Predicate Devices

Reference Devices

K182246, K081751, K172505, K103089, K173961, K140293, K173326, K210903, K200817, K212628

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and its components, focusing on mechanical properties, biocompatibility, and sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies. While it mentions "digitally designed custom abutments," this refers to CAD/CAM technology, not necessarily AI/ML.

Therapeutic

Yes.
Explanation: The device is intended to restore masticatory function in edentulous patients, which falls under the definition of therapy by restoring a bodily function.

Diagnostic

No

Explanation: The UniFit Dental Implant System is described as being intended for surgical placement to support dental prosthetics, restore masticatory function, and includes implants, screws, and prosthetic components. Its purpose is to replace lost teeth and restore function, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the UniFit Dental Implant System includes dental implants, screws, and prosthetic components, which are physical hardware. The performance studies also detail testing of physical components like connections, screws, and implants.

IVD (In Vitro Diagnostic)

Based on the provided text, the UniFit Dental Implant System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states the device is for surgical placement in the body to support prosthetic devices and restore masticatory function. This is an in-vivo application (within a living organism).
Device Description: The description details a system of implants, screws, and prosthetic components designed for surgical and restorative procedures. These are physical devices implanted into the patient.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or calibrators.

The UniFit Dental Implant System is a medical device intended for surgical implantation and restoration, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

UniFit Dental Implant System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.

UniFit short implants (6 mm L) are intended to be used only with straight abutments.

All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

Adin's UniFit Dental Implant System is a new model that provides an additional connection platform to Adin's legally marketed Dental Implant Systems, indicated for use in surgical and restorative applications for placement in the maxillary and/or mandibular arch to provide support for prosthetic devices such as crowns, bridges, or overdentures in order to restore masticatory function.

This new UniFit model is identical to Adin's cleared Touareg™ CloseFit (RP- Regular Platform, and WP- Wide Platform) and Adin's Touareg™-S implant systems (cleared under K112585 and K081751, respectively) except for the "Star" (Torx) connection and new 6mm length for specific diameters.

The UniFit Dental Implant System includes dental implants, screws and prosthetic components for CAD/CAM restorations.

The UniFit dental implants are tapered core implants with a spiral tap, and a dome apex and double lead thread design.

	Outer Diameter (mm)	Length (mm)
CloseFit Based	3.5	8, 10, 11.5, 13, 16, 18
CloseFit Based	3.75	8, 10, 11.5, 13, 16, 18
CloseFit Based	4.3, 5	6, 8, 10, 11.5, 13, 16, 18
Toureg-S Based	6	6, 8, 10, 11.5, 13

UniFit implants are available in the following diameters and lengths: .
The UniFit healing abutments are available in heights of 6.8-11.3mm, with diameters of ● 3.5-5.5mm and gingival heights of 2.0-6.0mm.
The UniFit cement-retained and screw-retained abutments are available in diameters of . 3.5-5.5mm, total heights of 10.20-18.20mm and angulations of 15°-30°.
The UniFit UCLA Abutments are available in diameters 4.7-5.2mm. .
The UniFit Overdenture Attachments (ball attachment) are available in a diameter of ● 3.1mm and length of 9.3-13.8mm.
The UniFit Implant Cover Screws are available in length of 5.0mm and outer diameters of ● 2.93mm.
The UniFit Abutment Screws are available in length of 7.0-12.0mm and outer diameters of ● 2.2 and 3.1mm.
Flat connection abutment's components: ●
Flat Connection Gluing Ring is available with outer diameters of 4.5mm and total height of 3.8mm.
Flat connection retaining screw available in length of 5.0mm and outer diameter of 2.5mm.
The UniFit Prosthetic Components for CAD/CAM Restorations are available in the ● following dimensions:
- Ti Blanks outer diameters of 11.50mm and 15.80mm, total height of 24mm.
TMA Cementing Cone and Single TMA Cementing Cone - outer diameters of 4.30mm and 4.90mm, total height of 4.90mm.
Ti Bases - outer diameters of 4.5mm-6.5mm, lengths of 7.7mm-14.7mm, gingival heights of 1.2mm and 3.4 mm, and restoration height / post height of 4.0mm-8.0mm.

All UniFit implants have the OsseoFix™ Calcium Phosphate blast surface treatment, and all UniFit implants, abutments and respective screws are intended for single use only.

UniFit implants and abutments are made of 6Al-4V-ELI Titanium alloy complying with ASTM F136-13(2021)e1 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications) and ISO 5832-3:2021 (Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy).

The submission also includes two-piece abutments, with a titanium base as a pre-manufactured abutment used to support a CAD/CAM designed superstructure (the second part of the twopiece abutment). The zirconia material is Argen Z Ultra, cleared in K071410, and the cement is Panavia V5, cleared in K150704.

