The Single Platform SP1 Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For the conventional abutment and screws:

The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.

For the Titanium Abutment Bases and Passive Abutments:

The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

For the Temporary Titanium Cylinders:

The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Device Description

This submission includes fully threaded root-form dental implants with an internal cone and hexagon interface and mating abutments. The implants are provided in three diameters: Ø3.5, Ø4.0 and Ø5.0 mm. The implants are provided in a straight (0° angled) configuration only, with a 3.0 mm extended machined coronal section. The implants are provided in one prosthetic diameter (2.95 mm implants are provided in overall leneths of 8, 10, 11.5, 13, 16, 18 and 20 mm. The Ø4.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, 18, 20, 22 and 24 mm. The Ø5.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, and 18 mm.

This submission also includes: a Cover Screw, Healing Abutments in four diameters and multiple gingival heights, Titanium Cylinder Abutments for temporary restorations, Passive Abutments with a plastic burn-out component, Equator Overdenture Abutments in multiple gingival heights, Compact Conical Abutments in straight (0) and angled (17° and 30°) designs, TIB Abutment Bases, and abutment screws.

The Passive Abutments may be restored using either traditional cast-on workflows or digital CAD/CAM workflows using milled zirconia restorations (similar use to the TIB Abutment Bases).

Using the traditional cast-on workflow, the Passive Abutments function as UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration when utilizing precious metal cast-on restorations.

Using digital CAD/CAM workflows, the TIB Abutment Bases and Passive Abutments function as two-piece abutment designs, consisting of standard premanufactured titanium alloy abutments for supporting the second half (or top-half) of the abutment, a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB Abutment Bases and Passive Abutments then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Bases and Passive Abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.

All Single Platform SP1 implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (extended machined surface of 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K222457 and K163060. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K222457 and K163060.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Single Platform SP1 Implant System." This document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance test.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical performance with statistical measures, expert reading, and ground truth establishment is not present in the provided document. The 510(k) pathway for medical devices typically relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring new clinical efficacy studies unless there are significant technological differences or new intended uses that raise new safety or effectiveness questions.

The "Performance Data" section explicitly states: "No clinical data were included in this submission."

However, I can extract information related to the non-clinical performance data provided to support substantial equivalence and the device's characteristics compared to predicates.

Here's a breakdown of what is available:

1. Table of Acceptance Criteria and Reported Device Performance:
The document does not define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) or report device performance against such metrics. Instead, it demonstrates through non-clinical testing that the device's mechanical, material, and functional properties are substantially equivalent to marketed predicate devices.

Here's a table summarizing the non-clinical performance data and findings:

Acceptance Criteria (Proxy: Demonstration of Substantial Equivalence via Non-Clinical Performance)	Reported Device Performance (Findings)
Engineering Analysis	Demonstrated equivalence.
Dimensional Analysis	Demonstrated equivalence.
Sterilization Validation (ISO 11137-1, ISO 17665-1, ISO 17665-2)	Validated.
Bacterial Endotoxin (USP 39-NF 34)	Tested according to standard.
Static and Dynamic Compression-Bending (ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants)	Results demonstrated fatigue performance of the subject device that exceeds its indication.
Scanning and Milling Validation for Passive Abutments	Validated.
MR Safety Testing (FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" - ASTM F2503, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119)	Subject devices "can be considered equally MR Safe as the predicate devices" (as tested on previously cleared devices and compared).
Biocompatibility Evaluations (ISO 10993-1)	Supported by identical materials, processing, and storage conditions as predicate devices (referenced from K222457 and K163060).
Sterile Barrier Shelf Life	Referenced from K222457.
Validated Steam Sterilization Instructions (ISO 17665-2)	Referenced from K193084 (for non-sterile components intended for end-user sterilization).
Software Validation Testing (FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices)	Software verification and validation testing provided for abutment design library, including restrictions to prevent designs outside allowable limits and locked design limitations/specifications. (referenced from K193084, applicable to TIB Abutment Bases and Passive Abutments for digital CAD/CAM workflows).

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

Test Set Sample Size: Not applicable in the context of clinical efficacy; the "test set" here refers to the non-clinical testing of the physical device. For example, "dynamic compression-bending testing was performed on worst-case subject device constructs." The exact number of constructs tested is not specified but would be dictated by the ISO standard.
Data Provenance: The document does not specify the country of origin for the non-clinical testing data directly, but the manufacturer is Southern Implants (Pty) Ltd from Irene, Gauteng, SOUTH AFRICA. The data is retrospective in the sense that it supports a submission for a new device, often using internal lab data.

