AccessGUDID - DEVICE: Atlas Surgical and Prosthetic Instrumentation Kit (07350081494872)

GUDID

Device Identifier (DI) Information

Brand Name: Atlas Surgical and Prosthetic Instrumentation Kit
Version or Model: AK-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AK-3
Company Name: Dentatus AB

Primary DI Number: 07350081494872
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355803412 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b3fcb02c-cdeb-4010-a6ca-70ec5c97f33a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 10, 2016