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.

All digitally-designed custom abutments for use with Pre-Milled 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 K221453, K222231, K211921, K193096, and K170392.

This submission adds Pre-Milled CAD-CAM Abutments to the S.I.N. Dental Implant System. The subject device abutments are provided with 11.5° CM and 16° CM connections compatible with the above S.I.N. dental implants.

The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are the same for the 11.5° CM implant connection and the 16° CM implant connection. The design limit parameters are:

Minimum wall thickness - 0.55 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.55 mm Maximum gingival height - 3.5 mm Minimum prosthetic platform diameter - 3.5 mm Maximum prosthetic post height - 6 mm Maximum angulation - 30°

The subject device abutments are compatible with previously cleared S.I.N. Dental Implant bodies summarized in the following table.

All subject device abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and are to be used with compatible abutment screws previously cleared in K170392. All subject device abutments are provided non-sterile and are to be moist heat sterilized by the end user.

AI/ML Overview

This document describes the regulatory clearance for the S.I.N. Dental Implant System, specifically focusing on the addition of Pre-Milled CAD-CAM Abutments. This is a 510(k) submission, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes for test sets, ground truth establishment by experts, MRMC studies, and training sets, is not applicable to this type of regulatory submission.

Here's why and what information is provided in the document related to "acceptance criteria" from a substantial equivalence perspective:

In a 510(k) submission for a device like this, "acceptance criteria" are primarily met through non-clinical performance data demonstrating that the new device (the subject device with the added components) is as safe and effective as the predicate device(s). The "study" proving this typically involves engineering analyses and bench testing, comparing the subject device to the predicate device(s) or established standards.

Detailed breakdown based on the provided document:

1. Table of Acceptance Criteria (from a Substantial Equivalence Perspective) and Reported Device Performance:

The "acceptance criteria" for a 510(k) are essentially demonstrating that the new device has the same intended use and similar technological characteristics as the predicates and that any differences do not raise new questions of safety or effectiveness. The reported performance is shown through the non-clinical tests.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance/Evidence from Document
Intended Use Equivalence	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. All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture. This statement is identical to the primary predicate device (K193096) for the core indications, and similar to reference devices with minor differences that are addressed (e.g., specific implant lengths not relevant to the subject device, or predicate not explicitly mentioning CAD-CAM abutments which is addressed by K193096).
Technological Characteristics Equivalence	Abutment Design Parameters: The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are provided (Minimum wall thickness - 0.55 mm, Minimum post height for single-unit restoration - 4.0 mm, Minimum gingival height - 0.55 mm, Maximum gingival height - 3.5 mm, Minimum prosthetic platform diameter - 3.5 mm, Maximum prosthetic post height - 6 mm, Maximum angulation - 30°). These parameters are compared to those of predicate abutments (e.g., Abutment Cemented Angled Indexed SIT with CM 11.5° interface and Abutment Cemented Morse Angled with CM 16° interface). Material: Titanium alloy (Ti-6Al-4V) conforming to ASTM F136, same as predicate devices. Sterilization Method: Non-sterile, to be moist heat sterilized by end-user. Validation performed to a sterility assurance level of 10^-5 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2. Similar to some predicate devices. Biocompatibility: Referenced from K170398 for abutment material ASTM F136 (ISO 10993-5 cytotoxicity). MR Safety: Referenced from K221453 (ASTM F2052, F2213, F2182, F2119, and FDA guidance). Mechanical Performance: Engineering analysis provided to demonstrate that the subject device abutments, in combination with compatible previously cleared dental implants, do not create a new worst-case construct in terms of mechanical testing according to ISO 14801. Mechanical testing data were referenced from K200992 conducted according to ISO 14801.
Safety and Effectiveness Equivalence (absence of new risks)	An engineering rationale was provided to demonstrate that the use of the subject device abutments in combination with the compatible implants raise no new risks and that mechanical testing data provided in a prior submission (K200992) are applicable to the subject abutments. The non-clinical performance data (sterilization, biocompatibility, MR safety, mechanical) supports this.

