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 Implants with lengths of 18, 20, 22, or 24 mm 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.

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, K200992, and K170392.

This submission includes dental implants Epikut S with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut S Plus implants with an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M). The implant design and endosseous surfaces are nearly identical to the Epikut Plus CM implants cleared in K211921, with the exception of the implant-abutment connection (subject device 16° Morse taper, K211921 11.5° Morse taper), the additional body/platform diameter (4.0 mm), and the longer lengths (18, 20, 22, and 24 mm).

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 HA100 surface treatment is identical to that cleared in K211921.

AI/ML Overview

This FDA 510(k) summary (K222231) describes a dental implant system and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on presenting a study with specific acceptance criteria, test sets, or performance metrics in the way these terms are typically used for AI/ML-based diagnostic devices.

The document is a regulatory submission for a medical device (S.I.N. Dental Implant System), not a study evaluating algorithm performance. Therefore, it does not contain information about:

A table of acceptance criteria and reported device performance in the context of an algorithm's diagnostic accuracy.
Sample sizes, data provenance, number of experts, adjudication methods for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Sample size for training sets or how ground truth for training sets was established.

Instead, the document focuses on non-clinical performance data to show that the new components of the S.I.N. Dental Implant System (subject device) are as safe and effective as existing legally marketed devices.

Here's an breakdown of the acceptance criteria (or rather, the demonstration of equivalence) and the studies (non-clinical tests and analyses) that prove the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating that the subject device's design, materials, manufacturing, sterilization, and performance characteristics are substantially equivalent to predicate devices already cleared by the FDA. The performance data presented are non-clinical and relate to the physical and biological properties of the implant.

Acceptance Criteria (Demonstrated Equivalence to Predicate Devices)	Reported Device Performance (as demonstrated by non-clinical studies/analysis)
Intended Use (Functional and esthetic rehabilitation of edentulous mandible or maxilla)	Equivalent to K211921, K203725, K170392, and K050406. The subject device's Indications for Use statement is largely identical or similar to the predicate devices, with specific language related to tilting angles and required number of implants/splinting justified by K050406 and K203725.
Material Composition (Unalloyed titanium, ASTM F67)	Equivalent to K211921, K203725, K170392. All subject device implants are manufactured from the same material.
Endosseous Surface Treatment (Acid-etched; HA™ for Epikut S Plus)	Equivalent to K211921 and K170392 for acid-etching. The HA™ treatment is identical to that cleared in K211921. Characterization (SEM, XPS, TEM, XRD, adherence) from K211921 leveraged.
Sterilization Method & Sterility Assurance Level (SAL) (Gamma irradiation to 10⁻⁶ SAL at 25 kGy)	Equivalent to K211921 and K203725. Sterilization method selected and substantiated according to ISO 11137-1 and ISO 11137-2.
Bacterial Endotoxin Limit (< 20 EU/device)	Equivalent to K211921. Demonstrated via Limulus amebocyte lysate (LAL) testing according to ANSI/AAMI ST72 on samples from manufacturing water (weekly) and sterilized product (quarterly).
Shelf Life/Packaging Integrity (4 years real-time aging)	Equivalent to K211921. Testing of samples after 4 years of real-time aging according to ASTM F1929 and F88/F88M (packaging sterile barrier) and sterility testing of product.
Biocompatibility	Equivalent to K211921. Biological evaluation performed according to ISO 10993-1, with test results leveraged from K211921.
MR Safety (Magnetically induced displacement force, torque, RF heating, image artifact)	Non-clinical analysis and testing performed according to ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119, and FDA guidance. Results demonstrate safety in the MR environment.
Mechanical Performance / Implant-Abutment Connection (Engineering analysis of new components)	Equivalent to K200992 (for mechanical testing applicability). Engineering analysis demonstrated that the subject device implants, with compatible previously-cleared abutments, do not create a new worst-case construct, thus making previous mechanical testing applicable. (Note: Specific mechanical test results/values are not provided in this summary, but the applicability of prior testing is the demonstration of equivalence here).
Physical Dimensions (Body/platform diameters and lengths, including new 4.0mm diameter and 18-24mm lengths)	Equivalent or within the range of previously cleared devices. New 4.0mm diameter is within the range of K170392. 18-24mm lengths are similar to K203725.

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

This is not applicable as this document describes a 510(k) submission for a physical medical device, not an algorithm's test set. The "test sets" here refer to batches of physical devices or materials undergoing non-clinical laboratory testing. The provenance of the data is the manufacturer (S.I.N. - Sistema de Implante Nacional S.A.) or its testing facilities, and the studies are non-clinical evaluations.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

This is not applicable for a non-clinical device submission. Ground truth, in this context, would relate to objective measurements against established standards (e.g., ASTM, ISO standards) rather than expert consensus on medical images.

4. Adjudication Method

Not applicable. Adjudication methods are typically associated with resolving discrepancies in expert interpretations during clinical or algorithm performance studies. The non-clinical tests described have defined protocols and objective pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) submission for a dental implant.

