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.

Device Description

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

This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and a double acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by double acid-etching followed by application of a hydroxyapatite coating (HA™Y). These implant endosseous surfaces are identical to those cleared in K200992.

This submission also includes dental implants Epikut HE with an external hexagon (HE) abutment interface and a double acid-etched endosseous surface, and Epikut Plus HE implants with an endosseous surface produced by double acid-etching followed by application of a hydroxyapatite coating (HA1000). These implant endosseous surfaces also are identical to those cleared in K200992.

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 K200992. K193096, and K170398. The Epikut Plus CM and Epikut Plus HE implants have the identical HA™ surface treatment cleared in K200992 and K193096.

The subject device dental implants are compatible with abutments and prosthetic components cleared previously in K200992. K193096. K170398. and K051859. Epikut HE and Epikut Plus HE dental implants are not for use with angled abutments.

AI/ML Overview

The provided document (K211921 510(k) Summary for S.I.N. Dental Implant System) is a 510(k) premarket notification summary submitted to the FDA. It does not describe an AI medical device or a clinical study intended to prove its performance against acceptance criteria for such a device.

Instead, this document describes a dental implant system and its substantial equivalence to previously cleared predicate devices. The performance data presented are non-clinical bench tests (sterilization, bacterial endotoxin, shelf-life, biocompatibility, and coating characterization) to demonstrate the device's physical and biological properties.

Therefore, I cannot directly answer your prompt using the provided text, as the information regarding acceptance criteria, AI device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to the content of this document.

The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through non-clinical data and comparisons to predicate devices.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

October 20, 2021

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

Re: K211921

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: September 17, 2021 Received: September 20, 2021

Dear Kevin Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

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

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

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

Sincerely,

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

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

Indications for Use

510(k) Number (if known) K211921

Device Name

S.I.N. Dental Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary K211921 S.I.N. - Sistema de Implante Nacional S.A.

S.I.N Dental Implant System

October 19, 2021

ADMINISTRATIVE INFORMATION

Manufacturer Name	S.I.N. - Sistema de Implante Nacional S.A.
	Avenida Vereador Abel Ferreira, 1100
	São Paulo, São Paulo
	03340-000 Brazil
	Telephone	+55-11-21693000 ext 3236
Official Contact		Denise Domiciano, Quality and Regulatory Manager
Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson, MS, MBA
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone	+1 858-792-1235
	Fax	+1 858-792-1236
	Email	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 K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

Additional Predicate Devices K193096, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K170398, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.

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

INDICATIONS FOR USE STATEMENT

SUBJECT DEVICE DESCRIPTION

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

Implant Lines	Body Ø, mm	Platform Ø, mm		Lengths, mm
Epikut CM	3.5	3.5		8.5	10	11.5	13	15
Epikut Plus CM	3.8	3.8		8.5	10	11.5	13	15
	4.5	4.5		8.5	10	11.5	13	15
	5.0	5.0		8.5	10	11.5	13	15
Epikut HE	3.5	3.65	7.0	8.5	10	11.5	13	15
Epikut Plus HE	4.5	4.5		8.5	10	11.5	13	15
	5.0	5.0	7.0	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 10th by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2, referenced from K200992);

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

bacterial endotoxin testing (referenced from K200992) 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 K200992) including testing of samples after 4 years of real time aging according to ASTM F1929 and F88/F88M (packaging sterile barrier) and sterility testing of product;

biocompatibility testing for the HAnao hydroxyapatite coating leveraged from K200992 and provided in K170392 included ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization, irritation), and ISO 10993-11 (systemic toxicity);

and characterization of the HAnao hydroxyapatite coating leveraged from K200992 and provided in K170392 included scanning electron microscopy (SEM), x-ray photoelectron spectroscopy (XPS), transmission electron microscopy (TEM), x-ray diffraction (XRD), and testing of the adherence of the coating.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the predicate device and the additional predicate 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 additional predicate devices.

The Indications for Use Statement (IFUS) for the subject device is identical to that of the primary predicate K200992, and is very similar to the IFUS of the additional predicates K193096 and K170398. The minor difference between the IFUS for the subject device and the additional predicate K193096 is the language concerning CAD-CAM abutments in K193096. The minor difference between the IFUS for the subject device and the additional predicate K170398 is the language concerning Revolution Company implants in K170398. These minor differences do not impact safety or effectiveness because all IFUS express equivalent intended use to facilitate functional and esthetic rehabilitation of the edentulous mandible or maxilla.

The subject device Epikut CM and Epikut Plus CM implants are similar in design and sizes to the Strong SW and Strong SW Plus implants, respectively, cleared in K200992. The subject device Epikut CM and Evikut Plus CM implants and the Strong SW Plus implants have the same 11.5° internal Morse taper abutment connection, and are provided in the same sizes of body/platform diameters and overall lengths. The subject device Epikut CM implants and the Strong SW implants have the same acidetched endosseous surface treatment. The subject device Epikut Plus CM implants and the Strong SW Plus implants have the same acid-etched and HA™®º endosseous surface treatment.

The subject device Epikut HE implants are similar in design and sizes to the Strong SW HE implants cleared in K170398. The subject device Epikut HE implants and the Strong SW HE implants have the external hexagon abutment interface and are provided in the same sizes of body/platform diameters and overall lengths. The subject device Epikut HE implants and the Strong SW HE implants have the same acid-etched endosseous surface treatment.

