Nucleoss T6 Dental Implants are intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function. Nucleoss T6 Dental Implants are intended for delayed loading after 12 weeks.

Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures for edentulous or partially edentulous patients.

Device Description

The Nucleoss T6 Dental Implant is a bone level implant constructed of unalloyed titanium (ISO 5832-2). The surface of the T6 implant is a sand-blast and acid-etch (SLA) surface treatment.

T6 Implants: Nucleoss T6 implants have a cylindrical form design, with a double lead thread form and two helical anti-rotation grooves. The thread structure is a reverse buttress. The internal structure is designed as a conical internal hex connection with 140 degrees.

The Nucleoss Dental Abutments are intended for use with the Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Abutments: The Nucleoss Dental Abutments consist of the following designs: Standard Straight, Esthetic Straight, Esthetic Angled, Ball and Equator, Cover, Gingiva Former and Screw. Nucleoss Dental Abutments are cement-retained and screw-retained restorations and intended for placement on Nucleoss T6 implants with diameters of 3.5, 4.1 and 4.8 mm. The connection to the dental implant is achieved by an internal hexagon. These devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.

Covers and Gingiva Formers: The Nucleoss Cover and Gingiva Former are used during the healing and prosthesis period following surgical placement of the dental implant. All of these devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.

Screws: The Nucleoss Dental Implant and Abutments devices also include screws for securing abutments to the implant to provide a secure coupling for the denture prosthetic attachment to the abutment.

AI/ML Overview

The provided text is a 510(k) Summary for the Nucleoss T6 Dental Implant System. It details the device, its indications for use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study proving that an AI/Machine Learning device meets specific performance criteria. The entire document focuses on a dental implant system, which is a physical medical device, and the testing described (pull-out, fatigue, sterilization, accelerated aging, biocompatibility) are all standard engineering and material science tests for such a device. There is no mention of an algorithm, AI, machine learning, or any form of digital image analysis.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria or performance from this document. The questions about sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are relevant only for AI/ML device studies, which are not described in this submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

August 27, 2020

Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. Sti % Semih Oktay President CardioMed Device Consultants 3168 Braverton St., Suite 200 Edgewater, Maryland 21037

Re: K192062

Trade/Device Name: Nucleoss T6 Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 24, 2020 Received: July 27, 2020

Dear Semih Oktay:

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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): K192062

Device Name: Nucleoss T6 Dental Implant System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary [as required by 21 CFR 807.92(c)]

Nucleoss T6 Dental Implant 510(k) K192062

DATE PREPARED	August 27, 2020
APPLICANT INFORMATION	Ezgi Ozbudak10018 Sok. No: 7 ITOB Organize Sanayi Bölgesi TekeliMenderes/IZMIR TURKEYPhone: +90 232 799 03 04Email: kalite@nucleoss.com
CONTACT INFORMATION	Semih Oktay, Ph.D,President and CEO, CardioMed Device ConsultantsPhone:(410) 674-2060Email: soktay@cardiomedllc.com
TRADE NAME	Nucleoss T6 Dental Implant System
DEVICE CLASSIFICATION	Class II per 21 CFR §872.3640
CLASSIFICATION NAME	Endosseous dental implant
PRODUCT CODE	DZENHA
PREDICATE DEVICE	TPure Dental Implant (K160850)
REFERENCE DEVICES	Straumann Dental Implant System (K171784)Thommen Medical (K093615)

INDICATIONS FOR USE

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DEVICE DESCRIPTION

The Nucleoss T6 Dental Implant is a bone level implant constructed of unalloyed titanium (ISO 5832-2). The surface of the T6 implant is a sand-blast and acid-etch (SLA) surface treatment.

T6 Implants

Nucleoss T6 implants have a cylindrical form design, with a double lead thread form and two helical anti-rotation grooves. The thread structure is a reverse buttress. The internal structure is designed as a conical internal hex connection with 140 degrees.

Abutments

The Nucleoss Dental Abutments consist of the following designs: Standard Straight, Esthetic Straight, Esthetic Angled, Ball and Equator, Cover, Gingiva Former and Screw. Nucleoss Dental Abutments are cement-retained and screw-retained restorations and intended for placement on Nucleoss T6 implants with diameters of 3.5, 4.1 and 4.8 mm. The connection to the dental implant is achieved by an internal hexagon.

These devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.

The Standard Straight Abutment is intended for cement-retained single and multiple restorations. There is no angulation. The Standard Straight abutments can be used in anterior and posterior maxillary and/or mandibular arches. Prior to cementing in place, the Standard Straight abutment is secured on the implant with a screw.

