RetroMTA(RetroMTA-OrthoMTAII)

GUDID 08800027200054

RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy metal contents in it and no discoloration after application. RetroMTA has a wide variety of clinical indications such as for pulp capping or pulpotomy for deciduous and young teeth, apexification and base cement for prevention of discoloration or for tooth whitening procedure.

BioMTA

Endodontic filling/sealing material
Primary Device ID08800027200054
NIH Device Record Key1ebfc16e-c64d-4223-a644-1436cf552b76
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetroMTA(RetroMTA-OrthoMTAII)
Version Model NumberRM02
Company DUNS694860083
Company NameBioMTA
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800027200054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-04-10
Device Publish Date2017-06-19

On-Brand Devices [RetroMTA(RetroMTA-OrthoMTAII)]

08800027200054RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/
08800027200047RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/

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