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

Sample Size for Test Set: Not applicable in the context of clinical performance evaluation for this 510(k). The "test set" here refers to the samples of the device and implant components used for bench testing (e.g., mechanical testing, sterility validation). The document indicates mechanical testing was done per ISO 14801, which would have defined the number of samples required for that specific test, but the exact number isn't provided in this summary.
Data Provenance: The manufacturing entity, S.I.N. - Sistema de Implante Nacional S.A., is based in São Paulo, Brazil. The testing would typically be performed either in-house by the manufacturer or by contract research organizations (CROs) in a relevant country. The document does not specify the country where the non-clinical tests (e.g., mechanical, sterilization validation) were explicitly conducted. These non-clinical tests are prospective, meaning they are performed specifically to support the submission.

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

Not Applicable. This device clearance is based on non-clinical performance data (bench testing, engineering analysis) and substantial equivalence to predicate devices, not on human interpretation or diagnosis. Therefore, there is no "ground truth" established by medical experts in the way it would be for an AI diagnostic device.

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

Not Applicable. As no expert review or clinical trial data requiring adjudication was performed, this concept is irrelevant to this 510(k) submission.

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

No. This is not an AI/software as a medical device (SaMD) and no MRMC study was conducted or is required for this type of implant device.

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

Not Applicable. This is a physical dental implant system, not a software algorithm.

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

For this 510(k) submission, the "ground truth" for demonstrating device performance is typically established by:
- International Standards: e.g., ISO 14801 for mechanical testing of dental implants, ISO 10993 for biocompatibility, ISO 17665 for sterilization. These standards provide accepted methodologies and performance requirements.
- Engineering Principles and Analyses: Demonstrating that the new components, when combined with existing cleared components, do not introduce new failure modes or decrease mechanical integrity compared to the predicate.
- Comparison to Predicate Devices: Showing that the subject device's characteristics (design, material, intended use) are sufficiently similar to legally marketed devices.

8. The sample size for the training set:

Not Applicable. This is not a machine learning/AI device, so there is no "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) clearance letter for a dental implant system, a physical medical device. The "acceptance criteria" and "proof" are demonstrated through extensive non-clinical (bench) testing and engineering analyses to show substantial equivalence to predicate devices and adherence to relevant industry standards, rather than clinical trials involving human subjects or AI algorithm performance metrics.

Summary

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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: K230069

Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 9, 2023 Received: January 10, 2023

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)

K230069

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.

All digitally-designed custom abutments for use with Pre-Milled 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 K230069 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System

April 6, 2023

ADMINISTRATIVE INFORMATION

Manufacturer Name	S.I.N. - Sistema de Implante Nacional S.A.Avenida Vereador Abel Ferreira, 1100São Paulo, São Paulo03340-000 BrazilTelephone +55-11-21693000 ext 3236
Official Contact	Denise Domiciano, Quality and Regulatory Manager
Representative/Consultant	Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	S.I.N. Dental Implant System
Common Names	Dental implant abutment
Regulation Number	21 CFR 872.3630
Regulation Name	Endosseous dental implant abutment
Regulatory Class	Class II
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 and ENT Devices

PREDICATE DEVICE INFORMATION

Primary Predicate Device K 193096, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

Reference Devices K221453, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K222231, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

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K211921, 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. K 170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

INDICATIONS FOR USE STATEMENT

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

SUBJECT 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 K221453, K222231, K211921, K193096, and K170392.

The subject device abutments are compatible with previously cleared S.I.N. Dental Implant bodies summarized in the following table.

Compatible Previously Cleared Implants, 11.5° CM	510(k) Number
Unitite Implant, body Ø 3.5 mm, 4.3 mm, 5.0 mm	K170392
Implant Strong SW, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm
Implant Strong SW Plus, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm
Implant Tryon CM Conical, body Ø 3.5 mm, 4.0 mm, 5.0 mm	K200992
Implant Tryon CM Cylindrical Body and Conical Apex, body Ø 3.5 mm, 3.75 mm, 4.0 mm
Implant Tryon CM Cylindrical, body Ø 3.5 mm, 3.75 mm, 4.0 mm, 5.0 mm
Implant Epikut CM, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm
Implant Epikut Plus CM, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm	K211921
Implant Epikut CM, body Ø 3.8 mm, 4.0 mm, 4.5 mm
Implant Epikut Plus CM, body Ø 3.8 mm, 4.0 mm, 4.5 mm	K221453

