FDA.reportPublic FDA data

AccuPlan System

Primary DI
00810007631202
Brand
AccuPlan System
Company
Medcad
Model
ZB-KT001
Catalog number
ZB-KT001
Device description
ORTHOGNATHIC, TITANIUM SURGICAL GUIDE
Published
2023-11-01
Public version status
New
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
K223024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223024000MedCAD AccuPlan SystemMedcad2023-03-07DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007631202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007631202008100076312028100076312020810007631202

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
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
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
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
00817886020394JointsMEDSTRAT, INC.LLZ2021-10-15
00817886020387JointsMEDSTRAT, INC.LLZ2021-09-08
00817886020370JointsMEDSTRAT, INC.LLZ2021-07-30
00817886020363JointsMEDSTRAT, INC.LLZ2021-07-02
00817886020356JointsMEDSTRAT, INC.LLZ2021-06-01
00817886020349JointsMEDSTRAT, INC.LLZ2021-04-05
00817886020332JointsMEDSTRAT, INC.LLZ2021-02-26
00817886020325JointsMEDSTRAT, INC.LLZ2021-01-29
00817886020318JointsMEDSTRAT, INC.LLZ2020-12-11
00817886020301JointsMEDSTRAT, INC.LLZ2020-11-02
00817886020295JointsMEDSTRAT, INC.LLZ2020-10-05
00350227300071FUSEPATTERSON TECHNOLOGY CENTERLLZ2020-09-19
00817886020288JointsMEDSTRAT, INC.LLZ2020-08-31
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