S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For Zygomatic Implants and Abutments

S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

The purpose of this submission is to add components to the S.I.N. Dental Implant System cleared in K170398, including a line of zygomatic dental implants and abutments.

The subject device Strong SW HE dental implants are nearly identical to the Strong SW HE dental implants cleared in K170398, with a cylindrical design that tapers slightly to the apex, a body/endosseous thread diameter of 3.75 mm, and a platform diameter of 4.1 mm. This submission adds overall lengths of 18, 20, 22, and 24 mm. The endosseous threads have a uniform trapezoidal design and have an acidetched surface. The implants have an external hexagon ("HE") abutment interface connection, internal threads, and an internal hexolobular feature for instrument attachment.

The subject device Zygomatic dental implants have a body diameter of 4.5 mm at the coronal end and a body diameter of 3.85 mm at the apical end with additional tapering to the apex. The abutment platform is 4.1 mm and is angled 45° to the long axis of the implant. The coronal end of the Zygomatic implants have a micro-channel surface feature starting at approximately the angled abutment platform extending over a length of approximately 2.9 mm; the micro-channel blends to a micro-thread and extends apically over a length of 2.15 mm. The micro-thread major diameter is 4.5 mm. All Zygomatic implants also are threaded over a length of 10.7 mm at the apical end with a major thread diameter of 3.85 mm. The endosseous threads at the apical aspect of the Zygomatic implants have the same uniform trapezoidal design and acid-etched surface as the Strong SW HE implants are provided in a range of lengths from 34 mm to 59 mm increments. The implant length is measured from the start of the micro-threads to the apex.

This submission includes an implant cover for the subject Zygomatic implants, with a coronal diameter of 4.1 mm that matches the implant platform, and is threaded to match the internal thread of the Zygomatic implants. This submission also includes Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical; these abutments are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.5 mm), and in gingival heights of 3 mm, and 5.5 mm. Mini Abutment Zygomatic Conical are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.8 mm), and in gingival heights of 2 mm, 3 mm, and 4 mm. Each abutment requires a corresponding subject device abutment screw to match the gingival height of the abutment. The Mini Abutment Standard and Mini Abutment Conical are the only abutments that are compatible with the subject device Zygomatic implants. For the Mini Abutment Zygomatic Standard, this submission also includes an Abutment Protector and a castable Co-Cr Base. For the Mini Abutment Zygomatic Conical, this submission also includes an Abutment Protector, Temporary Titanium Cylinder, and a castable Co-Cr Base. A Coping Screw is also included for use with all zygomatic abutments.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (S.I.N. Dental Implant System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, ground truth for training set) is not typically included in such a submission.

However, the document does contain information about performance data used to support the substantial equivalence claim.

Here's a breakdown of the available information relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" are stated in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. Instead, the performance data provided relates to the safety and mechanical integrity of the dental implants. The device performance is demonstrated through conformance to relevant standards and established methods for dental implants.

Performance Characteristic	Acceptance Criteria (Implicit from Standards/Methods)	Reported Device Performance (as stated in the submission)
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶ (according to ISO 11137-1 and ISO 11137-2).	Gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10⁻⁶ by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2, referenced from K170398). All subject device components are provided sterile by gamma irradiation, the same sterilization method used in K170398.
Bacterial Endotoxin	Limit of < 20 EU/device (according to ANSI/AAMI ST72).	Bacterial endotoxin testing (referenced from K170398) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of < 20 EU/device.
Shelf Life	Maintenance of packaging sterile barrier (according to ASTM F1929 and F88/F88M) and sterility for the stated shelf life.	Shelf life testing (referenced from K170398) including testing of samples after 4 years of real time aging according to ASTM F1929 and F88/F88M (packaging sterile barrier) and sterility testing of product.
Biocompatibility	Biocompatibility requirements for medical devices (implicitly referencing standards like ISO 10993).	Biocompatibility data on subject device materials and manufacturing processes (including the acid-etching surface treatment for dental implants and anodization for abutment screws) leveraged from K170398. The materials (ASTM F67 and ASTM F136) are identical to those used in K170398. The acid etching process and anodization process are identical to those used in K170398.
Mechanical Strength	Sufficient strength for intended use (implicitly referencing ISO 14801 for dynamic fatigue testing and zygomatic implant placement protocols).	Static compression and compression fatigue testing of worst-case constructs comprising the subject device Zygomatic implants and compatible subject device Mini Abutment Zygomatic Standard in conformance with ISO 14801 and the zygomatic implant placement protocol for nominal bone level. Based on results of dynamic testing in conformance with ISO 14801 and the zygomatic implant placement protocol for nominal bone level, the subject device zygomatic implants were shown to have sufficient strength for their intended use. Performance in accordance with the specified standard. Labeling mitigations for implant placement and matched surgical protocol for bone contact, as demonstrated by dynamic fatigue testing in conformance with ISO 14801.

