OrthoMTA

GUDID 08800027200061

OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely infected canal, and re-endo of acute periapical abscess. Furthermore, OrthoMTA has a wide variety of clinical indications such as for apexification, repair of root perforations, and internal root resporption.

BioMTA

Endodontic filling/sealing material

• Primary Device ID: 08800027200061
• NIH Device Record Key: dce417f0-7c33-42da-8b82-315ce9a4c13a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoMTA
• Version Model Number: OM05
• 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: true
• 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	08800027200061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102575

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: 2017-06-22

On-Brand Devices [OrthoMTA]

• 08800027200078: OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, cr
• 08800027200061: OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, cr