AccessGUDID - DEVICE: ArgenIS (D818115137)

GUDID

Device Identifier (DI) Information

Brand Name: ArgenIS
Version or Model: BC 5.0 Ti Blank
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 115137
Company Name: ARGEN CORPORATION, THE

Primary DI Number: D818115137
Issuing Agency: HIBCC
Commercial Distribution End Date: January 12, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 103095543 *Terms of Use

Device Description: Titanium 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):	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?
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: 45229b33-dbfd-43bb-a86a-e3ff83b50b69
Public Version Date: January 23, 2023
Public Version Number: 1
DI Record Publish Date: January 13, 2023