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

Sample Size for Test Set: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical performance. The "testing" refers to non-clinical tests (e.g., mechanical, sterilization).
- For bacterial endotoxin testing: "samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis."
- For shelf life testing: "samples after 4 years of real time aging."
- For mechanical strength: "worst-case constructs comprising the subject device Zygomatic implants and compatible subject device Mini Abutment Zygomatic Standard."
Data Provenance: The data is primarily non-clinical and internal to the manufacturer, leveraging past submissions (K170398) and conducted according to international standards (ISO, ASTM, ANSI/AAMI). No country of origin for the "test set" is applicable in the human data sense. It is all retrospective in the sense that previous testing for predicate devices and ongoing quality control testing is referenced.

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

This information is not applicable to this submission, as no human-expert-validated "ground truth" test set (clinical data) was used. The performance data is based on non-clinical engineering and biological safety tests.

4. Adjudication Method for the Test Set

This information is not applicable since no human expert review or adjudication of a clinical test set was involved.

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

This information is not applicable, as the device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic device. No AI component is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable, as the device is a physical dental implant system and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by engineering standards and biological safety standards. For example:

Sterility: Defined by a Sterility Assurance Level (SAL) of 10⁻⁶.
Bacterial Endotoxin: Defined by a quantifiable limit (< 20 EU/device) per standard.
Mechanical Strength: Defined by performance criteria within the ISO 14801 standard.
Biocompatibility: Defined by compliance with ISO 10993 standards (leveraged from predicate).

8. The Sample Size for the Training Set

This information is not applicable, as there is no mention of a "training set" for an algorithm. The device design and materials are based on established engineering principles and prior validated devices.

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

This information is not applicable, as there is no "training set" and associated ground truth for an algorithm.

Summary

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

Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

S.I.N.- Sistema de Implante Nacional S.A. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International. LLC 12264 El Camino Real Suite 400 San Diego, California 92130

Re: K203725

Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 30, 2021 Received: March 31, 2021

Dear Kevin Thomas:

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.

{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) 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 (QS) 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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K203725

Device Name

S.I.N. Dental Implant System

Indications for Use (Describe)

For Strong SW HE Implants

For Zygomatic Implants and Abutments

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 FDA 3881 (6/20) .svg

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

510(k) Summary K203725 S.I.N. - Sistema de Implante Nacional S.A.

S.I.N Dental Implant System

June 23, 2021

ADMINISTRATIVE INFORMATION

Manufacturer Name	S.I.N. - Sistema de Implante Nacional S.A.
	Avenida Vereador Abel Ferreira, 1100
	São Paulo, São Paulo
	03340-000 Brazil
	Telephone +55-11-21693000 ext 3236
Official Contact	Denise Domiciano, Quality and Regulatory Manager
Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson, MS, MBA
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone +1 858-792-1235
	Fax +1 858-792-1236
	kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	S.I.N. Dental Implant System
Common Names	Endosseous dental implant
Regulation Number	21 CFR 872.3640
Regulation Name	Endosseous dental implant
Regulatory Class	Class II
Product Code	DZE
Secondary Product Code	NHA
Classification Panel	Dental
Reviewing Office	Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory,ENT and Dental Devices)
Reviewing Division	Division of Health Technology 1 B (Dental Devices)

flarson@paxmed.com

PREDICATE DEVICE INFORMATION

Primary Predicate Device K170398, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

Reference Devices K160119, NobelSpeedy® Groovy, Nobel Biocare AB K173343, Zygomatic Implant System, Southern Implants (Pty) Ltd

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

INDICATIONS FOR USE STATEMENTS

For Strong SW HE Implants

S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splications that utilize at least two implants.

