Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

This submission includes partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in two designs: the ZAGA Regular zygomatic implant, coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 35 mm and 55 mm; and the ZAGA Advanced zygomatic implant, apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm to 52.5 mm, with a flat cut into the buccalfacing side of the implant body.

This submission includes designs of the ZAGA screw-retained abutments in four gingival heights (1.5, 2.5, 3.5, and 4.5 mm) for use with the ZAGA zygomatic implants. The subject device abutments are for support of screwretained overdenture prosthetic restorations.

All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The apically threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K173343. The subject device ZAGA screw-retained abutments are manufactured titanium conforming to ASTM F67, and have the same anodized surface treatment as the healing abutments cleared in K163634. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants previously cleared in K173343 and K163634.

AI/ML Overview

The provided text is a 510(k) Summary for the Southern Implants ZAGA Zygomatic System (K192651). This document assesses the substantial equivalence of a new medical device to existing, legally marketed predicate devices. It does not describe acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving such a device meets acceptance criteria.

The document specifically states under "PERFORMANCE DATA": "No clinical data were included in this submission." This indicates that the evaluation was based on non-clinical data, primarily engineering analysis and comparison to predicate devices, rather than a human-in-the-loop or standalone algorithm study.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets these criteria, as the input document does not contain this type of data for an AI/algorithm-based device.

The "Performance Data" section in the document focuses on:

Biocompatibility (referenced from K173343 and K163634)
Engineering analysis
Dimensional analysis
Sterilization validation (according to ISO 11137-1, ISO 11137-2)
Bacterial endotoxin (according to USP 39-NF34<85>)
Sterile barrier shelf life (referenced from K173343)
Static and dynamic compression-bending (according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants)

These are standard non-clinical tests for dental implants to demonstrate mechanical performance and safety, not for evaluating an AI algorithm's performance.

Summary

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May 7, 2020

Southern Implants (Pty) Ltd Lauranda Breytenbach Head of Regulatory Affairs and Ouality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA

Re: K192651

Trade/Device Name: ZAGA Zygomatic System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 23, 2020 Received: April 7, 2020

Dear Lauranda Breytenbach:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192651

Device Name ZAGA Zygomatic System

Indications for Use (Describe)

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)

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510(k) Summary

ZAGA Zygomatic System

K192651

May 6, 2020

ADMINISTRATIVE INFORMATION

Manufacturer Name	Southern Implants (Pty) Ltd
	1 Albert RoadIrene, Gauteng, 0062 South Africa
	Telephone:	+27 12 667 1046
	Fax:	+27 12 667 1029
Official Contact	Lauranda G. Breytenbach
	Head of Regulatory Affairs and Quality
		Email: lauranda.b@southernimplants.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	ZAGA Zygomatic System
Common Name	Dental implant
Classification Name	Endosseous dental implant
Classification Regulation	21 CFR 872.3640, Class II
Product Code	DZE, NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

The primary predicate device is K173343. The reference devices are K163634 and K181703.

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INDICATIONS FOR USE STATEMENT

Southern Implants ZAGA Zygomatic System implants are intended to the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

SUBJECT DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K173343 and K163634); engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 11137-2; bacterial endotoxin according to USP 39-NF34<85>; sterile barrier shelf life (referenced from K173343); and static an dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K173343, Zygomatic Implant System, Southern Implants (Pty) Ltd. K163634, External Hex Implants, Southern Implants (Pty) Ltd. K181703, Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments, Straumann USA, LLC (on behalf of Institut Straumann AG)

The primary predicate device is K173343. The reference devices are K163634 and K181703.

A comparison of the technological characteristics of the subject device and the primary predicate device K17343 is provided in the following table.

