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.

Unitite Slim, Unitite, Unitite Compact, Strong SW CM S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.

Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus 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.

Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus 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 labeling claims for a surface treatment designated HA™®, which is applied to implants of the S.I.N. Dental Implant System, as previously cleared in K170392. K193096. K200992, K211921, K221453, and K222231. The new labeling claims and the information supporting the claims are shown below in Performance Data.

The following information is a summary of the designs of the subject device implants, as they have been previously cleared with the HA"" surface treatment. Note that there are no changes to any aspect of the design, nor to the HA" surface treatment, as described in the respective 510(k) Premarket Notifications referenced above.

The previously cleared implants that are the subject of this submission includes eleven (11) product lines from six (6) 510(k)s. Implant body diameters, platform diameters and lengths for each product line are shown below in Table 10.1 Summary of Subject Device Designs and Sizes.

K170392: Unitite Slim, Unitite, Unitite Compact K193096: Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus K200992: Strong SW Plus K211921: Epikut Plus CM, Epikut Plus HE K221453: Epikut Plus CM (additional lengths) K22231: Epikut S Plus

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The HA1000 surface treatment is identical to that cleared in K211921.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the U.S. FDA for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices by comparing their indications for use, designs, materials, and manufacturing processes, with an emphasis on adding new labeling claims related to a surface treatment.

Crucially, this document states: "No clinical data were included in this submission." This means that the device's performance was not proven through a study involving human subjects or artificial intelligence (AI). The document relies on non-clinical data such as in vitro testing, animal testing referenced from published literature, sterilization, endotoxin, shelf-life, biological evaluation, MR compatibility, and fatigue testing to support the claims and substantial equivalence.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and specific performance metrics for an AI/device study cannot be extracted from this document.

However, I can extract the information related to the non-clinical performance data presented to meet the criteria for substantial equivalence to predicates.

Here's a breakdown of what can be extracted and an explanation of why other requested information is not present:

Information that CANNOT be extracted from this document (and why):

A table of acceptance criteria and the reported device performance (for clinical/AI studies): Not applicable as no clinical or AI study was performed. The acceptance criteria relate to demonstrating substantial equivalence through non-clinical data, not specific performance metrics against a ground truth for a diagnostic claim.
Sample sizes used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set: Not applicable as no clinical study or diagnostic AI was evaluated.
The sample size for the training set: Not applicable (not an AI device).
How the ground truth for the training set was established: Not applicable (not an AI device).

What CAN be extracted/inferred regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission:

The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to existing legally marketed devices (predicates). The "study that proves the device meets the acceptance criteria" in this case refers to the non-clinical tests and comparisons performed to show this equivalence and support the new labeling claims.

1. A table of acceptance criteria and the reported "device performance" (in terms of non-clinical criteria):

The acceptance criteria for this 510(k) submission are implicitly met by demonstrating that the subject device is as safe and effective as the predicate devices and that the new labeling claims are supported by scientific evidence. The "performance" here refers to meeting specific engineering, biological, and material standards, not diagnostic accuracy.

