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 may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implant System implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

Device Description

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K211921, K203725, K200992, K193096, K170398, and K051859.

This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA ""0"). The implant design and endosseous surfaces are identical to those cleared in K211921, with the exception of the additional body/platform diameter (4.0 mm) and the longer lengths (18, 20, 22, and 24 mm).

This submission includes Multifunctional Abutments with Morse taper connections (16°, 11.5°, and 4°), and protectors and temporary cylinders for these abutments; the subject device Multifunctional Abutments are compatible with subject device implants (CM 11.5°) and previously-cleared implants (CM 16° and 4°). This submission also includes Multifunctional Abutment components (cylinders) manufactured from Co-Cr-Mo alloy compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; CAD-CAM abutment components (called "Interface") manufactured from Ti-6A1-4V alloy and Co-Cr-Mo alloy, compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; and screws compatible with subject device components and previously cleared components with the 11.5° Morse taper connection. All subject device abutments are straight, with no angulation allowed.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. 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 K211921, and the HAM00 surface treatment is identical to that cleared in K211921.

The subject device implants are compatible with abutments and prosthetic components in this submission and components cleared previously in K200992, K193096, K170392, and K051859.

The subject device abutments and prosthetic components are compatible with implants and components in this submission and components cleared previously in K211921. K200992. K193096, and K170392.

AI/ML Overview

This document is a 510(k) Premarket Notification for the S.I.N. Dental Implant System. It does not describe an acceptance criteria or a study proving device performance against an acceptance criteria in the way typically found for AI/ML-driven medical devices. Instead, it demonstrates substantial equivalence to previously cleared predicate devices through non-clinical performance data and detailed comparisons of technological characteristics.

Therefore, the requested information elements related to acceptance criteria, specific study designs (test sets, training sets, expert review, MRMC studies, standalone performance), and ground truth establishment are not applicable to this type of submission.

The document focuses on showing that the new components (implants and abutments) of the S.I.N. Dental Implant System are as safe and effective as existing legally marketed predicate devices. This involves demonstrating equivalency in:

Intended Use: The indications for use are substantially equivalent to the predicate devices.
Technological Characteristics: Materials, manufacturing processes, design principles, sterilization methods, and performance data (non-clinical) are comparable or identical.

Here's a breakdown of the requested information based on the provided document, highlighting why most are not directly present:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table, with specific numerical acceptance criteria and a corresponding performance metric for an AI device, is not present because this is a 510(k) for a physical medical device (dental implants and components) and not an AI/ML software. The "performance data" provided are non-clinical tests demonstrating material properties, sterilization efficacy, biocompatibility, and mechanical integrity, which are described qualitatively or by reference to established standards (e.g., ISO, ASTM).

Here's an illustrative table based on the provided "PERFORMANCE DATA" section, but it does not represent AI/ML acceptance criteria:

Acceptance Criterion (Implicitly based on standards)	Reported Device Performance (as summarized)
Sterility Assurance Level (SAL) of 10⁻⁶ (ISO 11137-1 & 11137-2 for gamma; ANSI/AAMI/ISO 17665-1 & TIR 17665-2 for moist heat)	Demonstrated by selecting/substantiating a 25 kGy dose (gamma) and by overkill method (moist heat), referenced from predicate devices.
Bacterial Endotoxin Limit < 20 EU/device (ANSI/AAMI ST72)	Demonstrated by LAL test on water samples (weekly) and sterilized product samples (quarterly), referenced from predicate devices.
Shelf Life (packaging sterile barrier integrity and product sterility) after 4 years (ASTM F1929, F88/F88M)	Demonstrated by testing samples after 4 years of real-time aging, referenced from predicate devices.
Biocompatibility (ISO 10993-5, -3, -6, -10, -11)	Demonstrated for implant (ASTM F67), abutment (ASTM F136, F1537), and zirconia coping (ISO 13356) materials, and for HAnano coating, referenced from predicate devices.
HAnano Coating Characterization (SEM, XPS, TEM, XRD, adherence)	Characterization performed and leveraged from predicate devices.
Implant Acid-Etched Surface Characterization (SEM)	Characterization performed and leveraged from predicate devices.
MR Environment Safety (ASTM F2052, F2213, F2182, F2119 and FDA guidance)	Non-clinical analysis and testing performed to evaluate metallic subject devices in MR environment.
Mechanical Integrity (Implants with Abutments) (ISO 14801)	Engineering analysis demonstrated subject devices do not create a new worst-case construct; previous mechanical testing applicable.

