AccessGUDID - DEVICE: K3Pro Konus Dental Implants (EAGN30009K3PROS9)

GUDID

Device Identifier (DI) Information

Brand Name: K3Pro Konus Dental Implants
Version or Model: 30009K3Pro.S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30009K3Pro.S
Company Name: Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

Primary DI Number: EAGN30009K3PROS9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312649568 *Terms of Use

Device Description: 3.0 x 9.0mm K3Pro "Sure" Implant with 2mm Well

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:	Yes
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?
55849	Screw endosteal dental implant, two-piece	A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Lumen/Inner Diameter: 2 Millimeter
Length: 9 Millimeter
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: 5de86d0e-314b-49b5-be1a-fca3aee45c3a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016