SureSmile

GUDID D001V181021

Dentsply International Inc.

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