2. Sample size used for the test set and the data provenance: Not applicable (no AI/ML test set mentioned). The document refers to non-clinical testing of physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no AI/ML ground truth mentioned).

4. Adjudication method for the test set: Not applicable (no AI/ML test set mentioned).

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: Not applicable (no AI/ML or human reader study mentioned).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (no AI/ML algorithm mentioned).

7. The type of ground truth used: Not applicable (no AI/ML ground truth mentioned). The "ground truth" for this submission are the established performance characteristics and safety profiles of the predicate devices and general standards for dental implants.

8. The sample size for the training set: Not applicable (no AI/ML training set mentioned).

9. How the ground truth for the training set was established: Not applicable (no AI/ML training set mentioned).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K221453

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: November 14, 2022 Received: November 15, 2022

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.

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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 (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 mediation-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 -S

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

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Indications for Use

510(k) Number (if known) K221453

Device Name

S.I.N. Dental Implant System

Indications for Use (Describe)

S.I.N. Dental Implant System is intended for placement in the maxillary or mandbular 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 may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

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 K221453 S.I.N. - Sistema de Implante Nacional S.A.

S.I.N Dental Implant System

December 14, 2022

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
	Email 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 Dental Devices and ENT

flarson@paxmed.com

PREDICATE DEVICE INFORMATION

Primary Predicate Device K222231, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. Reference Devices K211921, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K 193096, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

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INDICATIONS FOR USE STATEMENT

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

SUBJECT DEVICE DESCRIPTION

Epikut Plus CM

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K211921, K203725, K200992, K193096, K170398, and K051859.

Implant Lines	Body Ø, mm	Platform Ø, mm		Lengths, mm
Enikut CM	J:U	00راهان وال	1 C	00ﮯ ﮐﺎ ﺭﻗﺒﮧ 1998 ﻣﺮﺑﻊ ﮐﯿﻠﺌﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ	Cسك سك

4.0

4.5

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

4.0

4.5

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Abutment	Connection	Prosthetic Platformdiameter, mm	GingivalHeight, mm	Material
Multifunctional	CM 16°, CM 11.5°, CM 4°implants	4.8	0.8-5.5	Ti-6Al-4V
Protector for Multifunctional	n/a	n/a	n/a	Ti-6Al-4V
Temporary Cylinder Abutment	Micro Mini, Multifunctional	3.5, 4.8	0.2-0.5	Ti-6Al-4V
Chrome Cobalt Multifunctional	Multifunctional	5.0	0.5-2.0	Co-Cr-Mo
Chrome Cobalt Micro Mini	Micro Mini	3.3	2.0	Co-Cr-Mo
Interface Titanium Multifunctional	Multifunctional	5.5	0.35	Ti-6Al-4V
Interface Titanium Micro Mini	Micro Mini	3.8	0.5	Ti-6Al-4V
Interface Chrome Cobalt Multifunctional	Multifunctional	5.5	0.35	Co-Cr-Mo
Interface Chrome Cobalt Micro Mini	Micro Mini	3.8	0.5	Co-Cr-Mo
Screw for Protector Multifunctional	Multifunctional	n/a	n/a	Ti-6Al-4V
Screws forTemporary Cylinder Multifunctional;Interface Titanium Multifunctional;Cobalt Chrome Multifunctional:Interface Titanium Multifunctional;Interface Chrome Cobalt Multifunctional	Multifunctional	n/a	n/a	Ti-6Al-4V

For the Abutment Chrome Cobalt Multifunctional and Abutment Chrome Cobalt Micro Mini, the design limit parameters are:

Wall thickness of the final abutment before glazing must be at least 1.1 mm (0.3 mm after casting + 0.8 mm overlay)

Gingival margin diameter must be at least 0.5 mm beyond the prosthetic platform of the abutment. Gingival margin height must be at least 1 mm up to 3 mm.