All body contact materials of the UniFit Dental Implant System were evaluated for biocompatibility in accordance with ISO 10993-1, ISO 7405 and FDA guidance for Use of ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", dated September 4, 2020.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary and/or mandibular arch

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)

A series of safety and performance tests and evaluations were performed to demonstrate that Adin's UniFit Dental Implant System is substantially equivalent to the Predicate and Reference devices. These tests and evaluations included:

UniFit connection design effectiveness test (including system assembly) The purpose of this test is to verify the effectiveness of the UniFit implant-abutment connection design and assembly in accordance with the tolerance analysis performed during design phase. UniFit assemblies (implant, abutment and abutment screw) were tested together, in accordance with Adin internal protocol under predefined applied tightening torque, as expected in the clinical use. All tested specimens showed stable connection and all measurements were found to be within each component's specification.
UniFit implant connection performance test maximal applicable torque resistance - The purpose of this test is to verify that the UniFit implants' internal connection, withstands the maximal insertion torque as predefined in the implants' specification, considering safety margins and device design). This test was conducted in accordance with Adin internal protocol.
UniFit tool to implant connection life time performance The purpose of this test is to verify the interaction between the UniFit implant and its designated insertion reusable tool. The test was conducted at the end of the reusable tool's recommended lifetime. During this test, the maximal applied torque and deformation test met the predefined acceptance criteria and no mechanical or visual damages were observed. The test was conducted in accordance with Adin internal protocol.
UniFit Implant-abutment connection analysis degree of rotation The purpose of this test is to verify UniFit implant-abutment connection degree of free rotation after applying closure torque. All tested specimens met the predefined acceptance criterion. The test was conducted in accordance with Adin internal protocol.
UniFit abutment screw performance test maximum applicable torque The purpose of this test is to verify the torque resistance of the connecting screw and to verify that once breakage occurs, the break location is under the screw head (groove). The test was conducted by insertion of the abutment and the abutment screw into a fixated implant and to apply torque until the screw fails (breaks). All the tested screws failed in values above the acceptance criteria and at the desired location (weak-point). The test was conducted in accordance with Adin internal protocol.
UniFit screw loosening and abutment extraction by retrieval tool test The purpose of this test is to verify the ability to screw and loosen the screw with no deformation or fracture and to release the abutment after connection under lateral pressure. The test verified that UniFit screw retrieval torque withstands the predefined torque per its specification requirements. It was also verified that the abutment can easily retrieved from the implant, under the test conditions. All tested screws and abutments were successfully unscrewed and retrieved. The test was conducted in accordance with Adin internal protocol.
UniFit regular platform dynamic loading test The tests were performed in order to determine the fatigue load (fatigue limit) for endosseous dental implants under "worst case" conditions and their prosthetic components in accordance with ISO 14801:2016 requirements. All of the success criteria were met.
UniFit Torsion Testing The test was performed in order to determine the torsional yield strength and maximum torque of the worse-case implant/connecting part joints of UniFit implant system. All tested specimens met acceptance criteria for UniFit implant system torsional performance according per YY0315:2016.
UniFit 6.00mm Implants Pull-Out test The tests were performed to determining the axial pull-out strength of the Adin Short Implants as compared to the proposed predicate devices MIS short implants (K103089) according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device. The test met its acceptance criteria.
Comparative Surface Area Analysis Before Surface Treatment between Adin's UniFit 6mmL Implants against MIS SEVEN Implants- Adin's UniFit Short Implant's actual surface area before surface treatment was compared to both legally marketed devices (MIS short implants cleared under 510(k) K103089), at worst case implant variation. The total surface area measurements of the tested items were greater than the legally marketed reference item, the acceptance criteria was met.
Comparative Bone to Implant Contact Surface Area Analysis between Adin's UniFit 6mmL Implants against MIS Implants - Contact surface area was analysed in comparison to legally marketed devices (MIS implants cleared under 510(k) K103089) at worst case implant variation. this test was conducted to determine the comparative equivalence of bone to implant contact (B.I.C.) for the tested item (Adin's UniFit short implant, 6.0 mm) and the reference item (MIS's SEVEN MF7-06420) using state of the art 3D-CAD techniques utilizing two type of bone conditions: Hard Bone (Type I - referred as H.B) and Soft Bone (Type IV - referred as S.B). Test article, at both conditions of the bone, exceeded the MIS reference item in term of B.I.C volume and surface area.
Single TMA Fatigue Rationale the purpose of the Fatigue Rationale is to evaluate Fatigue limit of the Single TMA abutments assembled to designated Dental Implants including their compatible Screw (in accordance with ISO 14801:2016 - Dentistry -Implants – Dynamic fatigue test for endosseous dental implants) - The Single TMA and designated superstructures do not present any new worst-case when compare to the existing and approved TMA system.
Fatigue testing of TiBase Abutments The worst-case combination of subject device implants. TiBase abutments and zirconia superstructure was tested according to ISO 14801 to determine that the subject devices are strong enough for their clinical application.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112585

