(400 days)
Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant.
The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.
The provided text is related to a 510(k) premarket notification for a dental device called "Bonafix TiBase." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical claim.
Therefore, the input document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used (beyond what might be inferred from the "Non-Clinical Testing Summary" referring to standards compliance).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on non-clinical testing for biocompatibility, sterilization, and engineering/dimensional analysis to support substantial equivalence.
The "Non-Clinical Testing Summary" mentions an "Engineering and dimensional analysis... for determination of compatibility" and compliance with ISO 10993-5 (cytotoxicity) and ANSI/AAMI/ISO 17665-1 (sterilization). It also refers to an MRI review based on scientific rationale and published literature. However, these are evaluations of the device's characteristics against standards and existing knowledge, not a study proving a specific performance metric against a defined acceptance criterion in the way an AI/ML device might be evaluated for diagnostic accuracy.
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix TiBase to its predicate device." This further confirms that the type of study you're asking about (e.g., related to diagnostic accuracy, clinical outcomes for a new claim, or AI performance) was not conducted or deemed necessary for this 510(k) submission.
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Zentek Medical LLC % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445
Re: K221673
Trade/Device Name: Bonafix TiBase Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 15, 2023 Received: June 15, 2023
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 medical devices and radiation-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) K221673
Device Name Bonafix TiBase abutment
Indications for Use (Describe)
Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
| Compatible Implant System | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| HIOSSEN ET III | 3.5 4.0, 4.5, 5.0, 6.0, 7.0 | Mini Regular |
| Nobel Active | 3.5 4.3, 5.0 | NP RP |
| Straumann Bone Level | 3.3 4.1, 4.8 | NC RC |
| Zimmer Screw-Vent/Tapered Screw Vent | 3.3, 3.7, 4.1 4.7 6.0 | 3.5 4.5 5.7 |
| Bonafix 2 Plus Implants | 3.5, 3.75, 4.20, 5.0, 6.0 | 3.5 |
All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to a Bonafix validated milling center for manufacture.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D)
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Bonafix TiBase (K221673) July 14th, 2023 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 Juan Tezak
510(k) Summary
Representative/Consultant
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: Common Name: Classification Regulation: Classification Name: Device Classification: Classification Panel: Primary Product Code:
Bonafix TiBase Dental implant abutment 21 CFR 872.3630 Endosseous dental implant abutment Class II Dental Products Panel NHA
PREDICATE DEVICE INFORMATION
Primary predicate K212108, Dynamic Ti-base. Talladium España, SL
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Reference Devices
| K140934 | HIOSSEN ETIII SA. HIOSEEN® Implant |
|---|---|
| K153758 | STRAUMANN DENTAL IMPLANT SYSTEM. STRAUMANN USA |
| K061410 | Tapered Screw-Vent. Zimmer Dental |
| K142260 | Nobel Active conical. Nobel Biocare AB |
| K153332 | ETIII SA Fixture System (Ø3.2mm). HIOSEEN® Implant |
| K193352 | Abutment CAD. Exocad GmbH |
| K120243 | G-CEM LinkAce™. GC AMERICA INC |
| K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated; Zimmer DentalTapered Screw-Vent M Implant, HA Coated, Zimmer Dental |
Intended Use
Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
| COMPATIBLE IMPLANT SYSTEM | IMPLANT BODY DIAMETER(mm) | IMPLANT PLATFORM DIAMETER(mm) |
|---|---|---|
| HIOSSEN ET III | 3.5 | Mini |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| Nobel Active | 3.5 | NP |
| 4.3, 5.0 | RP | |
| Straumann Bone Level | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Zimmer Screw-Vent/Tapered Screw-Vent | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 | |
| Bonafix 2 Plus Implants | 3.5, 3.75, 4.20, 5.0, 6.0 | 3.5 |
All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture.
Device Description
The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant.
The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.
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The design parameters for the fabrication of the restoration on Bonafix TiBase abutments, which are already locked in the EXOCAD CAD/CAM software (K193352), are as follows:
- Minimum wall thickness 0.43 mm
- Minimum abutment post height 4.0 mm
- Maximum post height 6.5 mm
- Maximum gingival height 5.0 mm
- Minimum gingival height 0.7 mm
- Angulation 0°
The recommended cement for bonding the zirconia superstructure to the Bonafix TiBase abutments to create the final two-piece abutment is G-CEM LinkAce™ cleared in K120243.
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Equivalence to Marketed Device
The subject device is substantially equivalent in inciples to the primary predicate device. Below is a table comparing the indications for use and technological characteristics of the subject device and the primary predicate device.
The subject device is equivalent to the identified primary predicate, with the compatible implant systems for which the reference devices are included and supported by reverse engineering.