Height of the abutment post must be between 4-9.5 mm.

Maximum angle - 0°, Straight only

For the Interface Titanium Multifunctional and Interface Titanium Micro Mini abutments, the design limit parameters are:

Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Maximum angle - 0°, Straight only Maximum gingival height - 5.0 mm Minimum Gingival height of superstructure - 0 mm (gingival height provided by underlying apical base) Maximum allowable Post Height – 6 mm Total abutment height - 10 mm

For the Interface Chrome Cobalt Multifunctional and Interface Chrome Cobalt Micro Mini abutments, the design limits are:

Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Maximum angle - 0°, Straight only Maximum gingival height - 5.0 mm Minimum Gingival height - 0 mm (gingival height provided by underlying apical base) Maximum allowable Post Height – 6 mm Total abutment height - 10 mm

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The subject device implants are compatible with abutments and prosthetic components in this submission and components cleared previously in K200992, K193096, K170392, and K051859.

The subject device abutments and prosthetic components are compatible with implants and components in this submission and components cleared previously in K211921. K200992. K193096, and K170392.

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:

gamma irradiation sterilization for subject devices provided sterile to the end user 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 K211921 and K203725);

bacterial endotoxin testing (referenced from K211921) 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 testing (referenced from K211921) 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;

moist heat sterilization for subject devices provided non-sterile to the end user to a sterility assurance level of 10 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2 (referenced from K193096);

biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the implant material ASTM F67, for the abutment and prosthetic component material ASTM F136, and for the abutment material ASTM F1537 (all provided in K170398);

biocompatibility testing according to ISO 10993-5 (cytotoxicity) for zirconia coping material ISO 13356 provided in K193096;

biocompatibility testing and characterization of the HAnano hydroxyapatite coating leveraged from K211921 (provided in K170392) included ISO 10993-3 (genotoxicity). ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization, irritation), and ISO 10993-11 (systemic toxicity);

characterization of the HAnano hydroxyapatite coating leveraged from K211921 provided in K170392) included scanning electron microscopy (SEM), x-ray photoelectron spectroscopy (XPS), transmission electron microscopy (TEM), x-ray diffraction (XRD), and testing of the adherence of the coating;

characterization of the implant acid-etched surface included scanning electron microscopy (SEM) leveraged from K211921 (provided in K051859);

non-clinical analysis and testing to evaluate the metallic subject devices in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021); and

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engineering analysis provided in this submission demonstrated that the subject device implants, in combination with compatible previously-cleared abutments, do not create a new worst-case construct, and that previous mechanical testing conducted according to ISO 14801 (submitted in K200992) is applicable to the subject device implants.

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 primary 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 primary predicate device K222231 is for support of substantial equivalence of the implant designs, including implant lengths of 18 mm, materials, manufacturing, and sterilization. The primary predicate K222231 also is for support of substantial equivalence of the Indications for Use statement for implants tilted up to 30°, as described below.

The reference device K211921 also is for support of substantial equivalence of the implant designs (11.5° Morse taper connection), materials, manufacturing, and sterilization.

The reference devices K193096 and K170392 are for support of substantial equivalence of the abutments and prosthetic components as described below.

The Indications for Use Statement (IFUS) for the subject device includes language concerning placement in the maxillary or mandibular arches and regarding immediate loading that is identical to the language in K222231, K211921, K193096, and K170392. The IFUS for the subject device also includes identical language to that included in K222231 regarding longer length implants, and identical language to that included in K193096 regarding CAD-CAM abutments. The IFUS for the subject device includes language that implants may be tilted up to 30°, and language that requires, for an angulation of 30°, a minimum of four (4) implants must be used and must be splinted. This language is identical to the language in the IFUS of the primary predicate device K222231. The IFUS for the subject device also includes language that implants with lengths of 18 mm to 24 mm placed at angulations between 0° and less than 30° are only indicated for multiple unit restorations in splications that utilize at least two implants. This language also is identical to language in the IFUS of the primary predicate device K222231.

