Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

Device Description

The current submission requests clearance for the Class II Bonafix 2 Plus implant system. The Bonafix 2 Plus Implant is a bone level type implant, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. The implant has a conventional internal hex connection style. The crestal zone of implant have micro-rings. The design crestal zone (straight or tapered) depends on Implant diameter because the implant system has only one platform. The body of the implant is tapered, designed with a double progressive thread with a small internal channel at the bottom of the thread; and the apex of the implant has a flat shape. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant.

The implants are provided in several different dimensions, 3.5, 3.75, 4.2, 5.0, and 6.0mm of diameter, and lengths of 8, 10, 11.5, 13 and 16mm. Hex Connection 6.0 diameter implants do not come in 13 or 16mm length.

Cover screw, Healing Caps (3.8 and 4.6mm of diameters) and 3 types of abutments: Straight abutments, Angled abutment and Multi-unit abutments, are included in the system.

AI/ML Overview

The FDA 510(k) summary for the Bonafix 2 Plus implant system does not contain the level of detail regarding device performance metrics that you are requesting for a typical AI or software as a medical device (SaMD) study.

This document describes a premarket notification for a Class II medical device, which is an endosseous dental implant. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific performance against quantitative acceptance criteria in a clinical study as would be done for an AI/SaMD product.

Here’s a breakdown of why I cannot fulfill your request as phrased, and what information is available:

The document does not describe a study that proves the device meets specific performance acceptance criteria in the way an AI/SaMD device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and material analysis.

Missing Information (for an AI/SaMD context):

Table of Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, or AUC) typically used for AI/SaMD, nor does it report such performance for the Bonafix 2 Plus. The "performance" here is related to mechanical and biological properties demonstrating equivalence to existing devices.
Sample size used for the test set and data provenance: No test set is described in the context of an AI/SaMD study.
Number of experts used to establish ground truth & qualifications: Not applicable, as there's no diagnostic AI component requiring ground truth establishment by experts.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. There is no AI component for human-in-the-loop performance evaluation.
Standalone (i.e., algorithm only without human-in-the-loop) performance: Not applicable. This is a physical medical device.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does provide, reframed:

The "acceptance criteria" for this device are largely implied through meeting established industry standards for mechanical properties, biocompatibility, and sterilization, and demonstrating that any differences from predicate devices do not raise new safety or effectiveness concerns.

1. "Acceptance Criteria" (Implied by Standards) and "Reported Device Performance":

Since the "acceptance criteria" are not quantitative performance metrics in the AI/SaMD sense, I will list the standards to which the device was tested and the conclusion of those tests regarding "performance" relative to the predicate.

Category	Acceptance Criteria (Implicit via Standards)	Reported Device Performance / Conclusion
Fatigue Endurance	Compliance with ISO 14801:2016 and FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants.	"A testing has been conducted to substantiate sufficient fatigue endurance limits for the Bonafix 2 Plus Implants for placement in the anterior and posterior regions of the mouth with compatible abutments. The worst-case scenario for the subject devices has demonstrated substantially equivalent to others device legally marketed regard to mechanical performance."
Material Composition	ASTM F136 (Ti-6Al-4V ELI)	Implants are built in Grade 5 ELI Titanium Alloy (Ti-6Al-4V ELI (ASTM F136)).
Surface Treatment Integrity	Absence of residual blast media particles on the device.	"SEM/EDS analysis for worst-case representative implant body was conducted... has demonstrated that after the surface treatment the implant doesn't have any different components than Titanium alloy ASTM F 136."
Biocompatibility	Compliance with ISO 10993-1 and current FDA guidance (Sept 2020).	"Concluded that the Bonafix 2 plus Implants are substantially equivalent to the predicate devices in terms of biocompatibility inclusive of base materials, manufacturing processes inclusive of surface treatments."
Sterilization (Implants)	Sterility Assurance Level (SAL) of 10-6 via ISO 11137-1 and 11137-2.	"Radiation sterilization validation... demonstrating a sterility assurance level (SAL) of 10-6."
Sterilization (Abutments)	Sterility via ISO 17665-1.	"Steam sterilization validation... demonstrating a sterility assurance of sterilization protocol of abutment."
Shelf Life	Demonstrated shelf life.	"Accelerated aging study demonstrating a shelf life of one (5) year." (Note: The text states "one (5) year," possibly a typo meaning "five (5) years.")
Pyrogenicity	LAL Endotoxin Analysis with testing limit of 20 EU/device.	"Pyrogenicity information provided is based on FDA Guidance... The method to be used... is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." This test will be conducted on every batch.
Packaging Integrity	Compliance with ASTM F2096-11, ASTM F88, ISO 11607-1.	Bench tests were conducted to verify design specifications and substantial equivalence regarding packaging. (Specific results not detailed in summary).

