Dentis s-Clean SQ-SL Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Device Description

Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).

The dimensions of fixtures are as following:

No.	Device Name	Dimension Ranges
1	s-Clean SQ-SL Fixture	Ø4.35, 4.8 and 5.2 (D) X 15.5 and 17.5mm
2	s-Clean SQ-SL Fixture Mini	Ø3.7 and 4.1 (D) X 15.5 and 17.5

Tolerance of dimension shall be within ± 1% range.

s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:

510(K)	Abutment Name	Diameter(Ø)	Angulation	Length(mm)
K192688	s-Clean Cover Screw	Ø3.6mm	0	5.9mm
K192688	s-Clen (TiN Half Coating)Sole Abutment S-Line	Ø4.5, 5.5, 6.5 and7.5	0	11.6, 12.6 and 13.6
K210134	s-Celan (TiN Half Coating)Angled Abutment	Ø4.5	15	12.6

s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:

510(K)	Abutment Name	Diameter(Ø)	Angulation	Length(mm)
K210080	s-Clean Cover Screw Mini	Ø3.2mm	0	5.0mm
K2100080	s-Clean Healing Abutment S-Line Mini	Ø4.3, 4.8 and 5.8	0	7.61, 8.61, 9.61, 10.61, 11.61,12.61 and 14.61
K210080	s-Celan (TiN Half Coating)Sole Abutment Mini	Ø4.5 and 5.5	0	11.01, 12.01, 12.51, 13.01,13.521, 14.01, 14.51, 15.01,15.51, 16.01 and 17.01
K210080	s-Celan (TiN Half Coating)Couple Abutment Mini	Ø4.0, 4.5 and 5.5	0	8.35, 8.6, 9.35, 9.6, 9.85, 10.1,10.35, 10.6, 11.1, 11.35, 11.6,12.1, 12.85, 13.1, 13.35, 13.6,14.35 and 14.6
K210080	s-Celan (TiN Half Coating)Angled Abutment Mini	Ø4.0 and 4.5	15	12.09, 12.34, 12.51 and 12.76

Denis s-Clean SQ-SL Fixture is provided sterilized.

Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

AI/ML Overview

This document is a 510(k) Summary for the Dentis s-Clean SQ-SL Fixture, a dental implant. It does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information regarding AI/algorithm acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The "Non-Clinical Test Data" section describes engineering and biocompatibility tests conducted on the device, not an AI algorithm.

Non-Clinical Test Data Summary (from the document):

Tests performed on the subject device: Fatigue Testing (ISO 14801:2016).
Tests performed on predicate devices and leveraged for the subject device:
- Sterilization Validation Test on Fixtures (ISO 11137-1,2,3 referenced in K192688).
- Shelf-Life Test on Fixtures (ASTM F1980 referenced in K153639).
- Biocompatibility testing on fixtures (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639).
- Bacterial Endotoxin Test Report on Fixtures (ANSI/AAMI ST72:2011, USP <161>, and USP <85> referenced in K192688).
Acceptance Criteria for these non-clinical tests: "met the criteria of the standards" (e.g., ISO 14801:2016 for fatigue).
Study Design/Purpose: To demonstrate substantial equivalence to predicate devices.
MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to evaluate magnetic safety, addressing magnetically induced displacement force and torque.

This document describes a traditional medical device (dental implant) clearance process, not one involving Artificial Intelligence.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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.

May 20, 2024

Dentis Co., Ltd. % April Lee Regulatory Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K240511

Trade/Device Name: Dentis s-Clean SO-SL Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 21, 2024 Received: February 22, 2024

Dear April Lee:

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.

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"

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(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 OS 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.

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

Sincerely.

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Submission Number (if known)

K240511

Device Name

Dentis s-Clean SQ-SL Fixture

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)

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510(K) Summary

Submitter

Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922

Device Information

Trade Name: Dentis s-Clean SQ-SL Fixture
Common Name: implant, endosseous, root-form
Classification Name: Endosseous dental implant
Product Code: DZE ●
Panel: Dental ●
Regulation Number: 872.3640
Device Class: Class II
Date Prepared: 05/16/2024

Predicate Devices:

Primary and Reference Device

K192688, s-Clean SQ-SL Implant System Regular by Dentis Co., Ltd. .
Reference Device
K140934, HIOSSEN Implant System manufactured by HIOSSEN, Incorporated
K153639, OneO-SL s-Clean Implant System by Dentis Co., Ltd. ●
K202773, S-Clean SQ-SL Implant System Mini by Dentis Co., Ltd.
K210080, Dentis s-Clean s-Line Mini by Dentis Co., Ltd. ●
K210134, Dentis s-Clean s-Line by Dentis Co., Ltd.
K222778, Osstem Implant System by Osstem Implant Co., Ltd. ●

Indications for Use:

Official Correspondent

Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

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Device Description:

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).