Acceptance Criterion (Implicitly required for 510(k) & specific claims)	Reported Device "Performance" (Evidence provided)
Equivalence in Intended Use	Subject device's Indications for Use (IFUS) are identical or substantially similar to those of predicate and reference devices (K170392, K193096, K200992, K211921, K221453, K222231). This includes general placement, loading conditions, specific length limitations for delayed loading, and angulation requirements for longer implants.
Equivalence in Design/Physical Characteristics	The design (body/platform diameters, lengths, implant/abutment interface) of the subject device implants (including the new HA™® surface) is identical to those previously cleared in predicate/reference 510(k)s (K170392, K193096, K200992, K211921, K221453, K222231).
Equivalence in Materials	Subject device is manufactured from unalloyed titanium conforming to ASTM F67, identical to predicate devices. The HA™® surface treatment is identical to that cleared in K211921.
Sterilization Efficacy	Demonstrated by gamma irradiation sterilization to a sterility assurance level of 10^-6 by VDmax25 method, according to ISO 11137-1 and ISO 11137-2 (referenced from K211921).
Absence of Pyrogens/Endotoxins	Bacterial endotoxin testing (LAL test) according to ANSI/AAMI ST72 on manufacturing water (weekly) and sterilized product (quarterly) demonstrated all sterile product meets a limit of < 20 EU/device (referenced from K211921).
Shelf-Life Stability	Shelf life testing, 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 (referenced from K211921).
Biocompatibility	Biological evaluation performed according to ISO 10993-1, with test results leveraged from K170392 for ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization, irritation), and ISO 10993-11 (systemic toxicity) to support biocompatibility.
MRI Safety and Compatibility	Non-clinical analysis and testing 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). No specific results are provided in the summary.
Mechanical Strength/Fatigue	Fatigue testing according to ISO 14801 referenced from K170392, K193096, K200992, K211921, K221453, and K222231 is applicable to the subject device (the specific results or "performance" against a benchmark are not provided in the summary, just that such testing was leveraged).
Support for HAnano Surface Claims	Surface Wettability (Hydrophilicity): Referenced Bezerra et al., 2017. Page 6: "Water contact angle was significantly less on HAnano treated titanium surface than on dual acid-etched titanium surface."Osteoblast Behavior/Differentiation: Referenced Bezerra et al., 2017 (Pages 4, 10) and da Silva et al., 2020 (Page 7). Claims include greater transition to differentiation-related signaling, changes in osteogenic gene marker expression, and spreading morphology different from machined/hydrophilic dual acid-etched surfaces. Results of in vitro testing are not necessarily predictive of human clinical performance.

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: Not applicable. The "test set" here would refer to the samples used in the non-clinical tests (e.g., in vitro cell cultures, physical test samples, animal models where applicable for referenced studies). Exact sample sizes for these referenced non-clinical studies are not provided in this summary.
Data Provenance:
- Country of Origin: Not specified for the referenced studies (Bezerra et al., da Silva et al.). The manufacturing country for the device is Brazil (S.I.N. - Sistema de Implante Nacional S.A., São Paulo, Brazil).
- Retrospective or Prospective: Not applicable as these were non-clinical, in vitro, or animal studies, not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a non-clinical submission for a dental implant, not an AI/diagnostic device requiring expert ground truth for imaging interpretation. The "ground truth" for the non-clinical properties is established by the methods, standards, and scientific literature cited (e.g., ASTM, ISO standards, and published research papers).

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

Not applicable. There was no expert reader study.

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, an MRMC study was not done. This is not an AI-enabled device.

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

No, a standalone algorithm performance study was not done. This is not an AI-enabled device.

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

The "ground truth" for the claims made are based on non-clinical in vitro and animal studies, and adherence to recognized standards for material properties, sterilization, biocompatibility, and mechanical performance. Specifically for the HAnano claims, the ground truth is derived from the experimental results reported in the referenced scientific publications (e.g., measurements of water contact angle, observation of cell morphology, assessment of gene marker expression).

8. The sample size for the training set:

Not applicable. This is not an AI device trained on a dataset.

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

Not applicable. This is not an AI device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. % Floyd Larson President PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, California 92130

May 31, 2024

Re: K232821

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 Dated: Mav 8, 2024 Received: May 8, 2024

Dear Floyd Larson:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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 -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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K232821

Device Name

S.I.N. Dental Implant System

Indications for Use (Describe)

Unitite Slim, Unitite, Unitite Compact, Strong SW CM S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.

Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus

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.

Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K232821 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System

May 22, 2024

ADMINISTRATIVE INFORMATION

Manufacturer Name	S.I.N. - Sistema de Implante Nacional S.A.Avenida Vereador Abel Ferreira, 2140São Paulo, São Paulo03340-000 BrazilTelephone +55-11-21693000 ext 3236
Official Contact	Denise Domiciano, Quality and Regulatory Manager
Representative/Consultant	Floyd G. Larson, MS, MBAKevin A. Thomas, PhDPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email flarson@paxmed.com 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
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)

PREDICATE DEVICE INFORMATION

Primary Predicate Device K170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

Reference Devices

K193096, 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
K211921, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A
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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INDICATIONS FOR USE STATEMENT

Unitite Slim, Unitite, Unitite Compact, Strong SW CM

S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.

Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus

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.

Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to a S.I.N.-validated milling center for manufacture.

SUBJECT DEVICE DESCRIPTION

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510k	Implant Line	ImageNot toScale	Body Ø,mm	PlatformØ,mm	Length, mm
	Unitite Slim	Image: Unitite Slim	2.9	2.9		10	11.5	13
K170392	Unitite	Image: Unitite	3.5	3.5	8.5	10	11.5	13	15
		Image: Unitite	4.3	4.3	8.5	10	11.5	13	15
		Image: Unitite	5.0	5.0	8.5	10	11.5	13	15
	Unitite Compact	Image: Unitite Compact	4.0	4.0	5	6	7
		Image: Unitite Compact	5.0	5.0	5	6	7
		Image: Unitite Compact	6.0	6.0	5	6	7
K193096	Strong SW CM Plus	Image: Strong SW CM Plus	3.5	3.5	8.5	10	11.5	13	15
		Image: Strong SW CM Plus	3.8	3.8	8.5	10	11.5	13	15
		Image: Strong SW CM Plus	4.5	4.5	8.5	10	11.5	13	15
		Image: Strong SW CM Plus	5.0	5.0	8.5	10	11.5	13	15
	Strong SW HE Plus	Image: Strong SW HE Plus	3.5	3.65	7	8.5	10	11.5	13	15
		Image: Strong SW HE Plus	3.75	4.1	7	8.5	10	11.5	13	15
		Image: Strong SW HE Plus	4.0	4.1	7	8.5	10	11.5	13	15
		Image: Strong SW HE Plus	4.5	4.5		8.5	10	11.5	13	15
		Image: Strong SW HE Plus	5.0	5.0	7	8.5	10	11.5	13	15
	Strong SW HI Plus	Image: Strong SW HI Plus	3.8	3.8		8.5	10	11.5	13	15
		Image: Strong SW HI Plus	4.5	4.5		8.5	10	11.5	13	15
		Image: Strong SW HI Plus	5.0	5.0		8.5	10	11.5	13	15
K200992	Strong SW Plus	Image: Strong SW Plus	3.5	3.5		8.5	10	11.5	13	15
		Image: Strong SW Plus	3.8	3.8		8.5	10	11.5	13	15
		Image: Strong SW Plus	4.5	4.5		8.5	10	11.5	13	15
		Image: Strong SW Plus	5.0	5.0		8.5	10	11.5	13	15
K211921	Epikut Plus CM	Image: Epikut Plus CM	3.5	3.5		8.5	10	11.5	13	15
			3.8	3.8		8.5	10	11.5	13	15
			4.5	4.5		8.5	10	11.5	13	15
		Image: Epikut Plus CM	5.0	5.0		8.5	10	11.5	13	15
	Epikut Plus HE	Image: Epikut Plus HE	3.5	3.65	7	8.5	10	11.5	13	15
		Image: Epikut Plus HE	4.5	4.5		8.5	10	11.5	13	15
		Image: Epikut Plus HE	5.0	5.0	7	8.5	10	11.5	13	15

Table 10.1 – Summary of Subject Device Designs and Sizes

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510k	Implant Line	ImageNot toScale	Body Ø, mm	Platform Ø, mm
K221453	Epikut Plus CM	Image: Epikut Plus CM	3.8	3.8							18	20	22	24
			4.0	4.0							18	20	22	24
			4.5	4.5							18	20	22	24
K222231	Epikut S Plus	Image: Epikut S Plus	3.5	3.5	8.5	10	11.5	13	15
			3.8	3.8	8.5	10	11.5	13	15	18	20	22	24
			4.0	4.0	8.5	10	11.5	13	15	18	20	22	24
			4.5	4.5	8.5	10	11.5	13	15	18	20	22	24
			5.0	5.0	8.5	10	11.5	13	15

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The HA1000 surface treatment is identical to that cleared in K211921.

