Good Fit Denture Base Acrylic

GUDID 00817610025022

Good Fit Denture Base Acrylic - High Impact - DV - 2.5kg

GOOD FIT TECHNOLOGIES, LLC

Dental appliance fabrication material, cured
Primary Device ID00817610025022
NIH Device Record Key755327f3-be9f-4e9e-af6a-3c3842d68b44
Commercial Distribution StatusIn Commercial Distribution
Brand NameGood Fit Denture Base Acrylic
Version Model Number817610025022
Company DUNS080341158
Company NameGOOD FIT TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817610025022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-06-24

On-Brand Devices [Good Fit Denture Base Acrylic]

00817610025022Good Fit Denture Base Acrylic - High Impact - DV - 2.5kg
00817610023349Good Fit Denture Base Acrylic - High Impact - 2.5kg
00817610023332Good Fit Denture Base Acrylic - High Impact - 0.5kg

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