FDA.report

Good Fit Immediate Denture Trays

Primary DI
00817610023219
Brand
Good Fit Immediate Denture Trays
Company
GOOD FIT TECHNOLOGIES, LLC
Model
817610023219
Device description
Good Fit Immediate Denture Trays - Lower - M
Published
2017-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EHYTray, Impression, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817610023219PrimaryGS10

GMDN Terms

TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080341158
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00817610025596Good Fit Instant Denture Setups8176100255962019-12-17
00817610025602Good Fit Instant Denture Setups8176100256022019-12-17
00817610025619Good Fit Instant Denture Setups8176100256192019-12-17

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