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: in vitro testing and animal testing referenced from published literature to support the labeling claims for HAmano included in the submission, as shown below:

Labeling Claim	Reference**	Discussion
The HAnano surface increases the surface wettability.*	Bezerra, et al.,2017	Page 6: Water contact angle wassignificantly less on HAnano treatedtitanium surface than on dual acid-etched titanium surface
The HAnano surface is hydrophilic.*	Bezerra, et al.,2017	Page 6: Water contact angle wassignificantly less on HAnano treatedtitanium surface than on dual acid-etched titanium surface
In vitro studies using pre-osteoblast cells, evaluating the HAnanocoating by assessment of cell signaling dynamics, have demonstrated agreater transition from adhesion/proliferative-related signaling todifferentiation-related signaling compared to uncoated titanium, thusculminating in changes in osteogenic gene marker expression, which isimportant in bone regeneration processes.*	Bezerra, et al.,2017	Page 10, correcting name of surface(HAnano vs. Nano Hydroxyapatite-Blasted)
Cells grown on HAnano surfaces demonstrated a spreading morphologydifferent than that of cells grown on machined surfaces.*	Bezerra, et al.,2017	Page 4, Figure 2 caption, correctingname of surface
The HAnano Surface promotes osteoblast differentiation by significantlyupregulating RUNX2 and ALP activity when pre-osteoblasts weregrown directly on titanium discs.*	Bezerra, et al.,2017	Page 10
Osteoblasts were observed to have a morphology that spread across theHAnano surface differently than over a hydrophilic dual acid-etchedsurface (SLActive) in in vitro experiments.*	da Silva, et al.,2020	Page 7. "Firstly, our data shows thereis a differential behavior ofosteoblasts adhering on both surfaces;osteoblast spreads better overHAnano®, while osteoblast onSLActive presented a fusiformmorphology."

*Results of in vitro testing are not necessarily predictive of human clinical performance.

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** References

Bezerra F, Ferreira MR, Fontes GN, da Costa Fernandes CJ, Andia DC, Cruz NC, da Silva RA, Zambuzzi WF. Nano hydroxyapatite-blasted titanium surface affects pre-osteoblast morphology by modulating critical intracellular pathways. Biotechnol Bioeng. 2017 Aug;114(8):1888-1898.

da Silva RA, da Silva Feltran G, Ferreira MR, Wood PF, Bezerra F, Zambuzzi WF. The Impact of Bioactive Surfaces in the Early Stages of Osseointegration: An In Vitro Comparative Study Evaluating the HAnano® and SLActive® Super Hydrophilic Surfaces. Biomed Res Int. 2020 Sep 13.

Other 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 K211921);
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:
· biological evaluation was performed according to ISO 10993-1 and test results leveraged from K170392 for ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization, irritation), and ISO 10993-11 (systemic toxicity) to support biocompatibility of the subject device;
· information for the HA "and hydroxyapatite coating was leveraged from K 170392;
· 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).
· Fatigue testing according to ISO 14801 referenced from K170392, K193096, K200992, K211921, K221453, and K222231 is applicable to the subject device.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The primary predicate device K170392 is in support of substantial equivalence for the implant designs, materials, HA1200 surface, manufacturing, sterilization, shelf-life and biocompatibility. The reference devices are in support of the specific designs of each of the HA™® coated implants.

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 K170392. K193096. K200992. K211921. K221453 and K222231. The IFUS for the subject device also includes identical language to that included in K221453 and K222231 regarding longer implants and identical language to that included in K170392 regarding short implants.

The IFUS for the subject device includes language that implants may be tilted up to 30°, and language that requires, for implants with lengths of 18, 20, 22 or 24 mm and angulation of 30°, that a minimum of four (4) implants must be used and must be splinted. It also includes language that, when placed in the

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maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, implants are indicated only for multiple unit restorations in splinted applications that utilize at least two implants. This language is identical to the language in the IFUS of the reference devices K221453 and K222231.