Differences between the IFUS for the subject device and the primary predicate device and reference devices include language in the subject device IFUS regarding CAD-CAM abutments that is only applicable to K193096, and language in K170392 regarding implant lengths less than 7 mm that is not relevant to the subject device.

Subject Device Dental Implants

The subject device Epikut CM and Epikut Plus CM implants have nearly identical designs (except for lengths), materials, and manufacturing as used for the Epikut Plus CM implants cleared in K211921. The subject device Epikut CM and Epikut Plus CM implants have the same 11.5° internal

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Morse taper abutment connection and are provided in the same range of body/platform diameters as the implants cleared in K211921; the subject implants are provided in an additional body/platform diameter of 4.0/4.0, which is within the range of the implant sizes cleared in K211921.

The subject device implants are provided in lengths of 18 mm and may be tilted up to 30° for full-arch restorations using a minimum of four (4) implants that must be splinted; these lengths and the requirement for splinting are identical to the primary predicate K222231.

All subject device dental implants are manufactured from the same unalloyed titanium and all have the same acid-etched surface treatment used for the dental implants cleared in K22231 and K211921. The subject device Epikut Plus CM implants have the same acid-etched and HA™ endosseous surface treatment as used for implants cleared in K222231 and K211921.

All subject device implants and selected abutment and prosthetic components are provided sterile by gamma irradiation. The subject devices that are provided sterile have the same sterilization method, packaging, and sterile barrier shelf life as devices cleared in K222231, K211921, K203725, K193096, and K170392.

Subject Device Abutments and Prosthetic Components

The subject devices Abutment Multifunctional with 16°, 11.5°, and 4° Morse taper (CM) connections are substantially equivalent to the Mini Abutment Strong SW CM, Mini Abutment Unitite, and Mini Abutment Unitite Compact, respectively, cleared in K170392. These subject devices are provided in similar designs, the same prosthetic platform diameters, the same gingival heights, and the identical material as the abutments cleared in K170392.

The subject device Abutment Protector (for the subject device Multifunctional Abutments) is substantially equivalent to the Abutment Protectors cleared in K193096 because they are provided in similar design, in the identical material, and have a maximum (coronal) diameter that is within the range of diameters cleared in K193096.

The subject device Provisional Abutments (Temporary Cylinders Micro Mini and Temporary Cylinders Multifunctional) are substantially equivalent to the Abutment Provisional Micro Mini and Abutment Mini Provisional, respectively, cleared in K193096. These subject devices are provided in similar designs, the same prosthetic platform diameters, the same gingival heights, and the identical material as the abutments cleared in K193096.

The subject devices Abutment Chrome Cobalt Multifunctional and Abutment Chrome Cobalt Micro Mini are substantially equivalent to Interface Mini Abutments and Interface Micro Mini Abutments cleared in K 193096, and to the Mini Abutment Unitite components cleared in K 170392.

The subject Abutment Chrome Cobalt Multifunctional components are provided in similar designs and with a platform to abutment diameter (for connection to the subject device Multifunctional Abutments) as the Interface Mini Abutments cleared in K193096. The gingival height of the subject Abutment Chrome Cobalt Multifunctional components is within the range of gingival height for the Interface Mini Abutments (K193096) and the Mini Abutment Unitite (K170392). The subject Abutment Chrome Cobalt Micro Mini components are provided in similar designs and with a platform to abutment diameter (for connection to the subject device Mini Abutments) as the Interface Micro Mini Abutments cleared

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in K193096. The gingival height of the subject Abutment Chrome Cobalt Micro Mini components is within the range of gingival heights for the Mini Abutment Unitite (K170392). The subject devices Abutment Chrome Cobalt Multifunctional and Abutment Chrome Cobalt Micro Mini are manufactured from the identical Co-Cr allov used for the Interface Mini Abutments and Interface Micro Mini Abutments cleared in K193096.

