTION *O - D7753003090 Catalog Number : 300-309

Device Description : LG HICKHAM PROTRACTION *O

Device Class : 2

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DZB

Prescription Use : Yes

Device Count : 1

SM DRYFIELD KIT RED *I - D7753004000 Catalog Number : 300-400

Device Description : SM DRYFIELD KIT RED *I

Device Class : 1

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : Yes

Device Count : 1

LG DRYFIELD KIT WHITE *I - D7753004010 Catalog Number : 300-401

Device Description : LG DRYFIELD KIT WHITE *I

Device Class : 1

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : Yes

Device Count : 1

RETRACTOR - LARGE WHITE *I - D7753004060 Catalog Number : 300-406

Device Description : RETRACTOR - LARGE WHITE *I

Device Class : 1

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : Yes

Device Count : 1

RETRACTOR - SMALL RED *I - D7753004140 Catalog Number : 300-414

Device Description : RETRACTOR - SMALL RED *I

Device Class : 1

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : Yes

Device Count : 1

LARGE LIP RETRACTOR *O - D7753006120 Catalog Number : 300-612

Device Description : LARGE LIP RETRACTOR *O

Device Class : 1

Duns Number: 041854332

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

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