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

This information is not applicable as no clinical study with human readers or ground truth established by experts for diagnostic performance was conducted or reported.

4. Adjudication Method for the Test Set:

Not applicable, as there was no human reader interpretation or clinical assessment requiring adjudication.

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

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data were included in this submission." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm-Only) Performance:

Not applicable. This is a physical dental implant system, not an AI algorithm. The only "software" mentioned is for design (CAD/CAM workflow), and its validation is to ensure it prevents designs outside of allowable limitations.

7. Type of Ground Truth Used:

For the non-clinical performance data, the "ground truth" is established by adherence to recognized international standards (ISO, ASTM, USP) and internal engineering specifications. For instance, the "ground truth" for fatigue performance is the passing criteria defined by ISO 14801.

8. Sample Size for the Training Set:

Not applicable. This product does not involve machine learning or AI models that require a training set.

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

Not applicable as there is no training set for an AI/ML model.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Southern Implants (Pty) Ltd Michelle dos Santos Senior Design Engineer 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA

Re: K232418

Trade/Device Name: Single Platform SP1 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE. NHA. PNP Dated: November 1, 2023 Received: November 2, 2023

Dear Michelle dos Santos:

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.

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

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

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

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

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

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

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,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K232418

Device Name Single Platform SP1 Implant System

Indications for Use (Describe)

For the implants:

The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For the conventional abutment and screws:

For the Titanium Abutment Bases and Passive Abutments:

For the Temporary Titanium Cylinders:

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.

Form Approved:	OMB No. 0910-0120
Expiration Date:	06/30/2023

See PRA Statement below.

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

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."

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

510(k) Summary - K232418

Single Platform SP1 Implant System

Southern Implants (Pty) Ltd

December 01, 2023

ADMINISTRATIVE INFORMATION

Manufacturer Name	Southern Implants (Pty) Ltd1 Albert RoadIrene, Gauteng, 0062 South AfricaTelephone: +27 12 667 1046Fax: +27 12 667 1029
Official Contact	Colin SaffyHead of Regulatory Affairs and QualityEmail: colin.s@southernimplants.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Single Platform SP1 Implant System
Common Name	Dental implant
Classification Name	Endosseous dental implant
Classification Regulation	21 CFR 872.3640, Class II
Product Code	DZE, NHA, PNP
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary predicate devices:

K163194, Neodent Implant System – GM Line, JJGC Industria e Comercio de Materiais Dentarios SA.

Reference devices:

K190958, Neodent Implant System - GM Helix LG, JJGC Industria e Comercio de Materiais Dentarios SA. K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd.

K222457, Provata Implant System, Southern Implants (Pty) Ltd.
K180536, Neodent Implant System GM Line, JJGC Industria e Comercio de Materiais Dentarios SA.
K191191. Neodent Implant System Temporary Abutments, JJGC Industria e Comercio de Materiais Dentarios SA.
K212785, Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments, Blue Sky Bio, LLC.
K130991, NexxZRTM T and NexxZRTM T, Sagemax Bioceramics, Inc.
K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent, Inc.

INDICATIONS FOR USE STATEMENT

For the implants:

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

Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For the conventional abutment and screws:

The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental imended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures.

For the Titanium Abutment Bases (TIB) and Passive Abutments:

For the Temporary Titanium Cylinders:

The Southern Implants Temporary Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

SUBJECT DEVICE DESCRIPTION

The Passive Abutments may be restored using either traditional cast-on workflows or digital CAD/CAM workflows using milled zirconia restorations (similar use to the TIB Abutment Bases).

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

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence.

Non-clinical data submitted to demonstrate substantial equivalence includes: engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 17665-1, ISO 17665-1, ISO 17665-2; bacterial endotoxin according to USP 39-NF 34; static and dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants; scanning and milling validation for the Passive Abutments; and MR safety testing as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".

Non-clinical data referenced, or relied upon to demonstrate substantial equivalence includes: biocompatibility evaluations according to ISO 10993-1 (referenced from K222457 and K163060); sterile barrier shelf life (referenced from K222457); validated steam sterilization instructions per ISO 17665-2 (applicable to the Passive Abutments and Titanium Abutment Bases (TIB) which are provided non-sterile and intended for end-user sterilization - referenced from K193084); software validation testing as per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices (referenced from K193084); and scanning and milling validation for the Titanium Abutment Bases (TIB) (referenced from K193084).

