AccessGUDID - DEVICE: K3Pro Konus Dental Implants (EAGNCGSBK3PRO2PK0)

GUDID

Device Identifier (DI) Information

Brand Name: K3Pro Konus Dental Implants
Version or Model: CGSB_K3Pro/2.PK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CGSB_K3Pro/2.PK
Company Name: Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

Primary DI Number: EAGNCGSBK3PRO2PK0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312649568 *Terms of Use

Device Description: Scan Post for K3Pro Ti-Base w/ 2mm Post - Peek

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141159	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 06f0b053-2bb8-4a28-9b87-1f5e58ddfbdf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016