Ultrasonic Tip 0.3mm (BUST-03)

GUDID 08800027200108

Used to remove dental calculus. Also, it is used to remove foreign substances in the middle to apical area of the root canal.

BioMTA

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

• Primary Device ID: 08800027200108
• NIH Device Record Key: abd55f48-d0e6-4bd5-9490-c2e951d4d22d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasonic Tip 0.3mm (BUST-03)
• Version Model Number: BUST-03
• Company DUNS: 694860083
• Company Name: BioMTA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08800027200108 [Primary]

FDA Product Code

• DZP: Instrument, Diamond, Dental

Sterilization

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

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-04-10
• Device Publish Date: 2017-09-01

Devices Manufactured by BioMTA

• 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.