Dongle
| Catalog Number: | N/A |
|---|---|
| Company Name: | ZIRKONZAHN SRL |
| Device Combination Product: | N/A |
| Device Commercial Dsitribution End Date: | N/A |
| Device Commercial Dsitribution Status: | In Commercial Distribution |
| Device Count: | 1 |
| Device Description: | Dongle for Scanner S600 ARTI |
| Device hctp: | N/A |
| Device kit: | N/A |
| Device Publish Date: | 2018-07-06 |
| Device Record Status: | Published |
| Direct Market Exempt: | N/A |
| Has Donation ID number? | N/A |
| DUNS Number: | 564251911 |
| Has Expiration Date? | N/A |
| Is Labelled as NRL: | N/A |
| Is Labelled As No NRL: | N/A |
| Has Lot Batch Number: | N/A |
| Has Manufacutring Date: | N/A |
| MRI Safety Status: | Labeling does not contain MRI Safety Information |
| Is OTC? | N/A |
| Is Devic Premarket Exempt: | true |
| Public Device Record Key: | 27bf55b7-a4db-4d2e-850f-70c53850fd9d |
| Public Version Date: | 2022-02-21 |
| Public Version Number: | 2 |
| Public Version Status: | Update |
| Is Rx? | N/A |
| Has Serial Number? | true |
| Is Single Use: | N/A |
| Version Model Number: | ZBAC1401 |
| Adress: | N/A |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
Dental CAD/CAM system, laboratory
An 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.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
ZBAC1401
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
false
false
Product Codes
Product Code
Product Code Name
NOF
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A