maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Device Description

The maxFiT II Dental Implant System includes implant, screw and abutment. The maxFiT II Dental Implant System is designed for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The maxFiT II Dental Implant System consists of solid threaded, self-tapping dental implants in Ø3.5."604."70."5.6mm diameters with 8."32."34."14mm lengths. The implant of maxFiT II Dental Implant System is made from CP titanium Grade 4 which complies with ISO 5832-2 and ASTM F67. The implant surface treatment is SLA (Sand-blasted, Large grit, Acid -etched) technology which involves sandblasting with large grit and acid etching techniques, creates micron and macrosubmicron pores morphology. The abutments are made of Ti6A14V Eli, which complies with ISO 5832-3 and ASTM F136.

AI/ML Overview

The maxFiT II Dental Implant System does not involve an AI algorithm, therefore, the following information is not available:

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
Multi-reader multi-case (MRMC) comparative effectiveness study information
Standalone algorithm only without human-in-the-loop performance
Sample size for the training set
How the ground truth for the training set was established

1. Table of Acceptance Criteria and Reported Device Performance for the maxFiT II Dental Implant System

Test	Acceptance Criteria	Reported Device Performance
Corrosion Test (SLA-surface treated CP4 dental implant and Ti-6Al-4V abutment)	Compliant with ASTM F746, ASTM F2129, and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Endosseous Dental Implants and Root-form Endosseous Dental Implant Abutments"	The results prove the maxFiT II Dental Implant System is corrosion resistant.
Fatigue Test	Compliant with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"	All test results demonstrate that maxFiT II Dental Implant System meets the requirements of its pre-defined acceptance criteria.
Sterilization Test	Not explicitly stated but implied to meet relevant standards for sterile medical devices.	Performed; results implicitly met requirements for substantial equivalence.
Shelf Life Test	Not explicitly stated but implied to meet relevant standards for medical devices.	Performed; results implicitly met requirements for substantial equivalence.
Biocompatibility Tests (In vitro Cytotoxicity, Intracutaneous Reactivity, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, In vitro Bacterial Reverse Mutation (AMES), In vitro Chromosome Aberration, In vitro Mammalian Cell Gene Mutation, 14-Day Repeated Exposure Systemic Toxicity, 90-Day Bone Implantation Study)	Not explicitly stated but implied to meet relevant standards for biocompatibility.	Performed; results implicitly met requirements for substantial equivalence.

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

Not applicable. This device is a physical dental implant system and the testing involves bench testing (physical and chemical properties), not a retrospective or prospective study with a test set of data.

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

Not applicable. Ground truth for the performance of a physical dental implant (e.g., corrosion resistance, fatigue strength) is established through standardized engineering and material science tests, not expert consensus on medical images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. Physical performance tests do not involve an adjudication method in the human evaluation context. The results are quantitative and determined by the test protocols.

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

No, an MRMC comparative effectiveness study was not done as this is a physical medical device, not an AI algorithm for diagnostic or screening purposes involving human readers.

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

Yes, the regulatory submission describes "Non-clinical Testing" which constitutes standalone performance evaluations of the device itself (e.g., sterilization, biocompatibility, corrosion, fatigue). These are "algorithm only" in the sense that they assess the device's inherent physical and material properties without human intervention in the performance measurement.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through internationally recognized standards and test protocols, such as ASTM F746, ASTM F2129, ISO 14801, ISO 5832-2, ASTM F67, ISO 5832-3, and ASTM F136, as well as FDA guidance documents for specific device types. These standards define the expected physical, chemical, and biological properties and behaviors (e.g., corrosion resistance, fatigue life, material composition via spectroscopy, biocompatibility assays).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set or associated ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, with three wave-like lines below them.

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

April 25,2016

Taiwan Implant Technology Company, Ltd. Kaohsiung Science Park Branch Huang Ching-Chieh Assistant Manager 5f., No.63, Luke 2nd Rd., Luzhu Dist Kaohsiung, 82151 TAIWAN

Re: K151588

Trade/Device Name: maxFiT II Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 16, 2016 Received: March 25, 2016

Dear Huang Ching-Chieh:

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.

