The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Device Description

The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths. The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.

AI/ML Overview

This document is a 510(k) premarket notification for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study that proves the device meets specific performance acceptance criteria for a new and innovative AI/software functionality.

Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for AI, effect size of human reader improvement with AI) are not applicable or extractable from this document as it pertains to a medical device (dental implant system), not an AI/Software as a Medical Device (SaMD).

However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this physical device.

Summary of Acceptance Criteria and Proving the Device Meets Them (Based on the Provided Document which is for a Physical Medical Device - Dental Implant System)

This 510(k) submission establishes substantial equivalence for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System to legally marketed predicate devices. The "acceptance criteria" here are not about software performance metrics but rather about demonstrating that the new device shares fundamental scientific technology, materials, design, and performance characteristics with existing devices, and that any differences do not raise new questions of safety or effectiveness. The "study" largely refers to non-clinical testing and comparison to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Demonstrated)	Reported Device Performance / Assessment
Intended Use	The device is used in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework, for single and two-stage surgical procedures, intended for delayed loading.	Demonstrated Equivalence: The subject device (LOTA SLA/HA Dental Implant System) has the same indications for use as the primary predicate device (KJ Submerged System, K103810).
Fundamental Scientific Technology	The device should employ similar principles and mechanisms as legally marketed devices.	Demonstrated Equivalence: The subject device and the predicate device (KJ Submerged System, K103810) have the same fundamental scientific technology.
Materials	Biocompatibility and mechanical properties of materials (Titanium 6AL 4V ELI alloy, ASTM F136).	Demonstrated Equivalence: The subject and predicate devices employ the same materials (Titanium 6AL 4V ELI alloy, ASTM F136).
Design	Similar design elements (Implant Type: Bone Level, Connection Type: Internal Locking Taper, Neck Design: Straight walled neck, Body Design: Tapered) and dimensional ranges (diameters, lengths).	Demonstrated Similarity/Mitigation: The subject and predicate devices have very similar in design. Differences identified (fixture thread design, fixture size, abutment design) were addressed by identifying reference devices with similar features and size ranges (Bicon Implants K092035, J2a/J2c Dental Implant System K150060, MegaGen AnyRidge® Implant System K170044) to demonstrate these changes do not raise new concerns.
Surface Treatment	The SLA treatment should not introduce new safety concerns (e.g., biocompatibility, residual contaminants).	Mitigation/Equivalence: The SLA treatment is a difference from the primary predicate's RBM Treatment/HA Coating. This was addressed by identifying a reference device made by the same company (J2A SLA Dental Implant System, K161923) that goes through the same manufacturing processes and has the same material/surface treatment. Additionally, SEM analysis was performed to validate no residual contaminants remained on the implants.
Sterilization & Shelf Life	The device must be adequately sterilized and maintain sterility and integrity over its shelf life.	Testing Performed: Sterilization validation testing was conducted in accordance with ISO 11137-1 and 11137-2 (Gamma sterilization). Shelf life validation tests were performed in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2. The results support substantial equivalence.
Endotoxins	Endotoxin levels must be within acceptable limits for lot release.	Testing Performed: Endotoxin testing for lot release was evaluated in accordance with USP 39 <85>, confirming the endotoxin limit is 0.5 EU/mL.
Risk Management	Risks associated with modifications must be identified and mitigated.	Risk Analysis Conducted: Risk analysis was conducted according to ISO 14971 to evaluate the effect of the modifications. The activities/tests listed above (identification of reference devices, sterilization/shelf-life validation, endotoxin testing, SEM analysis) were performed based on this analysis to mitigate identified potential risks.

Regarding AI/Software specific criteria (not applicable for this document):

The provided document is a 510(k) premarket notification for a physical medical device (dental implants). It is not for a software or AI device. Therefore, the specific questions related to AI/Software performance, test sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not detailed or relevant in this context.