2. Sample Size for Test Set and Data Provenance:

Test Set Description: The document describes non-clinical bench testing on devices, not a test set of patient data.
Sample Size: Not explicitly stated for each test, but implied to be sufficient for the validation of each standard (e.g., number of implants for fatigue testing, number of samples for SEM/EDS, etc.).
Data Provenance: The "data" comes from bench tests conducted by the manufacturer, not from retrospective or prospective patient data from specific countries.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable as this is not an AI/SaMD device requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established scientific principles and standard requirements (e.g., proper material composition, the ability to withstand a certain load, sterilization effectiveness).

4. Adjudication Method:

Not applicable.

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

No. This is a physical dental implant, not an AI system.

6. Standalone Performance (Algorithm Only):

No. This refers to the performance of the physical device in bench tests against established standards.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the validated and established scientific standards and testing protocols (e.g., ISO 14801 for dynamic fatigue, ISO 10993 for biocompatibility, ISO 11137 for radiation sterilization). It's not expert consensus, pathology, or outcomes data in the typical AI/SaMD context.

8. Sample Size for the Training Set:

Not applicable. There is no AI model or training set discussed.

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

Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (dental implant). It demonstrates substantial equivalence to existing devices through a series of non-clinical bench tests conforming to recognized standards, rather than through comparative clinical performance studies or specific performance metrics typical of AI/SaMD.

Summary

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Zentek Medical LLC % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445

Re: K213677

Trade/Device Name: Bonafix 2 Plus Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 22, 2022 Received: November 22, 2022

Dear Juan Tezak:

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

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

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

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

For comprehensive regulatory information about 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213677

Device Name Bonafix 2 Plus

Indications for Use (Describe)

Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Bonafix 2 Plus December 12th, 2022

ADMINISTRATIVE INFORMATION

Applicant

ZENTEK MEDICAL LLC 200 Craig Rd Ste 107 Manalapan, NJ 077268735 Phone: +1 732-2840545

Establishment Registration Number

Official Contact

Michael Vinnik Owner 200 Craig Rd Ste 107 Manalapan, NJ 077268735 +1 732-2840545 E-mail: mvinnik2@gmail.com

Representative/Consultant

Juan Tezak Carlos Marín Compliance4Devices 118 W Prive Cr. Delray Beach Fl, 33445 Phone: +1 561-789-2411 E-mail: compliance4devices@gmail.com

DEVICE AND CLASSIFICATION NAME

Device Trade Name:	Bonafix 2 Plus
Common Name:	Endosseous dental implant
Classification Regulation:	21 CFR 872.3640
Classification Name:	Implant, Endosseous, Root-form
Device Classification:	Class II
Classification Panel:	Dental
Primary Product Code:	DZE
Secondary Product Code:	NHA

PREDICATE DEVICES INFORMATION

Primary predicate K191443, MSDI Dental Implants System Reference devices K191191 Neodent Implant System - Temporary Abutments K160213, s-Clean Tapered II RBM Implant System

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Intended Use

Device Description

Cover screw, Healing Caps (3.8 and 4.6mm of diameters) and 3 types of abutments: Straight abutments, Angled abutment and Multi-unit abutments, are included in the system.

Equivalence to Marketed Device

Bonafix 2 Plus is substantially equivalent to the MSDI Dental Implants System (K191443) predicate device in almost all of its characteristics. Is similar in terms of intended use, indications for use, operating principle, fundamental scientific technology, implant connections and material. The technological characteristics such as implant diameters, length, connection and platform geometry, as well as mating abutments are similar to that of the predicate devices, except for the temporary abutments which are similar to the reference device K191121.

Other differences with predicate device are on the surface treatment (RBM vs Grit blasted + Acid Etched Surface) but here is similar to reference device K160213.