The Esthetic Straight Abutment is intended for cement-retained single and multiple restorations. There is no angulation. The Esthetic Straight abutments can be used in anterior and posterior maxillary and/or mandibular arches. Prior to cementing in place, the Esthetic Straight abutment is secured on the implant with a screw. The front and back gingival heights of these abutments are different from each other. The front heights are shorter and the back heights are greater. These height differences offer the dentist an esthetically beneficial option as required.

The Esthetic Angled Abutment is intended for cement-retained single and multiple restorations. The Esthetic Angled Abutment is provided in angles of 15 and 25 degrees for cases where angle correction is required. The Esthetic Angled abutments can be used in anterior and posterior maxillary and/or mandibular arches. Prior to cementing in place, the Esthetic Angled abutment is secured on the implant with a screw. The front and back gingival heights of these abutments are different from each other. The front heights are shorter and the back heights are greater. These height differences offer the dentist an esthetically beneficial option as required.

The Angled Abutment is intended for cement-retained single and multiple restorations. The Angled Abutment is provided in angles of 15 and 25 degrees for cases where an angle correction is required. The Angled Abutment can be used in anterior and posterior maxillary and/or

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mandibular arches. Prior to cementing in place, the Angled Abutment is secured on the implant with a screw.

The Ball abutment is intended for overdenture restorations. The top part of the abutment is designed as a ball with a dimeter of 2.25 mm. There is no angulation. The Ball Abutment can be used in anterior and posterior maxillary and/or mandibular arches. The Ball abutment is inserted and combined with the fixture in order to support the overdenture.

The Equator abutment is intended for overdenture restorations. There is no angulation. The Equator Abutment can be used in anterior and posterior maxillary and/or mandibular arches. The Equator abutment is inserted and combined with the fixture in order to support the overdenture.

The Abutments are single-use devices. The Abutments are provided non-sterile for end-user steam sterilization.

Covers and Gingiva Formers

The Nucleoss Cover and Gingiva Former are used during the healing and prosthesis period following surgical placement of the dental implant. All of these devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.

Covers and Gingiva Formers are single-use devices. The Cover is provided sterile in the same packaging tube as the Nucleoss T6 Dental Implant. The Gingiva Formers are provided nonsterile for end-user steam sterilization.

Screws

The Nucleoss Dental Implant and Abutments devices also include screws for securing abutments to the implant to provide a secure coupling for the denture prosthetic attachment to the abutment. They are provided non-sterile and are packaged together with the abutments.

COMPARISON WITH PREDICATE DEVICES

A comparison of the Subject Device and its primary predicate has been conducted. The indications for use of the T6 is identical to that of the predicate device.

A comparison of the T6 and predicate device shows that the technological characteristics such as the components, design, materials, sterilization method, and operating principle of the T6 are similar to the currently marketed Tpure predicate device.