The subject devices Interface Titanium Abutment Multifunctional, Interface Titanium Micro Mini Abutment, Interface Chrome Cobalt Multifunctional, and Interface Chrome Cobalt Micro Mini are used as the apical base of a two-piece abutment. The coronal portion of the two-piece abutment is designed and manufactured using CAD-CAM techniques. For the titanium alloy CAD-CAM abutments, the coronal portion is a coping manufactured from zirconia conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y TZP). For the Co-Cr alloy CAD-CAM abutments, CAD-CAM is used to design and fabricate a wax-up model, and the final abutment is cast using traditional techniques

The subject devices Interface Titanium Abutment Multifunctional and Interface Titanium Micro Mini Abutment are substantially equivalent to the Interface Mini Abutments and Interface Micro Mini Abutments, respectively, cleared in K193096. These subject devices are provided in similar designs, the same prosthetic platform diameters, the same gingival heights, and the identical (Ti-6A1-4V alloy) as the abutments cleared in K170392. These subject devices and those referenced from K193096 also require a zirconia coping fabricated by CAD-CAM technology.

The subject devices Interface Chrome Cobalt Multifunctional and Interface Chrome Cobalt Micro Mini are substantially equivalent to the Interface Mini Abutments and Interface Micro Mini Abutments, respectively, cleared in K193096. These subject devices are provided in similar designs, the same prosthetic platform diameters, the same gingival heights, and the identical material (Co-Cr alloy) as the abutments cleared in K170392. These subject devices and those referenced from K193096 also require a zirconia coping fabricated by CAD-CAM technology.

All subject device abutments and prosthetic components are provided sterile by gamma irradiation except the following to be sterilized by moist heat by the end user:

Provisional Abutments (Temporary Cylinder Abutment Multifunctional, and Temporary Cylinder Abutment Micro Mini),

Abutment Chrome Cobalt Multifunctional,

Abutment Chrome Cobalt Micro Mini.

Interface Chrome Cobalt Multifunctional, and Interface Chrome Cobalt Micro Mini.

For these components to be end-user sterilized, validated instructions are included in the Instructions for Use to be provided to the end user. Similar components to be end-user sterilized were cleared in K193096 and K170392.

Engineering analysis provided in this submission demonstrated that the subject device implants, in combination with compatible previously-cleared abutments, do not create a new worst-case construct, and that prior mechanical testing is applicable to the subject device implants.

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CONCLUSION

The subject device, the primary predicate device, and the additional predicate 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 additional predicate 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.

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Table of Substantial Equivalence

