Byte

GUDID D001V181151

Dentsply International Inc.

Orthodontic vibrator

• Primary Device ID: D001V181151
• NIH Device Record Key: dda813bb-f100-4b2f-a4d4-19fdd168d9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Byte
• Version Model Number: V18115
• Company DUNS: 795572718
• Company Name: Dentsply International Inc.
• 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: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D001V181151 [Primary]

FDA Product Code

• OYH: Orthodontic vibratory accessory

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-21
• Device Publish Date: 2022-11-11

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• D0019064170 - Lucitone: 2025-07-09 Primeprint Lucitone Digital Value Trial Placement B2
• D0019064180 - Lucitone: 2025-07-09 Primeprint Lucitone Digital Value Trial Placement BL3
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• D0016055421 - DENTSPLY Sirona®: 2025-03-25 Overglaze High Flu