The basis for the belief of S.I.N. - Sistema de Implante Nacional S.A. that the subject device is substantially equivalent to the predicate devices is summarized in the following Table of Substantial Equivalence.

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 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.

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Table of Substantial Equivalence

	Subject Device	Primary Predicate Device	Reference Devices
	S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K170392S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K193096S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K200992S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K211921S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K221453S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K222231S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.
Indications for UseStatement	S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primary stability isachieved and with appropriate occlusalloading.Unitite Slim, Unitite, Unitite Compact,Strong SW CMS.I.N Dental Implant System implantswith lengths less than 7 mm are intendedfor delayed loading only.Epikut CM, Epikut Plus CM, Epikut S,Epikut S PlusS.I.N. Dental Implant System implantswith lengths of 18, 20, 22, or 24 mm maybe tilted up to 30°. When used in themandible or maxilla with implants withlengths of 18, 20, 22, or 24 mm at anangulation of 30°, a minimum of fourimplants must be used and must besplinted. When placed in the maxillawith lengths of 18, 20, 22, or 24 mm atangulations between 0° and less than 30°, the S.I.N. Dental Implant Systemimplants are only indicated for multipleunit restorations in splinted applicationsthat utilize at least two implants.Epikut CM, Epikut Plus CM, Strong SWCM Plus, Strong SW HE Plus, StrongSW HI PlusAll digitally-designed custom abutmentsfor use with Interface CAD-CAMabutments are to be sent to a S.I.N.-validated milling center for manufacture.	S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primary stability isachieved and with appropriate occlusalloading. Implants with lengths less than 7mm are intended for delayed loadingonly.	S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primary stability isachieved and with appropriate occlusalloading.All digitally-designed custom abutmentsfor use with Interface CAD-CAMabutments are to be sent to aS.I.N.-validated milling center formanufacture.	S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primary stability isachieved and with appropriate occlusalloading.	S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primary stability isachieved and with appropriate occlusalloading.	S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primary stability isachieved and with appropriate occlusalloading.S.I.N. Dental Implant System implantswith lengths of 18, 20, 22, or 24 mm maybe tilted up to 30°. When used in themandible or maxilla with implants withlengths of 18, 20, 22, or 24 mm at anangulation of 30°, a minimum of fourimplants must be used and must besplinted. When placed in the maxillawith lengths of 18, 20, 22, or 24 mm atangulations between 0° and less than 30°, the S.I.N. Dental Implant Systemimplants are only indicated for multipleunit restorations in splinted applicationsthat utilize at least two implants.All digitally-designed custom abutmentsfor use with Interface CAD-CAMabutments are to be sent to a S.I.N.-validated milling center for manufacture.	S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primary stability isachieved and with appropriate occlusalloading.S.I.N. Dental Implant System implantswith lengths of 18, 20, 22, or 24 mm maybe tilted up to 30°. When used in themandible or maxilla with implants withlengths of 18, 20, 22, or 24 mm at anangulation of 30°, a minimum of fourimplants must be used and must besplinted. When placed in the maxillawith lengths of 18, 20, 22, or 24 mm atangulations between 0° and less than 30°, the S.I.N. Dental Implant Systemimplants are only indicated for multipleunit restorations in splinted applicationsthat utilize at least two implants.