The dimensions of fixtures are as following:

No.	Device Name	Dimension Ranges
1	s-Clean SQ-SL Fixture	Ø4.35, 4.8 and 5.2 (D) X 15.5 and 17.5mm
2	s-Clean SQ-SL Fixture Mini	Ø3.7 and 4.1 (D) X 15.5 and 17.5

Tolerance of dimension shall be within ± 1% range.

s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:

510(K)	Abutment Name	Diameter(Ø)	Angulation	Length(mm)
K192688	s-Clean Cover Screw	Ø3.6mm	0	5.9mm
K192688	s-Clen (TiN Half Coating)Sole Abutment S-Line	Ø4.5, 5.5, 6.5 and7.5	0	11.6, 12.6 and 13.6
K210134	s-Celan (TiN Half Coating)Angled Abutment	Ø4.5	15	12.6

s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:

510(K)	Abutment Name	Diameter(Ø)	Angulation	Length(mm)
K210080	s-Clean Cover Screw Mini	Ø3.2mm	0	5.0mm
K210080	s-Clean Healing Abutment S-Line Mini	Ø4.3, 4.8 and 5.8	0	7.61, 8.61, 9.61, 10.61, 11.61,12.61 and 14.61
K210080	s-Celan (TiN Half Coating)Sole Abutment Mini	Ø4.5 and 5.5	0	11.01, 12.01, 12.51, 13.01,13.521, 14.01, 14.51, 15.01,15.51, 16.01 and 17.01
K210080	s-Celan (TiN Half Coating)Couple Abutment Mini	Ø4.0, 4.5 and 5.5	0	8.35, 8.6, 9.35, 9.6, 9.85, 10.1,10.35, 10.6, 11.1, 11.35, 11.6,12.1, 12.85, 13.1, 13.35, 13.6,14.35 and 14.6
K210080	s-Celan (TiN Half Coating)Angled Abutment Mini	Ø4.0 and 4.5	15	12.09, 12.34, 12.51 and 12.76

Denis s-Clean SQ-SL Fixture is provided sterilized.

Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

Materials:

Dentis s-Clean SQ-SL Fixture is fabricated from Pure titanium of ASTM F67 .

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Summaries of Technological Characteristics & Substantial Equivalence Discussion

s-Clean SQ-SL Fixture

Subject Device	Primary Predicate	Reference Device	Predicate Device
K240511	K192688	K140934	K222778
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	HIOSSEN Inc.	Osstem Implant CO.,Ltd.
Trade Name	Dentis s-Clean SQ-SL Fixture	s-Clean SQ-SL ImplantSystem Regular	HIOSSENIMPLANT SYSTEM	Osstem ImplantSystem
ProductName	s-Clean SQ-SLFixture	s-Clean SQ-SL Fixture	ETII SA Fixture	TSIV SA Implant
Design
Indicationsfor Use	Dentis s-Clean SQ-SLFixture is indicated foruse in partially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. Thissystem is dedicated forone and two stagesurgical procedures.This system is intendedfor delayed loading.	s-Clean SQ-SL ImplantSystem Regular isindicated for use inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. This systemis dedicated for one andtwo stage surgicalprocedures and notdedicated for immediateloading. This system isintended for delayedloading.	The HIOSSEN ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, in supportof single or multipleunitrestorations including;cemented retained,screw retained, oroverdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading. ETIII SAUltra-Wide Fixture isintended to be used inthe molar region.	The Osstem ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-units restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading. Ultra wideImplant system isintended to be used inthe molar region.Products with diameteror less than 3.25mmshould be usedexclusively for thelateral incisor in themaxilla and a central orlateral incisor in themandible.
Diameter andLength	Ø4.35 x 15.5,17.5mmØ4.8 x 15.5, 17.5mmØ5.2 x 15.5, 17.5mm	Ø4.1 x 7, 7.5, 9.5, 11.5,13.5mmØ4.35 x 7, 7.5, 9.5,11.5, 13.5mmØ4.8 x 7, 7.5, 9.5, 11.5,13.5mmØ5.8 x 7, 7.5, 9.5,11.5mmØ6.8 x 7, 7.5, 9.5,11.5mmØ7.8 x 7, 7.5, 9.5,11.5mm	Ø3.5 x 8.7, 10.2,11.7,13.2, 15.2, 18.2mmØ4.2 x 7.2, 8.7, 10.2,11.7, 13.2, 15.2,18.2mmØ4.45 x 7.2, 8.7,10.2,11.7, 13.2, 15.2mmØ5.0x 6.2mmØ4.9 x 7.2, 8.7, 10.2,11.7, 13.2, 15.2mm	Ø4.4 x 18mmØ4.8 x 18mmØ5.25 x 18mm
SurfaceTreatment	SLA		SA	SA
Material	CP Titanium Gr4(ASTM F67)	CP Titanium Gr4(ASTM F67)	CP Titanium Gr4(ASTM F67)	CP Titanium Gr4(ASTM F67)
Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Shelf Life	8years	8years	8years	8years
Comparison	The Subject Device and primary device, K192688 have same characteristics such as indicationsfor Use, design, surface treatment, material, sterilization, and shelf life. The difference betweensubject device and primary predicate is dimension. The subject device has longer lengths fixtures,such as 15.5 and 17.5mm. To support this difference, K140934 and K222778 were addedbecause the dimension combination of two devices covers all range of the subject device'sdimensions.

