AccessGUDID - DEVICE: K3Pro Konus Dental Implants (EAGNSK06K3PRO0)

GUDID

Device Identifier (DI) Information

Brand Name: K3Pro Konus Dental Implants
Version or Model: SK06_K3Pro
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SK06_K3Pro
Company Name: Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

Primary DI Number: EAGNSK06K3PRO0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312649568 *Terms of Use

Device Description: K3Pro Rapid Precision Tray for Guided Surgery

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44883	Dental implant/prosthesis surgical procedure kit	A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.	Obsolete	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: Yes

Sterilization Method [?]
Moist Heat or Steam 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: d741794c-edf5-4e8f-8c6d-1e690f64f6ab
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016