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K182246, K081751, K172505, K103089, K173961, K140293, K173326, K210903, K200817, K212628

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

December 29, 2023

Adin Dental Implant Systems Ltd. Kevin Thomas Vice President and Director of Regulatory Affairs 12264 El Camino Real Suite 400 San Diego, California 92130

Re: K223714

Trade/Device Name: UniFit Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 30, 2023 Received: December 1, 2023

Dear Kevin Thomas:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K223714

Device Name

UniFit Dental Implant System

Indications for Use (Describe)

UniFit Dental Implant System is intended for surgical placement in the maxillary and or mandibular arch to support crowns, bridges or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.

UniFit short implants (6 mm L) are intended to be used only with straight abutments.

All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY ADIN UNIFIT DENTAL IMPLANT SYSTEM K223714

DATE PREPARED: December 23, 2023

1. ADMINISTRATIVE INFORMATION

510(K) OWNER NAME

Adin Dental Implants Systems Ltd. Alon Tavor Industrial Zone P.O.Box 1128, Afula 1811101, Israel Phone: +972-4-642-6732, Fax: +972-4-642-6733 E mail: Dimitry@adin-implants.com Contact person: Dimitry Beliavsky, RA Coordinator Phone: +972-4-911-6152, Fax: +972-4-642-6733 Email: Dimitry@adin-implants.com

REPRESENTATIVE/CONSULTANT

PaxMed International, LLC 12264 El Camino Real, Suite 400, San Diego, CA 92130, USA Phone: +1-858-792-1235 Contact person: Floyd G. Larson, President Kevin A. Thomas, Ph.D., VP, Dir Reg Affairs E mail; flarson@paxmed.com, kthomas(@paxmed.com

2. DEVICE NAME

Common/Usual Name: UniFit Dental Implant System Proprietary/Trade name: UniFit Dental Implant System Classification: Adin UniFit Dental Implant System has been classified as Class II devices under the following classification names:

Classification Name#	Product Code	21 CFR Ref.
Endosseous dental implant	DZE
(Primary)	872.3640	Dental
Endosseous dental implant
abutment	NHA
(Secondary)	872.3630

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3. PREDICATE AND REFERENCE DEVICES

Adin's UniFit Dental Implant System is substantially equivalent to the following Predicate and Reference Devices:

3.1 Primary predicate device: Adin's Touareg™ CloseFit Dental Implant System, cleared under 510(k) number K112585 on May 24, 2012.
3.2 Reference device (for Ti Blank only): Imagine Milling Technologies, LLC's MIST IC abutments (PREFIT), cleared under 510(k) number K182246 on April 16. 2019.
3.3 Reference device Adin's Dental Implants System, cleared under 510(k) number K081751 on December 19, 2008.
3.4 Reference device: MIS's MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments, cleared under 510(k) number K172505 on December 27, 2017.
3.5 Reference device: MIS's Short Implants, cleared under 510(k) number K103089 on September 15, 2011.
3.6 Reference device: Straumann's BLX Implant System, cleared under 510(k) number K173961 on June 05, 2018.
3.7 Reference device: Adin's Touareg NP CloseFit™ Dental Implant System, cleared under 510(k) number K140293 on October 31, 2014.
3.8 Reference device: MIS CONNECT Superstructures (Cementing Caps), cleared under 510(k) number K173326 on March 16, 2018.
3.9 Reference device: Neobiotech Co., Ltd. IS Multi-Unit Abutment System (Multi-Unit Abutment Cylinder), cleared under 510(k) number K210903 on March 16, 2018.
3.10 Reference device: TruAbutment Inc., URIS OMNI Narrow System & Prosthetic (Multi-unit Base), cleared under 510(k) number K200817 on October 7, 2020.
3.11 Reference device: DESS Dental, Smart Solutions Terrats Medical SL, DESS Aurum Base, cleared under 510(k) number K212628 on March 11, 2022.

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4. DEVICE DESCRIPTION

Adin's UniFit Dental Implant System is a new model that provides an additional connection platform to Adin's legally marketed Dental Implant Systems, indicated for use in surgical and restorative applications for placement in the maxillary and/or mandibular arch to provide support for prosthetic devices such as crowns, bridges, or overdentures in order to restore masticatory function.

This new UniFit model is identical to Adin's cleared Touareg™ CloseFit (RP- Regular Platform, and WP- Wide Platform) and Adin's Touareg™-S implant systems (cleared under K112585 and K081751, respectively) except for the "Star" (Torx) connection and new 6mm length for specific diameters.

The UniFit Dental Implant System includes dental implants, screws and prosthetic components for CAD/CAM restorations.