6. Standalone Performance Study

No. This refers to the performance of an algorithm without human intervention. This document details the performance characteristics of a physical implant device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by compliance with recognized consensus standards (e.g., ISO, ASTM, AAMI) and the device's adherence to its design specifications, materials testing, and performance against these standards. For example:

Sterility: Achieved according to ISO 11137-1 and ISO 11137-2.
Bacterial Endotoxin: Meets limits (< 20 EU/device) as per ANSI/AAMI ST72.
Packaging: Integrity verified against ASTM F1929 and F88/F88M.
Biocompatibility: Evaluated against ISO 10993-1.
MR Safety: Assessed against ASTM F2052, F2213, F2182, F2119.
Mechanical Performance: Demonstrated through engineering analysis applying previous mechanical testing (K200992).
Material Composition: Conforms to ASTM F67.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

In summary, this 510(k) pertains to a physical dental implant and uses non-clinical testing and engineering analysis to establish substantial equivalence to previously cleared predicate devices, rather than performing clinical studies or AI/ML algorithm validation.

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

10/27/22

Re: K222231

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: September 26, 2022 Received: September 26, 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

Page 2

has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Andrew 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) K222231

Device Name

S.I.N. Dental Implant System

Indications for Use (Describe)

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 K22231 S.I.N. - Sistema de Implante Nacional S.A.

S.I.N Dental Implant System

October 27, 2022

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

Additional Predicate Devices K203725, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K050406, NOBELSPEEDY™ Implants, Nobel Biocare USA LLC K 170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

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INDICATIONS FOR USE STATEMENT

S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm 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 splications that utilize at least two implants.

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 K211921, K200992, and K170392.

Implant Lines	Body Ø, mm	Platform Ø, mm	Lengths, mm
Epikut SEpikut 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

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

PERFORMANCE DATA

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

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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 reference device, K211921 to support biocompatibility of the subject device;

characterization of the HAMM hydroxyapatite coating leveraged from K211921 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;

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

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 from K200992 is applicable to the subject device implants.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The primary predicate device K211921 is in support of substantial equivalence for the implant designs, materials, manufacturing, and sterilization. The additional predicate device K203725 is for the implant lengths of 18 mm to 24 mm, and the additional predicate K050406 is in support of substantial equivalence of the Indications for Use statement for implants tilted up to 30°, as described below. The additional predicate device K170392 is in support of substantial equivalence of the subject device implant-abutment connection (16° Morse taper).

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 K211921, K203725, and K170392. The IFUS for the subject device also includes language similar to that included in K203725 regarding longer length implants.

The IFUS for the subject device includes language that implants with lengths of 18 mm to 24 mm 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 similar to the language in the IFUS of the predicate device K050406. 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 splinted applications that utilize at least two implants. This language is nearly identical to language in the IFUS of the predicate device K203725.

Differences between the IFUS for the subject device and the predicate devices include: language in K203725 regarding zygomatic implants that is not relevant to the subject device; language in K050406 regarding features of the implants (grooves and surface treatment) that is not relevant to the subject device, and language for tilting of the implants up to 45°; and language in K170392 regarding implant lengths less than 7 mm that is not relevant to the subject device.

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Subject Device Dental Implants

The subject device Epikut S and Epikut S Plus implants have nearly identical designs (except for the Morse taper connection and 18-24 mm lengths), materials, and manufacturing as used for the Epikut CM and Epikut Plus CM implants cleared in K211921. The subject device Epikut S and Epikut S Plus implants have the same 16° internal Morse taper abutment connection and are provided in the same range of body/platform diameters as the implants cleared in K170392; 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 K170392. The subject device implant lengths 18 mm are the same as implants cleared in K203725.

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 K211921 and K170392. The subject device Epikut S Plus implants have the same acid-etched and HA™ endosseous surface treatment as used for implants cleared in K211921.

