DISPOSABLE EDENTULOUS TRAYS SMALL UPPER 7158226

GUDID 00723896025215

Impression tray used for edentulous patients, can be heated and molded to fit patient's mouth.

PRACTICON, INC.

Dental impression tray, single-use
Primary Device ID00723896025215
NIH Device Record Key4f70546a-e3b3-4e5a-80d3-ce93c435fb19
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISPOSABLE EDENTULOUS TRAYS SMALL UPPER
Version Model Number7158226
Catalog Number7158226
Company DUNS119193803
Company NamePRACTICON, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100723896025154 [Primary]
GS100723896025215 [Package]
Contains: 00723896025154
Package: case [10 Units]
In Commercial Distribution

FDA Product Code

EHYTray, Impression, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-02
Device Publish Date2024-07-25

Devices Manufactured by PRACTICON, INC.

00723896025994 - SMILEGOODS 3 IN 1 FLOSSERS2024-08-15 Flosser that combines a flosser, pick, and interdental brush. Individually wrapped. 500 per pack.
00723896026342 - 2.75" X 10" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026373 - 3.5" X 6.5" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026403 - 3.5" X 10" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026434 - 5.25" X 11" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026632 - PRACTIFILM BARRIER FILM BLUE2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
00723896026663 - PRACTIFILM BARRIER FILM BLACK2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
00723896026694 - PRACTIFILM BARRIER FILM CLEAR2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.