AccuPlan System MC-K004

GUDID 00810007630342

ORTHOGNATHIC, SURGICAL GUIDE

Medcad

Dental CAD/CAM system, laboratory

• Primary Device ID: 00810007630342
• NIH Device Record Key: 767e8a81-9e87-4bed-921f-a78fb21fd7dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuPlan System
• Version Model Number: MC-K004
• Catalog Number: MC-K004
• Company DUNS: 144723868
• Company Name: Medcad
• 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: false
• Expiration Date: false
• 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: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007630342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192282

FDA Product Code

• DZJ: Driver, Wire, And Bone Drill, Manual

Sterilization

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

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

[00810007630342]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [AccuPlan System]

• 00810007630533: ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT
• 00810007630441: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT
• 00810007630427: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT
• 00810007630373: MIDFACE RECONSTRUCTION, SURGICAL GUIDE
• 00810007630366: MANDIBLE RECONSTRUCTION, SURGICAL GUIDE
• 00810007630359: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT
• 00810007630342: ORTHOGNATHIC, SURGICAL GUIDE
• 00810007630335: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT
• 00810007630328: ORTHOGNATHIC, 3D PRINTED DENTAL MODELS
• 00810007630311: ORTHOGNATHIC, FINAL SPLINT
• 00810007630304: ORTHOGNATHIC, INTERMEDIATE SPLINT
• 00810007630298: ORTHOGNATHIC, SURGICAL PLANNING KIT
• 00864582000298: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SI
• 00864582000281: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JA
• 00864582000274: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
• 00810007632452: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
• 00810007632445: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
• 00810007632438: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID
• 00810007632421: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES
• 00810007632414: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID
• 00810007632407: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES
• 00810007632391: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE AND TITANIUM HYBRID GUIDES BUNDLE
• 00810007632384: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE AND TITANIUM GUIDES BUNDLE
• 00810007632377: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE AND TITANIUM HYBRID GUIDES BUNDLE
• 00810007632360: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE AND TITANIUM GUIDES BUNDLE
• 00810007632353: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND GUIDES, DOUBLE JAW BUNDLE
• 00810007632346: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES, DOUBLE JAW BUNDLE
• 00810007632339: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND GUIDES, SINGLE JAW BUNDLE
• 00810007632322: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES, SINGLE JAW BUNDLE
• 00810007632315: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND GUIDES BUNDLE
• 00810007632308: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
• 00810007632292: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, DO
• 00810007632285: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, DOUBLE JA
• 00810007632278: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SI
• 00810007632261: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JA
• 00810007632254: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
• 00810007632247: ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES
• 00810007632216: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
• 00810007632193: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID
• 00810007632186: MIDFACE RECONSTRUCTION, TITANIUM HYBRID SURGICAL GUIDE
• 00810007632179: MIDFACE RECONSTRUCTION, TITANIUM SURGICAL GUIDE
• 00810007632162: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM HYBRID GUIDES
• 00810007632155: MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM GUIDES
• 00810007632148: ORTHOPEDIC, TITANIUM HYBRID SURGICAL GUIDE, FIBULA
• 00810007632131: ORTHOPEDIC, TITANIUM SURGICAL GUIDE, FIBULA
• 00810007632124: ORTHOPEDIC, TITANIUM HYBRID SURGICAL GUIDE, GRAFT
• 00810007632117: ORTHOPEDIC, TITANIUM SURGICAL GUIDE, GRAFT
• 00810007632087: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM HYBRID GUIDES
• 00810007632070: MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT, W/ TITANIUM GUIDES
• 00810007632063: ORTHOPEDIC, SURGICAL GUIDE, FIBULA