DentalMark

Basic Information

• Brand Name: DentalMark
• Primary DI: B971DM81
• Version / Model: DentalMark 2.0mm flat fiducial markers
• Company Name: Jessop Precision Products Inc.
• Labeler DUNS: 055127831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 110
• Record Status: Published
• Publish Date: 2021-10-08
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 5d8dc801-52e5-457b-aa1b-2852c9d08481

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: 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
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	892.1640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63530	Dental guided surgery registration/navigation spatial marker	A non-powered device designed to be attached to the patient’s tooth/teeth to mark the location where a dental procedure (e.g., drilling, implant placement) is to occur during guided dental implantation surgery. It is intended to remain in situ during the preoperative patient registration chairside cone beam computerized tomography (CBCT) scan, and during the dental procedure, to assist with intraoperative navigation (e.g., using optical tracking). Also referred as a navigation fiducial marker, it is made of plastic and radiopaque materials and is attached via dental impression. This is a single-patient device which may be reattached to the patient during the procedure before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B971DM80	HIBCC
Primary	B971DM81	HIBCC

Customer Contacts

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