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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 (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,

Susan Runno DDS, MA

Erin I. Keith, M.S. 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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maxFiT II Dental Implant System 510(k) Notification

Indications for Use

510(k) Number (if known): K151588

Device Name: maxFiT II 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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maxFiT II Dental Implant System 510(k) Notification, K151588/S002

510(k) Summary

5.1	Type of Submission:	Traditional
5.2	Date of Summary:	04/19/2016
5.3	Submitter:	Taiwan Implant Technology Company, Ltd.
	Address:	Kaohsiung Science Park Branch5F., No.63, Luke 2nd Rd., Luzhu Dist.,
		Kaohsiung City 82151, Taiwan
	Phone:	+886-7-695-5561
	Fax:	+886-7-695-5528
	Contact:	Ching-Chieh, Huang
		(xjay@titc-dental.com)
	Registration number:	—

5.4 Identification of the Device:

Proprietary/Trade name:	maxFiT II Dental Implant System
Classification Name:	Endosseous Dental Implant
Review Panel:	Dental
Regulation Number:	872.3640
Primary Product Code:	DZE
Secondary Product Code	NHA
Device Classification:	II

ર્ રંડ Identification of the Predicate Device:

Predicate Device Name:	ANKYLOS® C/X Dental Implant System
Manufacturer:	DENTSPLY International
Regulation Number:	872.3640
Product Code:	DZE
Device Classification:	II
510(k) Number:	K083805

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5.6 Intended Use and Indications for Use of the subject device.

5.7 Device Description

. Implant

The maxFiT II Dental Implant System consists of solid threaded, self-tapping dental implants in Ø3.5."604."70."5.6mm diameters with 8."32."34."14mm lengths. The implant of maxFiT II Dental Implant System is made from CP titanium Grade 4 which complies with ISO 5832-2 and ASTM F67. The implant surface treatment is SLA (Sand-blasted, Large grit, Acid -etched) technology which involves sandblasting with large grit and acid etching techniques, creates micron and macrosubmicron pores morphology.

Abutment Models .

The abutments are made of Ti6A14V Eli, which complies with ISO 5832-3 and ASTM F136.

Item	Description	Specification
Healing Abutment	To protect the inner configuration of the implant, and help the soft tissue of gum naturally formed during the healing process.	D: 4.0mm、4.5mm、5.0mm、5.5mmAH: 1.0mm、3.0mmGH: 1.0mm、2.0mm、3.0mm、4.0mm、5.0mm
TemporaryAbutment	To manufacture temporaryprostheses. For the temporarycrowns and bridges. The abutmentheight can be modified for clinicalcases. The allowable abutmentheight range is between 4.5 ~ 17mm.And its diameter, wall thickness andangulation cannot be modified.	D: 4.0mm、5.0mmAH: 17mmGH: 1.0mm
Ball Abutment	Used for implant retainedmucosa-supported restorations, suchas overdentures for fully edentulouspatients.	D: 4.0mmGH: 2.0mm、4.0mm
Angled Abutment /Non-hex AngledAbutment	Intended for use in partially or fullyedentulous mandibles and maxillae,to support for single or multiple-unitcement retained restorations. It isused when the prosthetic angulationof implant correction is required forbite direction.	D: 4.0mm、4.5mmAH: 7.0mmGH: 2.0mm、4.0mmAngle: 15°、25°Type: A、B (For Angledabutment)
TransferAbutment /Non-hex TransferAbutment	Used as an aid in prostheticrestoration, such as cement-retainedcrowns and bridges.	D: 4.0mm、4.5mm、5.0mm、5.5mmAH: 4.0mm、5.5mmGH: 1.0mm、2.0mm、3.0mm、4.0mm、5.0mm、6.0mm、7.0mm
Locator Abutment	Appropriate for use withoverdentures or partial denturesretained in whole or in part byendosseous implants in the mandibleor maxilla.	D: 3.5mmH: 1.0mm、2.0mm、3.0mm、4.0mm、5.0mm、6.0mm

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maxFiT II Dental Implant System 510(k) Notification, K151588/S002

Hex	The hex abutment is the external hexagonal design forpreventing implant/abutment rotation. The hexagonal conecould ensure optimum stability.
Non-hex	The non-hex abutment is no anti-rotation, but it still bepositioned as desired. The abutment and implant are completelyfriction-locked by the cone in order to prevent rotation.

. Abutment connection platforms

5.8 Non-clinical Testing

A series of tests were performed on the proposed device, maxFiT II Dental Implant System.

. Sterilization Test
. Shelf Life Test
. Biocompatibility Test
- In vitro Cytotoxicity Study <>
- や Intracutaneous Reactivity Study
- ゃ Skin Sensitization Study
- や Acute Systemic Toxicity (Systemic Injection) Study
- ゃ Pyrogenicity Study
- や In vitro Bacterial Reverse Mutation (AMES) Study
- ゃ In vitro Chromosome Aberration Study
- や In vitro Mammalian Cell Gene Mutation Study
- ゃ 14-Day Repeated Exposure Systemic Toxicity Study
- や 90-Day Bone Implantation Study
Performance Test ●
- や Corrosion test
- < Fatigue test

Corrosion test has been conducted on SLA-surface treated CP4 dental implant and Ti-6Al-4V abutment. The study is complied with ASTM F746, ASTM F2129 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document:

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Endosseous Dental Implants and Root-form Endosseous Dental Implant Abutments". The results could prove the maxFiT II Dental Implant System is corrosion resistance.