No clinical data were included in this submission.

Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer Software (only applicable to the TIB Abutment Bases and Passive Abutments when using the digital CAD/CAM workflows for milled zirconia restoration design). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.

MR safety testing as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment'' (ASTM F2503, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) was performed on the previously cleared devices, K222457, PROVATA Implant System. The subject devices were compared to the predicate devices. The subject devices are not worst-case Southern Implants components in terms of material, size or shape and therefore the subject devices can be considered equally MR Safe as the predicate devices.

EQUIVALENCE TO MARKETED DEVICE

Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices listed above.

{8}------------------------------------------------

For the subject device Single Platform SP1 implants, the primary predicate device is K163194, and the reference devices are K190958, K163060, K222457 and K212785.

For the subject device Conventional Abutments and Prosthetic Screws for Single Platform SP1 implants, the reference devices are K163194, K163060 and K222457.

For the subject device TIB Abutment Bases and Passive Abutments for Single Platform SP1 implants, the reference devices are K222457, K180536 and K163060.

For the subject device Temporary Titanium Abutments for Single Platform SP1 implants, the reference devices are K222457 and K191191.

A comparison of the technological characteristics of the subject devices and the predicate devices is provided in the following tables.

{9}------------------------------------------------

	Subject Device	PrimaryPredicateDevice	ReferenceDevice	ReferenceDevice	ReferenceDevice	ReferenceDevice
Comparison	Single PlatformSP1 ImplantSystemSouthernImplants (Pty)Ltd	K163194NeodentImplant System- GM LineJJGC Industriae Comercio deMateriaisDentarios SA	K190958NeodentImplant System- GM Helix LGJJGC Industriae Comercio deMateriaisDentarios SA	K163060Deep Conical(DC) Implantsand AccessoriesSouthernImplants (Pty)Ltd	K222457ProvataImplant SystemSouthernImplants (Pty)Ltd	K212785Blue Sky BioDental ImplantSystem -BIO MAXMULTI ONEBlue Sky Bio,LLC
Implant
Indicationsfor UseStatement	TheSinglePlatformSP1Implant System isintendedforsurgical placementin the upper orlower jaw toprovide a means forprostheticattachmentofcrowns, bridges oroverdenturesutilizing delayed orimmediate loading.TheSinglePlatformSP1Implant System isintendedforimmediate functionwhen good primarystabilitywithappropriateocclusal loading isachieved.TheSinglePlatformSP1implants in lengths20, 22 and 24 mmwhen placed in themaxilla are onlyindicatedformultipleunitrestorationsinsplintedapplicationsthatutilize at least twoimplants.	TheNeodentImplant System isintended to besurgically placed inthe bone of theupper or lower jawto provide supportfor prostheticdevices such asartificial teeth, torestore chewingfunction. It may beused with single-stage or two-stageprocedures, forsingle or multipleunit restorations,and may be loadedimmediately whengood primarystability is achievedand withappropriateocclusal loading.	TheNeodentImplant System isintended to besurgically placed inthe bone of theupper or lower jawto provide supportfor prostheticdevices, such asartificial teeth, torestore chewingfunction. It may beused with single-stage or two-stageprocedures, forsingle or multipleunit restorations,and may be loadedimmediately whengood primarystability is achievedand withappropriateocclusalloading.The Neodent GMHelix LG implantscan be placedbicortically in casesof reduced bonedensity.TheNeodent GM HelixLG implants areonly indicated formultiple unitrestorations insplintedapplications thatutilize at least twoimplants.	Southern ImplantsDental Implants areintended for bothone- and two-stagesurgical proceduresin the followingsituations and withthe followingclinical protocols:- replacingsingle andmultiplemissing teethin the mandibleand maxilla,- immediateplacement inextraction sitesand insituations witha partially orcompletelyhealed alveolarridge,- immediateloading in allindications,except insingle toothsituations onimplantsshorter than8mm or in softbone (type IV)where implantstability maybe difficult toobtain andimmediateloading maynot beappropriate.The intended usefor 3.0 DeepConical implants islimited toreplacement ofmaxillary lateralincisors andmandibularincisors.	TheProvataImplant System isintended forsurgical placementin the upper orlower jaw toprovide a means forprostheticattachment ofcrowns, bridges oroverdenturesutilizing delayed orimmediate loading.TheProvataImplant System isintended forimmediate functionwhen good primarystability withappropriateocclusal loading isachieved.The intended usefor the 03.30Provata implants islimited toreplacement ofmaxillary andmandibular lateraland central incisors.The 12° angled Co-Axis ProvataImplants areintended to only beused with straightabutments.	Blue Sky Bio MultiOne Implant Systemis intended forsurgical placementin the bone of theupper or lower jawto provide supportfor prostheticdevices to restorechewing function.Implants may beused with single-stage or two-stageprocedures.They can beloaded immediately whengood primarystability is achievedand withappropriate occlusalloading. Blue SkyBio Multi OneImplants areindicated for multi-unit restorations insplintedapplications.BlueSky Bio Multi OneImplant Systemwith a 45°angulation areindicated forsurgical installationin the pterygoidregion only, in casesof severe jawresorption, in orderto restore patientesthetics andchewing function.
ProductCode	DZE	DZE	DZE	DZE	DZE	DZE
IntendedUse	Functionaland estheticrehabilitation ofthe edentulousmaxilla.	Root-formimplantsintended toreplace naturaltooth root.	Root-formimplantsintended toreplace naturaltooth root.	Bone anchoreddental prosthetic	Functionaland estheticrehabilitation ofthe edentulousmaxilla.	Root-formimplants intendedto replace naturaltooth root.
Reason forPredicate/Reference	Not applicable	General implantdesign, lengthand diameterInternal coneand hexconnection	Implant lengths	General designand diameterImplant materialand surfaceSterilitySterilizationUsage	Machined collarImplant materialand surfaceShelf-life ofpackagingSterilitySterilizationUsage	Implant diameterand lengthcombination

