GOOD FIT TECHNOLOGIES, LLC

Address:13 Way Rd,Gloucester,MA,01930,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

Tray, Impression, Preformed (EHY) (8) Denture Preformed (Partially Prefabricated Denture) (EKO) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

No Yes

Clear

Good Fit Instant Overdentures - 00817610024629 Catalog Number :

Device Description : Good Fit Instant Overdentures - Arch - DV - Lower - L3 - B1

Device Class : 2

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EKO

Prescription Use : No

Device Count : 1

Good Fit Denture Base Acrylic - 00817610025022 Catalog Number :

Device Description : Good Fit Denture Base Acrylic - High Impact - DV - 2.5kg

Device Class : 2

Duns Number: 080341158

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025060 Catalog Number :

Device Description : Good Fit Implant Trays - Upper - SS

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025077 Catalog Number :

Device Description : Good Fit Implant Trays - Upper - MS

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025084 Catalog Number :

Device Description : Good Fit Implant Trays - Upper - MM

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025091 Catalog Number :

Device Description : Good Fit Implant Trays - Upper - ML

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025107 Catalog Number :

Device Description : Good Fit Implant Trays - Upper - LM

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025114 Catalog Number :

Device Description : Good Fit Implant Trays - Upper - LL

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025121 Catalog Number :

Device Description : Good Fit Implant Trays - Lower - SS

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

Good Fit Implant Trays - 00817610025138 Catalog Number :

Device Description : Good Fit Implant Trays - Lower - MS

Device Class : 1

Duns Number: 080341158

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

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