ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The Argents Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.

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

Implant Brand Name	Platform	Manufacturer	Implant Trade Name	ImplantLine/Connection	Implant Diameter
Hiossen ET III SA	3.5mm	Hiossen	Hiossen Implant System	Internal Hex	3.75, 3.77mm
Hiossen ET III SA	4.0/4.5/5.0mm	Hiossen	Hiossen Implant System	Internal Hex	4.25, 4.65, 4.63,4.6, 5.1, 5.08,5.05mm
Nobel Active WidePlatform (WP)	5.5mm	Nobel Biocare AB	Nobel Active WidePlatform (WP)	Internal Hex	5.5mm

Device Description

The ArgenIS Titanium 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. The titanium abutment may be designed with a maximum angulation of 30°. The abutment is then fixed with the use of a lab screw to a model containing the implant analog for final construction of the related prosthetic restoration. The ArgenIS Titanium Abutments are then intended to be fixed in the mouth with the prosthetic final screw. The ArgenIS Titanium Abutments are supplied with two package configurations. One includes two final screws and the abutment and another includes one final screw and one lab screw and the abutment. The final screw is used for fixing abutment to the endosseous implant body, and the lab screw is used 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 endosseous implant body 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. There are no accessories associated with the subject devices.

Minimum and Maximum Gingival Height is 0.5mm - 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 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°

All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.

AI/ML Overview

The document primarily focuses on establishing "substantial equivalence" of the ArgenIS Titanium Abutments to legally marketed predicate devices, rather than defining specific acceptance criteria for a new device and proving its performance against those criteria in a typical clinical study.

However, based on the non-clinical performance testing summarized in section 14 and the comparison table in section 13, we can infer some "acceptance criteria" related to the device's physical and mechanical properties, and how it was evaluated.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary)
Mechanical Strength/Fatigue Life: The device must withstand fatigue forces representative of oral use.	"Fatigue testing was performed on worst case scenario samples in accordance with the Class II Special Controls Guidance Document and ISO 14801. Performance testing demonstrated conformance to design input and indications for use."
Dimensional Accuracy/Compatibility: The abutments must accurately fit specified implant systems.	"Non-Clinical testing consisted of reverse engineering of the OEM implant body, abutment and abutment screw and tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant/abutment connection checks."
Sterility Assurance Level (SAL): The sterilization process must achieve an SAL of 10^-6.	"Moist Heat sterilization validation testing was performed in accordance with ANSI/AAMI/ISO 17665-1: 2006 and ISO ANSI/AAMI/ISO 17665-2: 2009. Test results demonstrate a sterility assurance level of 10-6."
Biocompatibility: The materials must be biocompatible.	"The Argen IS Titanium Abutments have the same sterilization process and biocompatibility as previously cleared Argen and Sterngold devices. Therefore sterility and bio-compatibility testing performed on cleared Argen devices is applicable to the proposed devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify exact sample sizes for the fatigue or dimensional testing. It mentions "worst case scenario samples" for fatigue testing.
Data Provenance: The data is from non-clinical testing (laboratory testing) and not a clinical study involving human subjects. Therefore, "country of origin of data" or "retrospective/prospective" are not applicable in the typical sense of a human clinical trial. This is manufacturer-led testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The evaluations described are technical and engineering-based (fatigue, dimensional analysis, sterilization validation), not subjective assessments requiring expert interpretation of clinical data or images to establish a "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the testing involves objective measurements against engineering standards and material properties, not subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC or human-in-the-loop study was conducted. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in the context of interpretation of data.

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

No standalone (algorithm only) performance study was done as this is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical testing was based on engineering standards and specifications (e.g., ISO 14801 for fatigue testing, ANSI/AAMI/ISO 17665-1/2 for sterilization), and the design input/specifications for the abutment and its compatibility with implant systems. For biocompatibility, it relied on the "ground truth" established for previously cleared Argen and Sterngold devices with similar materials.

8. The sample size for the training set

This question is not applicable. There is no software algorithm or AI model being "trained" for this physical device.

