SureSmile

GUDID D001V181021

Dentsply International Inc.

Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator

• Primary Device ID: D001V181021
• NIH Device Record Key: 7dead2d7-a266-45e2-87ed-46618a50bae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureSmile
• Version Model Number: V18102
• 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	D001V181021 [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

On-Brand Devices [SureSmile]

• D001V181021: V18102
• D001V181001: V18100