The basis for Zentek Medical LLC belief that Bonafix 2 Plus is substantially equivalent to the predicated and referenced device is summarized in the following Tables of Substantial Equivalence.

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Feature	Subject Device	Primary Predicate Device	Comparison
Device Trade Name	Bonafix 2 Plus	MSDI Dental Implants System
Indications for Use	Bonafix 2 Plus Implants areendosseous implants intendedto be surgically placed in theupper or lower jaw arches toprovide support for prostheticdevices, such as an artificialtooth, in order to restorepatient's esthetics and chewingfunction. Bonafix 2 Plus implantsare intended for immediateloading when good primarystability is achieved, and withappropriate occlusive loading.	MSDI Dental Implants System isindicated for use in surgical andrestorative applications forplacement in the bone of theupper or lower jaw to providesupport or prosthetic devices,such as artificial teeth, in orderto restore the patient's chewingfunction.It is intended for immediateloading when good primarystability is achieved and withappropriate occlusal loading.	Same
Connection	Internal hex	Internal Hexagon	Same
Diameter of Implants Hex Connection	3.5mm3.75mm4.2mm5.0mm6.0mm	3.3, 3.7, 4.2, 5.0 and 6.0 mm	Similar.The predicatedevice has asmallerdiameterimplant. Thisdoes notaffect thesubstantialequivalenceof the device.a worseperformancescenario
Implant Lengths (mm)	⌀ 3.5mm(8,10,11.5,13,16)⌀ 3.75mm(8,10,11.5,13,16)⌀ 4.2mm(8,10,11.5,13,16)⌀ 5.0mm(8,10,11.5,13,16)⌀ 6.0mm(8,10,11.5)	8, 10, 11.5, 13 and 16mm	Same
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium Alloy – Ti6Al4V ELI	Same
Cover screw	One size	One size	Same
Surface Treatment	RBM	Grit Blasted and Acid EtchedSurface	DifferentSame asReferencedeviceK160213
Sterilization of Implants	Gamma ray	Gamma ray	Same
Feature	Subject Device	Primary Predicate Device	Comparison
Device Trade Name	Bonafix 2 Plus	MSDI Dental Implants System

Table 1. Comparison with predicate device

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Zentek Medical LLC

Feature	Subject Device	Primary PredicateDevice	ReferenceDevice
Device Trade Name	Bonafix 2 Plus	MSDI Dental ImplantsSystem (1)	Neodent ImplantSystem - TemporaryAbutments (2)	Comparison
Straight abutments	• Straight abutmentØ4.5 / Length: 9 and13 mmØ5.5 mm / Length: 9and 12 mm• Straight abutmentw/shoulderØ Standard / Tissueheight: 1, 2 and 3• Anatomic straightabutmentØ Standard / Tissueheight: 1, 2 and 3.	• Standard TitaniumAbutment withheight of 7mm• Standard narrowabutment withheights of 7, 9, and11mm	N/A	(1) Similar. Thesubject devicehasadditionallyanatomicalandw/shoulderabutments.(2) N/A
Angled abutments	• Angled abutmentsØ StandardDegrees: 15° and 25°• Anatomic angledabutmentØ StandardDegrees: 15°Tissue height: 1, 2and 3.• Anatomic angledabutmentØ StandardDegrees: 25°Tissue height: 1 and2.	• Standard 15°Abutment withheights of 8, 12, and13mm.• Standard 25°Abutment withheights of 9 and12mm	N/A	(1) Similar. Thesubject devicehasadditionallyanatomicalangledabutments.(2) N/A
Multi-unitabutment (*)	• Multi-unit straightabutmentØ StandardTissue height: 1, 2, 3and 4• Angled multi-unitabutmentØ StandardDegrees: 17°Tissue height: 2 and3Degrees: 30°Tissue height: 3 and4	Multi-unit abutmentsin heights of 1,2,3 and4 mm.	N/A	(1)Similar. Thesubject devicehasadditionallyangled multi-unitabutments.(2) N/A