The UniFit dental implants are tapered core implants with a spiral tap, and a dome apex and double lead thread design.

	Outer Diameter (mm)	Length (mm)
CloseFit Based	3.5	8, 10, 11.5, 13, 16, 18
CloseFit Based	3.75	8, 10, 11.5, 13, 16, 18
CloseFit Based	4.3, 5	6, 8, 10, 11.5, 13, 16, 18
Toureg-S Based	6	6, 8, 10, 11.5, 13

UniFit implants are available in the following diameters and lengths: .
The UniFit healing abutments are available in heights of 6.8-11.3mm, with diameters of ● 3.5-5.5mm and gingival heights of 2.0-6.0mm.
The UniFit cement-retained and screw-retained abutments are available in diameters of . 3.5-5.5mm, total heights of 10.20-18.20mm and angulations of 15°-30°.
The UniFit UCLA Abutments are available in diameters 4.7-5.2mm. .
The UniFit Overdenture Attachments (ball attachment) are available in a diameter of ● 3.1mm and length of 9.3-13.8mm.
The UniFit Implant Cover Screws are available in length of 5.0mm and outer diameters of ● 2.93mm.
The UniFit Abutment Screws are available in length of 7.0-12.0mm and outer diameters of ● 2.2 and 3.1mm.
Flat connection abutment's components: ●

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Image /page/7/Picture/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a blue triangle pointing downwards inside of a circle. The third icon is a green six-pointed star inside of a circle. The fourth icon is the letters VA inside of a circle.

Flat Connection Gluing Ring is available with outer diameters of 4.5mm and total height of 3.8mm.
Flat connection retaining screw available in length of 5.0mm and outer diameter of 2.5mm.
The UniFit Prosthetic Components for CAD/CAM Restorations are available in the ● following dimensions:
- Ti Blanks outer diameters of 11.50mm and 15.80mm, total height of 24mm.
TMA Cementing Cone and Single TMA Cementing Cone - outer diameters of 4.30mm and 4.90mm, total height of 4.90mm.
Ti Bases - outer diameters of 4.5mm-6.5mm, lengths of 7.7mm-14.7mm, gingival heights of 1.2mm and 3.4 mm, and restoration height / post height of 4.0mm-8.0mm.

All UniFit implants have the OsseoFix™ Calcium Phosphate blast surface treatment, and all UniFit implants, abutments and respective screws are intended for single use only.

UniFit implants and abutments are made of 6Al-4V-ELI Titanium alloy complying with ASTM F136-13(2021)e1 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications) and ISO 5832-3:2021 (Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy).

The submission also includes two-piece abutments, with a titanium base as a pre-manufactured abutment used to support a CAD/CAM designed superstructure (the second part of the twopiece abutment). The zirconia material is Argen Z Ultra, cleared in K071410, and the cement is Panavia V5, cleared in K150704.

All body contact materials of the UniFit Dental Implant System were evaluated for biocompatibility in accordance with ISO 10993-1, ISO 7405 and FDA guidance for Use of ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", dated September 4, 2020.

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Image /page/8/Picture/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle pointing downwards inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is two grey lines that form a V shape inside of a circle.

5. INDICATIONS FOR USE

UniFit Dental Implant System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.

UniFit short implants (6 mm L) are intended to be used only with straight abutments.

All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Adin's UniFit Dental Implant System has the same intended use as Primary predicate Adin Touareg CloseFit™ cleared under K112585 and Reference devices Adin Dental Implant System cleared under K081751, MIS's MIS C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments cleared under K172505, MIS's MIS Short Implants cleared under K103089, and Strauman's BLX Implant System cleared under K173961.

All UniFit implants have the OsseoFix™ Calcium Phosphate blast surface treatment, also used for Primary predicate Adin Touareg CloseFit™ cleared under 510(k) K112585.

For the purpose of substantial equivalency, UniFit Dental Implant System is supported by Primary predicate Adin Touareg CloseFit™ cleared under K112585, and further supported by Reference devices K081751 and K103089 to cover the length and Outer Diameter (OD) dimensions, and by Reference devices K172505 and K173971 to cover the conical "Star" (Torx) shaped connection.

The subject device and its Predicate and Reference devices have the same technology and basic performance characteristics. Adin's Touareg CloseFit™ implant external design (RP and WP platforms, Primary predicate K112585) is identical to the subject device for almost all dimensions (OD and length). The length dimensions' differences were bridged by Reference devices Adin Touareg™-S Implant System (K081751 and MIS short implants (K103089).

The subject and Predicate and Reference devices are manufactured from the same biocompatible Titanium alloy and undergo same machining, surface treatment and sterilization processes.

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It was therefore concluded that Adin's UniFit Dental Implant System is substantially equivalent to the Predicate and Reference devices.

