DEVICE: Atlas Surgical and Prosthetic Instrumentation Kit (07350081494872)
Device Identifier (DI) Information
Atlas Surgical and Prosthetic Instrumentation Kit
AK-3
In Commercial Distribution
AK-3
Dentatus AB
AK-3
In Commercial Distribution
AK-3
Dentatus AB
ATLAS Surgical and Prosthetic Instrumentation kit - Drill System 2
3x CePo Drills - Short (=1.8 mm implants, 2.2, 2.4 ) - Drill System 2
1x R/A Hpc. Implant Driver
1x Manual R/A Adaptor
1x Set of 3 Denture Profile Forming Instruments
1x Sterilizable Instrumentation Kit Box
1x Instruction for use
1x X-ray template
5x Moisture Absorbing Papers
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Dental implant suprastructure kit | A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NDP | Accessories, Implant, Dental, Endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
b3fcb02c-cdeb-4010-a6ca-70ec5c97f33a
March 29, 2018
2
August 10, 2016
March 29, 2018
2
August 10, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+12124811010
dentatus@dentatus.com +46854650900
info@dentatus.se
dentatus@dentatus.com +46854650900
info@dentatus.se