{10}------------------------------------------------

Item Code	MSC-SP35;MSC-SP40;MSC-SP50	GM Helix	GM Helix LG	DCC35;DCC40;DCC50; DCT35;DCT40; DCT50	MSC-PRO300	BIOMAXMULTI ONEØ 3.25 mmStraight
ImplantDesign	Fully threadedtapered root-form dentalimplants	Threaded root-form implantwith internalGM Morse taperconnection withinternal hex	Threaded root-form implantwith internalGM Morse taperconnection withinternal hex	Fully threadedcylindrical andtapered root-form dentalimplants	Fully threadedtapered root-form dentalimplants	One-pieceimplant/abutment
ImplantDiameter	3.50, 4.0 and 5.0mm	3.50, 3.75, 4.0,4.3 and 5.0 mm	3.75 and 4.0 mm	3.52, 4.0 and5.0mm	3.30 mm	3.25 mm
ImplantLength	For Ø3.5implants: 8, 10,11.5, 13, 16, 18,20 mmFor Ø4.0implants: 8, 10,11.5, 13, 16, 18,20, 22, 24 mmFor Ø5.0implants: 8, 10,11.5, 13, 16, 18mm	8, 10, 11.5, 13,16, 18 mm	20, 22, 25 mm	8, 9, 11, 13, 15mm	8.5, 10, 11.5, 13,15, 18 mm	10, 11.5, 13, 16,18, 20 mm
PlatformAngle,Relative toorthogonalto implantlong axis	0° (straight)	0° (straight)	0° (straight)	0° (straight)	0° (straight)	0° (straight)
ImplantPlatformDiameter	For Ø3.5implants: 3.30mmFor Ø4.0implants: 3.80mmFor Ø5.0implants: 4.50mm	Not provided	Not provided	For Ø3.52 andØ4.0 implants:3.10 mmFor Ø5.0implants: 4.10mm	3.10 mm	3.50 mm
ImplantProstheticDiameter	2.95 mm	Not provided	Not provided	For Ø3.52 andØ4.0 implants:2.80 mmFor Ø5.0implants: 3.83mm	2.90 mm	3.50 mm
ImplantInterface	Internal Coneand Hex	GM interface,16° Morse taperwith anti-rotationalfeatures (Internalcone and hex)	GM interface,16° Morse taperwith anti-rotationalfeatures (Internalcone and hex)	Deep Conical(internal coneand double hex)	Internal Hex	One piece
ImplantMaterial	Unalloyedtitanium (ASTMF67) Grade 4,and UTS ≥900MPa (cold-worked)	Unalloyedtitanium (ASTMF67) Grade 4	Unalloyedtitanium (ASTMF67) Grade 4	Unalloyedtitanium (ASTMF67) Grade 4,and UTS ≥900MPa (cold-worked)	Unalloyedtitanium (ASTMF67) Grade 4,and UTS ≥900MPa (cold-worked)	Ti-6Al-4VTitanium Grade5 alloy (ASTMF136)
ImplantEndosseousSurface	Grit-blasted witha 3.0mmmachinedsection only atcoronal end	Grit-blasted andacid etched(NeoPoros andAcqua)	Grit-blasted andacid etched(NeoPoros)	Grit-blasted witha 0.3mmmachinedsection only atcoronal end	Grit-blasted witha 3.0mmmachinedsection only atcoronal end	Grit blasted andacid etched
How Provided
Sterility	Provided sterile	Provided sterile	Provided sterile	Provided sterile	Provided sterile	Provided sterile
Sterilization	Gammairradiation	Gammairradiation	Gammairradiation	Gammairradiation	Gammairradiation	Gammairradiation
Usage	Single-patient,single-use	Single-patient,single-use	Not provided	Single-patient,single-use	Single-patient,single-use	Single-patient,single-use
Shelf life ofpackaging	10 years	Not provided	Not provided	5 years	10 years	Not provided

