(393 days)
No
The device description and performance studies focus on the physical properties, materials, and mechanical performance of the dental implant system. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No
The device is an endosseous implant that provides support for prosthetic devices to restore esthetics and chewing function, which is a supportive and reconstructive function rather than directly therapeutic.
No
Explanation: The device is an endosseous implant intended to provide support for prosthetic devices, not to diagnose a condition. Its function is restorative, not diagnostic.
No
The device is described as a physical implant made of titanium alloy, along with associated hardware components like cover screws, healing caps, and abutments. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Bonafix 2 Plus Implants are surgically placed in the jaw to support prosthetic devices. This is a direct medical intervention, not a test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of a dental implant, including materials, design, and dimensions. This aligns with a surgical implant, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The device is a surgical implant used to restore function and aesthetics, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: ANSI/AAMI/ISO 17665-1, ISO 10993-12, ASTM F2096-11, ISO 10993-5, ISO 14801, ASTM F1980-16, ASTM F88, ISO 10993-1, ISO 11607-1, ISO 11137-1, ISO 11137-2.
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, 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.
Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix 2 Plus to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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3
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
4
Intended Use
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.
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.
5
| Feature | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Device Trade Name | Bonafix 2 Plus | MSDI Dental Implants System | |
| Indications for Use | 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. | MSDI Dental Implants System is | ||
| indicated for use in surgical and | |||
| restorative applications for | |||
| placement in the bone of the | |||
| upper or lower jaw to provide | |||
| support or prosthetic devices, | |||
| such as artificial teeth, in order | |||
| to restore the patient's chewing | |||
| function. | |||
| It is intended for immediate | |||
| loading when good primary | |||
| stability is achieved and with | |||
| appropriate occlusal loading. | Same | ||
| Connection | Internal hex | Internal Hexagon | Same |
| Diameter of Implants Hex Connection | 3.5mm | ||
| 3.75mm | |||
| 4.2mm | |||
| 5.0mm | |||
| 6.0mm | 3.3, 3.7, 4.2, 5.0 and 6.0 mm | Similar. | |
| The predicate | |||
| device has a | |||
| smaller | |||
| diameter | |||
| implant. This | |||
| does not | |||
| affect the | |||
| substantial | |||
| equivalence | |||
| of the device. | |||
| a worse | |||
| performance | |||
| scenario | |||
| 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 Etched | |
| Surface | Different | ||
| Same as | |||
| Reference | |||
| device | |||
| K160213 | |||
| 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
6
Zentek Medical LLC
| Feature | Subject Device | Primary Predicate
Device | Reference
Device | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Bonafix 2 Plus | MSDI Dental Implants
System (1) | Neodent Implant
System - Temporary
Abutments (2) | Comparison |
| Straight abutments | • Straight abutment
Ø4.5 / Length: 9 and
13 mm
Ø5.5 mm / Length: 9
and 12 mm
• Straight abutment
w/shoulder
Ø Standard / Tissue
height: 1, 2 and 3
• Anatomic straight
abutment
Ø Standard / Tissue
height: 1, 2 and 3. | • Standard Titanium
Abutment with
height of 7mm
• Standard narrow
abutment with
heights of 7, 9, and
11mm | N/A | (1) Similar. The
subject device
has
additionally
anatomical
and
w/shoulder
abutments.
(2) N/A |
| Angled abutments | • Angled abutments
Ø Standard
Degrees: 15° and 25°
• Anatomic angled
abutment
Ø Standard
Degrees: 15°
Tissue height: 1, 2
and 3.
• Anatomic angled
abutment
Ø Standard
Degrees: 25°
Tissue height: 1 and
2. | • Standard 15°
Abutment with
heights of 8, 12, and
13mm.
• Standard 25°
Abutment with
heights of 9 and
12mm | N/A | (1) Similar. The
subject device
has
additionally
anatomical
angled
abutments.
(2) N/A |
| Multi-unit
abutment (*) | • Multi-unit straight
abutment
Ø Standard
Tissue height: 1, 2, 3
and 4
• Angled multi-unit
abutment
Ø Standard
Degrees: 17°
Tissue height: 2 and
3
Degrees: 30°
Tissue height: 3 and
4 | Multi-unit abutments
in heights of 1,2,3 and
4 mm. | N/A | (1)
Similar. The
subject device
has
additionally
angled multi-
unit
abutments.
(2) N/A |
Table 2. Comparison with predicate and referenced device for abutments
7
Zentek Medical LLC
| Feature | Subject Device | Primary Predicate
Device | Reference
Device | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Device Trade Name | Bonafix 2 Plus | MSDI Dental Implants
System (1) | Neodent Implant
System - Temporary
Abutments (2) | Comparison |
| Temporary
abutments | Design: Straight,
cylindrical with
retention rings.
Model: With Hex and
Without Hex
Diameter (Ø): 3.5
Angulation: Straight
Duration of use: 180
days | N/A | Design: Straight,
cylindrical with
retention rings.
Model: With Hex and
Without Hex
Diameter (Ø): 3.5 and
4.5
Angulation: Straight
Duration of use: 180
days | (1) Different
(2) Same as
the reference
device. |
| Sterilization of
abutments | Steam sterilization | Steam sterilization | Ethylene Oxide to an
SAL of 1x10-6 | (1) Same as the
reference
device.
(2) Different |
| Material | Ti-6Al-4V ELI (ASTM
F136) | 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/ISO | ||
| 17665-1 | 2006/ | |
| (R)2013 | Sterilization of health care products - Moist heat - Part 1: Requirements for | |
| the development, validation and routine control of a sterilization process for | ||
| medical devices, Annex D. | ||
| ISO 10993-12 | 2012 | Biological evaluation of medical devices - Part 12: Sample preparation and |
| reference materials. | ||
| ASTM F2096-11 | 2013 | Standard Test Method for Detecting Gross Leaks in Medical Packaging by |
| Internal Pressurization (Bubble Test). | ||
| ISO 10993-5 | 2014 | Biological evaluation of medical devices - Part 5: Tests for in vitro |
| cytotoxicity. | ||
| 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 Medical |
| Devices. | ||
| 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 testing |
| within a risk management process. | ||
| ISO 11607-1 | 2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements |
| for materials, sterile barrier systems and packaging systems. | ||
| ISO 11137-1 | 2006/(R)2015 | Sterilization of health care products - Radiation - Part 1: Requirements for |
| development, validation, and routine control of a sterilization process for | ||
| medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] | ||
| ISO 11137-2 | 2013 | Sterilization of health care products - Radiation - Part 2: Establishing the |
| sterilization dose |
Table 3 Standards compliance
8
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.
9
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.