The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.

The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.

The Zeramex® P6 implants are intended for delayed loading.

The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

Device Description

The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.

The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm. 4.1 mm. and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.

Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN: 4.0mm) and regular neck (RN. 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.

The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.

The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.

Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.

The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).

The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes).

Healing caps and gingiva formers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingiva formers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zeramex® P6 Dental Implant System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., a specific percentage for success rates or a certain threshold for complications). Instead, it describes a retrospective clinical study and non-clinical tests whose positive results support the substantial equivalence claim.

However, based on the non-clinical and clinical study outcomes, we can infer the implied acceptance criteria from the reported success:

Acceptance Criteria (Inferred)	Reported Device Performance
Non-Clinical:
Cleaning and Sterilization Validation (ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2)	Device met standards (implied by positive review).
Shelf-life, Packaging, and Transport Validation (ASTM F1980, ASTM F88, ASTM F1886, ASTM F1929, ISO 11607-1, ISO 11607-2)	Device met standards (implied by positive review).
Biocompatibility (ISO 10993-5)	Device met standards (implied by positive review).
Surface Chemical & Roughness Analysis (XPS, SEM, Contact Angle)	Analysis performed; results support design (implied by positive review).
Fatigue Testing (ISO 14801, for new and aged samples)	Device met standards (implied by positive review).
Clinical:
Absence of Post-operative Complications (e.g., anesthesia, paresthesia, mandibular fracture, alveolar ridge height loss, adverse impact on adjacent teeth, abnormal/prolonged pain, fistula, infection, osteomyelitis)	No complications reported at implant placement, loading, and follow-up (up to >1 year).
Absence of Adverse Reactions (e.g., infection, pain, altered sensation, TMJ problems, implant loss, implant breakage, abutment breakage)	No adverse reactions reported at implant placement, loading, and follow-up (up to >1 year).
Absence of Screw Issues (movement, fracture, replacement)	No reports of screw movement, fracture, or replacement.

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

Sample Size (Clinical Test Set): 19 patients, receiving a total of 35 screw-retained abutments. Follow-up data was obtained on 15 of those patients (representing 27 screw-retained abutments). Specific follow-up numbers are:
- 6 months follow-up: 8 patients
- 1 year follow-up: 3 patients
Data Provenance: Retrospective clinical data. The country of origin is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish a "ground truth" for the retrospective clinical test set. The data appears to rely on clinical observations and professional documentation from the treatment of the 19 patients. It's implied that the treating clinicians (dentists/surgeons) made the assessments of complications and adverse events.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set data. Given it's retrospective clinical data, it's highly likely that the outcomes were recorded as part of routine patient care, without a formalized independent adjudication process mentioned for the purpose of this 510(k) submission. Therefore, the adjudication method is effectively "none" in the context of this regulatory submission.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the safety and performance of the device itself, not on comparing differences in human reader performance with or without AI assistance, as the device is a dental implant system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The Zeramex® P6 Dental Implant System is a physical medical device (dental implant and associated components), not an algorithm or software-as-a-medical-device (SaMD). Therefore, "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was based on clinical observations and outcomes data from real patients. This includes:

Absence of complications (e.g., infection, pain, fracture).
Absence of adverse events.
Stability and function of the implant and abutment over time.

For the non-clinical studies, the "ground truth" was established by adherence to recognized international and national standards (e.g., ISO, ASTM) for material properties testing, biocompatibility, sterilization validation, and fatigue strength.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This is a traditional medical device submission, not an AI/ML device. Therefore, this question is not applicable.

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

As there is no training set mentioned or implied for an AI/ML device, this question is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2016

Dentalpoint AG % Roshana Ahmed, MA, RAC Senior Manager, Regulatory Affairs- Medical Devices Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

Re: K152385

Trade/Device Name: Zeramax® P6 Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 6, 2016 Received: June 7, 2016

Dear Roshana Ahmed:

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. 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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152385

Device Name Zeramex® P6 Dental Implant System

Indications for Use (Describe)

The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.

