FDA.reportPublic FDA data

Good Fit Instant Denture Setups

Primary DI
00817610021123
Brand
Good Fit Instant Denture Setups
Company
GOOD FIT TECHNOLOGIES, LLC
Model
817610021123
Device description
Good Fit Instant Denture Setups - Arch - Lower - M2 - A2
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EKODenture Preformed (Partially Prefabricated Denture)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKODenture Preformed (Partially Prefabricated Denture)Dental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817610021123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817610021123008176100211238176100211230817610021123

GMDN Terms#

Term, Definition table
TermDefinition
Preformed complete dentureA prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080341158
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817610023332Good Fit Denture Base Acrylic8176100233322017-01-10
00817610023349Good Fit Denture Base Acrylic8176100233492017-01-10
00817610025022Good Fit Denture Base Acrylic8176100250222017-06-24
00817610025190Good Fit Instant Overdentures8176100251902019-12-17
00817610025206Good Fit Instant Overdentures8176100252062019-12-17
00817610025213Good Fit Instant Overdentures8176100252132019-12-17
00817610025220Good Fit Instant Overdentures8176100252202019-12-17
00817610025237Good Fit Instant Overdentures8176100252372019-12-17
00817610025244Good Fit Instant Overdentures8176100252442019-12-17
00817610025251Good Fit Instant Overdentures8176100252512019-12-17
00817610025268Good Fit Instant Overdentures8176100252682019-12-17
00817610025275Good Fit Instant Overdentures8176100252752019-12-17
00817610025282Good Fit Instant Overdentures8176100252822019-12-17
00817610025299Good Fit Instant Overdentures8176100252992019-12-17
00817610025305Good Fit Instant Overdentures8176100253052019-12-17
00817610025541Good Fit Instant Denture Setups8176100255412019-12-17
00817610025558Good Fit Instant Denture Setups8176100255582019-12-17
00817610025565Good Fit Instant Denture Setups8176100255652019-12-17
00817610025572Good Fit Instant Denture Setups8176100255722019-12-17
00817610025589Good Fit Instant Denture Setups8176100255892019-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7091032138Baltic Denture System BDCreatorMerz Dental GmbHEKO2017-11-25
D7091032228Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032229Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032230Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032231Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032232Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032233Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032234Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032235Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032236Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032237Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032238Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032239Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032240Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032241Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032242Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032243Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032244Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032245Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032246Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032247Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032248Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032249Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032250Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032251Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032252Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032253Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032254Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032255Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032256Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03