AccessGUDID - DEVICE: ArgenIS (D818115079)

GUDID

Device Identifier (DI) Information

Brand Name: ArgenIS
Version or Model: NR 5.0 Ti Blank
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 115079
Company Name: ARGEN CORPORATION, THE

Primary DI Number: D818115079
Issuing Agency: HIBCC
Commercial Distribution End Date: January 11, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 103095543 *Terms of Use

Device Description: NR 5.0 Ti Blank

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
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?
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170588	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: 761fe993-2111-4c6a-8324-d3696a134d69
Public Version Date: January 20, 2023
Public Version Number: 1
DI Record Publish Date: January 12, 2023