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	Subject Device	Primary Predicate Device
		K173343
Comparison	ZAGA Zygomatic System	Zygomatic Implant System
	Southern Implants (Pty) Ltd	Southern Implants (Pty) Ltd
Indications for Use Statement	Southern Implants ZAGA Zygomatic Systemimplants are intended to be implanted in theupper jaw arch to provide support for fixeddental prostheses in patients with partially orfully edentulous maxillae. All implants areappropriate for immediate loading when goodprimary stability is achieved and withappropriate occlusal loading.	Southern Implants Zygomatic System Standardimplants, Zygan (narrow apex) implants, andOncology implants are intended to be implantedin the upper jaw arch to provide support forfixed or removable dental prostheses in patientswith partially or fully edentulous maxillae. Allimplants are appropriate for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading.
Implant
Implant Design	Partially threaded root-form implants forplacement into the zygoma.	Zygan and Oncology: Partially threaded root-form implants for placement into the zygoma.
Implant Diameter	ZAGA Regular: 4.3 mm (coronal) taper to 3.4mm (apical)ZAGA Advanced: 4.3 mm (coronal with 3.35mm flat) taper to 3.4 mm (apical)	Zygan: 4.3 mm (coronal) taper to 3.4 mm(apical)Oncology: 4.3 mm (coronal) taper to 3.8 mm(apical)
Implant Length	ZAGA Regular: 35, 37.5, 40, 42.5, 45, 47.5, 50,52.5, 55 mmZAGA Advanced: 30, 32.5, 35, 37.5, 40, 42.5,45, 47.5, 50, 52.5 mm	Zygan: 30, 35, 37.5, 40, 42.5, 45, 47.5, 50,52.5, 55, 57.5 mmOncology: 27.5, 30, 32.5, 37.5, 42.5, 47.5 mm
Threaded Lengths	ZAGA Regular: 5 mm coronal + 17 mm apicalZAGA Advanced: 17 mm (apical only)	Standard implant: Fully threadedZygan implant: 6 mm coronal + 15 mm apicalOncology implant: 20 mm (apical only)
Platform Angle, Relative toorthogonal to implant long axis	55° angulation at head of implant	55° angulation at head of implant
Implant Prosthetic Diameter	4.07 mm	4.05 mm
Implant Interface	External Hex	External Hex
Implant Material	Unalloyed titanium (ASTM F67) Grade 4, andUTS ≥ 900MPa (cold-worked)	Unalloyed titanium (ASTM F67) Grade 4, andUTS ≥ 900MPa (cold-worked)
Implant Endosseous Surface	Grit-blasted	Grit-blasted
Abutment
Abutment Design	Non-engaging; Compact conical design	Non-engaging; Compact conical design
Prosthetic Attachment	Screw-retained	Screw-retained
Collar Height	1.5, 2.5, 3.5, 4.5 mm	1.5, 2.0, 3.0, 4.0, 5.5 mm
Collar Diameter	4.6 mm	4.8 mm
Abutment Angle	None (straight only)	None (straight only)
Abutment Material	Unalloyed titanium (ASTM F67) Grade 4; withanodized surface treatment	Titanium alloy (ASTM F136) Grade 5;Titanium Nitride (TiN) coating
Restoration	Multi-unit	Multi-unit

The Indications for Use Statement for the subject device is similar to the primary predicate device K173343, with the difference being the name of the device and the exclusion of removable dental prosthesis support. The limitation in the subject device Indications for Use Statement does not change the risk-based assessment of the subject device, nor does it result in the identification of any new risks or the modification of existing risks for the subject device. The difference limits the restorative options for the subject device implants to fixed prosthetic unit support, forgoing removable prosthetic unit support while maintaining the intended use of the subject device implants as placement of the device into the zygoma for rehabilitation of the edentulous maxilla.

The primary predicate device K173343 is for substantial equivalence of the subject device implant designs. The subject device ZAGA Regular zygomatic implants have a design that is substantially equivalent design to implants in K173343, specifically the Zygan zygomatic implants. Similarly, the subject device ZAGA Advanced zygomatic implants have a design that is substantially equivalent design to implants in K173343, specifically the Oncology and Zygan zygomatic implants, with the only difference being the buccal-face of the implant coronal region. This feature of the ZAGA Advanced zygomatic implant does not negatively impact the mechanical performance of the implant.

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The primary predicate device K173343 also serves as the primary predicate for substantial equivalence of the subject device screw-retained abutment designs.

The reference device K163634 is for the substantial equivalence of the subject device screw-retained abutment implant prosthetic diameter, material and surface treatment. The reference device K181703 is for the substantial equivalence of the subject device screw-retained abutment collar diameter, and abutment collar height.

The subject device implants incorporate the same materials and encompass similar ranges of dimensions as the predicate device cleared in K173343. The surface treatment applied to the endosseous threads of the subject device implants is identical to that cleared in K173343. The material and surface treatment applied to the subject device abutments is identical to that of the healing abutments cleared in K163634. All subject device components are for single-patient, single-use, and all are provided sterile. Similarly, the components cleared in the primary predicate K173343 are for single-patient, single-use and are provided sterile.

Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K173343.

In support of substantial equivalence in terms of mechanical performance, dynamic compression-bending testing was performed according to ISO 14801. The results from the testing demonstrated fatigue performance of the subject device to be substantially equivalent to that of the primary predicate K173343.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of the same materials. The subject device and the predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. The subject device and the predicate devices are packaged in similar materials and sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.