DEVICE: NobelProcera® (07332747124989)
Device Identifier (DI) Information
NobelProcera®
4.13
Not in Commercial Distribution
35669
Nobel Biocare AB
4.13
Not in Commercial Distribution
35669
Nobel Biocare AB
NobelProcera 4.13 for Windows 64-bit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34713 | Dental milling system, CAD/CAM, 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K053602 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
85c1b4a2-4413-4e64-b44b-d6c5a9f6d6e6
April 04, 2023
7
September 17, 2016
April 04, 2023
7
September 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)322-5001
us.customerservice@nobelbiocare.com
us.customerservice@nobelbiocare.com