If this were an AI/Software as a Medical Device (SaMD) submission, these sections would be crucial. Since it's for a physical implant, the "acceptance criteria" are based on material properties, design, manufacturing processes, intended use equivalence to predicates, and standard biological and physical testing.

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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

KJ Meditech Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620

Re: K202046

Trade/Device Name: LOTA SLA Dental Implant System and LOTA HA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 9, 2022 Received: February 18, 2022

Dear Priscilla Chung:

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

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

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

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

For comprehensive regulatory information about 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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

LOTA SLA Dental Implant System and LOTA HA 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)

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510(k) Summary (K202046)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 2/28/2022

1. Submitter

KJ Meditech Co., Ltd. 959-21 Daechon-dong, Buk-gu, Gwang-ju, Republic of Korea

Tel: +82-62-972 -5476

Contract Person: Hyuckki Moon / President

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

Trade Name: LOTA SLA Dental Implant System ● LOTA HA Dental Implant System
Common Name: Dental implant system
Classification Name: Endosseous dental implant ●
. Product Code: DZE, NHA
Classification regulation: 21 CFR 872.3640

4. Predicate Device

Primary Predicate: ●
- KJ Submerged System by KJ Meditech Co., Ltd. (K103810) -
. Reference Devices:

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-Bicon Implants with a 2.5mm Internal Connection by BICON, LLC (K092035)
-Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System by Megagen Implant Co., Ltd. (K170044)
J2a Dental Implant System, J2c Dental Implant System by KJ Meditech Co., Ltd. -(K150060)
J2A SLA Dental Implant System by KJ Meditech Co., Ltd. (K161923) -

5. Device Description

Implant Diameter	3.8mm, 4.3mm, 4.8mm, 5.3mm, 6.3mm, 7.3mm
Implant Length	8.0mm, 9.0mm, 10.0mm, 11.0mm, 12.0mm, 13.0mm, 14.0mm

The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.

I Shouldered Abutment
트 Shouldered Hex Abutment
트 Shouldered Removal Abutment

The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

6. Indication for Use

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7. Basis for Substantial Equivalence

The subject device and the predicate device (KJ Submerged System, K103810) have the same indications and fundamental scientific technology. The subject and predicate devices employ the same materials and have very similar in design. The fixture thread design, the fixture size, and abutment design have changed, and we have identified a reference device which are similar in design and size. The Bicon Implants (K092035) has similar thread design, and the J2a Dental Implant System, J2c Dental Implant System have similar neck micro-threading design. We identified MegaGen AnyRidge® Implant System (K170044) as a reference device which encompasses the size range of the subject device.

Another difference is that the subject fixtures have SLA treatment. This difference poses potential risks in biocompatibility, sterilization/shelf-life validation, and residual remining on the fixtures. To mitigate these risks, we identified a predicate device made by our company(K161923) which go through the same manufacturing processes and have the same material/surface treatment. Also, we performed sterilization/shelf-life validation tests, and SEM analysis to validate that the modification would not raise an issue to support substantial equivalence.