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Compatible Previously Cleared Implants, 16° CM	510(k) Number
Strong SW CM Implant, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm	K170392
Strong SW CM Plus Implant, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm	K193096
Implant Epikut S, body Ø 3.5 mm, 3.8 mm, 4.0 mm, 4.5 mm, 5.0 mm	K222231
Implant Epikut S Plus, body Ø 3.5 mm, 3.8 mm, 4.0 mm, 4.5 mm, 5.0 mm

PERFORMANCE DATA

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

. provided in this submission was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 105 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
. referenced from K170398 was biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the abutment material ASTM F136;
. referenced from K221453 was non-clinical analysis and testing to evaluate the metallic subject devices and compatible dental implants 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);
. provided in this submission was engineering analysis to demonstrate that the subject device abutments, in combination with compatible previously cleared dental implants, do not create a new worst-case construct in terms of mechanical testing according to ISO 14801; and
referenced from K200992 was mechanical testing conducted according to ISO 14801 to support the ● performance of the subject device abutments, in conjunction with the engineering analysis provided in this submission.

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 K193096 is in support of substantial equivalence of the Indications for Use including CAD-CAM abutments, abutment designs, materials, manufacturing, sterilization, and compatible implants. The reference devices K221453, K222231, K211921, K200992, and K170392 are in support of substantial equivalence of the Indications for Use including CAD-CAM abutments (K221453), abutment designs, materials, manufacturing, sterilization, and compatible implants.

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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 K193096. The IFUS for the subject device also includes language concerning CAD-CAM abutments and validated milling centers that is identical, besides the trade name, to that included in K193096.

Differences between the IFUS for the subject device and the reference devices include: language in K221453 and K222231 regarding indications for implants with lengths of 18-24 mm that is not relevant to the subject device; language in K170392 regarding implant lengths less than 7 mm that is not relevant to the subject device; and the IFUS for K222231, K211921, K200992, and K170392 do not contain language regarding CAD-CAM abutments and validated milling centers.

The subject device abutments with the 11.5° CM interface are compatible with implants cleared in K200992, K221453, K211921, and K170392 in terms of the abutment-implant connection. The subject device abutments with the 11.5° CM interface in final finished form are substantially equivalent to the Abutment Cemented Angled Indexed SIT cleared in K200992 in terms of material and design limit parameters including prosthetic platform diameter, maximum gingival height, and maximum angulation.

The subject device abutments with the 16° CM interface are compatible with implants cleared in K222231, K193096, and K170392 in terms of the abutment-implant connection. The subject device abutments with the 16° CM interface in final finished form are substantially equivalent to the Abutment Cemented Morse Angled cleared in K200992 in terms of material and design limit parameters including prosthetic platform diameter, maximum gingival height, and maximum angulation.

The subject device abutments are to be end user sterilization instructions are provided in the Instructions for Use. Similar components to be end-user sterilized (abutments manufactured from Ti-6Al-4V alloy material) were cleared in K221453, K193096, and K170392.

The subject device abutments are packaged in a polyethylene terephthalate blister pack with a Tyvek cover. The Tyvek cover for the blister pack is printed with the appropriate label for the corresponding component. This is the same packaging used for similar abutments (provided non-sterile) in K221453.

An engineering rationale was provided to demonstrate that the use of the subject device abutments in combination with the compatible implants raise no new risks and that mechanical testing data provided in a prior submission (K200992) are applicable to the subject abutments.

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 primary predicate device and the reference devices listed above.

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Table of Substantial Equivalence