Reason for Predicate Device	Not applicable	Implant design, materials;manufacturing, sterilization	Implant design, materials;manufacturing, sterilization	Implant design, materials;manufacturing, sterilization	Implant design, materials;manufacturing, sterilization	Implant design, materials;manufacturing, sterilization	Implant design, materials;manufacturing, sterilization
Product Code(s)	DZE	DZE, NHA	DZE, NHA	DZE, NHA	DZE	DZE, NHA	DZE, NHA
Intended Use	Functional and estheticrehabilitation of the edentulousmandible or maxilla	Functional and estheticrehabilitation of the edentulousmandible or maxilla	Functional and estheticrehabilitation of the edentulousmandible or maxilla	Functional and estheticrehabilitation of the edentulousmandible or maxilla	Functional and estheticrehabilitation of the edentulousmandible or maxilla	Functional and estheticrehabilitation of the edentulousmandible or maxilla	Functional and estheticrehabilitation of the edentulousmandible or maxilla
	Subject Device	Primary Predicate Device	Reference Devices
	S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K170392S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K193096S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K200992S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K211921S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K221453S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.	K222231S.I.N. Dental Implant SystemS.I.N. - Sistema de ImplanteNacional S.A.
Designs
Body/Platform Diameters, mmLengths, mm	Unitite Slim2.9/2.9Lengths: 10, 11.5, 13Unitite3.5/3.5; 4.3/4.3; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Unitite Compact4.0/4.0; 5.0/5.0; 6.0/6.0Lengths: 5, 6, 7Strong SW CM Plus3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Strong SW HE Plus3.5/3.65; 3.75/4.1; 4.0/4.1; 4.5/4.5;5.0/5.0Lengths: 7, 8.5, 10, 11.5, 13, 15 (7not for 4.5/4.5)Strong SW HI Plus3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Strong SW Plus3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Epikut Plus CM3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Epikut Plus HE3.5/3.65; 4.5/4.5/5.0/5.0Lengths: 7, 8.5, 10, 11.5, 13, 15 (7not for 4.5/4.5)Epikut Plus CM3.8/3.8; 4.0/4.0; 4.5/4.5; 5Lengths: 18, 20, 22, 24Epikut S Plus3.5/3.5; 3.8/3.8; 4.0/4.0; 4.5/4.5;5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15, 18,20, 22, 24 (18, 20, 22, 24 not for3.5/3.5 and 5.0/5.0)	Unitite Slim2.9/2.9Lengths: 10, 11.5, 13Unitite3.5/3.5; 4.3/4.3; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Unitite Compact4.0/4.0; 5.0/5.0; 6.0/6.0Lengths: 5, 6, 7	Strong SW CM Plus3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Strong SW HE Plus3.5/3.65; 3.75/4.1; 4.0/4.1; 4.5/4.5;5.0/5.0Lengths: 7, 8.5, 10, 11.5, 13, 15(7 not for 4.5/4.5)Strong SW HI Plus3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15	Strong SW Plus3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15	Epikut Plus CM3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15Epikut Plus HE3.5/3.65; 4.5/4.5/5.0/5.0Lengths: 7, 8.5, 10, 11.5, 13, 15 (7not for 4.5/4.5)	Epikut Plus CM3.8/3.8; 4.0/4.0; 4.5/4.5; 5Lengths: 18, 20, 22, 24	Epikut S Plus3.5/3.5; 3.8/3.8; 4.0/4.0; 4.5/4.5;5.0/5.0Lengths: 8.5, 10, 11.5, 13, 15, 18,20, 22, 24 (18, 20, 22, 24 not for3.5/3.5 and 5.0/5.0)
Implant/abutment interface	Morse taper (CM) 3°, 4°, 11.5°, 16°External hex (HE), Internal hex (HI)	Morse taper (CM) 3°, 4°, 11.5°, 16°External hex (HE)	Morse taper (CM) 3°, 4°, 11.5°, 16°External hex (HE), Internal hex (HI)	Morse taper (CM) 11.5°	Morse taper (CM) 11.5°External hex (HE)	Morse taper (CM) 11.5°	Morse taper (CM) 16°
Material	Ti (ASTM F67)	Ti (ASTM F67)	Ti (ASTM F67)	Ti (ASTM F67)	Ti (ASTM F67)	Ti (ASTM F67)	Ti (ASTM F67)
Implant Endosseous Surface	Acid-etched, HAnano	Acid-etched, HAnano	Acid-etched, HAnano	Acid-etched, HAnano	Acid-etched, HAnano	Acid-etched, HAnano	Acid-etched, HAnano
How Provided
Sterility	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation
Usage	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use

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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.