The Indications for Use Statement (IFUS) for the subject device is identified primary predicate K212108, with the differences being the compatible implant systems for which the reference devices K14034, K142260, K15332, and K13339 are included and which are supported by reverse engineering.
The other reference devices K120243 and K193352 serve as references for the cement and software used in the design of the Bonafix TiBase abutment restoration.
| COMPARISON | SUBJECT DEVICE | PREDICATE DEVICE | COMPARISON | ||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device | Bonafix TiBase abutment (K221673)Zentek Medical LLC | Dynamic Ti-base (K212108).Talladium España, SL | |||||||||||||||||||||||||||||||||||||||||||||||||
| Intended Use | Bonafix TiBase abutments are intended foruse with dental implants as a support forsingle-unit or multi-unit prostheses in themaxillary or mandibular arch of a partially orfully edentulous patient. | Dynamic TiBase abutments are intended for usewith dental implants as a support for single-unit ormulti-unit prostheses in the maxillary or mandibulararch of a partially or fully edentulous patient. | Similar | ||||||||||||||||||||||||||||||||||||||||||||||||
| COMPATIBLE IMPLANT SYSTEM IMPLANT BODY DIAMETER (mm) IMPLANT PLATFORM DIAMETER (mm) HIOSSEN ET III 3.5 Mini Nobel Active 4.0, 4.5, 5.0, 6.0, 7.0 Regular 3.5 NP Straumann Bone Level 4.3, 5.0 RP 3.3 NC Zimmer Screw-Vent/Tapered Screw-Vent 4.1, 4.8 RC 3.3, 3.7, 4.1 3.5 4.7 4.5 6.0 5.7 Bonafix 2 Plus Implants 3.5, 3.75, 4.20, 5.0, 6.0 3.5 | Implant Compatibility Implant Body Diameter, mm Implant Platform, mm 2.7 3.5 SPI CONTACT Dental Implant 3.5 4.0 3.5 4.5 4.2 5.0 |
Table 1. Comparison with predicate device for Summary
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| COMPARISON | SUBJECT DEVICE | PREDICATE DEVICE | COMPARISON |
|---|---|---|---|
| All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture. | All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Thommen Medical validated milling center for manufacture. | ||
| AbutmentDesigns | Titanium Base EngagingTitanium Base Non-Engaging | Titanium Base EngagingTitanium Base Non-Engaging | Same |
| Prosthesis | Cement-retained | Cement-retained | Same |
| Attachment | Screw-retained | Screw-retained | |
| Abutment/Implant PlatformDiameter (mm) | 3.0 – 5.7 | 3.5, 4.0, 4.5, 5.0 | Similar |
| AbutmentAngle | Straight (0°) | Up to 30° | Different |
| CAD/CAM Abutment Design Parameters | |||
| Minimum postheight, mm | 4.0 | 4.0 | Same |
| Maximun postheigth, mm | 6.5 | 9.0 | Different |
| Maximumgingival height,mm | 5.0 | 5.83 | Similar |
| Minimumgingival height,mm | 0.7 | 0.7 | Same |
| Wall Minimumwall thickness | 0.43 | 0.43 | Same |
| COMPARISON | SUBJECT DEVICE | PREDICATE DEVICE | COMPARISON |
| Maximumabutmentangulation | 0° | Up to 30° | Different |
| Abutmentattachment toimplant | Screw | Screw | Same |
| Prosthesisattachment toabutment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Same |
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Same |
| Abutment/ImplantInterface | Internal connection | Internal | Same |
| Materials | |||
| Abutment | Ti-6Al-4V alloy (ASTM F136) | Titanium alloy, ASTM F136 | Same |
| Screw | Ti-6Al-4V alloy (ASTM F136) | Titanium alloy, ASTM F136 | Same |
| Superstructure | Zirconia - ISO 13356 | Zirconia - ISO 13356 | Same |
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Non-Clinical Testing Summary
Bonafix TiBase underwent evaluation tests based on the following standards:
| ISO 10993-5 | 2014 | Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity. |
|---|---|---|
| ANSI/AAMI/ISO17665-1 | (2006/(R)2013) | Sterilization of health care products — Moist heat — Part 1: Requirementsfor the development, validation and routine control of a sterilization processfor medical devices, Annex D |
Table 2 Standards compliance for Summary
End User Sterilization Validation Test according to ISO 17665-1.
Engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility. A plan for ongoing monitoring to ensure continued compatibility is also implemented.
Additional, Non-clinical worst-case MRI review was performed to evaluate the metallic Bonafix TiBase device 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.
Clinical Testing Summary
Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix TiBase to its predicate device.
Conclusion
Based on the information presented in this 510(k), the Bonafix TiBase is considered substantially equivalent to the identified predicate devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)