The Bonafix TWO Dental Implant System is indicated for delayed loading in surgical and restorative applications placement in the upper or lower jaw and to provide support for prosthetic devices such as artificial teeth with the goal of restoring the patient's chewing function.

Device Description

Bonafix TWO Implant is a bone level type implant indicated for delayed loading only, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. To prevent unnecessary rotations between the implant and the abutment, the implant has an internal hex connection style. The body of the implant is tapered, the implant neck is straight and has micro-rings; and the apex of the implant has a dome shape. Was designed with a double-thread that has a constant depth and thickness. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant. This system has 3.35, 3.75, 4.20, 5.00, 6.00 diameter distributed in three (3) platform (Narrow, Standard and Wide) and 8, 10, 11.5, 13 and 15 mm lengths. The 3.35 mm diameter excludes the 8 mm length, and the 6.00 mm diameter excludes the 15 mm length. The implants are provided sterile and are ready to be implanted. The system includes various prosthetic device such as, Cover screw, Healing caps, and two (2) abutments, Straight abutments and Angle abutments are connected to implant through the hex and secured by retained screw. The Straight abutment has 2 to 3 emergence profiles depending on platform. The Angle abutments has a single emergence profile by platform. The angle abutment has axis inclined of 20° compared to the implant's axis. The abutments are provided non-sterile and are intended to be sterilized before use. All prosthetic device are made in Grade 5 ELI Titanium Alloy.

AI/ML Overview

This document describes the Bonafix TWO - Dental Implant System. Here's a breakdown of the acceptance criteria and study information provided, focusing on what is present and what is not mentioned in the text.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" against which a direct performance measure is reported in a pass/fail manner. Instead, it details various performance tests and their outcomes, indicating that the device's performance was found to be "comparable" or "demonstrated."

Here's an attempt to extract the relevant information into a table format based on the "Performance Data" section:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility according to ISO 10993-5:2009	Cytotoxicity testing demonstrated the biocompatibility of the devices.
Bacterial Endotoxins Test according to USP <85>	(Result implicit in "laboratory testing and determined device functionality")
Fatigue Testing according to ISO 14801:2007	Fatigue testing of BONAFIX TWO implants and predicate devices were comparable.
Sterilization validation according to ISO 11137 series and ISO 17665 series	Sterility validation testing was performed and demonstrated the equivalence of the devices to their predicates.
Device functionality and conformance to design input requirements	BONAFIX has conducted laboratory testing and determined device functionality and conformance to design input requirements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "laboratory testing," but does not provide any details regarding sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the studies described are non-clinical (laboratory) tests and do not involve human expert review for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the studies described are non-clinical (laboratory) tests and do not involve human review with adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study, AI assistance, or human reader improvement in this document. The device is a physical dental implant system, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical dental implant system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards for laboratory testing (e.g., ISO 10993-5, USP <85>, ISO 14801, ISO 11137, ISO 17665). The outcomes are objective measurements against these standards. There is no mention of expert consensus, pathology, or outcomes data in the context of these specific performance tests.

8. The sample size for the training set

This is not applicable/not provided. The document describes a physical medical device and non-clinical performance testing, not a machine learning model that would require a training set.

9. How the ground truth for the training set was established

This is not applicable/not provided as there is no training set for a machine learning model.

Summary

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

BONAFIX Surgical and Dental Implants, LLC Juan Tezak President 118 W Prive Circle Delray Beach, Florida 33445

July 14, 2017

Re: K162853

Trade/Device Name: Bonafix TWO - Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 14, 2017 Received: June 14, 2017

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. 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,

Mary S. Runner -A

Lori A. Wiggins, MPT, CLT 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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Image /page/2/Picture/0 description: The image shows the logo for "bonafix surgical & dental implants". The word "bonafix" is written in a sans-serif font, with the "bona" portion in a light blue-green color and the "fix" portion in a darker blue. Below the word "bonafix" is the text "surgical & dental implants" in a smaller font size.

SECTION 2 Indications for Use

510(k) Number (if known): K162853

Device Name: Bonafix TWO - Dental Implant System

Indications for Use:

Prescription Use X (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)

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Image /page/3/Picture/0 description: The image shows the logo for Bonafix surgical & dental implants. The word "bonafix" is written in a sans-serif font, with the "bona" portion in a light blue color and the "fix" portion in a darker blue color. Below the word "bonafix" is the phrase "surgical & dental implants" in a smaller, sans-serif font.

