Smart MTA

GUDID 08800027200023

SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is ideal for one-visit treatment. SmartMTA contains no heavy metals and will not discolor after application. SmartMTA has a wide variety of clinical indications such as partial and complete pulpotomy for deciduous teeth, direct and indirect pulp capping, base formation, root repair and prevention of discoloration when used for tooth whitening procedures.

BioMTA

Endodontic filling/sealing material
Primary Device ID08800027200023
NIH Device Record Key8248c305-0f14-46bb-926e-73df994fd504
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart MTA
Version Model NumberSmMTA-10
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
GS108800027200023 [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 Date2017-06-13

Devices Manufactured by BioMTA

08800027200023 - Smart MTA2024-04-10SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is ideal for one-visit treatment. SmartMTA contains no heavy metals and will not discolor after application. SmartMTA has a wide variety of clinical indications such as partial and complete pulpotomy for deciduous teeth, direct and indirect pulp capping, base formation, root repair and prevention of discoloration when used for tooth whitening procedures.
08800027200023 - Smart MTA2024-04-10 SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is i
08800027200030 - SmartMTA2024-04-10 SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is i
08800027200047 - RetroMTA(RetroMTA-OrthoMTAII)2024-04-10 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 met
08800027200054 - RetroMTA(RetroMTA-OrthoMTAII)2024-04-10 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 met
08800027200061 - OrthoMTA2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf
08800027200078 - OrthoMTA2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf
08800027200085 - OrhtoMTA Needle Tips2024-04-10 Disposable and bendable and it is compatible with OrthoMTA Carrier.
08800027200092 - Ultrasonic Tip CM (BUST-CM)2024-04-10 Used to remove dental calculus. Also, it is used to remove foreign substances in the apical foramen of the root canal.

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