The Zeramex® P6 implants are intended for delayed loading.

The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® P6 (03.3mm SN) implant may only be used in the lower jaw and lateral teeth in the upper jaw.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Dentalpoint AG Hohlstrasse 614 Zurich, Switzerland 8048

Phone: (+41) 44 388 36 36 Fax: (+41) 44 388 36 39

Contact Person: Viktor Lienhard, COO Date Prepared: July 25, 2016

II. Device

Name of Device:	Zeramex® P6 Dental Implant System
Common or Usual Name:	Dental Implant System
Classification Name:	Endosseous Dental Implant (21 CFR 872.3640)
Regulatory Class:	II
Product Code:	DZE, NHA

III.Predicate and Reference Devices

Substantial equivalence is claimed to the following predicate device:

Zeramex® T Dental Implant System, Dentalpoint AG, K133255 ●
The following devices are cited as reference devices:
Branemark System Dental Implant Products, Nobel Biocare AB, K022562
. Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC, K130222
Procera® Abutment Branemark, Nobel Biocare USA LLC, K042658

IV. Device Description

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or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.

The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes).

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temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.

V. Indications for Use

The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.

The Zeramex® P6 implants are intended for delayed loading.

The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

VI. Comparison of Technological Characteristics

The Zeramex® P6 Dental Implant System and the predicate devices share the following characteristics:

. Two-piece design
. Abutments and implants have the same material of construction
Cement retained abutments are fixed via an adhesive process which affixes the . abutment to the implant, in conjunction with the internal cylindrical connection (anti-rotation feature)
. Screw retained abutments which fit on the implant's external hexagonal connection (anti-rotation feature)
. The implants and abutments are provided in similar diameters and lengths as the predicate devices
Abutments are provided in straight and angled (15°) configurations .
Implant surfaces are treated via grit blasting and acid etching processes .

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The Zeramex® P6 Dental Implant System is technologically different from the predicate devices as follows:

. Provision of carbon-fiber reinforced PEEK screws for the screw retained abutments
A comparison of the subject and predicate devices is provided in the tables below.

Comparison of Dental Implants

	Zeramex® P6Dental ImplantSystem	Zeramex® TDental ImplantSystem(K133255)	Straumann®Dental ImplantSystem(K130222)	BranemarkSystem DentalImplant Products(K022562)
Indications forUse Statement	The Zeramex P6Dental ImplantSystems is intendedto be surgicallyplaced in the bone ofthe upper and lowerjaw to providesupport for prostheticdevices, such asartificial teeth, inorder to restoreaesthetics andchewing function.The Zeramex P6Dental ImplantSystem can be usedfor single or multipleunit restorations. TheZeramex P6 implantsare intended fordelayed loading. TheZeramex P6 DentalImplants are speciallyindicated for patientswith metalallergies/intolerancesand chronic illnessesdue to metalallergies/intolerances.The Zeramex P6(Ø3.3) implant mayonly be used in theanterior teeth in thelower jaw and lateralteeth in the upperjaw.	The Zeramex TDental ImplantSystems is intendedto be surgicallyplaced in the bone ofthe upper and lowerjaw to providesupport for prostheticdevices, such asartificial teeth, inorder to restoreaesthetics andchewing function.The Zeramex TDental ImplantSystem can be usedfor single or multipleunit restorations. TheZeramex T implantsare intended fordelayed loading. TheZeramex T DentalImplants are speciallyindicated for patientswith metal allergiesand chronic illnessesdue to metal allergies.The Zeramex T(Ø3.5) implant mayonly be used in theanterior teeth in thelower jaw and lateralteeth in the upperjaw.	Straumann dentalimplants are indicatedfor oral endostealimplantation in theupper and lwer jawarches for thefunctional andaesthetic oralrehabilitation ofedentulous andpartially dentatepatients. Straumanndental implants arealso indicated forimmediate or earlyimplantationfollowing extractionor loss of naturalteeth. Implants canbe placed withimmediate functionon single-tooth and/ormultiple toothapplications whengood primarystability is achievedand with appropriateocclusal loading torestore chewingfunction. Theprosthetic restorationused are singlecrowns, bridges andpartial or fulldentures, which areconnected to theimplants through thecorrespondingcomponents(abutments).	The Branemarksystem implants arefor single stage ortwo stage surgicalprocedures andcement or screwretained restoration.The Branemarksystem implants areintended forimmediate placementand function onsingle tooth and/ormultiple toothapplicationsrecognizing sufficientbone stability (type Ior ii bone) andappropriate occlusalloading, to restorechewing function.Multiple toothapplicants may besplinted with a bar.

