Bonafix

GUDID 00850074346012

Bonafix Two Implant 3.50 x 10mm Finished

Zentek Medical LLC

Screw endosteal dental implant, two-piece

• Primary Device ID: 00850074346012
• NIH Device Record Key: 727a8267-3df0-41b6-aabc-6a399610387d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonafix
• Version Model Number: BTIM3510N
• Company DUNS: 086804993
• Company Name: Zentek Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com
• Phone: 7329792502
• Email: info@bonafixsdi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850074346012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213677

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-11
• Device Publish Date: 2025-06-03

On-Brand Devices [Bonafix]

• 00850074346241: Tapered Screw Vent 35 Long Ti base NE
• 00850074346234: Tapered Screw Vent 35 Long Ti base
• 00850074346227: Bonafix Two Implant 6.00 x 11.5mm Finished.
• 00850074346210: Bonafix Two Implant 6.00 x 10mm Finished
• 00850074346203: Bonafix Two Implant 6.00 x 8mm Finished
• 00850074346197: Bonafix Two Implant 5.00 x 16mm Finished
• 00850074346180: Bonafix Two Implant 5.00 x 13mm Finished
• 00850074346173: Bonafix Two Implant 5.00 x 10mm Finished
• 00850074346166: Bonafix Two Implant 5.00 x 11.5mm Finished
• 00850074346159: Bonafix Two Implant 5.00 x 8mm Finished
• 00850074346142: Bonafix Two Implant 4.20 x 16mm Finished
• 00850074346135: Bonafix Two Implant 4.20 x 13mm Finished
• 00850074346128: Bonafix Two Implant 4.20 x 11.5mm Finished
• 00850074346111: Bonafix Two Implant 4.20 x 10mm Finished
• 00850074346104: Bonafix Two Implant 4.20 x 8mm Finished
• 00850074346098: Bonafix Two Implant 3.70 x 16mm Finished
• 00850074346081: Bonafix Two Implant 3.70 x 13mm Finished
• 00850074346074: Bonafix Two Implant 3.70 x 11.5mm Finished
• 00850074346067: Bonafix Two Implant 3.70 x 10mm Finished
• 00850074346050: Bonafix Two Implant 3.70 x 8mm Finished
• 00850074346043: Bonafix Two Implant 3.50 x 16mm Finished
• 00850074346036: Bonafix Two Implant 3.50 x 13mm Finished
• 00850074346029: Bonafix Two Implant 3.50 x 11.5mm Finished
• 00850074346012: Bonafix Two Implant 3.50 x 10mm Finished
• 00850074346005: Bonafix Two Implant 3.50 x 8mm Finished