OneBite™ Facial Axis Recorder

Basic Information

• Brand Name: OneBite™ Facial Axis Recorder
• Primary DI: 07540172012768
• Version / Model: 052148
• Catalog Number: 052148
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• Labeler DUNS: 626406016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-17
• Public Version: 2
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: 1f05aa7b-7a00-4f31-bd9d-5867f464ef61

Device Description

Dental facebow measuring device

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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	07540172012768	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]