{11}------------------------------------------------

Comparison	Subject Device	Primary Predicate DeviceK163194	Reference DeviceK163060
	Conventional Abutments and	Neodent Implant System - GM	Deep Conical (DC) Implants and
	Prosthetic Screws for SinglePlatform SP1 Implant System	LineJJGC Industria e Comercio de	Accessories
	Southern Implants (Pty) Ltd	Materiais Dentarios SA	Southern Implants (Pty) Ltd
Indications for UseStatement	The Conventional Abutments andProsthetic Screws arepremanufactured prostheticcomponents directly connected toendosseous dental implants andintended for use in fullyedentulous or partially edentulousmaxilla and/or mandible toprovide support for crowns,bridges or overdentures.	The Neodent Implant System isintended to be surgically placed inthe bone of the upper or lower jawto provide support for prostheticdevices such as artificial teeth, torestore chewing function. It may beused with single-stage or two-stageprocedures, for single or multipleunit restorations, and may beloaded immediately when goodprimary stability is achieved andwith appropriate occlusal loading.	Southern Implants Dental Implantsare intended for both one- and two-stage surgical procedures in thefollowing situations and with thefollowing clinical protocols:- replacing single and multiplemissing teeth in the mandibleand maxilla,- immediate placement inextraction sites and in situationswith a partially or completelyhealed alveolar ridge,- immediate loading in allindications, except in singletooth situations on implantsshorter than 8mm or in soft bone(type IV) where implant stabilitymay be difficult to obtain andimmediate loading may not beappropriate.The intended use for 3.0 DeepConical implants is limited toreplacement of maxillary lateral
			incisors and mandibular incisors.
Product Code	NHA	NHA	NHA
Intended Use	Functional and estheticrehabilitation of the edentulousmaxilla.	Immediate or conventionalrehabilitation procedures on themaxilla or mandible.	Functional and estheticrehabilitation of the edentulousmaxilla.
Reason forPredicate/ Reference	Not applicable	Cover ScrewHealing AbutmentCompact Conical Abutment(general design and functioning)	Cover ScrewHealing AbutmentCompact Conical AbutmentEquator Overdenture Abutment(general design and functioning)
Implant Connection	Internal Cone and Hex (SP1)	GM interface, 16° Morse taperwith anti-rotational features(Internal cone and hex)	Deep Conical (internal cone anddouble hex)
Cover Screw
Item Code	CS-SP	GM Cover screw	CS-DC
Platform diameter	2.95 mm	Not provided	2.35, 2.85, 3.90 mm
Maximum diameter	3.10 mm	Not provided	2.38, 2.88, 3.93 mm
Abutment material	Unalloyed titanium (ASTM F67)Grade 4	Ti-6Al-4V ELI Titanium Alloy(ASTM F136)	Unalloyed titanium (ASTM F67)Grade 4
Abutment surface	Machined	Machined and anodized	Machined and anodized
Healing Abutment
Item Code	HA-SP	GM Healing abutment	HA-DC
Collar height	2.5, 3.5, 4.5, 5.5 mm	0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm	1.8, 3.8, 5.8 mm
Collar diameter	4.5, 5.0, 5.5, 6.5 mm	3.5, 4.5, 5.5, 6.5 mm	4.5, 5.5, 6.5 mm
Abutment material	Unalloyed titanium (ASTM F67)Grade 4	Ti-6Al-4V ELI Titanium Alloy(ASTM F136)	Unalloyed titanium (ASTM F67)Grade 4
Abutment surface	Machined and anodized	Machined and anodized	Machined and anodized
Equator Overdenture Abutment
Item Code	EQ-SP		EQ-DC
Connectionconfigurations	Non-engaging; Multi-unit		Non-engaging; Multi-unit
Prosthesisattachment	Removable	N/A	Removable
Collar height	2.0, 4.0, 6.0 mm		2.0, 4.0, 6.0 mm
Collar diameter	4.5 mm		3.5, 4.0 mm
Abutment angle	0°		0°
Abutment material	Ti-6Al-4V Titanium Grade 5alloy (ASTM F136)	GM Mini Conical Abutments	Ti-6Al-4V Titanium Grade 5 alloy(ASTM F136)
Abutment surface	Machined with TiN coating	Machined	Machined with TiN coating
Compact Conical Abutment
Item Code	MC-SP; MC-SP-17D; MC-SP-30D	GM Mini Conical Abutments	MC-DC
Connectionconfigurations	0°: Non-engaging; Multi-unit17° and 30°: Engaging; Multi-unit	0°: Non-engaging; Multi-unit17° and 30°: Engaging; Multi-unit	Non-engaging; Multi-unit
Prosthesisattachment	Screw-retained	Screw-retained	Screw-retained
Collar height	0°: 1.5, 2.5, 3.5, 4.5 mm17°: 1.5, 2.5, 3.5 mm (low sideheight)30°: 2.5, 3.5 mm (low side height)	0°: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm17° and 30°: 1.5, 2.5, 3.5 mm	1.5, 3.0, 4.0, 5.0 mm
Collar diameter	4.8 mm	4.8 mm	4.8, 6.0 mm
Abutment angle	0°, 17°, 30°	0°, 17°, 30°	0°
Abutment material	Ti-6Al-4V Titanium Grade 5alloy (ASTM F136)	Ti-6Al-4V ELI Titanium Alloy(ASTM F136)	Ti-6Al-4V Titanium Grade 5 alloy(ASTM F136)
Abutment surface	Machined with TiN coating	Machined	Machined with TiN coating
Abutment screwmaterial	Ti-6Al-4V Titanium Grade 5alloy (ASTM F136)	Not provided	Ti-6Al-4V Titanium Grade 5 alloy(ASTM F136)
How Provided
Sterility	Provided sterile	Sterile	Provided sterile
Sterilization	Gamma irradiation	Ethylene Oxide	Gamma irradiation
Usage	Single-patient, single-use	Single-patient, single-use	Single-patient, single-use
Shelf life ofpackaging	5 years	Not provided	5 years