	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	K230069S.I.N. Dental Implant System	K193096S.I.N. Dental Implant System	K200992S.I.N. Dental Implant System	K221453S.I.N. Dental Implant System	K170392S.I.N. Dental Implant System
	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.
Indications for Use Statement(IFUS)	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 loading whengood primary stability is achieved and with appropriateocclusal loading.All digitally-designed custom abutments for use withPre-Milled 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 loading whengood primary stability is achieved and with appropriateocclusal 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.	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 loading whengood primary stability is achieved and with appropriateocclusal loading.	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 loading whengood primary stability is achieved and with appropriateocclusal loading.S.I.N. Dental Implant System implants with lengths of18, 20, 22, or 24 mm may be tilted up to 30°. When usedin the mandible or maxilla with implants with lengths of18, 20, 22, or 24 mm at an angulation of 30°, aminimum of four implants must be used and must besplinted. When placed in the maxilla with lengths of 18,20, 22, or 24 mm at angulations between 0° and lessthan 30°, the S.I.N. Dental Implant System implants areonly indicated for multiple unit restorations in splintedapplications that utilize at least two 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 loading whengood primary stability is achieved and with appropriateocclusal loading. Implants with lengths less than 7 mmare intended for delayed loading only.
Reason forPredicate Device	Not applicable	IFUS including CAD-CAM abutments and validatedmilling centers;Compatible implants	Abutment designs; materials; manufacturing;sterilization;Compatible implants	IFUS including CAD-CAM abutments and validatedmilling centers;Compatible implants	Abutment designs; materials; manufacturing;sterilizationCompatible implants
Product Codes	NHA	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
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	Functional and esthetic rehabilitation of the edentulousmandible or maxilla	Functional and esthetic rehabilitation of the edentulousmandible or maxilla
Abutment Designs
CM 11.5° interface	Pre-Milled Blank AbutmentsCM 11.5° interfaceMinimum post height for single-unit restoration: 4 mmProsthetic platform Ø: 3.5 mm (min)Gingival height: 3.5 mm (max), 0.55 mm (min)Angle: 30° (max)Indexed		Abutment Cemented Angled Indexed SITCM 11.5° interfaceProsthetic platform Ø: 3.3, 4.5 mmGingival height: 1.5-3.5 mmAngle: 17°, 30°Indexed
CM 16° interface	Pre-Milled Blank AbutmentsCM 16° interfaceMinimum post height for single-unit restoration: 4 mmProsthetic platform Ø: 3.5 mm (min)Gingival height: 3.5 mm (max), 0.55 mm (min)Angle: 30° (max)Indexed		Abutment Cemented Morse AngledCM 16° interfaceProsthetic platform Ø: 3.3, 4.5 mmGingival height: 1.5-3.5 mmAngle: 17°, 30Indexed
Abutment Materials	Titanium alloy, ASTM F136	Titanium alloy, ASTM F136	Titanium alloy, ASTM F136	Titanium alloy, ASTM F136	Titanium alloy, ASTM F136
	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	K230069S.I.N. Dental Implant System	K193096S.I.N. Dental Implant System	K200992S.I.N. Dental Implant System	K221453S.I.N. Dental Implant System	K170392S.I.N. Dental Implant System
	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.	S.I.N. - Sistema de Implante Nacional S.A.
Compatible Implants
CM 11.5° Connection			Strong SW andStrong SW PlusBody/platform $Ø$ 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 mmLengths 8.5-15 mm	Epikut CMEpikut Plus CMBody/platform $Ø$ 3.8/3.8; 4.0/4.0; 4.5/4.5 mmLengths 18-24 mm	UnititeBody/platform $Ø$ 3.5/3.5; 4.3/4.3, 5.0/5.0 mmLengths 8.5-15 mm
			Tryon CM ConicalBody/platform $Ø$ 3.5/3.5, 4.0/4.0; 5.0/5.0 mmLengths 8.5-15 mm
			Tryon CM Cylindrical Body and Conical ApexBody/platform $Ø$ 3.5/3.5, 3.8/3.8, 4.5/4.5; 5.0/5.0 mmLengths 8.5-15 mm
			Tryon CM CylindricalBody/platform $Ø$ 3.5/3.5, 3.75/3.75, 4.0/4.0; 5.0/5.0 mmLengths 7-15 mm
CM 16° Connection		Strong SW CM PlusBody/platform $Ø$ 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 mmLengths 8.5-15 mm			Strong SW CMBody/platform $Ø$ 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 mmLengths 8.5-15 mm
How Provided
Abutments	Non-sterile,to be sterilized by moist heat by the end user	Sterile by gamma irradiationandNon-sterile,to be sterilized by moist heat by the end user	Sterile by gamma irradiation	Sterile by gamma irradiationandNon-sterile,to be sterilized by moist heat by the end user	Sterile by gamma irradiationandNon-sterile,to be sterilized by moist heat by the end user
Usage - All Components	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use	Not stated in 510(k) Summary

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S.I.N Dental Implant System

K230069

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

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