Fatigue evaluation was performed for demonstrating substantial equivalence under worst case scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

All the test results demonstrate that maxFiT II Dental Implant System meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device.

5.9 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

5.10 Substantial Equivalence Determination

The maxFiT II Dental Implant System submitted in this 510(k) file is substantially equivalent in intended use, technology/principles of operation, materials and performance to the cleared ANKYLOS® C/X Dental Implant System. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

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	maxFiT IIDental Implant System	ANKYLOS® C/X Dental ImplantSystem
510(k) Number	–	K083805
PrimaryProduct Code	DZE	DZE
SecondaryProduct Code	NHA	–
Intended use	maxFiT II Dental Implant System is forsingle-stage or two-stage surgicalprocedures and cemented or screwretained restorations. maxFiT II DentalImplant System is intended forimmediate placement and function onsingle tooth and/or multiple toothapplications when good primarystability is achieved, with appropriateocclusal loading, in order to restorechewing function. Multiple toothapplications may be splinted with a bar.	The ANKYLOS® C/X Dental ImplantSystem is for single-stage or two-stagesurgical procedures and cemented orscrew retained restorations. TheANKYLOS® C/X Dental ImplantSystem is intended for immediateplacement and function on single toothand/or multiple tooth applications whengood primary stability is achieved, withappropriate occlusal loading, in order torestore chewing function. Multiple toothapplications may be splinted with a bar.
Surgery Type	One or two stage surgery	One or two stage surgery

Implant
Drawing	Image: Thread	Image: Thread
Design	Thread	Thread

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Material	Pure Titanium Grade 4(ASTM F67 \ DIN ENISO5832-2)	Pure Titanium Grade 2(DIN ENISO5832-2)
Body Diameter (D)	Ø3.5mm - Ø5.6mm	Ø3.5mm - Ø7.0mm
Length (L)	8mm - 14mm	8mm - 14mm
Surface treatment	Sandblasted and acid-etched (SLA)	FRIADENT Surface.(Sandblasted and acid-etched )
Implant-AbutmentConnection	Tapered	Tapered
Sterilization	Sterile - Gamma Irradiation	Sterile - Gamma Irradiation

Screw
	Cover Screw	Spare part ANKYLOS C/X coverscrew
Design	The cover screw locked into the implant	The cover screw locked into the implant
Material	Titanium alloy (Ti-6A1-4V ELI, meetsASTM F-136)	Titanium alloy (Ti-6A1-4V ELI)
Specification	Ø1.8mm	Ø1.0mm
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	Non-sterile _ Steam Sterilization by user
	Screw	ANKYLOS Fixation Screw
Design	To connect abutment to fixture	To connect abutment to fixture
Material	Titanium alloy (Ti-6A1-4V ELI, meetsASTM F-136)	Titanium alloy (Ti-6A1-4V ELI)
Specification	Ø1.8mm	Ø1.4mm、Ø1.6mm
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	Non-sterile _ Steam Sterilization by user

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Abutment
AbutmentsConnection part withfixture			1.Internal connection2. Have “Hex” & “Non-hex” two size ofconnection		1.Internal connection2.Have “C/” & “/X” two size ofconnection (non-indexed & indexedprosthetics)
	Hex	The hex abutment is theexternal hexagonal design forpreventing implant/abutmentrotation.		/X	Are indexed. The index is used toposition the abutments in theimplants in one of six possiblepositions.
	Non-hex	The non-hex abutment is noanti-rotation, but it still bepositioned as desired. Theabutment and implant arecompletely friction-locked bythe cone in order to preventrotation.		C/	Only use the cone for theconnection and are not indexed.The abutment components can bepositioned as desired and arecompletely friction-locked by thecone in order to prevent rotation.
Design	Healing abutment			Sulcus Former / Gingiva Former
	To protect the inner configuration of theimplant, and help the soft tissue of gumnaturally formed			To protect the inner configuration of theimplant, and help the soft tissue of gumnaturally formed
Material	Titanium alloy (Ti-6A1-4V ELI, meetsASTM F-136)			Titanium alloy (Ti-6A1-4V ELI)
Specification	D: 4.0mm 、4.5mm 、5.0mm 、5.5mmAH: 1.0mm 、3.0mmGH: 1.0mm 、2.0mm 、3.0mm 、4.0mm 、5.0mm			(1)ANKYLOS Gingiva Former CD: 4.2mmGH: 0.75mm 、1.5mm 、3.0mm 、4.5mm(2) ANKYLOS Standard C/ SulcusFormerD: 3.3mm 、4.5mmAH: 4.0mm 、6.0mm

