DentaTRY A1

GUDID 09359215000161

ASIGA PTY LTD

Dental appliance fabrication material, resin
Primary Device ID09359215000161
NIH Device Record Key5ad8b25e-70bf-4d95-b4b5-afca5f1237c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDentaTRY A1
Version Model Number03768
Company DUNS745954045
Company NameASIGA PTY LTD
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109359215000161 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-14
Device Publish Date2024-02-06

Devices Manufactured by ASIGA PTY LTD

09359215000031 - DentaGUIDE2024-02-14
09359215000055 - DentaIBT2024-02-14
09359215000093 - DentaTRAY2024-02-14
09359215000161 - DentaTRY A12024-02-14
09359215000161 - DentaTRY A12024-02-14
09359215000178 - DentaTRY A22024-02-14
09359215000185 - DentaTRY A32024-02-14
09359215000192 - DentaTRY B12024-02-14
09359215000208 - DentaTRY B22024-02-14

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