DentaTOOTH

GUDID 09359215000109

DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce temproary dental restorations. DentaTOOTH has been validated for use with the Asiga Max and Pro Series printers for manufacture of temporary dental resins at 385nm wavelengths.

ASIGA PTY LTD

Dental appliance fabrication material, resin
Primary Device ID09359215000109
NIH Device Record Key2036026f-925d-414b-b314-b419fab6dcd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDentaTOOTH
Version Model Number03624
Company DUNS745954045
Company NameASIGA PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
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
GS109359215000109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

Devices Manufactured by ASIGA PTY LTD

09359215000109 - DentaTOOTH2025-05-20DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce temproary dental restorations. DentaTOOTH has been validated for use with the Asiga Max and Pro Series printers for manufacture of temporary dental resins at 385nm wavelengths.
09359215000109 - DentaTOOTH2025-05-20 DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including tempo
09359215000369 - DentaBASE2025-04-25 Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin
09359215000031 - DentaGUIDE2024-02-14
09359215000055 - DentaIBT2024-02-14
09359215000093 - DentaTRAY2024-02-14
09359215000161 - DentaTRY A12024-02-14
09359215000178 - DentaTRY A22024-02-14
09359215000185 - DentaTRY A32024-02-14

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