Furthermore, Adin UniFit Dental Implant System abutments share the same material, connection type, dimensions and angulation as the Primary predicate Adin Touareg CloseFit™ Dental Implant System (K112585) and Reference devices Adin Dental Implants System, cleared under K081751, Straumann's BLX Implant System, cleared under K173961, MIS's MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments, cleared under K172505, and Adin's Touareg NP CloseFit™ Dental Implant System, cleared under K140293.

Adin UniFit Dental Implant System Ball Attachments share the same material as the Primary predicate device Adin Touareg CloseFit™ Dental Implant System (K112585). The connection is identical to the Reference device MIS C1 Wide Platform Conical Connection Abutments (K172505). The dimensions are within the range of the Primary predicate, K112585, and Reference device, K172505. The angulation is identical to that of the Primary predicate, K112585, and similar to that of the Reference device, K172505.

Adin UniFit Dental Implant System TMA and STMA Cementing Cones are substantially equivalent to the Reference devices selected by Adin. For TMA and STMA Cementing Cones, Adin has identified the following three 510(k) cleared reference devices: MIS CONNECT Superstructures (Cementing Caps), cleared under K173326, Neobiotech Co., Ltd., IS Multi-Unit Abutment System (Multi-Unit Abutment Cylinder), cleared under K210903, and TruAbutment Inc., URIS OMNI Narrow System & Prosthetic (Multi-unit Base), cleared under K200817.

Adin UniFit Dental Implant System Ti Bases are substantially equivalent to the Reference devices selected by Adin. For Ti Bases, Adin has identified the following two 510(k) cleared Reference devices: DESS Dental Smart Solutions Terrats Medical SL, DESS Aurum Base, cleared under K212628, and previously mentioned MIS C1 Wide Platform Conical Connection Abutments, cleared under K172505.

Adin UniFit Dental Implant System Ti Blanks are substantially equivalent to the Primary Predicate device and Reference devices selected by Adin. For Ti Blanks, Adin has identified the 510(k) cleared Imagine Milling Technologies, LLC's MIST IC abutments (PREFIT), cleared under K182246 as a Reference device as well as two other 510(k) cleared products as Reference devices. The devices that are substantially equivalent to Adin UniFit Ti Blanks are the previously mentioned two devices, DESS Dental Smart Solutions Terrats Medical SL,

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DESS Aurum Base (K212628), and MIS C1 Wide Platform Conical Connection Abutments (K172505).

7. PERFORMANCE DATA

A series of safety and performance tests and evaluations were performed to demonstrate that Adin's UniFit Dental Implant System is substantially equivalent to the Predicate and Reference devices. These tests and evaluations included:

1. UniFit connection design effectiveness test (including system assembly) The purpose of this test is to verify the effectiveness of the UniFit implant-abutment connection design and assembly in accordance with the tolerance analysis performed during design phase. UniFit assemblies (implant, abutment and abutment screw) were tested together, in accordance with Adin internal protocol under predefined applied tightening torque, as expected in the clinical use. All tested specimens showed stable connection and all measurements were found to be within each component's specification.
1. UniFit implant connection performance test maximal applicable torque resistance - The purpose of this test is to verify that the UniFit implants' internal connection, withstands the maximal insertion torque as predefined in the implants' specification, considering safety margins and device design). This test was conducted in accordance with Adin internal protocol.
1. UniFit tool to implant connection life time performance The purpose of this test is to verify the interaction between the UniFit implant and its designated insertion reusable tool. The test was conducted at the end of the reusable tool's recommended lifetime. During this test, the maximal applied torque and deformation test met the predefined acceptance criteria and no mechanical or visual damages were observed. The test was conducted in accordance with Adin internal protocol.
1. UniFit Implant-abutment connection analysis degree of rotation The purpose of this test is to verify UniFit implant-abutment connection degree of free rotation after applying closure torque. All tested specimens met the predefined acceptance criterion. The test was conducted in accordance with Adin internal protocol.
1. UniFit abutment screw performance test maximum applicable torque The purpose of this test is to verify the torque resistance of the connecting screw and to verify that once breakage occurs, the break location is under the screw head (groove). The test was conducted by insertion of the abutment and the abutment screw into a fixated implant and to apply torque until the screw fails (breaks). All the tested screws failed in values above the

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acceptance criteria and at the desired location (weak-point). The test was conducted in accordance with Adin internal protocol.

