FDA.reportPublic FDA data

AccuPlan System

Primary DI
00810007630533
Brand
AccuPlan System
Company
Medcad
Model
MC-K000-R
Catalog number
MC-K000-R
Device description
ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT
Published
2021-07-30
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192282000MedCAD® AccuPlan® SystemMedcad2020-10-29DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007630533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007630533008100076305338100076305330810007630533

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, laboratoryAn assembly of software-based 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 for 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
00810007633282AccuStride SystemMC-3D132MC-3D1322025-06-30
00810007633299AccuStride SystemMC-3D133MC-3D1332025-06-30
00810007633305AccuStride SystemMC-3D134MC-3D1342025-06-30
00810007633312AccuStride SystemMC-3D131MC-3D1312025-06-30
00810007633244AccuStride SystemMC-KST000MC-KST0002025-06-10
00081000763324AccuStride SystemMC-KST000MC-KST0002025-05-05
00810007633251AccuStride SystemMC-KST000-RMC-KST000-R2025-05-05
00810007633268AccuStride SystemMC-KST001MC-KST0012025-05-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00860003424834OrthoGrid Hip AIOrthogrid Systems, Inc.LLZ2022-05-19
07649990819006OsiriX MDPixmeo SàrlLLZ2022-02-19
00860003424827OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2021-08-27
00860003424803OrthoGrid HipOrthogrid Systems, Inc.LLZ2021-03-05
00860003424810OrthoGrid Hip PreservationOrthogrid Systems, Inc.LLZ2021-03-05
00350227300071FUSEPATTERSON TECHNOLOGY CENTERLLZ2020-09-19
00817886020226JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020233JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020240JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020257JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020264JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020271JointsMEDSTRAT, INC.LLZ2020-08-03
00350227300064FUSEPATTERSON TECHNOLOGY CENTERLLZ2020-06-02