9. How the ground truth for the training set was established

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

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 18, 2018

Argen Corporation c/o Gordon Craig Regulatory Consultant Sterngold Dental. LLC 23 Frank Mossberg Drive Attleboro, Massachusetts 02703

Re: K172430

Trade/Device Name: ArgenIS Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 9, 2018 Received: April 16, 2018

Dear Gordon Craig:

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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172430

Device Name

ArgenIS Titanium Abutments

Indications for Use (Describe)

ArgentS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The Argents Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.

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

Implant Brand Name	Platform	Manufacturer	Implant Trade Name	ImplantLine/Connection	Implant Diameter
Hiossen ET III SA	3.5mm	Hiossen	Hiossen Implant System	Internal Hex	3.75, 3.77mm
Hiossen ET III SA	4.0/4.5/5.0mm	Hiossen	Hiossen Implant System	Internal Hex	4.25, 4.65, 4.63,4.6, 5.1, 5.08,5.05mm
Nobel Active WidePlatform (WP)	5.5mm	Nobel Biocare AB	Nobel Active WidePlatform (WP)	Internal Hex	5.5mm

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 08/30/2020 See PRA Statement below.

{3}------------------------------------------------

510(k) Summary

1. Sponsor: The Argen Corporation 5855 Oberlin Drive San Diego, CA 92121
1. Contact: Paul Cascone Senior Vice-President of Research & Development Phone: 858-455-7900
1. Date: May 18, 2018
Trade Name: ArgenIS Titanium Abutments 4.
1. Common Name: Implant Abutment
1. Classification Name: Endosseous Dental Implant Abutment
1. Classification: 872.3630, Class II
1. Product Code: NHA
1. Legally Marketed Device to which Equivalence is claimed (Predicate Devices):

Primary Predicate Device:

ArgenIS Titanium Abutments - K160248

Reference Devices:

Hiossen Implant System - K140934 Nobel Biocare Nobel Active Wide Platform (WP) - K133731

10. Description of Device:

{4}------------------------------------------------

provided to the dental laboratory in a final patient specific form. There are no accessories associated with the subject devices.

All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.

11. Indications for Use

ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.

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

Implant Brand Name	Platform	Manufacturer	Implant Trade Name	ImplantLine/Connection	Implant Diameter
Hiossen ET III SA	3.5mm	Hiossen	Hiossen Implant System	Internal Hex	3.75, 3.77mm
Hiossen ET III SA	4.0/4.5/5.0mm	Hiossen	Hiossen Implant System	Internal Hex	4.25, 4.65, 4.63,4.6, 5.1, 5.08,5.05mm
Nobel Active WidePlatform (WP)	5.5mm	Nobel Biocare AB	Nobel Active WidePlatform (WP)	Internal Hex	5.5mm

12. Technological Characteristics

The Argen IS Titanium Abutments are substantially equivalent to the currently marketed predicate devices. The intended use, fundamental operating principles, materials, technology and processes are the same as other Argen dental devices previously cleared by FDA.

13. Substantial Equivalence

The Argen IS Titanium Abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and materials are the same as the predicate devices. The Indications for Use for the subject device differs from the primary predicate by the list of compatible implant bodies. Implant body compatibility and substantial equivalency was determined by comparing the design features including diameters, lengths, materials, implant-to-abutment connection platform and

{5}------------------------------------------------

intended use of proposed devices to predicate devices. Abutment design parameters are similar to the predicate devices and substantial equivalence has been demonstrated through performance testing data. Any differences between proposed devices and predicate devices do not render the device NSE. See Substantial Equivalence Comparison table below.

