FDA.reportPublic FDA data

AccuPlan System

Primary DI
00810007631912
Brand
AccuPlan System
Company
Medcad
Model
MC-KTP100-H
Catalog number
MC-KTP100-H
Device description
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE AND TITANIUM HYBRID GUIDES BUNDLE
Published
2023-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
JEYPlate, Bone
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
JEYPlate, BoneDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007631912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007631912008100076319128100076319120810007631912

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, laboratoryAn assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for production of the actual device(s) for delivery and final fitting to the patient.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(214) 453-8864support@medcad.com

Regulatory Flags#

DUNS number
144723868
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007633442AccuStride System MC-KSP003MC-KSP0032026-02-20
00810007633398AccuStride System MC-STP001MC-STP0012026-02-04
00810007633404AccuStride System MC-STP002MC-STP0022026-02-04
00810007633411AccuStride System MC-KSP000MC-KSP0002026-02-04
00810007633428AccuStride System MC-KSP001MC-KSP0012026-02-04
00810007633435AccuStride System MC-KSP002MC-KSP0022026-02-04
00810007633343AccuPlan SystemMC-3D217MC-3D2172025-10-31
00810007633350AccuPlan SystemMC-3D218MC-3D2182025-10-31
00810007633367AccuPlan SystemZB-3D217ZB-3D2172025-10-31
00810007633374AccuPlan SystemZB-3D218ZB-3D2182025-10-31
00810007633381AccuPlan SystemZB-KFITZB-KFIT2025-10-31
00810007633336AccuPlan System MC-KFITMC-KFIT2025-10-30
00810007633329AccuStride System MC-STP001MC-STP0012025-08-25
00810007633282AccuStride System MC-3D132MC-3D1322025-06-30
00810007633299AccuStride System MC-3D133MC-3D1332025-06-30
00810007633305AccuStride System MC-3D134MC-3D1342025-06-30
00810007633312AccuStride System MC-3D131MC-3D1312025-06-30
00810007633275AccuModelMC-3D131MC-3D1312025-05-05
00810007633244AccuStride System MC-KST000MC-KST0002025-06-10
00081000763324AccuStride System MC-KST000MC-KST0002025-05-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
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00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
00860012615315Denti.AI DetectDenti.AI Technology IncLLZ2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00850059977477TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-04-17
00850059977484TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-04-17
00850059977491TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-04-17
00850059977507TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-04-17
00850059977514TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-04-17
00850059977422TIMS SystemFORESIGHT IMAGING, LLCLLZ2025-10-06