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		GH: 1.0mm 、 3.0mm 、 4.5mm 、 6.0mm
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	Non-sterile _ Steam Sterilization by user
	Temporary abutment	Temporary abutment
Design	To manufacture temporary prostheses	To manufacture temporary prostheses
	For the temporary crowns and bridges	For the temporary crowns and bridges
Material	Titanium alloy (Ti-6Al-4V ELI, meetsASTM F-136)	Titanium alloy (Ti-6Al-4V ELI, meetsASTM F-136)
Specification	D: 4.0mm 、 5.0mm	D: 5.5mm 、 7.0mm
	AH: 17mm	AH: 6.0mm 、 7.5mm
	GH: 1.0mm	GH: 1.5mm 、 3.0mm
		Angle: 0° 、 15°
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	zirconia-reinforced PEEK
	Ball abutment	ANKYLOS® Snap Attachment C/
Design	Implant retained mucosa-supportedrestorations	Implant retained mucosa-supportedrestorations
Material	Titanium alloy (Ti-6Al-4V ELI, meetsASTM F-136)	Titanium alloy (Ti-6Al-4V ELI)
Specification	D: 4.0mm	D: 2.7mm
	GH: 2.0mm 、 4.0mm	GH: 1.5mm 、 3.0mm 、 4.5mm
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	Non-sterile _ Steam Sterilization by user
	Angled abutment 、 Non-hex Angledabutment	ANKYLOS Regular /X Abutment 、ANKYLOS Regular C/ Abutment
Design	To support for single or multiple-unitcement retained restorations	To support for single or multiple-unitcement retained restorations
Material	Titanium alloy (Ti-6Al-4V ELI, meetsASTM F-136)	Titanium alloy (Ti-6Al-4V ELI)
Specification	D: 4.0mm 、 4.5mm	D: 5.7mm
	AH: 7.0mm	Head height: 6.6mm 、 7.0mm 、 7.4mm
	GH: 2.0mm、4.0mm	7.7mm、8.0mm
	Angle: 15°、25°	GH: 0.75mm、1.5mm、3.0mm、4.5mm
	Type: A、B (For Angled abutment)	Angle: 7.5°、15°、22.5°、30°、37.5°
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	Non-sterile _ Steam Sterilization by user
	Transfer abutment、Non-hex Transferabutment	ANKYLOS Regular /X Abutment 、ANKYLOS Regular C/ Abutment
Design	Aid in prosthetic restoration	Aid in prosthetic restoration
Material	Titanium alloy (Ti-6Al-4V ELI, meetsASTM F-136)	Titanium alloy (Ti-6Al-4V ELI)
Specification	D: 4.0mm、4.5mm、5.0mm、5.5mmAH: 4.0mm、5.5mmGH: 1.0mm、2.0mm、3.0mm、4.0mm、5.0mm、6.0mm、7.0mm	D: 5.7mmHead height: 6.6mmGH: 0.75mm、1.5mm、3.0mm、4.5mm
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	Non-sterile _ Steam Sterilization by user
	Locator abutment	ANKYLOS LOCATOR Abutment C
Design	Use with overdentures or partialdentures retained restoration	Use with overdentures or partialdentures retained restoration
Material	Titanium alloy (Ti-6Al-4V ELI, meetsASTM F-136)	Titanium alloy (Ti-6Al-4V ELI)
Specification	D: 3.5mm	D: 3.8mm
	H: 1.0mm、2.0mm、3.0mm、4.0mm、	GH: 2.0mm、3.0mm、4.0mm、5.0mm、
	5.0mm、6.0mm	6.0mm
Sterilization	Sterile _ Gamma IrradiationNon-sterile _ Steam Sterilization by user	Non-sterile _ Steam Sterilization by user

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maxFiT II Dental Implant System 510(k) Notification, K151588/S002

5.11 Similarity and differences

The differences between the proposed device and predicate device are the Grade of Titanium and the design of abutments connection part. The proposed device has tested on safety and performance tests and the results were complied with the test requests. Therefore, the differences of proposed device and predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in intended use, main materials, safety and performance claims.

5.12 Conclusion

After analyzing bench tests, device description and intended use/indications for use, it can be concluded that maxFiT II Dental Implant System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.