Item	SubjectDevice	PredicateDevice	ReferenceDevice	Reference Device	ReferenceDevice	Reference Device
510(K)Number	K202046	K103810	K092035	K170044	K150060	K161923
Device Name	LOTA SLA/HA DentalImplant	KJSubmergedSystem	BiconImplantswith a2.5mmInternalConnection	Inclusive® TitaniumAbutmentscompatible with:MegaGenAnyRidge® ImplantSystem	J2a DentalImplantSystem, J2cDentalImplantSystem	J2A SLA DentalImplant
Manufacturer	KJ MeditechCo., Ltd.	KJ MeditechCo., Ltd.	BICON,LLC	Megagen ImplantCo.,Ltd.	KJ MeditechCo., Ltd.	KJ Meditech Co.,Ltd.
Indicationsfor Use	The LOTASLADentalImplantSystem isindicated foruse inpartially orfullyedentulousmandiblesand maxillae,in support ofsingle ormultiple-unitrestorationsincluding;cementedretained.	The KJSubmergedSystem isindicated foruse inpartially orfullyedentulousmandiblesandmaxillae, insupport ofsingle ormultiple-unitrestorationsincluding;cemented	The Biconimplant isdesigned foruse inedentuloussites in themandible ormaxilla forsupport of acompletedentureprosthesis, afinal orintermediateabutment forfixedbridgeworkor for partial	Inclusive®TitaniumAbutments arepremanufacturedprostheticcomponentsconnected toendosseousdental implantsin theedentulous orpartiallyedentulousmaxilla ormandible toprovide supportfor cement-retained or	The J2CDentalImplantSystem isindicated foruse inpartially orfullyedentulousmandiblesand maxillae,in support ofsingle ormultiple-unitrestorationsincludingcementedretained.	The J2A SLADental ImplantSystem isindicated for usein partially orfully edentulousmandibles andmaxillae, insupport of singleor multiple-unitrestorationsincludingcementedretained, screwretained, oroverdenturerestorations, andterminal or
	screwretained, oroverdenturerestorations,and terminalorintermediateabutmentsupport forfixedbridgework.The LOTASLA DentalImplant is forsingle andtwo stagesurgicalprocedures.The system isintended fordelayedloading.	retained,screwretained, oroverdenturerestorations,and terminalorintermediateabutmentsupport forfixedbridgework.The KJSubmergedSystem isfor singleand twostagesurgicalprocedures.The systemis intendedfor delayedloading.	dentures, oras a singletoothreplacement.	screw-retainedprostheticrestorations.	screwretained, oroverdenturerestorations,and terminalorintermediateabutmentsupport forfixedbridgework.The J2CDentalImplantSystem is forsingle andtwo stagesurgicalprocedures.The system isintended fordelayedloading.	intermediateabutment supportfor fixedbridgework. TheJ2A SLA DentalImplant is forsingle and twostage surgicalprocedures. Thesystem is intendedfor delayedloading.
Design	• ImplantType:Bone LevelImplant• ConnectionType:InternalLockingTaper• NeckDesign:Straightwalledneck• BodyDesign:Tapereddesign	• ImplantType:BoneLevelImplant• Connection: InternalLockingTaper• NeckDesign:Straightwalledneck• BodyDesign:Tapereddesign	• ImplantType:BoneLevelImplant• Connection:InternalLockingTaper• NeckDesign:Straightwalledneck• BodyDesign:Tapereddesign	All digitallydesignedabutments foruse withInclusiveAbutments forCAD/CAM areintended to besent to aPrismatikDental craftvalidated millingcenter formanufacture.CompatibleImplant System:MegaGenAnyRidge®Implant SystemInclusive TitaniumAbutmentscompatible withMegaGen AnyRidgeImplant System	• ImplantType: BoneLevelImplant• ConnectionType:InternalHexagon• NeckDesign:Straightwalledneck withmicro-thread• BodyDesign:Tapereddesign	• Implant Type:Bone LevelImplant• ConnectionType: InternalHexagon• Neck Design:Straight walledneck• Body Design:Tapered design
EndosseousImplantMaterial	Ti 6Al 4VELI, ASTMF136	Ti 6Al 4VELI, ASTMF136	Ti 6Al 4VELI,ASTM F136	Ti 6Al 4V ELI,ASTM F136	Ti 6Al 4VELI, ASTMF136	Ti 6Al 4V ELI,ASTM F136
SurfaceTreatment	SLATreatment	RBMTreatmentHA Coating	HA Coating	S-L-A with NanoCa2+ incorporated	RBMTreatment	SLA Treatment