1. UniFit screw loosening and abutment extraction by retrieval tool test The purpose of this test is to verify the ability to screw and loosen the screw with no deformation or fracture and to release the abutment after connection under lateral pressure. The test verified that UniFit screw retrieval torque withstands the predefined torque per its specification requirements. It was also verified that the abutment can easily retrieved from the implant, under the test conditions.
  All tested screws and abutments were successfully unscrewed and retrieved. The test was conducted in accordance with Adin internal protocol.
1. UniFit regular platform dynamic loading test The tests were performed in order to determine the fatigue load (fatigue limit) for endosseous dental implants under "worst case" conditions and their prosthetic components in accordance with ISO 14801:2016 requirements. All of the success criteria were met.
1. UniFit Torsion Testing The test was performed in order to determine the torsional yield strength and maximum torque of the worse-case implant/connecting part joints of UniFit implant system. All tested specimens met acceptance criteria for UniFit implant system torsional performance according per YY0315:2016.
1. UniFit 6.00mm Implants Pull-Out test The tests were performed to determining the axial pull-out strength of the Adin Short Implants as compared to the proposed predicate devices MIS short implants (K103089) according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device. The test met its acceptance criteria.
1. Comparative Surface Area Analysis Before Surface Treatment between Adin's UniFit 6mmL Implants against MIS SEVEN Implants- Adin's UniFit Short Implant's actual surface area before surface treatment was compared to both legally marketed devices (MIS short implants cleared under 510(k) K103089), at worst case implant variation. The total surface area measurements of the tested items were greater than the legally marketed reference item, the acceptance criteria was met.
1. ) Comparative Bone to Implant Contact Surface Area Analysis between Adin's UniFit 6mmL Implants against MIS Implants - Contact surface area was analysed in comparison to legally marketed devices (MIS implants cleared under 510(k) K103089) at worst case implant variation. this test was conducted to determine the comparative equivalence of bone to implant contact (B.I.C.) for the tested item (Adin's UniFit short implant, 6.0 mm) and the reference item (MIS's SEVEN MF7-06420)

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using state of the art 3D-CAD techniques utilizing two type of bone conditions: Hard Bone (Type I - referred as H.B) and Soft Bone (Type IV - referred as S.B). Test article, at both conditions of the bone, exceeded the MIS reference item in term of B.I.C volume and surface area.

1. Single TMA Fatigue Rationale the purpose of the Fatigue Rationale is to evaluate Fatigue limit of the Single TMA abutments assembled to designated Dental Implants including their compatible Screw (in accordance with ISO 14801:2016 - Dentistry -Implants – Dynamic fatigue test for endosseous dental implants) - The Single TMA and designated superstructures do not present any new worst-case when compare to the existing and approved TMA system.
1. Fatigue testing of TiBase Abutments The worst-case combination of subject device implants. TiBase abutments and zirconia superstructure was tested according to ISO 14801 to determine that the subject devices are strong enough for their clinical application.

Biocompatibility

Biocompatibility tests were conducted in accordance with FDA Guidance for Use of ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, September 4, 2020, and; ISO 10993-1 for biological evaluation and; ISO 7405:2018 for evaluation of medical devices used in dentistry. In-vitro Cytotoxicity test of each surface treatment type, using the ISO Elution Method was conducted as well as Pyrogenic Material-Mediated and chemical extractions.

ISO 10993-5, ISO 10993-11 and ISO 10993-18 were used for the Cytotoxicity, Pyrogen Material-Mediated and chemical extractions, respectively.

Tests have been conducted at MDT Medical Device Testing GmbH using representative final implants including the OsseoFix™ surface treatment which went through Adin's entire production process, including packaging and sterilization (Gamma irradiation).

Tests of worst-case combinations of TiBase abutments, zirconia superstructure and the cement recommended in labeling showed that the devices were not cytotoxic in the test.

Gamma Irritation Sterilization

Adin's UniFit dental implants and cover screws are packed together and supplied sterile using gamma irradiation. They are intended for single use only.

The Gamma sterilization was conducted in accordance with ISO 11137-2:2013 for Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose in conjunction with ISO/TS 13004, in order to assure SAL (Sterility Assurance Level) of 10°

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using VDmax 20kGy. The sterilization validation includes both the implants and the cover screws.

Cleaning and Steam Sterilization

Adin's superstructures (UniFit abutments and their screws) are single use and provided as non-sterile, therefore, the user is instructed to preform cleaning and steam-sterilization prior to clinical use in accordance with validated methods stated in the device's IFU.

Steam sterilization was validation in accordance with ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1) was conducted using full cycle approach as detailed in Annex D4 of ISO 17665-1:2006 to assure a Sterility Assurance Level (SAL) of 10-6.

Disinfection

Adin's ball caps are part of the Overdenture Ball Attachment System and are provided as non-sterile; Therefore, disinfection is to be conducted before clinical use by the clinician in accordance with validated methods stated in the IFU accompanying the device.

The disinfection process validation was conducted with accordance with ISO 17664-1:2021 (Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices) and AAMI TIR12:2020 (Designing. Testing, And Labeling Medical Devices Intended for Processing by Health Care Facilities: A Guide for Device Manufacturers.