	Subject Device	Primary Predicate Device	Reference Device	Reference Device
Feature / Attribute	K221453S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K222231S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K211921S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K193096S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.
Indications for Use Statement	S.I.N. Dental Implant System is intended for placementin the maxillary or mandibular arch to provide supportfor single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. DentalImplant System is intended for immediate loadingwhen good primary stability is achieved and withappropriate occlusal loading.S.I.N. Dental Implant System implants with lengths of18, 20, 22, or 24 mm may be tilted up to 30°. Whenused in the mandible or maxilla with implants withlengths of 18, 20, 22, or 24 mm at an angulation of 30°,a minimum of four implants must be used and must besplinted. When placed in the maxilla with lengths of18, 20, 22, or 24 mm at angulations between 0° andless than 30°, the S.I.N. Dental Implant Systemimplants are only indicated for multiple unitrestorations in splinted applications that utilize at leasttwo implants.All digitally-designed custom abutments for use withInterface CAD-CAM abutments are to be sent to aS.I.N.-validated milling center for manufacture.	S.I.N. Dental Implant System is intended for placementin the maxillary or mandibular arch to provide supportfor single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. DentalImplant System is intended for immediate loadingwhen good primary stability is achieved and withappropriate occlusal loading.S.I.N. Dental Implant System implants with lengths of18, 20, 22, or 24 mm may be tilted up to 30°. Whenused in the mandible or maxilla with implants withlengths of 18, 20, 22, or 24 mm at an angulation of 30°,a minimum of four implants must be used and must besplinted. When placed in the maxilla with lengths of18, 20, 22, or 24 mm at angulations between 0° andless than 30°, the S.I.N. Dental Implant Systemimplants are only indicated for multiple unitrestorations in splinted applications that utilize at leasttwo implants.	S.I.N. Dental Implant System is intended forplacement in the maxillary or mandibular arch toprovide support for single-unit or multi-unitrestorations. When a one-stage surgical approach isapplied, the S.I.N. Dental Implant System is intendedfor immediate loading when good primary stability isachieved and with appropriate occlusal loading.	S.I.N. Dental Implant System is intended forplacement in the maxillary or mandibular arch toprovide support for single-unit or multi-unitrestorations. When a one-stage surgical approach isapplied, the S.I.N. Dental Implant System is intendedfor immediate loading when good primary stability isachieved and with appropriate occlusal loading.All digitally-designed custom abutments for use withInterface CAD-CAM abutments are to be sent to aS.I.N.-validated milling center for manufacture.
Reason for Predicate/Reference Device	Not applicable	Indications for tilting implants up to 30°;implant design; lengths 18 mm to 24 mm;materials; manufacturing; sterilization	Implant design; Morse taper (11.5°) connection;materials; manufacturing; sterilization	Indications for CAD-CAM abutments forconventional and CAD-CAM restorations;materials; manufacturing; sterilization
Product Codes	DZE, NHA	DZE	DZE	DZE, NHA
Intended Use	Functional and esthetic rehabilitation of theedentulous mandible or maxilla	Functional and esthetic rehabilitation of theedentulous mandible or maxilla	Functional and esthetic rehabilitation of theedentulous mandible or maxilla	Functional and esthetic rehabilitation of theedentulous mandible or maxilla
Implant Designs
Prosthetic Interface Connections	Morse taper (CM, 11.5°)	Morse taper (CM, 16°)	Morse taper (CM, 11.5°) and External Hex (HE)	Morse taper (CM, 11.5°)