For Zygomatic Implants and Abutments

SUBJECT DEVICE DESCRIPTION

The purpose of this submission is to add components to the S.I.N. Dental Implant System cleared in K170398, including a line of zygomatic dental implants and abutments.

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

Zygomatic implants. Mini Abutment Zygomatic Standard are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.5 mm), and in gingival heights of 3 mm, and 5.5 mm. Mini Abutment Zygomatic Conical are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.8 mm), and in gingival heights of 2 mm, 3 mm, and 4 mm. Each abutment requires a corresponding subject device abutment screw to match the gingival height of the abutment. The Mini Abutment Standard and Mini Abutment Conical are the only abutments that are compatible with the subject device Zygomatic implants. For the Mini Abutment Zygomatic Standard, this submission also includes an Abutment Protector and a castable Co-Cr Base. For the Mini Abutment Zygomatic Conical, this submission also includes an Abutment Protector, Temporary Titanium Cylinder, and a castable Co-Cr Base. A Coping Screw is also included for use with all zygomatic abutments.

Implant Line	Body Ø, mm	Platform Ø, mm	Lengths, mm
Strong SW HE	3.75	4.1	18, 20, 22, 24
Zygomatic	4.5 coronal3.85 apical	4.1	34, 36.5, 39,41.5, 44, 46.5, 49,51.5, 54, 56.5, 59

The subject device dental implants are summarized in the following table.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The subject device abutments, abutment screws, and implant cover are manufactured from titanium alloy conforming to ASTM F136. The materials in this submission (conforming to ASTM F67 and ASTM F136) are identical to the materials used to manufacture the dental implants and abutments cleared in K170398. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K170398.

The subject device Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical abutments and corresponding abutment screws manufactured from titanium alloy (ASTM F136) are anodized using standard electrolytic passivation processing to increase the thickness of the natural oxide layer on the surface and to impart a distinctive gold surface color. The anodization process used in this submission is identical to the anodization process used on abutments cleared in K170398. The Abutment Protectors and Coping Screw are manufactured from titanium alloy (ASTM F136), the Co-Cr Bases are manufactured from Co-Cr-Mo alloy (ASTM F1537), and the Temporary Titanium Cylinder is manufactured from unalloyed titanium (ASMT F67).

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10 % by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2, referenced from K170398);

bacterial endotoxin testing (referenced from K170398) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on

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

samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of < 20 EU/device;

shelf life testing (referenced from K170398) including testing of samples after 4 years of real time aging according to ASTM F1929 and F88/F88M (packaging sterile barrier) and sterility testing of product;

biocompatibility data on subject device materials and manufacturing processes (including the acid-etching surface treatment for dental implants and anodization for abutment screws) leveraged from K170398:

and static compression and compression fatigue testing of worst-case constructs comprising the subject device Zygomatic implants and compatible subject device Mini Abutment Zygomatic Standard in conformance with ISO 14801 and the zygomatic implant placement protocol for nominal bone level.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the predicate device and the reference devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.

The Indications for Use Statement (IFUS) for the subject device consists of two parts: the first is for the addition of longer lengths of conventional implants to those cleared in the primary predicate K 170398, and the second part for the subject device zygomatic implants.

The subject device IFUS for conventional implants is substantially equivalent to that of the primary predicate K170398, with differences in language regarding the longer subject device implant lengths. The primary predicate K170398 IFUS includes language regarding shorter implant lengths that is not applicable to the subject device. The language in the subject device IFUS concerning the longer length implants is substantially equivalent to similar language in the reference device K160119.

The IFUS for the subject device, K1709398, and K160119 all contain similar language regarding placement in the mandibular and maxillary arches, single-unit and multi-unit restorations, and immediate loading. Differences between the IFUS of the subject device and the reference device K160119 include slight differences in descriptions of loading protocols, details of implant placement, and the specific names of the devices. These differences in the language of the Indications for Use statements do not affect the intended use as an endosseous dental implant for support of a prosthesis to restore chewing function.