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	Subject Device	PrimaryPredicate Device	Reference Device	Reference Device
	Nucleoss T6 DentalImplant System	Nucleoss TpureImplant System(K160850)	Straumann DentalImplant System(K171784)	Thommen MedicalSPI Dental Implant,ELEMENT(K093615)
Indicationsfor UseStatement	Nucleoss T6Dental Implantsare intended to besurgically placedin the bone of themaxillary and/ormandibular archesto provide supportfor prostheticrestorations(crowns, bridgesor overdenture) inedentulous orpartiallyedentulous patientsto restore apatients' chewingfunction. NucleossT6 DentalImplants areintended fordelayed loadingafter 12 weeks.	Nucleoss TpureImplant system aremedical devicesintended to besurgically placedin the bone of themaxillary and/ormandibular archesto provide supportfor prostheticrestorations(crowns, bridgesor overdenture) inedentulous orpartiallyedentulous patientsto restore apatients' chewingfunction.Nucleoss TpureDental Implantsare intended fordelayed loadingafter 12 weeks.	Indicated for oralendosteal implantationin the upper and lowerjaw arches and for thefunctional and estheticoral rehabilitation ofedentulous and partiallydentate patients.Straumann dentalimplants are alsoindicated for immediateor early implantationfollowing extraction orloss of natural teeth.Implants can be placedwith immediatefunction on single-toothand/or multiple toothapplications when goodprimary stability isachieved and withappropriate occlusalloading to restorechewing function. Theprosthetic restorationsused are single crowns,bridges and partial orfull dentures, which areconnected to theimplants through thecorrespondingcomponents(abutments)	SPI® Dental Implant,ELEMENT is for one-stage or two-stagesurgical procedures.SPIDental Implant,ELEMENT is intendedfor immediateplacement and functionon singletoothand/or multiple toothapplications when goodprimary stability isachieved and withappropriate occlusalloading, to restorechewing function.Multiple toothapplicationsmay be rigidly splinted.In the case ofedentulous patients,four or more implantsmust beused in immediatelyloaded cases.
Technological	SUBJECTDEVICE	PRIMARYPREDICATEDEVICE	REFERENCEDEVICE	REFERENCEDEVICE
Characteristics	Nucleoss T6 DentalImplant System	Nucleoss TpureImplant System(K160850)	Straumann DentalImplant System(K1171784)	Thommen MedicalSPI Dental Implant,ELEMENT(K093615)
Material	Grade 4commercially puretitanium conformingwith ISO 5832-2	Grade 4commercially puretitanium conformingwith ISO 5832-2	Ti-13Zr alloy (tradenamed Roxolid) or TiGrade 4	CP Titanium(ISO 5832-2)
Surface	Sand blasted Largegrit Acid etched(SLA)	Sand blasted Largegrit Acid etched(SLA)	Sand blasted Largegrit Acid etched(SLActive)	Sand blasted, thermalacid etched
Implant Design	Two component /Bone level/Cylindrical form	Two component /Bone level/Conicalform	Bone level / TissuelevelInternal connection	Bone levelInternal connection / Rootform
Implant bodydiameter (mm)	3.5, 4.1, 4.8	3.4, 3.8, 4.2, 5.0	3.3, 4.1, 4.8	3.5, 4.0, 4.5, 5.0, 6.0
Implant length(mm)	6.5, 8, 10, 12, 14, 17	8, 10, 12, 14	8, 10, 12, 14, 16, 18	6.5, 8, 9.5, 11, 12.5
Diameter xLength (mm)	3.5x8, 3.5x10,3.5x12, 3.5x14,3.5x17,4.1x6.5, 4.1x8,4.1x10, 4.1x12,4.1x14, 4.1x17,4.8x6.5, 4.8x8,4.8x10, 4.8x12,4.8x14, 4.8x17	3.4x10, 3.4x12,3.4x14,3.8x8, 3.8x10,3.8x12, 3.8x14,4.2x8, 4.2x10,4.2x12, 4.2x14,5.0x8, 5.0x10,5.0x12, 5.0x14	3.3x8, 3.3x10,3.3x12, 3.3x14,3.3x16, 3.3x184.1x6, 4.1x8, 4.1x10,4.1x12, 4.1x14,4.1x16, 4.1x184.8x6, 4.8x8, 4.8x10,4.8x12, 4.8x14,4.8x16, 4.8x18	3.5x8, 3.5x9.5, 3.5x11,3.5x12.5,4.0x6.5, 4.0x8.0, 4.0x9.5,4.0x11, 4.0x12.54.5x6.5, 4.5x8.0, 4.5x9.5,4.5x11, 4.5x12.5,5.0x6.5, 5.0x8.0, 5.0x9.5,5.0x11,5.0x12.56.0x6.5, 6.0x8.0, 6.0x9.5,6.0x11, 6.0x12.5
Restoration	For single ormultiple restorations	For single ormultiple restorations	For single or multiplerestorations	For single or multiplerestorations
Implantconnection	Internal	Internal	Internal	Internal
Surgicaltechnique	Two stage surgicaltechnique	Two stage surgicaltechnique	One-stage or two-stage surgicaltechnique	One-stage or two-stagesurgical technique
Sterilization	Sterile (Gammairradiation)	Sterile (Gammairradiation)	Sterile (Gammairradiation)	Sterile (Gammairradiation)

Comparison of Indications for Use Statements to Predicate and Reference Devices

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Comparison of Technological Characteristics to Predicate and Reference Devices

