FDA.report

AccuPlan® System

Primary DI
00810007630656
Brand
AccuPlan® System
Company
Medcad
Model
ZB-K000-R
Catalog number
ZB-K000-R
Device description
ORTHOGNATHIC, 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

Related Records

Contact Domains

Product Codes

CodeName
DZJDriver, Wire, And Bone Drill, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810007630656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007630656008100076306568100076306560810007630656

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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