Table 2. Comparison with predicate and referenced device for abutments

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Zentek Medical LLC

Feature	Subject Device	Primary PredicateDevice	ReferenceDevice
Device Trade Name	Bonafix 2 Plus	MSDI Dental ImplantsSystem (1)	Neodent ImplantSystem - TemporaryAbutments (2)	Comparison
Temporaryabutments	Design: Straight,cylindrical withretention rings.Model: With Hex andWithout HexDiameter (Ø): 3.5Angulation: StraightDuration of use: 180days	N/A	Design: Straight,cylindrical withretention rings.Model: With Hex andWithout HexDiameter (Ø): 3.5 and4.5Angulation: StraightDuration of use: 180days	(1) Different(2) Same asthe referencedevice.
Sterilization ofabutments	Steam sterilization	Steam sterilization	Ethylene Oxide to anSAL of 1x10-6	(1) Same as thereferencedevice.(2) Different
Material	Ti-6Al-4V ELI (ASTMF136)	Titanium Alloy -Ti6Al4V ELI	Ti-6Al-4V ELI	(1) Same(2) Same

*These models of abutments are not for single crown use.

Non-Clinical Testing Summary

Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device based on the following standards:

Standard	Version	Title
ANSI/AAMI/ISO17665-1	2006/(R)2013	Sterilization of health care products - Moist heat - Part 1: Requirements forthe development, validation and routine control of a sterilization process formedical devices, Annex D.
ISO 10993-12	2012	Biological evaluation of medical devices - Part 12: Sample preparation andreference materials.
ASTM F2096-11	2013	Standard Test Method for Detecting Gross Leaks in Medical Packaging byInternal Pressurization (Bubble Test).
ISO 10993-5	2014	Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity.
ISO 14801	2016	Dentistry--Implants--Dynamic Fatigue Tests for Endosseous Dental Implants.
ASTM F1980-16	2016	Standard Guide for Accelerated Aging of Sterile Barrier Systems for MedicalDevices.
ASTM F88	2016	Standard Test Method for Seal Strength of Flexible Barrier Materials (Peel Test).
ISO 10993-1	2018	Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process.
ISO 11607-1	2019	Packaging for terminally sterilized medical devices — Part 1: Requirementsfor materials, sterile barrier systems and packaging systems.
ISO 11137-1	2006/(R)2015	Sterilization of health care products - Radiation - Part 1: Requirements fordevelopment, validation, and routine control of a sterilization process formedical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
ISO 11137-2	2013	Sterilization of health care products - Radiation - Part 2: Establishing thesterilization dose

Table 3 Standards compliance

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A testing has been conducted to substantiate sufficient fatigue endurance limits for the Bonafix 2 Plus Implants for placement in the anterior and posterior regions of the mouth with compatible abutments. Testing has been performed in accordance with ISO 14801:2016 and FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants. The worst-case scenario for the subject devices has demonstrated substantially equivalent to others device legally marketed regard to mechanical performance.

Non-clinical worst-case MRI review was performed to evaluate the metallic Bonafix 2 Plus Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

Radiation sterilization validation according to ISO 11137-1 and 11137-2 was provided, demonstrating a sterility assurance level (SAL) of 10-6 and accelerated aging study demonstrating a shelf life of one (5) year.

Steam sterilization validation according to ISO 17665-1 was provided, demonstrating a sterility assurance of sterilization protocol of abutment.

SEM/EDS analysis for worst-case representative implant body was conducted on the subject devices to assess the presence of residual blast media particles on the device due to the modification of the surface treatment in the subject device. SEM/EDS analysis has demonstrated that after the surface treatment the implant doesn't have any different components than Titanium alloy ASTM F 136.

Biocompatibility assessment of the final finished device per recommendations of current FDA guidance (issued on September 4, 2020) in accordance to "ISO 10993-1, Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process" has been conducted. It is concluded that the Bonafix 2 plus Implants are substantially equivalent to the predicate devices in terms of biocompatibility inclusive of base materials, manufacturing processes inclusive of surface treatments.

Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method to be used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device. This test will be conducted on every batch. The subject devices will not be labeled as non-pyrogenic or pyrogen-free, nor will any claims be made in regards to non-pyrogenicity.

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Clinical Testing Summary

Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix 2 Plus to its predicate device.

Conclusion

Based on the information presented in these 510(k) premarket notifications the Bonafix 2 Plus is considered substantially equivalent (as safe, as effective and performs as well as) to the currently marketed and referenced devices: K191443, MSDI Dental Implants System and Neodent Implant System (K191191), citied in this submission. The differences noted between the Bonafix 2 Plus and the predicate device do not impact safety or effectiveness based on the successfully conducted testing of the subject 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.