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TecnologicalCharacteristics	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE
Device	Nucleoss T6 Dental Implant System	Nucleoss Tpure Implant System(K160850)
Device	Nucleoss T6 Standard Straight,Esthetic Straight, Esthetic Angled,Angled, Ball and Equator abutments,Gingiva Former and Cover	Nucleoss Tpure Straight, Angled, Ball,and Equator abutments,Gingiva Former and Cover
Material	Titanium alloy (Ti6Al4V ELI) per ISO5832-3	Titanium alloy (Ti6Al4V ELI) per ISO5832-3
Abutment Diameter (mm)	Standard Straight, Esthetic Straight,Esthetic Angled, Angled abutment:4.3, 5.0, 6.0 mmBall and Equator Abutment: 4.5 mmGingiva Former: 4.3, 5.0, 6.0Cover: 4.3, 5.0, 6.0	Straight and Angled abutment:4.2, 5.0, 6.0 mmBall and Equator Abutment Abutment:4.5 mmGingiva Former: 4.2, 5.0, 6.0Cover: 4.2, 5.0, 6.0
Gingival Height (mm)	Standard straight abutment:1.0, 1.5, 2.0, 3.0, 4.0, 4.5, 5.0 mmEsthetic straight abutment:1.0-2.0, 2.0-3.0,1.5-2.5, 2.5-3.5 mmAngled abutment:1.0, 1.5, 2.0, 3.0, 4.0, 5.0 mm	Straight abutment:1.0, 2.0, 3.0, 5.0 mmAngled abutment:1.0, 2.0, 3.0, 4.0 mmBall and equator abutment:1.5, 3.0, 5.0 mm
	Esthetic angled abutment:1.0-2.0, 2.0-3.0,3.0-4.0 mm	Gingiva Former: 2.0, 4.0, 6.0
	Ball and equator abutment:1.5, 3.0, 5.0 mmGingiva Former: 2.0, 4.0, 6.0Cover: 0	Cover: 0
TechnologicalCharacteristics	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE
	Nucleoss T6 Dental Implant System	Nucleoss Tpure Implant System(K160850)
Abutment Design	Straight or Angled	Straight or Angled
Angulation	Standard straight abutment: 0°	Straight abutment: 0°
	Esthetic straight abutment: 0°	Angled abutment: 10°-20°-30°
	Angled abutment: 15° and 25°	Ball and equator abutment: 0°
	Esthetic angled abutment: 15° and 25°	Gingiva Former: 0°
	Ball and equator abutment: 0°	Cover: 0°
	Gingiva Former: 0°
	Cover: 0°
Restoration	The Standard straight abutment, Estheticstraight abutment, Angled abutment,Esthetic angled abutment are for single ormulti unit restorations.	The Straight abutment, Angledabutment are for single or multi unitrestorations.
	The Ball and Equator abutments are onlyfor multi unit restorations.	The Ball and Equator abutments areonly for multi unit restorations.
	There is no restoration type for cover andgingiva formers.	There is no restoration type for coverand gingiva formers.
Implant-Abutmentconnection	Internal	Internal
Sterilization	Nucleoss T6 Standard Straight, EstheticStraight, Esthetic Angled, Angled, BallEquator abutments and gingiva formersare provided non-sterile.Cover is packaged with the dental implantand sterilized via gamma irradiation.	The Nucleoss Tpure Straightabutment, Angled abutments, andgingiva formers are provided non-sterile.Cover is packaged with the dentalimplant and sterilized via gammairradiation.

Comparison of Technological Characteristics of Abutments

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Comparison of Technological Characteristics of Abutments

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NON-CLINICAL TESTING / PERFORMANCE DATA

Non-clinical testing of the Nucleoss T6 Implant System was performed following the FDA guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and applicable ISO and ASTM standards.

Bench Testing

The Pull-out test was performed to compare the Nucleoss T6 Implant and reference device in accordance with ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws with acceptable test results. A comparative surface area analysis was conducted on the Nucleoss T6 Implant and reference device with the original length and 3mm bone loss.

Fatigue Testing

Fatigue testing conducted in accordance with ISO 14801:2016 Dentistry- Implants-Dynamic Fatigue Test for Endosseous Dental Implants found the durability of the Nucleoss T6 Implant and Abutment combinations was acceptable. Testing was conducted on the worst-case implant abutment combinations.

Sterilization Validation

Nucleoss T6 Implants are sterilized using a gamma ray sterilization process that has been validated in accordance with ISO 11137-2 Sterilization of healthcare products-Radiation-Part 2 establishing the sterilization dose to ensure a SAL of 10-6.

Nucleoss Dental Abutments are provided non-sterile for end-user steam sterilization using a traditional cycle process. Since the raw material, production process, parameters and process materials of both Tpure and the predicate device are exactly same, the same steam sterilization parameters apply to the T6 Dental abutments as was used in the predicate device.

Accelerated Aging Test and Packaging Validation Test

Nucleoss T6 implants will be packaged and labeled based on new testing that was conducted to support a shelf life of 5 years on the predicate device. Package Validation and Simulated transportation testing on the predicate device that was accelerated aged to an equivalent 5 years found that the sterility of the dental implants was maintained.

Accelerated aging and packaging validation testing was not repeated for the T6 Dental Implants since the raw material, production process, parameters, process materials and all packaging materials/type of the T6 Dental Implants are exactly same as those of the predicate device.

Biocompatibility

All the materials used the T6 Dental Implant and the manufacturing processes were identical to those used in the predicate device.

Biocompatibility testing was not repeated for the T6 Dental Implants since the raw material, production process, parameters and process materials of the T6 Dental Implants and abutments and the predicate device are exactly the same.

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CONCLUSION

Data presented in this 510(k) Submission support the substantial equivalence of the T6 Dental Implant to the predicate devices. The Nucleoss T6 Dental Implant System have the similar indication for use, material composition, design, and surface treatment to the primary predicate device and reference predicate devices. Based on the comparative assessment including minor differences with the predicate devices, and based on performance test data, the Nucleoss T6 Dental Implant System is determined to be 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.