FDA.reportPublic FDA data

AccuPlan® System

Primary DI
00810007630748
Brand
AccuPlan® System
Company
Medcad
Model
ZB-K020-R
Catalog number
ZB-K020-R
Device description
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT
Published
2022-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007630748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007630748008100076307488100076307480810007630748

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
00810007633244AccuStride System MC-KST000MC-KST0002025-06-10
00081000763324AccuStride System MC-KST000MC-KST0002025-05-05
00810007633251AccuStride System MC-KST000-RMC-KST000-R2025-05-05
00810007633268AccuStride System MC-KST001MC-KST0012025-05-05
00810007633275AccuModelMC-3D131MC-3D1312025-05-05
00810007632889AccuPlan System MC-KTP130-H2024-10-18
00810007632896AccuPlan System MC-KTP2302024-10-18
00810007632902AccuPlan System MC-KTP230-H2024-10-18
00810007632919AccuPlan System MC-KP1302024-10-18

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Primary DI, Brand, Company table
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00840124519916PolyLock MidfootFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00888118145086IPSKLS-Martin L.P.DZJ2025-04-22
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00860012759446TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
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00860012759460TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
05420060380747TRUMATCHMaterialise NVDZJ2025-02-28
05420060380754TRUMATCHMaterialise NVDZJ2025-02-28
05420060380761TRUMATCHMaterialise NVDZJ2025-02-28
00840124514416FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCDZJ2024-12-04