Shelf-Life, Packaging and Transportation

Shelf-life tests were conducted to ensure 5 years shelf life under both accelerated and real-time aging. Shelf-life as performed in accordance with ISO 11607-1 for Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems. This validation confirmed that the sterility of Adin's sterile products will remain throughout the device shelf life and after packaging and transportation.

SUBSTANTIAL EQUIVALENCE 8.

Adin's UniFit Dental Implant System is substantially equivalent to the predicate devices selected in terms of indication for use, technology, performances, design, place of use, patient population and nature of body contact.

The substantial equivalent decision was received based on the following comparisons with the predicate devices:

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Table 5-1: Substantial Equivalence of Adin's Dental Implants System with

Predicate Device (Dental Implants)

| | Subject Device | Primary
Predicate
Device | Reference Device | Reference Device | Reference
Device | Reference Device | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Adin UniFit Dental
Implant System | Adin Touareg
CloseFitTM
Dental
Implant
System, | Adin Dental
Implants System | MIS'S MIS C1
Narrow Platform
Conical Connection
Implant System,
MIS C1 Wide
Platform Conical
Connection
Abutments | MIS
MIS Short
Implants | Straumann
BLX Implant
System | Equivalence
Discussion |
| 510(k) Number | K223714 | K112585 | K081751 | K172505 | K103089 | K173961 | |
| Classification | Class: II
Product code: DZE
(primary)
NHA (secondary)
Regulation No.:
872.3640 | Class: II
Product code:
DZE (primary)
NHA
(secondary)
Regulation
No.: 872.3640 | Class: II
Product code:
DZE (primary)
NHA (secondary)
Regulation No.:
872.3640 | Class: II
Product code:
DZE (primary)
NHA (secondary)
Regulation No.:
872.3640 | Class: II
Product code:
DZE
Regulation
No.: 872.3640 | Class: II
Product code:
DZE (primary)
NHA (secondary)
Regulation No.:
872.3640 | |
| Indications For
Use | UniFit Dental
Implants are
intended for surgical
placement in the
maxillary and/or
mandibular arch to | Touareg
CloseFitTM
Dental Implants
are intended for
surgical
placement in | Adin Dental
Implants are
intended for
surgical
placement in the
maxillary and/or | MIS dental implant
system is
intended to be
surgically placed
in the bone of the
upper or | MIS dental
implants are
intended to be
surgically
placed in the
bone of the | Straumann® BLX
Implants are
suitable for
endosteal
implantation in
the upper and | The subject
device has the
same
indication as
the primary
predicate |
| | Subject Device | Primary
Predicate
Device | Reference Device | Reference Device | Reference Device | Reference Device | Equivalence
Discussion |
| Feature | Adin UniFit Dental
Implant System | Adin Touareg
CloseFitTM
Dental
Implant
System, | Adin Dental
Implants System | MIS's MIS C1
Narrow Platform
Conical Connection
Implant System,
MIS C1 Wide
Platform Conical
Connection
Abutments | MIS
MIS Short
Implants | Straumann
BLX Implant
System | |
| 510(k) Number | K223714 | K112585 | K081751 | K172505 | K103089 | K173961 | |
| | support crowns,
bridges, or
overdentures in
partially or
completely
edentulous patients
in order to restore
masticatory
function. UniFit
Dental Implants may
be immediately
loaded when good
primary stability is
achieved and with
appropriate occlusal
loading. | the maxillary
and/or
mandibular
arch to support
crowns,
bridges, or
overdentures in
edentulous or
partially
edentulous
patients.
Touareg
CloseFitTM
Dental Implants
may be
immediately | mandibular arch
to support crowns,
bridges, or
overdentures in
edentulous or
partially
edentulous
patients.
Adin Dental
Implants may be
immediately
loaded when good
primary stability
is achieved and
with appropriate
occlusal loading. | lower jaw arches to
provide
support for
prosthetic devices,
such as artificial
teeth, in order to
restore masticatory
function. When a
one-stage surgical
procedure is applied,
the implant may be
immediately loaded
when good primary
stability is achieved
and the occlusal load
is appropriate. | upper or lower
jaw arches to
provide
support for
prosthetic
devices, such
as artificial
teeth, in order
to restore a
patient's
chewing
function.
When a one
stage surgical
procedure is
applied, the | lower jaw and for
the functional and
esthetic oral
rehabilitation of
edentulous and
partially
edentulous
patients. BLX
implants can be
placed with
immediate
function on
single-tooth
applications when
good primary
stability is | device and the
reference
devices, with
only minor
differences in
wording
which do not
affect the
indications for
use and does
not raise new
safety issues.
Limitation
exists for MIS
narrow
implants in |
| | Subject Device | Primary
Predicate
Device | Reference Device | Reference Device | Reference Device | Reference Device | Equivalence
Discussion |
| Feature | Adin UniFit Dental
Implant System | Adin Touareg
CloseFitTM
Dental
Implant
System, | Adin Dental
Implants System | MIS's MIS C1
Narrow Platform
Conical Connection
Implant System,
MIS C1 Wide
Platform Conical
Connection
Abutments | MIS
MIS Short
Implants | Straumann
BLX Implant
System | |
| 510(k) Number | K223714 | K112585 | K081751 | K172505 | K103089 | K173961 | |
| | UniFit short
implants are to be
used only with
straight abutments.

