RetroMTA(RetroMTA-OrthoMTAII)

GUDID 08800027200047

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 ID: 08800027200047
• NIH Device Record Key: 8fb14e62-d5fa-4ab3-b81f-5ae98be981b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RetroMTA(RetroMTA-OrthoMTAII)
• Version Model Number: RM08
• 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	08800027200047 [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: 2017-06-19

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

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