DEVICE: Anew Surgical and Prosthetic Instrumentation Kit (07350081494858)

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Device Identifier (DI) Information

Anew Surgical and Prosthetic Instrumentation Kit
SK-3
SK-3
Dentatus AB
07350081494858
GS1
1
ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 2 2 - 1.4 Center Point Pilot Drills (1 Short & 1 Long) (=1.8 Impl. Diam.) - Drill System 2 2 - CePo Drills for 2.2 and 2.4 Implants 1 - Manual Adaptor for R/A Driver 1 - Anew Chisel-End Screwcap Driver 1 - R/A Hpc Driver 1 - Trephine Hollow Drill 1 - Sterilizable Instrumentation Kit Box 1 - Instruction for use 1 - X-ray template 5 - Moisture Absorbing Papers
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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 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.
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FDA Product Code

[?]
Product Code Product Code Name
NDP Accessories, Implant, Dental, Endosseous
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 10, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+12124811010
dentatus@dentatus.com
+46854650900
info@dentatus.se
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