SECTION 3 510(k) Summary

SUBMITTER/510(K) HOLDER:

Sponsor:	BONAFIX Surgical and Dental Implants, LLC
Address:	118 W Prive Cr.Delray Beach Fl, 33445
Contact:	Juan TezakJuan@Bonafixsdi.com(561) 789-2411
Date Prepared:	September 20, 2016

DEVICE IDENTIFICATION:

Device Trade Name:	Bonafix TWO - Dental Implant System
Common Name:	Endosseous dental implant
Classification Regulation:	21 CFR 872.3640
Classification Name:	Implant, Endosseous,Root-form
Device Classification:	Class II
Classification Panel:	Dental
Product Code:	DZE

PREDICATE DEVICE:

Predicate Device	510 (k) No.	Predicate Type
MIS Dental Implant SystemMIS – Implant Technologies Ltd. (Israel)	K040807	Primary Predicate
Minifix ImplantBonafix Surgical and Dental Implants, LLC (USA)	K122052	Reference Predicate

DEVICE DESCRIPTION:

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Image /page/4/Picture/0 description: The image shows the logo for Bonafix surgical and dental implants. The word "bonafix" is written in a sans-serif font, with "bona" in a light blue color and "fix" in a darker blue color. Below the word "bonafix" is the phrase "surgical & dental implants" in a smaller font.

profiles depending on platform. The Angle abutments has a single emergence profile by platform. The angle abutment has axis inclined of 20° compared to the implant's axis. The abutments are provided non-sterile and are intended to be sterilized before use. All prosthetic device are made in Grade 5 ELI Titanium Alloy.

INDICATION FOR USE STATEMENT:

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

Based on its design, indications for use, materials, manufacture methods and sterility, the proposed Bonafix TWO implant is deemed to be substantially equivalent to the following two-stage implant device: The MIS Dental Implant System (Specifically the SEVEN line of implants) from MIS Implant Technologies.

The table that follows provides additional details on the equivalence of Bonafix TWO with the predicate devices.

	Bonafix TWO – Dental ImplantSystem	MIS Dental Implant System(SEVEN line of Implants)
510k Number	This Submission	K040807
Product Code	DZE	DZE
Endosseous DentalImplants	Root-form tapered	Root-form tapered
Indications for use	Implant System is indicated fordelayed loading in surgical andrestorative applications placementin the upper or lower jaw and toprovide support for prostheticdevices such as artificial teethwith the goal of restoring thepatient's chewing function.	Implant System is indicated foruse in surgical and restorativeapplications for placement in thebone of the upper or lower jaw toprovide support for prostheticdevices such as artificial teeth, inorder to restore the patient'schewing function.
Design implant	Implant Type:Bone-level implantConnection Type:Internal hex connection.For Standard and Wide platformthe internal hex is 2.45mm andNarrow platform the internal hexis 2.10mmNeck Design:	Implant Type:Bone-level implantConnection Type:Internal hex connection.For Standard and Wide platformthe internal hex is 2.45mm andNarrow platform the internal hexis 2.10mmNeck Design:
	Straight walled neck with micro-rings.Body Design:Tapered design with a double-thread that has a constant depthand thickness.Apex Design:Dome shape with two-spiralchannel.	Lightly tapered walled neck withmicro-rings.Body Design:Tapered design with a double-thread that has a constant depthand thickness.Apex Design:Dome shape with three-spiralchannel.
Diameter Implants	3.35mm, 3.75mm, 4.20mm,5.00mm, 6.00mm	3.30mm, 3.75mm, 4.20mm,5.00mm, 6.00mm
Length Implants	8mm, 10mm, 11.5mm, 13mm,15mm	6mm, 8mm, 10mm, 11.5mm,13mm, 16mm
Material	Titanium Grade 5 6Al-4VASTM F136	Titanium Grade 4 Pure TitaniumASTM F67
Fixture Sterile	Yes	Yes
Sterilization method	Gamma Ray	Gamma Ray
Surface Finish	Technology RBM	Sandblasted with Acid Etched
Cover Screw	The implants are supplied togetherwith cover screws, manufacturedfrom titanium Ti-6AL-4V. Thecover screws is placed in theimplant during the integrationperiod between the implant andthe bone. They completelyocclude the internal surface,keeping it free from ingrowth ofbone and debris. The cover screwis supplied sterile together withthe implant in the same individualpackage.	The implants are supplied togetherwith cover screws, manufacturedfrom titanium grade 4. The coverscrews is placed in the implantduring the integration periodbetween the implant and the bone.This completely occlude theinternal surface, keeping it freefrom ingrowth of bone and debris.The part is supplied steriletogether with the implant in thesame individual package.
Abutment system	Contained abutments in theSystem are straight and angleddental implant abutments intendedto be connected to the fixture withcrew, for screw retained andcemented restored. The abutmentsfit in/on the hexagonal part of theimplant and deliver maximumstability with the use of the screw.The abutments contain HealingCaps, Straight abutment, Angleabutment.	Anatomic abutments are used inconjunction with the implants forscrew retained or cementedreconstruction. The abutments fitin/on the hexagonal part of theimplant and deliver maximumstability with the use of the screw.The abutment contains temporaryabutments, Plastic and Gold-plastic cylinder abutments, Ballattachment system and bar andscrew attachment system.
Materials Abutment	For Abutments and Healing Capsis used the titanium Ti-6Al-4V.	Abutments are manufactured inceramic and titanium. Plastic andGold-Plastic abutments aremanufactured in burn-out plasticand gold.
Angulation for angleabutments	20°	20°
Fixture Sterile(Abutments)	NO, the user can sterilize theseparts of the system. Labelingcontains instructions forsterilization.	NO

