Bite Fork Adapter / Fusion Bite Adapter

Basic Information

• Brand Name: Bite Fork Adapter / Fusion Bite Adapter
• Primary DI: B915019604000
• Version / Model: 01960400
• Company Name: zebris MEDICAL GmbH
• Labeler DUNS: 328971791
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-13
• Public Version: 1
• Public Version Date: 2023-07-21
• Public Version Status: New
• Public Device Record Key: 33b8e6c3-db37-45f2-bd76-e8bfeaab3d41

Device Description

The Bite Fork Adapter is an accessory of the JMT+ facebow and used for connecting the lower jaw sensor to a bite fork.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions	Dental	872.2060	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	B915019604000	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius