Bonafix TWO - Dental Implant System

K162853 · Bonafix Surgical and Dental Implants · DZE · Jul 14, 2017 · Dental

Device Facts

• Record ID: K162853
• Device Name: Bonafix TWO - Dental Implant System
• Applicant: Bonafix Surgical and Dental Implants
• Product Code: DZE · Dental
• Decision Date: Jul 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Bonafix TWO is a bone-level, endosseous dental implant system; used in surgical and restorative dental applications to support prosthetic devices. System consists of tapered titanium alloy (Grade 5 ELI, ASTM F136) implants with RBM surface treatment, internal hex connection, double-thread body, and self-tapping apical channels. Includes cover screws, healing caps, and straight/angled abutments. Implants are provided sterile (gamma ray); abutments are provided non-sterile for clinician sterilization. Operated by dental professionals in clinical settings. Implant is placed in the jawbone to provide a stable foundation for artificial teeth; restoring patient chewing function. System dimensions range from 3.35-6.00mm diameter and 8-15mm length. Clinical benefit is the restoration of masticatory function through prosthetic support.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-5), bacterial endotoxins (USP <85>), fatigue testing (ISO 14801:2007), and sterilization validation (ISO 11137, ISO 17665). Results demonstrated device functionality, biocompatibility, and equivalence to predicate devices.

Technological Characteristics

Material: Titanium Grade 5 6Al-4V (ASTM F136). Design: Root-form, tapered, bone-level implant with internal hex connection, micro-rings on neck, and dome-shaped apex. Surface: RBM treated. Dimensions: 3.35-6.00mm diameter; 8-15mm length. Sterilization: Gamma ray (implants). Abutments: Straight and 20-degree angled, titanium alloy, non-sterile (user-sterilized).

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) for restoration of chewing function; specifically for delayed loading applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MIS Dental Implant System (K040807)

Reference Devices

• Minifix Implant (K122052)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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# SECTION 2 Indications for Use

510(k) Number (if known): K162853

Device Name: Bonafix TWO - Dental Implant System

Indications for Use:

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.

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.<br>Delray Beach Fl, 33445 | |
| Contact: | Juan Tezak<br>[e-mail]<br>[phone] | |
| 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 System<br>MIS – Implant Technologies Ltd. (Israel) | K040807 | Primary Predicate |
| Minifix Implant<br>Bonafix Surgical and Dental Implants, LLC (USA) | K122052 | Reference Predicate |

#### 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

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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:

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.

## 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 Implant<br>System | MIS Dental Implant System<br>(SEVEN line of Implants) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | This Submission | K040807 |
| Product Code | DZE | DZE |
| Endosseous Dental<br>Implants | Root-form tapered | Root-form tapered |
| Indications for use | Implant System is indicated for<br>delayed loading in surgical and<br>restorative applications placement<br>in the upper or lower jaw and to<br>provide support for prosthetic<br>devices such as artificial teeth<br>with the goal of restoring the<br>patient's chewing function. | Implant System is indicated for<br>use in surgical and restorative<br>applications for placement in the<br>bone of the upper or lower jaw to<br>provide support for prosthetic<br>devices such as artificial teeth, in<br>order to restore the patient's<br>chewing function. |
| Design implant | Implant Type:<br>Bone-level implant<br>Connection Type:<br>Internal hex connection.<br>For Standard and Wide platform<br>the internal hex is 2.45mm and<br>Narrow platform the internal hex<br>is 2.10mm<br>Neck Design: | Implant Type:<br>Bone-level implant<br>Connection Type:<br>Internal hex connection.<br>For Standard and Wide platform<br>the internal hex is 2.45mm and<br>Narrow platform the internal hex<br>is 2.10mm<br>Neck Design: |
| | Straight walled neck with micro-<br>rings.<br><i>Body Design:</i><br>Tapered design with a double-<br>thread that has a constant depth<br>and thickness.<br><i>Apex Design:</i><br>Dome shape with two-spiral<br>channel. | Lightly tapered walled neck with<br>micro-rings.<br><i>Body Design:</i><br>Tapered design with a double-<br>thread that has a constant depth<br>and thickness.<br><i>Apex Design:</i><br>Dome shape with three-spiral<br>channel. |
| Diameter Implants | 3.35mm, 3.75mm, 4.20mm,<br>5.00mm, 6.00mm | 3.30mm, 3.75mm, 4.20mm,<br>5.00mm, 6.00mm |
| Length Implants | 8mm, 10mm, 11.5mm, 13mm,<br>15mm | 6mm, 8mm, 10mm, 11.5mm,<br>13mm, 16mm |
| Material | Titanium Grade 5 6Al-4V<br>ASTM F136 | Titanium Grade 4 Pure Titanium<br>ASTM 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 together<br>with cover screws, manufactured<br>from titanium Ti-6AL-4V. The<br>cover screws is placed in the<br>implant during the integration<br>period between the implant and<br>the bone. They completely<br>occlude the internal surface,<br>keeping it free from ingrowth of<br>bone and debris. The cover screw<br>is supplied sterile together with<br>the implant in the same individual<br>package. | The implants are supplied together<br>with cover screws, manufactured<br>from titanium grade 4. The cover<br>screws is placed in the implant<br>during the integration period<br>between the implant and the bone.<br>This completely occlude the<br>internal surface, keeping it free<br>from ingrowth of bone and debris.<br>The part is supplied sterile<br>together with the implant in the<br>same individual package. |
| Abutment system | Contained abutments in the<br>System are straight and angled<br>dental implant abutments intended<br>to be connected to the fixture with<br>crew, for screw retained and<br>cemented restored. The abutments<br>fit in/on the hexagonal part of the<br>implant and deliver maximum<br>stability with the use of the screw.<br>The abutments contain Healing<br>Caps, Straight abutment, Angle<br>abutment. | Anatomic abutments are used in<br>conjunction with the implants for<br>screw retained or cemented<br>reconstruction. The abutments fit<br>in/on the hexagonal part of the<br>implant and deliver maximum<br>stability with the use of the screw.<br>The abutment contains temporary<br>abutments, Plastic and Gold-<br>plastic cylinder abutments, Ball<br>attachment system and bar and<br>screw attachment system. |
| Materials Abutment | For Abutments and Healing Caps<br>is used the titanium Ti-6Al-4V. | Abutments are manufactured in<br>ceramic and titanium. Plastic and<br>Gold-Plastic abutments are<br>manufactured in burn-out plastic<br>and gold. |
| Angulation for angle<br>abutments | 20° | 20° |
| Fixture Sterile<br>(Abutments) | NO, the user can sterilize these<br>parts of the system. Labeling<br>contains instructions for<br>sterilization. | NO |

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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 Implant<br>System | MINIFIX |
|----------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| 510k Number | This Submission | K122052 |
| Material | ASTM F136<br>(Ti-6Al-4V Extra Low Interstitial) | ASTM F136<br>(Ti-6Al-4V Extra Low Interstitial) |
| Fabrication | MACHINING PROCESS<br>(Turning, Milling, Drilling,<br>Tapping in Lathe Swiss<br>Type) | MACHINING PROCESS<br>(Turning, Milling, Drilling,<br>Tapping in Lathe Swiss<br>Type) |
| Surface Treatment | RBM | RBM |
| Supplier | JACKSONVILLE ADVANCE<br>MACHINE<br>(Actually) | JACKSONVILLE ADVANCE<br>MACHINE<br>(Actually) |
| Device duration in<br>body | 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.