{12}------------------------------------------------

{13}------------------------------------------------

	Subject Device	Reference Device
		K222457
Comparison	TIB Abutment Bases and Passive Abutmentsfor Single Platform SP1 Implant System	TIB Abutment Bases and Passive Abutmentsfor Ø3.30 Provata Implant System
	Southern Implants (Pty) Ltd	Southern Implants (Pty) Ltd
Indications for UseStatement	The TIB and Passive Abutments arepremanufactured prosthetic components directlyconnected to endosseous dental implants and areintended for use as an aid in prostheticrehabilitation. The TIB and Passive abutmentsconsist of two major parts. Specifically, thetitanium base and mesostructure components makeup a two-piece abutment. The system integratesmultiple components of the digital dentistryworkflow: Scan files from desktop scanners, CADsoftware, CAM software, ceramic material, millingmachine and associated tooling and accessories.	The TIB Abutments are premanufacturedprosthetic components directly connected toendosseous dental implants and are intended for useas an aid in prosthetic rehabilitation. The TIBabutments consist of two major parts. Specifically,the titanium base and mesostructure componentsmake up a two-piece abutment. The systemintegrates multiple components of the digitaldentistry workflow: Scan files from desktopscanners, CAD software, CAM software, ceramicmaterial, milling machine and associated toolingand accessories.
Product Code	NHA, PNP	NHA, PNP
Intended Use	Functional and esthetic rehabilitation of theedentulous maxilla.	Functional and esthetic rehabilitation of theedentulous maxilla.
Reason for Predicate/Reference	Not applicable	TIB AbutmentPassive Abutment(general design and functioning)Software Compatibility
Implant Connection	Internal Cone and Hex (SP1)	Internal Hex
TIB Abutment Base
Item Code	TIB-SP; TIB-NSP; TIB-SP-PM	TIBS-3M-C1.5TIBS-3M-C3
Abutment design	2 Piece - Premanufactured titanium abutment,mounted onto the implant and fixed with a screw.SageMaxx Zirconia (K130991) hybrid/crownrestoration milled and bonded to the titaniumabutment.	2 Piece - Premanufactured titanium abutment,mounted onto the implant and fixed with a screw.SageMaxx Zirconia (K130991) hybrid/crownrestoration milled and bonded to the titaniumabutment.
Collar height	1.5, 3.0 mm	1.5, 3.0 mm
Maximum abutment angle	20°	20°
Post height	Minimum 4.5 mm	Minimum 4.5 mm
Abutment RestorativePlatform Diameter	4.50, 5.50 mm	3.85 mm
Abutment titanium basecomponent material	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)
Abutment surface	Machined and anodized	Machined and anodized
Abutment screw material	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)
Passive Abutment
Item Code	PA-SP; PA-NSP; PA-SP-PM	PA-3EM-STC; PA-3NM-STC
Connection configurations	Engaging and non-engaging; Single-unit andmulti-unit	Engaging and non-engaging; Single-unit andmulti-unit
Prosthesis attachment	Screw-retained	Screw-retained
Collar height	1.0 mm	0.4 mm
Collar diameter	3.9, 5.0 mm	3 mm
Maximum abutment angle	20° for zirconia restorations (digital CAD/CAMworkflows)0° for precious metal cast-on restorations(traditional workflows)	0°
Abutment titanium basecomponent material	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)
