TORQUEMASTER 20 4HOLE

GUDID D826TM2040

TORQUE MASTER 20 4-HOLE IS AN ADJUSTABLE SPEED UP TO 20000 RPM LOW SPEED PNEUMATIC DENTAL MOTOR, USED IN CONJUNCTION WITH OTHER ATTACHMENTS SUCH AS BURS AND MANDRELS WHICH CONNECTS TO AN OPERATORY TO DRILL BONE, TEETH AND TOUGH TISSUES IN A DENTAL SETTING. REMOVING CALCULUS AND POLISHING TEEETH

MTI Precision Products, LLC

Dental surgical power tool motor, pneumatic

• Primary Device ID: D826TM2040
• NIH Device Record Key: e6e9fdf3-2d78-4635-93a3-3abae2e94ed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TORQUEMASTER 20 4HOLE
• Version Model Number: TM204
• Company DUNS: 081600128
• Company Name: MTI Precision Products, LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D826TM204 [Primary]
HIBCC	D826TM2040 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895736

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

[D826TM2040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-10

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