Body/Platform Diameters, mmLengths, mm	Epikut CM3.8/3.8; 4.0/4.0; 4.5/4.518, 20, 22, 24 for all body diameters	Epikut S3.5/3.5, 3.8/3.8; 4.0/4.0; 4.5/4.5, 5.0/5.08.5 - 15, all body diameters18-24, for diameters 3.8, 4.0, 4.5	Epikut CM3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5, 10, 11.5, 13, 15	Epikut CM3.5/3.5; 3.8/3.8; 4.0/4.0; 4.5/4.58.5, 10, 11.5, 13, 15
Interface	Morse taper interface (CM, 11.5°)	Morse taper interface (CM, 16°)	Morse taper interface (CM, 11.5°)	Morse taper interface (CM, 11.5°)
Body/Platform Diameters, mmLengths, mm	Epikut Plus CM (HAnano coating)3.8/3.8; 4.0/4.0; 4.5/4.518, 20, 22, 24 for all body diameters	Epikut S Plus (HAnano coating)3.5/3.5, 3.8/3.8; 4.0/4.0; 4.5/4.5, 5.0/5.08.5–15, all body diameters18-24, for diameters 3.8, 4.0, 4.5	Epikut Plus CM (HAnano coating)3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5, 10, 11.5, 13, 15	Epikut Plus CM (HAnano coating)3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5, 10, 11.5, 13, 15
Interface	Morse taper interface (CM, 11.5°)	Morse taper interface (CM, 16°)	Morse taper interface (CM, 11.5°)	Morse taper interface (CM, 11.5°)
Implant Material	All implants: unalloyed titanium,ASTM F67	All implants: unalloyed titanium,ASTM F67	All implants: unalloyed titanium,ASTM F67	All implants: unalloyed titanium,ASTM F67
Implant Endosseous Surface	All implants: acid-etched;HAnano coating applied to theEpikut Plus CM implants	All implants: acid-etched;HAnano coating applied to theEpikut S Plus implants	All implants: acid-etched;HAnano coating applied to theEpikut Plus CM implants	All implants: acid-etched;HAnano coating applied to theEpikut Plus CM implants
Conventional Abutment Designs	Abutment MultifunctionalMorse taper interface CM 16°Prosthetic Platform: Ø 4.8Gingival Height (GH): 1 mm - 4 mmStraight only, 0°Titanium alloy, ASTM F136
Feature / Attribute	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	K221453S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K222231S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K211921S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K193096S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K170392S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.
	Abutment MultifunctionalMorse taper interface CM 11.5°Prosthetic Platform Ø: 4.8GH: 0.8 mm – 5.5 mmStraight only, 0°Titanium alloy, ASTM F136				Mini Abutment UnititeMorse taper interface (CM 11.5°)Prosthetic platform Ø: 4.8 mmGH: 0.8 mm – 5.5 mmTitanium alloy, ASTM F136
	Abutment MultifunctionalMorse taper interface CM 4°Prosthetic Platform Ø: 4.8GH: 1 mm – 5 mmStraight only, 0°Titanium alloy, ASTM F136				Mini Abutment Unitite CompactMorse taper interface (CM 4°)Prosthetic platform Ø: 4.8 mmGH: 1 mm - 5 mmTitanium alloy, ASTM F136
	Abutment ProtectorFor Multifunctional abutmentsMaximum Ø: 5 mmTitanium alloy, ASTM F136			Abutment ProtectorsFor abutments with HE, HI, CM interfaceMaximum Ø: 3.65 mm – 6 mmTitanium alloy, ASTM F136
	Provisional AbutmentsTemporary Cylinders Micro MiniProsthetic Platform Ø: 3.5 mmGH: 0.5 mmStraight only, 0°Titanium alloy, ASTM F136			Abutment Provisional Micro MiniProsthetic Platform Ø: 3.5GH: 0.5 mmTitanium alloy, ASTM F136
	Provisional AbutmentsTemporary Cylinders MultifunctionalProsthetic Platform Ø: 4.8 mmGH: 0.2 mmStraight only, 0°Titanium alloy, ASTM F136			Abutment Mini ProvisionalProsthetic Platform Ø: 4.8GH: 0.2 mm – 1 mmTitanium alloy, ASTM F136
	Abutment Chrome Cobalt MultifunctionalCylinders to match subject MultifunctionalAbutmentsPlatform to abutment Ø: 4.8 mmProsthetic Platform Ø: 5 mmGH: 0.5 mmStraight only, 0°Co-Cr-Mo alloy, ASTM F1537			Interface Mini AbutmentsMatches Mini AbutmentsPlatform to abutment Ø: 4.8 mmProsthetic platform Ø: 5.5 mmGH: 0.35 mmCo-Cr-Mo alloy, ASTM F1537 andTitanium alloy, ASTM F136	Mini Abutment UnititeMorse taper interface (CM 11.5°)Prosthetic platform Ø: 4.8 mmGH: 0.8-5.5 mmTitanium alloy, ASTM F136