Abutment surface	Machined and anodized	Machined
Abutment screw material	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)
CAD/CAM Process
Restoration material	Zirconia - Sage Maxx NexxZr (K130991)	Zirconia - Sage Maxx NexxZr (K130991)
CAD/CAM DesignWorkflow	3Shape E3 Desktop Scanner (3Shape A/S)3Shape Abutment Designer Software	3Shape E3 Desktop Scanner (3Shape A/S)3Shape Abutment Designer Software
CAD/CAM ManufacturingWorkflow	WorkNC CAM software, Roland DWX51Dmilling unit	WorkNC CAM software, Roland DWX51Dmilling unit
How Provided
Sterility	Provided non-sterile	Provided non-sterile
Usage	Single-patient, single-use	Single-patient, single-use
Shelf life of packaging	5 years	5 years

{14}------------------------------------------------

{15}------------------------------------------------

	Subject Device	Reference Device
Comparison		K222457
	Temporary Titanium Abutments for SinglePlatform SP1 Implant System	Temporary Titanium Abutments for Ø3.30Provata Implant System
	Southern Implants (Pty) Ltd	Southern Implants (Pty) Ltd
Indications for UseStatement	The Southern Implants Temporary TitaniumAbutments are premanufactured prostheticcomponents directly connected to endosseousdental implants and are intended for provisionaluse up to 180 days as an aid in prostheticrehabilitation.	The Southern Implants Temporary TitaniumAbutments are premanufactured prostheticcomponents directly connected to endosseousdental implants and are intended for provisionaluse up to 180 days as an aid in prostheticrehabilitation.
Product Code	NHA	NHA
Intended Use	Functional and esthetic rehabilitation of theedentulous maxilla.	Functional and esthetic rehabilitation of theedentulous maxilla.
Reason forPredicate/Reference	Not applicable	Titanium Cylinder Abutment (general abutmentdesign)Abutment and screw materials and surfaceShelf-life of packagingSterility status and Sterilization MethodUsage
Implant Connection	Internal Cone and Hex (SP1)	Internal Hex
Titanium Cylinder Abutment
Item Code	TC-SP; TC-NSP; TC-SP-PM	TC-3M; TC-3NM
Connection configurations	Engaging and non-engaging; Single-unit andmulti-unit	Engaging and non-engaging; Single-unit andmulti-unit
Prosthesis attachment	Cement-retained	Cement-retained
Collar height	1.5 mm	2.0 mm
Collar diameter	4.5, 5.5 mm	3.5 mm
Abutment angle	0°	0°
Abutment material	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)
Abutment surface	Machined and anodized	Machined and anodized
Abutment screw material	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)	Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136)
Duration of use	180 days	180 days
How Provided
Sterility	Provided sterile	Provided sterile
Sterilization	Gamma irradiation	Gamma irradiation
Usage	Single-patient, single-use	Single-patient, single-use
Shelf life of packaging	5 years	5 years

{16}------------------------------------------------

The Indications for Use Statements for the subject device implants and the reference device K222457 are similar with the subject device statement including a restriction for the longer length implants (i.e., lengths 20 - 24 mm) to be splinted in multiple-unit restorations. This restriction is similar to that of reference devices K190958 and K212785.

