Multi-Adjustable Face Mask

GUDID D828FM220017296

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic extraoral headgear Orthodontic extraoral headgear

• Primary Device ID: D828FM220017296
• NIH Device Record Key: e274b669-0c76-48ac-b24f-4eebd01cac66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Adjustable Face Mask
• Version Model Number: FM220017296
• Company DUNS: 113352686
• Company Name: FIVE STAR ORTHODONTIC LABORATORY & SUPPLY 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D828FM220017296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000358

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-04

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