Ditron Dental MPI13500

GUDID 07290109280356

Molecular Precision Implant Ø 5.00mm x 13.0mm length

DITRON DENTAL LTD

Basket endosteal dental implant, two-piece

• Primary Device ID: 07290109280356
• NIH Device Record Key: f9292a33-55f0-4e17-8023-15fd8aa9d0d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ditron Dental
• Version Model Number: MPI-13500
• Catalog Number: MPI13500
• Company DUNS: 531878633
• Company Name: DITRON DENTAL LTD
• 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: true
• 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: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com
• Phone: +97286711884
• Email: info@ditrondental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109280356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140728

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-11

On-Brand Devices [Ditron Dental]

• 07290109285627: Surgical Tube
• 07290109285610: Mini Surgical Kit
• 07290109285603: Full Surgical Box
• 07290109285597: Short Twist Drill Ø5.5mm x 11.5mm length
• 07290109285580: Short Twist Drill Ø5.0mm x 11.5mm length
• 07290109285573: Short Twist Drill Ø4.5mm x 11.5mm length
• 07290109285566: Short Twist Drill Ø3.8mm x 11.5mm length
• 07290109285559: Short Twist Drill Ø3.2mm x 11.5mm length
• 07290109285542: Short Twist Drill Ø2.8mm x 11.5mm length
• 07290109285535: Short Twist Drill Ø2.5mm x 11.5mm length
• 07290109285528: Tissue Punch Drill Ø5.0mm
• 07290109285511: Tissue Punch Drill Ø4.5mm
• 07290109285504: Tissue Punch Drill Ø4.0mm
• 07290109285498: Tissue Punch Drill Ø3.0mm
• 07290109285481: Triphine Burr Drill Outer Ø6.0mm, Inner Ø5.0mm, length 16mm
• 07290109285474: Triphine Burr Drill Outer Ø5.0mm, Inner Ø4.0mm, length 16mm
• 07290109285467: Triphine Burr Drill Outer Ø4.0mm, Inner Ø3.0mm, length 16mm
• 07290109285450: Twist Drill Ø5.5mm
• 07290109285443: Twist Drill Ø5.2mm
• 07290109285436: Twist Drill Ø5.0mm
• 07290109285429: Twist Drill Ø4.5mm
• 07290109285412: Twist Drill Ø4.2mm
• 07290109285405: Twist Drill Ø3.8mm
• 07290109285399: Twist Drill Ø3.2mm
• 07290109285382: Twist Drill Ø2.8mm
• 07290109285375: Twist Drill Ø2.5mm
• 07290109285368: Short Pilot Drill Ø2.0mm x 11.5mm length
• 07290109285351: Pilot Drill Ø2.0mm
• 07290109285344: Marking Drill Ø1.9mm
• 07290109285337: Drill with Integral Stopper Ø4.5mm x 8.0mm length
• 07290109285320: Drill with Integral Stopper Ø4.5mm x 6.0mm length
• 07290109285313: Drill with Integral Stopper Ø4.5mm x 13mm length
• 07290109285306: Drill with Integral Stopper Ø4.5mm x 11.5mm length
• 07290109285290: Drill with Integral Stopper Ø4.5mm x 10mm length
• 07290109285283: Drill with Integral Stopper Ø3.8mm x 8.0mm length
• 07290109285276: Drill with Integral Stopper Ø3.8mm x 6.0mm length
• 07290109285269: Drill with Integral Stopper Ø3.8mm x 13mm length
• 07290109285252: Drill with Integral Stopper Ø3.8mm x 11.5mm length
• 07290109285245: Drill with Integral Stopper Ø3.8mm x 10mm length
• 07290109285238: Drill with Integral Stopper Ø3.2mm x 8.0mm length
• 07290109285221: Drill with Integral Stopper Ø3.2mm x 6.0mm length
• 07290109285214: Drill with Integral Stopper Ø3.2mm x 13mm length
• 07290109285207: Drill with Integral Stopper Ø3.2mm x 11.5mm length
• 07290109285191: Drill with Integral Stopper Ø3.2mm x 10mm length
• 07290109285184: Drill with Integral Stopper Ø2.8mm x 8.0mm length
• 07290109285177: Drill with Integral Stopper Ø2.8mm x 6.0mm length
• 07290109285160: Drill with Integral Stopper Ø2.8mm x 13mm length
• 07290109285153: Drill with Integral Stopper Ø2.8mm x 11.5mm length
• 07290109285146: Drill with Integral Stopper Ø2.8mm x 10mm length
• 07290109285139: Drill with Integral Stopper Ø2.5mm x 8.0mm length