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s-Clean SQ-SL Fixture Mini

	Subject Device	Reference Device	Reference Device
K number	K240511	K202773	K140934
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	HIOSSEN Inc.
Trade Name	Dentis s-Clean SQ-SLFixture	s-Clean SQ-SL ImplantSystem Mini	Osstem Implant System
Product Name	s-Clean SQ-SL Mini	s-Clean SQ-SL Mini Fixture	ETII SA Fixture
Design	Image: Dentis s-Clean SQ-SL Fixture	Image: s-Clean SQ-SL Implant System Mini	Image: ETII SA Fixture
Indications forUse	Dentis s-Clean SQ-SL Fixtureis indicated for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutment supportfor fixed bridgework. Thissystem is dedicated for one andtwo stage surgical procedures.This system is intended fordelayed loading.	s-Clean SQ-SL Implant SystemMini is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework.This system is dedicated for oneand two stage surgicalprocedures. This system isintended for delayed loading.	The HIOSSEN Implant System isindicated for use in partially or fullyedentulous mandibles and maxillae,in support of single or multipleunitrestorations including; cementedretained, screw retained, oroverdenture restorations, and final ortemporary abutment support for fixedbridgework. It is intended for delayedloading. ETIII SA Ultra-Wide Fixtureis intended to be used in the molarregion.
Diameter andLength	$Ø3.7 x 15.5, 17.5mm$$Ø4.17 x 15.5, 17.5mm$	$Ø3.7 x 7.5, 9.5, 11.5, 13.5mm$$Ø4.1 x 7.5, 9.5, 11.5, 13.5mm$	$Ø3.5 x 8.7, 10.2, 11.7, 13.2, 15.2,$$18.2mm$$Ø4.2 x 7.2, 8.7, 10.2, 11.7, 13.2,$$15.2, 18.2$$Ø4.45 x 7.2, 8.7, 10.2, 11.7, 13.2,$$15.2mm$$Ø5.0x 6.2mm$$Ø4.9 x 7.2, 8.7, 10.2, 11.7, 13.2,$$15.2mm$
SurfaceTreatment	SLA	SLA	SA
Material	CP Titanium Gr4 (ASTMF67)	CP Titanium Gr4 (ASTMF67)	CP Titanium Gr4 (ASTM F67)
Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Shelf Life	8years	8years	8years
Comparison	The Subject Device and reference device, K202773 have same characteristics such as indicationsfor Use, design (dual screw joint), surface treatment, material, sterilization, and shelf life. Thedifference between the two devices is dimension. To support this difference, K140934 was addedbecause the dimension combination of K140934 covers all range of the subject device'sdimensions.

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Non-Clinical Test Data

Below tests were performed on subject device:

Fatigue Testing under the worst-case scenario according to ISO 14801:2016
Below tests were performed for predicate devices and leveraged for the subject device:
Sterilization Validation Test on Fixtures according to ISO 11137-1,2,3 referenced in K192688 ●
. Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K153639
. Biocompatibility testing on fixtures according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639
. Bacterial Endotoxin Test Report on Fixtures according to ANSI/AAMI ST72:2011, USP <161>, and USP <85> referenced in K192688

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

Non-clinical test data was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Clinical testing was not necessary to establish substantial equivalency of the device.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic. Dentis s-Clean SQ-SL Fixture in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

Conclusion

Dentis s-Clean SO-SL Fixture constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, Dentis s-Clean SQ-SL Fixture and its predicates are substantially equivalent.

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.