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 Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material

• Primary Device ID: 08800027200023
• NIH Device Record Key: 8248c305-0f14-46bb-926e-73df994fd504
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart MTA
• Version Model Number: SmMTA-10
• Company DUNS: 694860083
• Company Name: BioMTA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800027200023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132825

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-04-10
• Device Publish Date: 2017-06-13

Devices Manufactured by BioMTA

• 08800027200023 - Smart MTA: 2024-04-10SmartMTA 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 MTA: 2024-04-10 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 - SmartMTA: 2024-04-10 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 - OrthoMTA: 2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf
• 08800027200078 - OrthoMTA: 2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf
• 08800027200085 - OrhtoMTA Needle Tips: 2024-04-10 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.