The subject device IFUS for zygomatic implants is substantially equivalent to that of the reference device K173343. Differences between the IFUS for the subject device zygomatic implants and the reference device K173343 include differences in the specific device names and slight differences in the exact wording, including "intended for placement" versus "intended to be implanted." These differences in the language of the Indications for Use statements do not affect the intended use as an endosseous dental implant for support of a prosthesis to restore chewing function.

None of these minor differences in specific wording among the IFUS impact substantial equivalence. All IFUS express equivalent intended use to facilitate functional and esthetic rehabilitation of the edentulous

{7}------------------------------------------------

mandible or maxilla, and the indications are expressed equivalently using different specific wording. Subject Device Strong SW HE Implants

The subject device Strong SW HE implants have an identical design, other than the implant lengths, to the Strong SW HE implants cleared in K170398. The subject device Strong SW HE implants have an external hex abutment connection, a body/endosseous thread major diameter of 3.75 mm, and a platform diameter of 4.1 mm, the same as implants cleared in K170398. The subject device Strong SW HE implant lengths are substantially equivalent to the lengths of the implants in predicate device K160119. The subject device Strong SW HE implants are manufactured from unalloyed titanium conforming to ASTM F67 and the endosseous threaded surface is acid etched. The unalloyed titanium material and acid etching used for the subject device implants are identical to that used to manufacture the Strong SW HE dental implants cleared in K170398. The subject device Strong SW HE implants are compatible with previously cleared S.I.N. - Sistema de Implante Nacional S.A. abutments and other components.

Subject Device Zygomatic Implants, Implant Cover, and Abutments

The subject device Zygomatic implants are substantially equivalent in design and material to the Zygan implants from Southern Implants cleared in K173343. The subject device Zygomatic implants and the Zygan implants both have a tapered, partially threaded design with similar coronal and apical threaded diameters, and both have angled external hex abutment platforms. Both implants are manufactured from unalloyed titanium conforming to ASTM F67. The threads of the subject device Zygomatic implants threads receive the same acid etching used for the subject device Strong SW HE implants, and is identical to acid etching used to manufacture the Strong SW HE dental implants cleared in K170398. The Zygan implants cleared in K173343 have an aluminum oxide blasted surface. Both acid etching and grit blasting are surface treatments to increase surface roughness; the subject zygomatic implants are otherwise substantially equivalent to the K173343 zygomatic implants. The difference in the method used to increase surface roughness does not affect substantial equivalence.

The subject device Zygomatic implants are provided in threaded lengths of 34 mm to 59 mm, with the length measured from the start of the micro-threads (at the coronal end) to the apex (tip). The Zygan implants cleared in K173343 are provided in lengths of 30 mm to 57.5 mm, with the length measured from the start of the coronal threads (below the base of the angled platform) to the apex (tip); this length is measured the same length in the same manner as the subject device. Additional length concerns in the subject device have been addressed and are supported by labeling mitigations for implant placement and matched surgical protocol for bone contact, as demonstrated by dynamic fatigue testing in conformance with ISO 14801.

The risks associated with the angled connection (platform angled 45° to the long axis of the implant) between the zygomatic implant and the compatible straight abutments was mitigated by mechanical testing performed in conformance with ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Based on results of dynamic testing in conformance with ISO 14801 and the zygomatic implant placement protocol for nominal bone level, the subject device zygomatic implants were shown to have sufficient strength for their intended use.

The subject device Zygomatic Implant Cover is substantially equivalent in design, material, and size to implant covers for the Strong SW HE external hex connection implants cleared in K170398.

{8}------------------------------------------------

Similarly, the subject device Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical are substantially equivalent in design, material, and sizes to Mini Abutments and Conical Abutments for S.I.N. (Sistema de Implante Nacional S.A.) external hex connection implants cleared in K170398. including the ranges of platform diameters, prosthetic platform diameters, and gingival heights. The primary predicate device K170398 includes Mini Abutments and Conical Abutments with the same designs for screw-retained, multi-unit prostheses. The subject device Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical are substantially equivalent in design, material, and sizes to zygomatic abutments in the predicate device K173343.

