FDA.reportPublic FDA data

Good Fit Instant Overdentures

Primary DI
00817610021697
Brand
Good Fit Instant Overdentures
Company
GOOD FIT TECHNOLOGIES, LLC
Model
817610021697
Device description
Good Fit Instant Overdentures - Arch - Upper - M2 - A1
Published
2017-01-10
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
00817610021697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817610021697008176100216978176100216970817610021697

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