The Indications for Use Statements for the subject device abutments and the reference device K222457 are identical for the Conventional Abutments and Prosthetic screws, the TIB Abutment Bases, and the Temporary Titanium Abutments.

For the subject device Single Platform SP1 implants, the primary predicate device is K163194, and the reference devices are K190958, K163060, K222457 and K212785. The primary predicate device K163194 is for substantial equivalence of the subject device implant connection interface, implant lengths, and general designs. The subject device implants have a similar internal cone and hex connection, similar implant diameters and lengths as implants in K163194. The reference device K190958 is for substantial equivalence of the subject device implant longer lengths of 20 – 24 mm. The subject device implants' indications for use is limited to splinted multiple-unit restorations for the longer length implants (i.e., lengths 20 - 24mm) which is similar to the indications for use of reference device K190958. The subject device implants' indications for use is similar to reference device K222457, with the reference device having an additional limitation for narrow diameter implants (</03.30 mm) which is not relevant to the subject device implants. The reference device K163060 is for substantial equivalence of the subject device implant material, surface, sterilization and usage. The reference devices K212785 are for substantial equivalence of the subject device implant diameter and length, specifically the Ø3.5 Single Platform SP1 implants. The reference device K222457 is for substantial equivalence of the subject device implant machined collar, and packaging shelf life.

For the subject device Conventional Abutments and Prosthetic Screws for Single Platform SP1 implants, the reference devices are K163194, K163060 and K222457. The reference device K163194 serves as a predicate for substantial equivalence of the subject device abutment connection interface, and general designs of the Cover Screw, Healing Abutments and Compact Conical Abutments. The reference devices K163060 and K222457 is for the substantial equivalence of the subject device abutment materials, surface treatment and general designs of the Cover Screw, Healing Abutments and Compact Conical Abutments. The reference device K163060 is for the substantial equivalence of the subject device abutment materials, surface treatment and general designs of the Cover Screw, Healing Abutments, Equator Overdenture Abutments and Compact Conical Abutments. -implant prosthetic diameter and surface treatment.

For the subject device TIB Abutment Bases and Passive Abutments for Single Platform SP1 implants, the reference devices are K222457, K180536 and K163060. The reference device K222457 serves as a predicate for substantial equivalence of the subject device abutment material, surface treatment, sterility, usage, software compatibility and general designs. The reference device K180536 is for the substantial equivalence of the subject device abutment connection interface and general design of the TIB Abutment Bases. The reference device K163060 is for the substantial equivalence of the subject device abutment general design of the Passive Abutments.

For the subject device Temporary Titanium Abutments for Single Platform SP1 implants, the reference devices are K222457 and K191191. The reference device K222457 serves as a predicate for substantial equivalence of the subject device abutment material, surface treatment, packaging shelf life, sterilization, usage and general design of the Temporary Titanium Abutments. The reference device K191191is for the substantial equivalence of the subject device abutment connection interface and general design of the Temporary Titanium Abutments.

The subject device and the predicate devices all incorporate the same materials and encompass similar ranges of dimensions. The surface treatment applied to the subject device implants is identical to that cleared in K163060 and K222457. All subject device components are for single-patient, single-use, and all are provided sterile (except the Passive Abutments and TIB Abutment Bases which are provided non-sterile identical to Passive Abutments and TIB Abutment Bases cleared in K222457, and the Passive Abutments cleared in K163060). Similarly, the components cleared in K163060 and K222457 are for single-patient, single-use and are provided sterile (excluding the Passive Abutments and TIB Abutment Bases).

{17}------------------------------------------------

Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K163060 and K222457.

In support of substantial equivalence of the Single Platform SP1 implants in terms of mechanical performance, dynamic compression-bending testing was performed according to ISO 14801. Dynamic testing was performed on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device that exceeds its indication.

CONCLUSION

The subject device and the predicate devices have a significantly similar intended use, have similar technological characteristics, and are made of the same materials. The subject device and the predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. The subject device and the predicate devices are packaged in similar materials and sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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.