LOTA SLA/HA Fixture

510(k) summary

3 / 6 page

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SterilizationMethod	Gamma	Gamma	Gamma	Gamma	Gamma	Gamma
ImplantDiameters	3.8mm,4.3mm,4.8mm,5.3mm,6.3mm,7.3mm	3.5mm,4.0mm,4.5mm,5.0mm,5.5mm, 6.0 mm	4.0 mm,4.5mm	3.5mm, 4.0mm,4.4mm, 4.9mm5.4mm, 5.9mm6.4mm, 6.9mm7.4mm, 7.9mm8.4mm	3.75mm,4.00mm,4.30mm,4.50mm,5.00mm,5.50mm,6.00mm	3.75mm, 4.0mm,4.3mm, 4.5mm,5.0 mm, 5.5mm,6.0mm
ImplantLengths	8.0mm,9.0mm,10.0mm,11.0mm,12.0mm,13.0mm,14.0mm	8.10mm,8.30mm,8.64mm,8.91mm,9.00mm,9.69mm,10.0mm,11.0mm,12.0mm,14.0mm	5.0mm,6.0 mm,8.0 mm,11.0mm	7.0mm, 8.5mm10.0mm, 11.5mm13.0mm, 15.0mm	7mm, 8.5mm,10.0mm,11.5mm,13.0mm,15mm	7mm – 15.0 mm
Cover Screw	N/A	N/A	N/A	N/A	Ti 6Al 4VELI, ASTMF136	Ti 6Al 4V ELI,ASTM F136

LOTA Abutment

LOTA Shouldered Abutments

Item	Subject Device	Predicate Device
510(K)Number	K202046	K103810
Device Name	LOTA SLA Dental Implant	KJ Submerged System
Manufacturer	KJ Meditech Co., Ltd.	KJ Meditech Co., Ltd.
One PieceAbutment	■ Ti 6Al 4V ELI, ASTM F136■ Well : Ø2.0~ Ø3.0■ Diameter: Ø4.0mm ~ Ø6.5mm■ Height:6.85mm~~11.35mmPost Length: 2mm~~4mm	■ Ti6Al4V ELI, ASTM F136■ Well: Ø 2.0~ Ø 3.0■ Diameter: Ø3.5mm~ Ø6.0mm■ Height:10.7mm~~15mm■ Post Length: 4mm~~6mm

LOTA Shouldered Removal Abutments

Item	Subject Device	Predicate Device
510(K)Number	K202046	K161923
DeviceName	LOTA SLA Dental Implant	J2A SLA Dental Implant System
Manufacturer	KJ Meditech Co., Ltd.	KJ Meditech Co., Ltd.

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Two PieceAbutment	• Ti 6Al 4V ELI, ASTM F136• Well: Ø2.5~~Ø3.0• Diameter: Ø5.0mm ~ Ø6.5mm• Height: 6.85mm~~11.35mm• Post Length: 2mm~4mm	• Ti 6Al 4V ELI, ASTM F136• TiN Coating• Well: Ø2.78~~Ø3.33• Diameter: Ø4~~Ø7• Cuff: 1mm~~5mm• Height: 4.0mm~~7.0mm
-----------------------	--------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------

8. Non-Clinical Testing

Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification and based on the analysis, the following activities/tests were performed.

" Identifying reference devices for the modifications in fixture thread design, the fixture size, and abutment design to make sure the subject device is not introducing new design or size range which will raise a concern.
For the modification in surface treatment, identifying a predicate device which is made by our company having the same material/surface treatment and going through the same manufacturing processes.
. Sterilization validation test in accordance with ISO 11137-1 and 11137-2, and shelf life validation tests in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2.
Endotoxin testing for lot release was evaluated in accordance with USP 39 <85> the endotoxin limit which is 0.5 EU/mL.
Scanning Electron Microscopy (SEM) to validate there is no residual remaining on the implants.

9. Conclusion

Based on the similarities and the test results of the validation activities, we conclude that the LOTA SLA Dental Implant System and LOTA HA Dental Implant System are substantially equivalent to the predicate device.

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.