DEVICE: NobelProcera® (07332747124989)

Device Identifier (DI) Information

NobelProcera®
4.13
In Commercial Distribution
35669
Nobel Biocare AB
07332747124989
GS1

1
353939929 *Terms of Use
NobelProcera 4.13 for Windows 64-bit
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental CAD/CAM system, laboratory An assembly of software-based 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 for final fitting to the patient.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NHA ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K053602 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

85c1b4a2-4413-4e64-b44b-d6c5a9f6d6e6
July 06, 2018
3
September 17, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)322-5001
us.customerservice@nobelbiocare.com
CLOSE