Features	New Device	Primary Predicate	Reference Device	Reference Device
	ArgenIS TitaniumAbutmentsThe Argen Corporation	Argen IS TitaniumAbutmentsK160248The Argen Corporation	Hiossen Implant SystemK140934Hiossen, Inc.	Nobel Biocare NobelActive Wide Platform(WP)K133731NobelBiocare AB
Material	Titanium-6AL-4Vanadium ELI Alloy	Titanium-6AL-4Vanadium ELI Alloy	CP Titanium	CP Titanium
ProstheticConnection	Hiossen ET III SA3.5mm, 4.0/4.5/5.0mmNobel Biocare 5.5mm	Nobel Biocare Replace6.0mmNobel Biocare ActiveStraumann Bone Level,Straumann Synocta,Astra Tech OsseoSpeed	3.5,3.77mm, 3.75mm, 4.2mm,4.25mm,4.45mm, 4.6mm, 4.63mm,4.65mm,4.9mm,5.0mm,5.05mm,5.08mm,5.1mm,5.92mm,5.95mm,6.0.6.8mm	Nobel Biocare ActiveWide Platform 5.5mm
Indications forUse	Intended to be single useavailable by prescriptiononly in the constructionof dental restorationssupported by theendosseous dentalimplant. The ArgenIsTitanium Abutments aredesigned to specificallyfit an individual patient'sneeds of the finalrestoration. All digitallydesigned abutment filesare intended to be sent toArgen manufacturer formilling.	Intended to be single useavailable by prescriptiononly in the construction ofdental restorationssupported by theendosseous dentalimplant. The ArgenIsTitanium Abutments aredesigned to specifically fitan individual patient'sneeds of the finalrestoration. All digitallydesigned abutment filesare intended to be sent toArgen manufacturer formilling.	Indicated for use in partially or fullyedentulous mandibles and maxillae insupport of single or multiple unitrestorations including cemented retained,screw retained or overdenture, and finalor temporary abutment support for fixedbridgework. It is intended for delayedloading. ETIII SA Ultra Wide Fixture isintended to be used in the molar region.	Intended to besurgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices,such as an artificialtooth, in order torestore patient estheticsand chewing function.Nobel Biocare'sNobelActive implantsare indicated for singleor multiple unitrestorations in splintedor nonsplintedapplications. NobelBiocare's NobelActiveimplants are intendedfor immediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.
ImplantDiameters	Hiossen3.77, 3.75, 4.25, 4.65,4.63, 4.6, 5.1, 5.08,5.05mm	3.3mm , 3.5mm, 4.0mm,4.1mm, 4.3mm, 4.5mm,4.8mm, 6.0mm, 6.5mm	3.5,3.77mm, 3.75mm, 4.25mm, 4.65mm,4.63mm, 4.6mm, 5.1mm, 5.08mm,5.05mm	5.5mm
Type of Retention	Nobel Biocare 5.5mmScrew-retained to theimplant. The prosthesiscan be cement-retained tothe abutment.	Screw-retained to theimplant. The prosthesiscan be cement-retained tothe abutment.	Screw-retained to the implant. Theprosthesis can be cement-retained to theabutment.	Screw-retained to theimplant. The prosthesiscan be cement-retainedto the abutment.
ManufacturingProcess	Machining	Machining	Machining	Machining
AbutmentSterilization	Moist Heat (Steam)	Moist Heat (Steam)	Gamma Radiation	Gamma Radiation
AbutmentAngulation	30°	30°	-	-

14. Summary of Non-Clinical Performance Testing

Non-clinical Test data was used to support substantial equivalency. Non-Clinical testing consisted of reverse engineering of the OEM implant body, abutment and abutment screw

{6}------------------------------------------------

and tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant/abutment connection checks.

Fatigue testing was performed on worst case scenario samples in accordance with the Class II Special Controls Guidance Document and ISO 14801. Worst case scenario was defined as the smallest diameter and shortest length from each platform. Performance testing demonstrated conformance to design input and indications for use.

The evaluation was based on FDA guidance "Class II Special Controls Guidance: Root -form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

Moist Heat sterilization validation testing was performed in accordance with ANSI/AAMI/ISO 17665-1: 2006 and ISO ANSI/AAMI/ISO 17665-2: 2009. Test results demonstrate a sterility assurance level of 10-6.

The Argen IS Titanium Abutments have the same sterilization process and biocompatibility as previously cleared Argen and Sterngold devices.

Therefore sterility and bio-compatibility testing performed on cleared Argen devices is applicable to the proposed devices.

15. Conclusion

The proposed devices have similar technological characteristics, performance specifications and intended use as of its predicates.

Similar technological characteristics, performance testing data and intended use supports a determination of substantial equivalence of proposed devices to the predicate and reference devices.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)