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Design	Two-piece design	Two-piece design	Two-piece design	Two-piece design
ImplantMaterial	Zirconia	Zirconia	Grade 4 Titanium	Titanium
ImplantLengths	8 mm10 mm12 mm	8 mm10 mm12 mm14 mm	6 mm8 mm10 mm12 mm14 mm	7 mm8.5 mm10 mm11.5 mm13 mm15 mm18 mm
ImplantDiameter	3.3 mm4.1 mm4.8 mm	3.5 mm4.2 mm5.5 mm	3.3 mm4.1 mm4.8 mm	3.3 mm3.75 mm4 mm5 mm
ImplantSurfaceTreatment	Grit blasted, acidetched	Grit blasted, acidetched	Grit blasted, acidetched - SLA orSLActive	Machined ormodified (TiUnite)Surface
Anti-RotationFeatures	Internal cylindricalconnection withinternal triangulardesign (used forcementedabutments) andexternal hexagonalconnections (usedfor screw retainedabutments)	Internal cylindricalconnection withinternal triangulardesign	Internal octagonconnection	Internal tri-channelor externalhexagonalconnection
Sterilization	Steam, SAL 10-6	Steam, SAL 10-6	Gamma	Gamma

Comparison of Abutments

	Zeramex® P6 DentalImplant System	Zeramex® T DentalImplant System(K133255)	Procera® AbutmentBranemark(K042658)
Indications forUse Statement	The Zeramex P6 DentalImplant Systems is intendedto be surgically placed in thebone of the upper and lowerjaw to provide support forprosthetic devices, such asartificial teeth, in order torestore aesthetics andchewing function. TheZeramex P6 Dental ImplantSystem can be used forsingle or multiple unitrestorations. The ZeramexP6 implants are intended fordelayed loading. The	The Zeramex T DentalImplant Systems isintended to be surgicallyplaced in the bone of theupper and lower jaw toprovide support forprosthetic devices, such asartificial teeth, in order torestore aesthetics andchewing function. TheZeramex T Dental ImplantSystem can be used forsingle or multiple unitrestorations. The ZeramexT implants are intended for	Nobel Biocare's ProceraAbutment Branemark isindicated for the treatment ofpartially edentulous patientsrequiring a prosthetic device. Inaddition to the Branemarkimplant, the abutments' hexagonconnector fits the externalhexagon of the followingendosseous implants: 3i3.75mm, Lifecore BiocmedicalRestore 3.75mm, Zimmer DentalTaperlock 4.0mm, and SterngoldImplamed 3.75mm.