The subject Abutment Protectors, castable Co-Cr Bases, Temporary Titanium Cylinder, and Coping Screw are identical in design, material, and sizes to these components cleared for use with conventional dental implants in K193096, K170398, and K051859.

Minor differences in the exact dimensions of the subject device components as compared to those of the primary predicate device and reference devices do not impact safety, effectiveness, or substantial equivalence.

All subject device components are provided sterile by gamma irradiation, the same sterilization method used in K170398.

CONCLUSION

The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, and the reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.

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

{9}------------------------------------------------

Table of Substantial Equivalence

	Subject Device	Primary Predicate	Reference Device
		K170398	K160119
	S.I.N. Dental Implant System	S.I.N. Dental Implant System	NobelSpeedy® Groovy
	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de ImplanteNacional S.A.	Nobel Biocare AB
Indications for Use Statement	S.I.N. Dental Implant System is intended for placement in themaxillary or mandibular arch to provide support for single-unitor multi-unit restorations. When a one-stage surgical approachis applied, the S.I.N. Dental Implant System is intended forimmediate loading when good primary stability is achievedand with appropriate occlusal loading.S.I.N. Dental Implant System implants with lengths of 18, 20,22, or 24 mm when placed in the maxilla are only indicated formultiple unit restorations in splinted applications that utilize atleast two implants.S.I.N. Dental Implant System Zygomatic implants are intendedfor placement in the maxillary arch to provide support forfixed or removable dental prostheses in patients with partiallyor fully edentulous maxillae. When a one-stage surgicalapproach is applied, the S.I.N. Dental Implant SystemZygomatic implants are intended for immediate loaded whengood primary stability is achieved and with appropriateocclusal loading.	S.I.N. Dental Implant System is intended for placement in themaxillary or mandibular arch to provide support for single-unitor multi-unit restorations. When a one-stage surgical approachis applied, the S.I.N. Dental Implant System is intended forimmediate loading when good primary stability is achievedand with appropriate occlusal loading. Revolution Compactwith a 6 mm length is intended for delayed loading only.	NobelSpeedy® Groovy implants are endosseous implanintended to be surgically placed in the upper or lower jafor anchoring or supporting tooth replacements to restopatient esthetics and chewing function.NobelSpeedy® Groovy implants are indicated for singlemultiple unit restorations in splinted or non-splintedapplications. This can be achieved by a 2-stage or 1-stasurgical technique in combination with immediate, earldelayed loading protocols, recognizing sufficient primastability and appropriate occlusal loading for the selectedtechnique. Implants allow also for bi-cortical anchoragecases of reduced bone density.NobelSpeedy® Groovy implants 20, 22, 25 mm when pthe maxilla are only indicated for multiple unit restoratisplinted applications that utilize at least two implants.
Reason for Predicate /Reference Devices	Not applicable	Implant designs; abutment designs; materials;sterilization; shelf life	Standard implant designs (lengths)
Product Codes	DZE, NHA	DZE, NHA	DZE
Intended Use	Functional and esthetic rehabilitation of the edentulousmandible or maxilla	Functional and esthetic rehabilitation of the edentulousmandible or maxilla	Functional and esthetic rehabilitation of the edentulousmandible or maxilla
Standard Implant Designs
	Strong SW HE Implants	Strong SW HE Implants
Prosthetic Interface Connections	External hex (HE)	External hex (HE)	External hex
Body/Platform Diameter, mm	3.75/4.1	3.5/3.65, 3.75/4.1, 4.0/4.1, 4.5/4.5, 5.0/5.0	4.0/RP (4.1)
Lengths, mm	18, 20, 22, 24	7, 8.5, 10, 11.5, 13, 15*no 7 mm for 4.5/4.5 diameter	20, 22, 25
Implant Material	Unalloyed titanium, ASTM F67	Unalloyed titanium, ASTM F67	CP titanium
Implant Endosseous Surface	Acid-etched	Acid-etched	TiUnite
Zygomatic Implant Designs
Prosthetic Interface Connections	External hex (HE)
Body DiameterCoronal aspectApical aspect	4.5 mm3.85 mm
Platform Diameter	4.1 mm
Platform-Implant Axis Angle	45°
Lengths	34 mm – 59 mm
Thread Diameter andThreaded Length	Coronal thread diameter: 4.5 mmCoronal threaded length: 2.15 mmApical thread diameter: 3.85 mmApical thread length: 10.7 mm
Implant Material	Unalloyed titanium, ASTM F67
Implant Endosseous Surface	Acid-etched
	Subject DeviceS.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	Primary PredicateK170398S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	Reference DeviceK160119NobelSpeedy® GroovyNobel Biocare AB
Abutment Designs – Zygomatic Implants
Implant Cover	Implant Cover for Zygomatic ImplantCoronal diameter 4.1 mm	Implant Cover for Strong SW HE ImplantCoronal diameters: 3.5, 4.1, 5.0 mm
Abutment Components	Mini Abutment Zygomatic StandardPlatform Ø: 4.1 mmProsthetic Platform Ø: 4.5 mmGingival heights: 3, 4, 5.5 mmStraight	Mini AbutmentPlatform Ø: 3.6 mmProsthetic Platform Ø: 4.8 mmGingival heights: 1, 2, 3, 4 mmStraight
	Mini Abutment Zygomatic ConicalPlatform Ø: 4.1 mmProsthetic Platform Ø: 4.8 mmGingival heights: 2, 3, 4 mmStraight	Conical AbutmentPlatform Ø: 3.6 mmProsthetic Platform Ø: 4.8 mmGingival heights: 1, 2, 3, 4 mmStraight
	Abutment Protector, Ø 5 mm	Abutment Protector, Ø 5 mm
	Co-Cr Base (castable), Ø 4.5 and Ø 5 mm
	Temporary Titanium Sleeve , Ø 4.8 mm(for Mini Abutment Zygomatic Conical)
	Coping Screw, Ø 2.3 x 4.4 mm