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

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	Additional Predicate	Additional Predicate	Additional Predicate
	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.	K050406NOBELSPEEDYTM ImplantsNobel Biocare USA LLC	K203725S.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.
Indications for Use Statement	S.I.N. Dental Implant System is intended for placement inthe maxillary or mandibular arch to provide support forsingle-unit or multi-unit restorations. When a one-stagesurgical approach is applied, the S.I.N. Dental ImplantSystem is intended for immediate loading when goodprimary stability is achieved and with appropriateocclusal loading.S.I.N. Dental Implant System implants with lengths of 18,20, 22, or 24 mm be tilted up to 30°. When used in themandible or maxilla with implants with lengths of 18, 20,22, or 24 mm at an angulation of 30°, a minimum of fourimplants must be used and must be splinted. When placedin the maxilla with lengths of 18, 20, 22, or 24 mm atangulations between 0° and less than 30°, the S.I.N.Dental Implant System implants are only indicated formultiple unit restorations in splinted applications thatutilize at least two implants.	S.I.N. Dental Implant System is intended for placement inthe maxillary or mandibular arch to provide support forsingle-unit or multi-unit restorations. When a one-stagesurgical approach is applied, the S.I.N. Dental ImplantSystem is intended for immediate loading when goodprimary stability is achieved and with appropriateocclusal loading.	NOBELSPEEDYTM Implants are root-form endosseousimplants intended to be surgically placed in the bone ofthe upper or lower jaw arches to provide support forprosthetic devices, such as an artificial tooth, in order torestore patient esthetics and chewing function. NobelBiocare's NOBELSPEEDYTM Implants are indicated forsingle or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare NOBELSPEEDYTMImplants may be placed immediately and put intoimmediate function providing that the initial stabilityrequirements detailed in the surgical manuals aresatisfied.NOBELSPEEDYTM Implants are indicated for use in softbone or whenever immediate or early loading is applied.The NOBELSPEEDYTM Implants incorporate a grooveon the implant thread and are preferred over modelswithout the groove in these soft bone indications becausebone forms more rapidly in the groove than on other partsof the implant resulting in increased stability whencompared to non-grooved implants. In addition, theNOBELSPEEDYTM Implants are preferred in these softbone indications because bone formation on the TiUnite®surface is more rapid and greater than on machinedsurface implants resulting in better maintenance of initialimplant stability, faster and stronger osseointegration, andhigher success rates.NOBELSPEEDYTM Implants may be tilted up to 45°.When used with angulations between 30° and 45° aminimum of four implants must be used and splinted.	S.I.N. Dental Implant System is intended for placement inthe maxillary or mandibular arch to provide support forsingle-unit or multi-unit restorations. When a one-stagesurgical approach is applied, the S.I.N. Dental ImplantSystem is intended for immediate loading when goodprimary stability is achieved and with appropriateocclusal loading.S.I.N. Dental Implant System implants with lengths of 18,20, 22, or 24 mm when placed in the maxilla are onlyindicated for multiple unit restorations in splintedapplications that utilize at least two implants.S.I.N. Dental Implant System Zygomatic implants areintended for placement in the maxillary arch to providesupport for fixed or removable dental prostheses inpatients with partially or fully edentulous maxillae. Whena one-stage surgical approach is applied, the S.I.N. DentalImplant System Zygomatic implants are intended forimmediate loaded when good primary stability isachieved and with appropriate occlusal loading.	S.I.N. Dental Implant System is intended for placement inthe maxillary or mandibular arch to provide support forsingle-unit or multi-unit restorations. When a one-stagesurgical approach is applied, the S.I.N. Dental ImplantSystem is intended for immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Implants with lengths less than 7 mmare intended for delayed loading only.
Reason for Predicate Device	Not applicable	Implant design; materials; manufacturing;sterilization	Indications for Use for implants tilted up to 45°	Implant design, lengths 18 mm to 24 mm;materials; manufacturing; sterilization	Implant designs; materials; manufacturing;sterilization
Product Codes	DZE, NHA	DZE	DZE	DZE, NHA	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	Functional and esthetic rehabilitation of theedentulous mandible or maxilla
Implant Designs
Prosthetic Interface Connections	Morse taper (CM, 16°)	Morse taper (CM, 11.5°) andExternal Hex (HE)	Not stated in 510(k) Summary	External hex (HE)	Morse taper (CM, 16°)
Body/Platform Diameters, mmLengths, mmInterface	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, 4.5Morse taper interface (CM, 16°)	Epikut CM3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5 - 15Morse taper interface (CM, 11.5°)	Not stated in 510(k) Summary	Strong SW HE3.75/4.118, 20, 22, 24External hex (HE)	Strong SW CM3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5 -15, all body diametersMorse taper interface (CM, 16°)
Body/Platform Diameters, mmLengths, mmInterface	Epikut S Plus3.5/3.5, 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, 4.5Morse taper interface (CM, 16°)	Epikut Plus CM3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5, 10, 11.5, 13, 15Morse taper interface (CM, 11.5°)
Implant Material	All implants: unalloyed titanium,ASTM F67	All implants: unalloyed titanium,ASTM F67	Not stated in 510(k) Summary	All implants: unalloyed titanium,ASTM F67	All implants: unalloyed titanium,ASTM F67
Implant Endosseous Surface	All implants: acid-etched;HAnano applied to the Epikut S Plus implants	All implants: acid-etched;HAnano applied to the Epikut Plus CM implants	TiUnite® surface	All implants: acid-etched	All implants: acid-etched
How Provided
Implants	Sterile by gamma irradiation	Sterile by gamma irradiation	Not stated in 510(k) Summary	Sterile by gamma irradiation	Sterile by gamma irradiation
Usage - All Components	Single patient, single use	Single patient, single use	Not stated in 510(k) Summary	Single patient, single use	Single patient, single use

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.