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Dentalpoint AG K152385

	Zeramex P6 Dental Implantsare specially indicated forpatients with metalallergies/intolerances andchronic illnesses due tometal allergies/intolerances.The Zeramex P6 (Ø3.3)implant may only be used inthe anterior teeth in thelower jaw and lateral teeth inthe upper jaw.	delayed loading. TheZeramex T Dental Implantsare specially indicated forpatients with metal allergiesand chronic illnesses due tometal allergies. TheZeramex T (Ø3.5) implantmay only be used in theanterior teeth in the lowerjaw and lateral teeth in theupper jaw.
AbutmentMaterial	Zirconia	Zirconia	ZirconiaTitaniumAlumina
AbutmentAngulation	StraightAngled, 15°	StraightAngled, 15°	StraightAngled, 10° and 15°
Connection toImplant	Cement Retained(internal cylindricalconnection withhexagonal design) &Screw Retained(external hexagonconnection)	Cement Retained(internal cylindricalconnection withhexagonal design)	-Screw Retained(external hexagonconnection)
Screw Material	Carbon-Fiber ReinforcedPEEK	N/A	Titan 6A17Nb (TAN) Screw
Sterilization	End User Sterilized	End User Sterilized	End User Sterilized

Discussion

There is only a slight difference between the indications for use statement of the Zeramex® P6 Dental Implant System and the Zeramex® T Dental Implant System which is the addition of the term "intolerances". The addition of patients with metal intolerances to the previous indication for patients with metal allergies does not change the intended use of the device for patients for which traditional titanium implant systems may not be appropriate.

The ZERAMEX® P6 Implants feature the same material, same connection concept (internal cylinder with triangular anti-rotation feature), same surface treatment, and similar abutments as the previously cleared ZERAMEX® T system for cemented abutments.

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As seen above, the differences between the subject and primary predicate is the provision of screw retained abutments, addition of an external hexagon anti-rotation feature for the screw-retained abutments, the inclusion of a carbon-fiber reinforced PEEK abutment fixation screw, and the reduction of the implant body diameter from 3.5 to 3.3mm.

The implants are similar in shape and diameter as the previously cleared Straumann® Implants. The ZERAMEX® P6 Implants additionally feature an external hexagon connection similar to the previously cleared Branemark Implants.

The connecting abutment features a fitting hexagon and is of same material as the previously cleared Procera® Abutment.

Performance Data VII.

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Studies

. Cleaning and Sterilization Validation according to ISO 17665-1, ISO 17665-2. ISO 11737-1 and ISO 11737-2.
Shelf-life, Packaging, and transport validation according to ASTM F1980, ASTM ● F88. ASTM F1886. ASTM F1929, ISO 11607-1, and ISO 11607-2.
. Biocompatibility in accordance with ISO 10993-5
Surface chemical and roughness analysis by XPS. SEM, and contact angle .
. Fatigue testing in accordance with ISO 14801 for new as well as artificially aged samples of the submission device

Clinical Studies

Retrospective clinical data on implants and prosthetics was obtained on 19 patients who received a total of 35 screw retained abutments. Follow up data was obtained on 15 of those patients (representing 27 screw retained abutments), with > 6 month follow up data on eight (8) patients, and > 1 year follow up data on three (3) patients.

Patients were between the ages of 36 and 69 years old, with no local risk factors. Implants were placed in the maxilla and mandible using a 2-step loading process with the time to loading ranging from 12 to 24 weeks.

Bone quantity ranged very heavy bone to soft bone, with all patients presenting with good bone quality.

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No post-operative complications or adverse events were reported for any of the patients at the implant placement and loading phases. Follow up data (n = 15 patients, 27 implants/abutments) shows that there were no post-operative complications defined as anesthesia or paresthesia, mandibular fracture, loss of alveolar ridge height, adverse impact on adjacent teeth, abnormal or prolonged pain, failure to maintain adequate oral hygiene, fistula, infection, or osteomyelitis. No adverse reactions (infection, pain, altered sensation, temporomandibular joint problems, implant loss prior to loading, loss of loaded implant, implant breakage, or abutment breakage) were reported. In addition, there were no reports of screw movement, fracture, or replacement.

Conclusion

Although differences in design and technology exist between the subject and predicate devices, these differences are supported by the biocompatibility, fatigue, and retrospective clinical study data described above. Therefore, it is concluded that the Zeramex® P6 Dental Implant System is substantially equivalent to the predicate devices.

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.