Facial Plane Relator

Basic Information

• Brand Name: Facial Plane Relator
• Primary DI: 00850211006144
• Version / Model: FPR-102
• Company Name: HO DENTAL COMPANY LLC
• Labeler DUNS: 012676012
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-05-17
• Public Version: 1
• Public Version Date: 2023-05-25
• Public Version Status: New
• Public Device Record Key: 9e0d1b47-ce00-4e92-b802-d45a1a33b22a

Device Description

This product can be used with bite registration material.The horizontal alignment bar features an arch with 25 fingers for stabilizing the unit within the registration material. The vertical alignment bar snaps on. Comes in bulk of 100

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCR	Facebow	Dental	872.3220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35700	Facebow	A caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850211006144	GS1
Unit of Use	00850211006571	GS1