ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.

The ArgenIS Titanium Abutments are compatible with the following implant systems:

Implant Brand and Type	Implant Diameter
Nobel Biocare Replace Select	3.5mm
Nobel Biocare Replace Select	4.3mm
Nobel Biocare Replace Select	5.0mm
Biomet 3i Certain	3.25mm
Biomet 3i Certain	4.0mm
Biomet 3i Certain	5.0mm
Straumann Tissue Level - RN	3.3mm
Straumann Tissue Level - RN	4.1mm
Straumann Tissue Level - RN	4.8mm
Zimmer Tapered Screw-Vent	3.7mm
Zimmer Tapered Screw-Vent	4.1mm
Zimmer Tapered Screw-Vent	4.7mm
Zimmer Tapered Screw-Vent	6.0mm

Device Description

Argen IS Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Abutment is then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Abutment is supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient-specific form.

Minimum and Maximum Gingival Height is 0-6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30°

The proposed ArgenIS Titanium Abutments are available in a range of diameters and connection type.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ArgenIS Titanium Abutments. This type of FDA submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study or by presenting detailed performance metrics against predefined benchmarks.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, or a detailed breakdown of test sets, ground truth establishment, or clinical study types (MRMC, standalone).

However, I can extract the information that is present and explain why other details are not available in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and direct "reported device performance" values for clinical outcomes. Instead, it relies on bench testing to show functionality and equivalence to predicate devices. The "performance data" section focuses on demonstrating mechanical integrity and compatibility.

Acceptance Criteria Category	Reported Device Performance (as described)
Functional Compatibility	- Tolerance analysis ensured abutment/implant interface compatibility.
	- Functional fit checks of abutment blank to compatible implant, analog, and prosthetic screw showed correct functionality, including dimensional compatibility.
Mechanical Performance / Fatigue	- Fatigue testing was conducted on "worst case scenario samples" (smallest diameter and shortest length from each platform) according to ISO 14801. (Specific results/metrics are not provided, only that it was conducted and supports substantial equivalence.)
Biocompatibility & Sterilization	- Argen IS Abutments have the "same sterilization process and parameters, and biocompatibility as previously cleared Sterngold devices." This implies adherence to established standards, but no specific test results are provided here.
Substantial Equivalence (Overall)	- Non-clinical test data (tolerance analysis, dimensional verification, implant mating checks) supports the claim of substantial equivalence to predicate devices based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "worst case scenario samples" for fatigue testing (one implant size from each proposed platform) but does not provide a specific numerical sample size for this or other bench tests. It refers to "non-clinical test data," indicating these are laboratory-based tests, not human subject data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as this is not a clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable. The "ground truth" for the non-clinical bench testing would be established by engineering specifications, material standards, and regulatory requirements (e.g., ISO 14801). There is no mention of human experts establishing a "ground truth" in the diagnostic or clinical sense for this type of device.

4. Adjudication Method for the Test Set

This is not applicable as the testing described is technical bench testing, not a clinical trial requiring adjudication of patient outcomes or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These are typically for diagnostic devices where human reader performance is being evaluated, often with and without AI assistance. This document is for a physical medical device (dental abutment) and focuses on mechanical and physical properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

This is not directly applicable. A "standalone" study usually refers to the performance of an algorithm or AI without human intervention. While the device itself functions without continuous human interaction once implanted, the performance evaluation here is on its manufactured properties and compatibility, not an "algorithm's" diagnostic accuracy. The bench tests described could be considered "standalone" in that they evaluate the device itself.

7. The Type of Ground Truth Used

For the described performance testing (tolerance analysis, functional fit checks, fatigue testing), the "ground truth" would be engineering specifications, material properties, and regulatory standards (e.g., ISO 14801 for fatigue testing, or dimensional specifications for fit). It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this is not an AI/ML device that requires data for model training.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2015

The Argen Corporation c/o Ms. Maria Rao Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703

Re: K143051

Trade/Device Name: ArgenIS Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 13, 2015 Received: August 17, 2015

Dear Ms. Rao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K143051

Device Name: ArgenIS Titanium Abutments

Indications for Use:

The ArgenIS titanium abutments are compatible with the following implant systems:

Implant Brand and Type	Implant Diameter
Nobel Biocare Replace Select	3.5mm
Nobel Biocare Replace Select	4.3mm
Nobel Biocare Replace Select	5.0mm
Biomet 3i Certain	3.25mm
Biomet 3i Certain	4.0mm
Biomet 3i Certain	5.0mm
Straumann Tissue Level - RN	3.3mm
Straumann Tissue Level - RN	4.1mm
Straumann Tissue Level - RN	4.8mm
Zimmer Tapered Screw-Vent	3.7mm
Zimmer Tapered Screw-Vent	4.1mm
Zimmer Tapered Screw-Vent	4.7mm
Zimmer Tapered Screw-Vent	6.0mm

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Part 21 CFR 801 Subparts D)

AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

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510(k) Summary

Sponsor:	The Argen Corporation5855 Oberlin DriveSan Diego, CA 92121
Contact:	Maria Rao, Regulatory ConsultantPhone: 401-871-3489
Date:	September 16, 2015
Trade Name:	ArgenIS Titanium Abutments
Common Name:	Implant Abutment
Classification Name: Endosseous Dental Implant Abutment
Classification:	872.3630, Class II
Product Code:	NHA

Legally Marketed Device to which Equivalence is claimed (Predicate Devices):