Full Form Extraoral Facebow

GUDID 00190730004574

Extraoral Facebow Universal Long

ORTHO TECHNOLOGY, INC.

Orthodontic face bow

• Primary Device ID: 00190730004574
• NIH Device Record Key: 61066510-4ae7-4bc9-810f-790defa0ef3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Full Form Extraoral Facebow
• Version Model Number: 551-110
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
GS1	00190730004574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980195

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: 2016-09-24

On-Brand Devices [Full Form Extraoral Facebow]

• 00190730004581: Extraoral Facebow Universal Standard
• 00190730004574: Extraoral Facebow Universal Long
• 00190730004567: Extraoral Facebow FF 111mm #5
• 00190730004550: Extraoral Facebow FF 104mm #4
• 00190730004543: Extraoral Facebow FF 97mm #3
• 00190730004536: Extraoral Facebow FF 90mm #2
• 00190730004529: Extraoral Facebow FF 83mm #1