AccuPlan System MC-K010

GUDID 00810007630335

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT

Medcad

Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory Dental milling system, CAD/CAM, laboratory
Primary Device ID00810007630335
NIH Device Record Keya745ce3e-8246-4f0e-85ba-305cf63a8534
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuPlan System
Version Model NumberMC-K010
Catalog NumberMC-K010
Company DUNS144723868
Company NameMedcad
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com
Phone(214) 453-8864
Emailsupport@medcad.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810007630335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZJDriver, Wire, And Bone Drill, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


[00810007630335]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-07-30

On-Brand Devices [AccuPlan System]

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

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