Prosthesis Attachment	Screw-retained, multi-unit	Screw-retained, multi-unit
Abutment Component Materials	Titanium alloy, ASTM F136: abutments, implant cover,abutment protectorsUnalloyed titanium ASTM F67: titanium cylinderCo-Cr-Mo alloy, ASTM F1537: Co-Cr bases	Titanium alloy, ASTM F136



Abutment Screws Material	Titanium alloy, ASTM F136: abutment screws andcoping screw	Titanium alloy, ASTM F136
Implants	All sterile by gamma irradiation	All sterile by gamma irradiation	All sterile by gamma irradiation
Abutments, Implant Cover	All sterile by gamma irradiation	All sterile by gamma irradiation	Not applicable (not in submission)
Abutment Screws	All sterile by gamma irradiation	All sterile by gamma irradiation	Not applicable (not in submission)

	Reference Device
	K173343
	Zygomatic Implant System
	Southern Implants (Pty) Ltd
	Southern Implants Zygomatic System Standard implants, Zygan (narrow apex) implants, and Oncology implants are intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
	Zygomatic implant designs (Zygan implant)
	DZE, NHA
	Functional and esthetic rehabilitation of the edentulous maxilla
	External hex
	Zygan Implant
	4.3 mm
	3.4 mm
	4.05 mm
	55°
	30 mm - 57.5 mm
	Coronal thread diameter: 4.3 mm
	Coronal threaded length: Not in 510(k) Summary
	Apical thread diameter: 3.4 mm
	Apical thread length: 15 mm
	Unalloyed titanium, ASTM F67
	Aluminum oxide grit blasted

{10}------------------------------------------------

Reference Device
K173343
Zygomatic Implant System
Southern Implants (Pty) Ltd

Not stated in 510(k) Summary
Compact Conical Abutments
Platform Ø: not in 510(k) Summary
Prosthetic Platform Ø: not in 510(k) Summary
Gingival height: 2, 3, 4, 5.5 mmStraight
Titanium Cylinder Abutment
(Coping for Compact Conical Abutments)
Gingival height 5 mm


Titanium Cylinder Abutment, prosthetic platform
Ø 3.4 mm

Screw-retained, multi-unit
Unalloyed titanium, ASTM F67;
Titanium alloy, ASTM F136
Not stated in 510(k) Summary
Sterile, method not stated in 510(k) Summary
Not stated in 510(k) Summary
Not stated in 510(k) Summary

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.