	Abutment Chrome Cobalt Micro MiniCylinders to match subject Micro MiniAbutmentsPlatform to abutment Ø: 3.5 mmProsthetic Platform Ø: 3.3 mmGH: 2 mmStraight only, 0°Co-Cr-Mo alloy, ASTM F1537			Interface Micro Mini AbutmentsMatches Micro Mini AbutmentsPlatform to abutment Ø: 3.5 mmProsthetic platform Ø: 3.8 mmGH: 0.5 mmCo-Cr-Mo alloy, ASTM F1537 andTitanium alloy, ASTM F136	Mini Abutment UnititeMorse taper interface (CM 11.5°)Prosthetic platform Ø: 4.8 mmGH: 0.8-5.5 mmTitanium alloy, ASTM F136
CAD-CAM Abutment Designs
	Interface Titanium Abutment MultifunctionalMatches subject Multifunctional AbutmentsProsthetic Platform Ø: 5.5 mmGH: 0.35 mmStraight only, 0°Titanium alloy, ASTM F136			Interface Mini AbutmentsMatches Mini AbutmentsProsthetic platform Ø: 5.5 mmGH: 0.35 mmCo-Cr-Mo alloy, ASTM F1537 andTitanium alloy, ASTM F136
	Interface Titanium Micro Mini AbutmentMatches Micro Mini AbutmentsProsthetic Platform Ø: 3.8 mmGH: 0.5 mmStraight only, 0°Titanium alloy, ASTM F136			Interface Micro Mini AbutmentsMatches Micro Mini AbutmentsProsthetic platform Ø: 3.8 mmGH: 0.5 mmCo-Cr-Mo alloy, ASTM F1537 andTitanium alloy, ASTM F136
Feature / Attribute	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	K221453	K222231	K211921	K193096	K170392
	S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.
	Interface Chrome Cobalt MultifunctionalMatches subject Multifunctional AbutmentsProsthetic Platform Ø: 5.5 mm;GH: 0.35 mmStraight only, 0°Co-Cr-Mo alloy, ASTM F1537			Interface Mini AbutmentsMatches Mini AbutmentsProsthetic platform Ø: 5.5 mmGH: 0.35 mmCo-Cr-Mo alloy, ASTM F1537 andTitanium alloy, ASTM F136
	Interface Chrome Cobalt Micro MiniMatches Micro Mini AbutmentsProsthetic Platform Ø: 3.8 mmGH: 0.5 mmStraight only, 0°Co-Cr-Mo alloy, ASTM F1537			Interface Micro Mini AbutmentsMatches Micro Mini AbutmentsProsthetic platform Ø: 3.8 mmGH: 0.5 mmCo-Cr-Mo alloy, ASTM F1537 andTitanium alloy, ASTM F136
Abutment Materials	Titanium alloy, ASTM F136Co-Cr-Mo alloy, ASTM F1537Zirconia, ISO 13356			Titanium alloy, ASTM F136Co-Cr-Mo alloy, ASTM F1537Zirconia, ISO 13356	Titanium alloy, ASTM F136
How Provided
Implants	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation
Abutments	All sterile by gamma irradiationExcept the following to be sterilized by moistheat by the end user:Provisional Abutments(Temporary Cylinder AbutmentMultifunctional, Temporary CylinderAbutment Micro Mini)Abutment Chrome Cobalt MultifunctionalAbutment Chrome Cobalt Micro MiniInterface Chrome Cobalt MultifunctionalInterface Chrome Cobalt Micro Mini			All sterile by gamma irradiationExcept the following to be sterilized by moistheat by the end user:Provisional AbutmentsUCLA-type AbutmentsInterface Conical AbutmentsInterface External Hex AbutmentsInterface Internal Hex AbutmentsInterface Mini AbutmentsInterface Micro Mini Abutments	All sterile by gamma irradiationExcept the following to be sterilized by moistheat by the end user:Provisional AbutmentsUCLA-type AbutmentsSIT Provisional Caps
Usage - All Components	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use

Device	Reference Device
6	K170392
lant System ante Nacional S.A.	S.I.N. Dental Implant System S.I.N. - Sistema de Implante Nacional S.A.
s intended for nandibular arch to or multi-unit surgical approach is nt System is intended d primary stability is cclusal loading. butments for use with s are to be sent to a for manufacture.	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. Implants with lengths less than 7 mm are intended for delayed loading only.
abutments; M abutment designs; erilization	Conventional abutment designs; materials; manufacturing; sterilization
	DZE, NHA
bilitation of the illa	Functional and esthetic rehabilitation of the edentulous mandible or maxilla







	Mini Abutment Strong SW CM Morse taper interface (CM 16°) Prosthetic platform Ø: 4.8 mm GH: 1 mm - 4 mm Titanium alloy, ASTM F136

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S.I.N Dental Implant System

K221453

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.