DentalMark

GUDID B971DM80

Jessop Precision Products Inc.

Dental guided surgery registration/navigation fiducial marker

• Primary Device ID: B971DM80
• NIH Device Record Key: 5d8dc801-52e5-457b-aa1b-2852c9d08481
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentalMark
• Version Model Number: DentalMark 2.0mm flat fiducial markers
• Company DUNS: 055127831
• Company Name: Jessop Precision Products Inc.
• Device Count: 110
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com
• Phone: 800-406-3399
• Email: orders@suremark.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B971DM80 [Unit of Use]
HIBCC	B971DM81 [Primary]

FDA Product Code

• JAC: System, X-Ray, Film Marking, Radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-18
• Device Publish Date: 2021-10-08

On-Brand Devices [DentalMark]

• B971VF200: DentalMark 2.0mm Visionline ball on denture sized
• B971VF100: DentalMark 1.0mm Visionline ball for Cone Beam CT
• B971SF100: DentalMark 1.0mm lead ball for conventional Cephal
• B971DM80: DentalMark 2.0mm flat fiducial markers
• B971CF230: 2.3mm CT ball on denture sized label