The subject device Epikut Plus HE implants are similar in design and sizes to the Strong SW HE Plus

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

implants cleared in K193096. The subject device Epikut Plus HE implants and the Strong SW HE Plus implants have the external hexagon abutment interface and are provided in the same sizes of body/platform diameters and overall lengths. The subject device Epikut Plus HE implants and the Strong SW HE Plus implants have the same acid-etched and HA™® endosseous surface treatment.

All subject device dental implants are manufactured from the same unalloyed titanium and have the same acid-etched surface treatment as the dental implants cleared in K200992, K193096, and K170398. In addition to the acid-etch, the subject device Epikut Plus CM and Epikut Plus HE implants also have the identical HAmano surface cleared in K200992 and K193096.

Minor differences in the exact dimensions of the subject device components as compared to those of the primary predicate device and additional predicate devices do not impact safety, effectiveness, or substantial equivalence. The cross sections of the subject device implants (Epikut CM and Epikut Plus CM) were compared to the cross sections of the worst-case implants cleared in K200992. The critical dimension evaluated was the minimum wall thickness from the top of the implant down to the potting level for ISO 14801 testing. This analysis demonstrated that the subject device CM implants do not introduce an additional or new worst-case construct that requires mitigation by additional mechanical testing. Therefore, the fatigue testing according to ISO 14801 provided in K200992 is applicable to the subject device CM implants.

All subject device implants components are provided sterile by gamma irradiation, the same sterilization method used in K200992, K193096, and K170398.

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.

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

Table of Substantial Equivalence

	Subject Device	Primary Predicate Device	Additional Predicate	Additional Predicate
	S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K200992S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K193096S.I.N. Dental Implant SystemS.I.N. - Sistema de Implante Nacional S.A.	K170398S.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 in themaxillary or mandibular arch to provide support for single-unit ormulti-unit restorations. When a one-stage surgical approach is applied,the S.I.N. Dental Implant System is intended for immediate loadingwhen good primary stability is achieved and with appropriate occlusalloading.	S.I.N. Dental Implant System is intended for placement in themaxillary or mandibular arch to provide support for single-unit ormulti-unit restorations. When a one-stage surgical approach is applied,the S.I.N. Dental Implant System is intended for immediate loadingwhen good primary stability is achieved and with appropriate occlusalloading.	S.I.N. Dental Implant System is intended for placement in themaxillary or mandibular arch to provide support for single-unit ormulti-unit restorations. When a one-stage surgical approach is applied,the S.I.N. Dental Implant System is intended for immediate loadingwhen good primary stability is achieved and with appropriate occlusalloading.All digitally-designed custom abutments for use with InterfaceCAM abutments are to be sent to a S.I.N.-validated millingmanufacture.	S.I.N. Dental Implant System is intended for placement in themaxillary or mandibular arch to provide support for single-unit ormulti-unit restorations. When a one-stage surgical approach is applied,the S.I.N. Dental Implant System is intended for immediate loadingwhen good primary stability is achieved and with appropriate occlusalloading. Revolution Compact with a 6 mm length is intended fordelayed loading only.
Reason for Predicate Device	Not applicable	Implant design; HAnano implant surface	Implant design; HAnano implant surface	Implant design
Product Codes	DZE	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
Implant Designs
Prosthetic Interface Connections	Morse taper (CM, 11.5°) and External Hex (HE)	Morse taper (CM, 11.5°)	Morse taper (CM, 16°) and External Hex (HE)	External hex (HE), and Internal Hex (HI)
Body/Platform Diameters, mmLengths, mmInterface	Epikut 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°)	Strong SW3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5, 10, 11.5, 13, 15Morse taper interface (CM, 11.5°)
Body/Platform Diameters, mmLengths, mmInterface	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°)	Strong SW Plus3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.08.5, 10, 11.5, 13, 15Morse taper interface (CM, 11.5°)
Body/Platform Diameters, mmLengths, mmInterface	Epikut HE3.5/3.65; 4.5/4.5; 5.0/5.07, 8.5, 10, 11.5, 13, 15 no 7 mm length for 4.5 mm bodyExternal hex interface (HE)			Strong SW HE3.5/3.65; 3.75/4.1; 4.0/4.1; 4.5/4.5; 5.0/5.0
Body/Platform Diameters, mmLengths, mmInterface	Epikut Plus HE3.5/3.65; 4.5/4.4; 5.0/5.07, 8.5, 10, 11.5, 13, 15 no 7 mm length for 4.5 mm bodyExternal hex interface (HE)		Strong SW HE Plus3.5/3.65; 3.75/4.1; 4.0/4.1; 4.5/4.5; 5.0/5.07, 8.5, 10, 11.5, 13, 15 no 7 mm length for 4.5 mm bodyExternal hex interface (HE)	7*, 8.5, 10, 11.5, 13, 15
Implant Material	All implants: unalloyed titanium, ASTM F67	All implants: unalloyed titanium, ASTM F67	All implants: unalloyed titanium, ASTM F67	* no 7 mm length for 4.5 mm bodyExternal hex interface (HE)
Implant Endosseous Surface	All implants: acid-etched;HAnano applied to the Epikut Plus CM and Epikut Plus HEimplants	All implants: acid-etched;HAnano applied to the Strong SW implants	All implants: acid-etched;HAnano applied to the Strong SW implants
Implant Placement	CM designs: 1.5 mm intra-bony (sub-crestal)HE designs: at bone level (at the crest)	CM designs: 1.5 mm intra-bony (sub-crestal)	HE designs: at bone level (at the crest)	All implants: unalloyed titanium, ASTM F67
How Provided				All implants: acid-etched
Implants	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation	HE designs: at bone level (at the crest)
Usage	Single patient, single use	Single patient, single use	Single patient, single use	Sterile by gamma irradiation
	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.