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Image /page/5/Picture/0 description: The image shows the logo for Bonafix. The word "bonafix" is written in a sans-serif font, with the "bona" portion in a light teal color and the "fix" portion in a darker blue color. Below the word "bonafix" is the phrase "surgical & dental implants" in a smaller font.

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Image /page/6/Picture/0 description: The image shows the logo for Bonafix surgical & dental implants. The word "bonafix" is written in a sans-serif font, with the "bona" portion in a light blue color and the "fix" portion in a darker blue color. Below the word "bonafix" is the phrase "surgical & dental implants" in a smaller, sans-serif font.

In addition to the two-stage implants listed as predicate devices, this submission references also the Minifix one stage mini-implant as equivalent in terms of composition, biocompatibility and sterility. Details shown in the tables that follow:

	Bonafix TWO – Dental ImplantSystem	MINIFIX
510k Number	This Submission	K122052
Material	ASTM F136(Ti-6Al-4V Extra Low Interstitial)	ASTM F136(Ti-6Al-4V Extra Low Interstitial)
Fabrication	MACHINING PROCESS(Turning, Milling, Drilling,Tapping in Lathe SwissType)	MACHINING PROCESS(Turning, Milling, Drilling,Tapping in Lathe SwissType)
Surface Treatment	RBM	RBM
Supplier	JACKSONVILLE ADVANCEMACHINE(Actually)	JACKSONVILLE ADVANCEMACHINE(Actually)
Device duration inbody	LONG TERM USE	LONG TERM USE

PERFORMANCE DATA

Additionally BONAFIX has conducted laboratory testing and determined device functionality and conformance to design input requirements. Non-clinical Testing of the subject device included the following:

Biocompatibility tests according to ISO 10993-5:2009.
Bacterial Endotoxins Test, Limulus Amebocyte Lysate (LAL) according to USP <85> ●
Fatigue Testing according to ISO 14801:2007
Sterilization validation test according to ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO ● 17665-1, and ISO 17665-2

As a result,

Regarding the fatigue testing of BONAFIX TWO implants and the predicate devices were ● comparable.
Regarding the cytotoxicity testing has demonstrated the biocompatibility of the devices. ●
Regarding the sterility validation testing was performed and is demonstrated the ● equivalence of the devices to their predicates.

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Image /page/7/Picture/0 description: The image shows the logo for Bonafix surgical and dental implants. The word "bonafix" is written in a sans-serif font, with the "bona" portion in a light blue color and the "fix" portion in a darker blue. Below the word "bonafix" is the phrase "surgical & dental implants" in a smaller font.

SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject device and the predicate device have slight differences in the language of the Indications for Use Statements; however, these slight differences do not change the intended use of the device. The subject device and the predicated device also have similar technological characteristics, and are made of similar, if not identical material is supported by reference device. The subject device and predicate device encompass a very similar or the exact same range of physical dimensions, including diameter and length of the implants and diameter, height and angle of the abutments and a comparative surface area.

CONCLUSION

Based on the foregoing, and in accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, BONAFIX SDI has demonstrated that the BONAFIX TWO Implant System is substantially equivalent to the predicate device legally marketed in terms of intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

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.