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16

17

18

19

20

21

22

23

24

25

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| | Subject Device | Primary
Predicate Device | Reference
Device | Reference Device | |
|------------------------------------|---------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Adin UniFit
Dental Implant
System | Adin Touareg
CloseFit™ Dental
Implant System | Adin Dental
Implants
System | Straumann
BLX Implant
System | Equivalence Discussion |
| 510(k) Number | K223714 | K112585 | K081751 | K173961 | |
| Material | Titanium Alloy -
6Al-4V-ELI | Titanium Alloy –
6Al-4V-ELI | Titanium Alloy -
6Al-4V-ELI | Titanium Grade 4 | Identical to the primary predicate device and the
reference devices (excluding K173961) |
| Connection | Conical "star"
(Torx) internal
connection | Conical hexagon | Internal hexagon | Conical Torx
internal
connection | Identical to the reference device K173961. |
| Diameter | 3.5-5.5mm# | 3.5-5.5mm | 4.5mm | 4.0-7.5mm | Identical to the primary device and within the
range of all the comparable cleared devices
(primary predicate and reference devices). |
| Height above
implant connection | 2.0-6.0mm# | 2.0-6.0mm | 2.0-6.0mm | 2.75-7.5mm | Identical to the primary and Adin's reference
device and within the range of all the comparable
cleared devices (primary predicate and reference
devices). |
| Sterilization | Non-sterile
provided.
Sterilized by end
user.# | Non-sterile
provided.
Sterilized by end
user. | Non-sterile
provided.
Sterilized by end
user. | Sterile using
gamma irradiation | Identical to the primary predicate device and the
reference devices (excluding K173961, which
does not affect substantial equivalence, since both
features are feasible and cleared). |

Table 5-2: Substantial Equivalence of Adin's Dental Implants System with Predicate Device (Healing Abutments)

27

@ @ @ @ @

Table 5-3: Substantial Equivalence of Adin's UniFit Dental Implants System with

Predicate Devices (Cement Retained Abutments)

| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device | |
|-----------------|-------------------------------------------------|----------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Adin UniFit
Dental Implant
System | Adin Touareg
CloseFit™ Dental
Implant System | Adin Dental
Implants System | MIS
MIS C1 Narrow Platform
Conical Connection
Implant System, MIS C1
Wide
Platform Conical
Connection Abutments | Equivalence Discussion |
| 510(k) Number | K223714 | K112585 | K081751 | K172505 | |
| Material | Titanium Alloy –
6Al-4V-ELI | Titanium Alloy –
6Al-4V-ELI | Titanium Alloy –
6Al-4V-ELI | Titanium Grade 4 | Identical to the primary predicate
device and the reference devices
(excluding K173961). |
| Connection | Conical "star"
(Torx) internal
connection | Conical hexagon | Internal hexagon | Conical with indexes (Torx) | Identical to the reference device
K172505. |
| Diameter | 4.0-5.5mm# | 4.0-5.5mm | 3.9-5.0mm | 3.3-5.0mm | Identical to the primary device
and within the range of all the
comparable cleared devices
(primary predicate and reference
devices). |
| Gingival Height | 1.0-3.0mm | 1.0-3.0mm | 0.6-4.0mm | Information not available | In the range of the primary
predicate device and the reference
devices (excluding K172505). |

28

Primary Predicate Reference Device Reference Device Device Adin Touareg Adin Dental MIS Equivalence Discussion CloseFit™ Dental Implants System MIS C1 Narrow Platform Implant System Conical Connection Implant System, MIS C1

510(k) Number	K223714	K112585	K081751	K172505
Angulation	Up to 25°	Up to 15°	Up to 25°	Up to 25°	In the range of the primary
predicate device and within the
range of all the comparable
cleared devices (primary predicate
and reference devices).
Sterilization	Non-sterile
provided. Sterilized
by end user.#	Non-sterile
provided. Sterilized
by end user.	Non-sterile
provided. Sterilized
by end user.	Non-sterile provided.
Sterilized by end user.	Identical to the primary predicate
device and the reference devices

Subject Device

Adin UniFit

Dental Implant

System

Feature

(1) (1) (1) (1) (1)

29

(1) (7) (7) @)

Table 5-4: Substantial Equivalence of Adin's UniFit Dental Implants System with

Predicate Devices (Screw Retained Abutments – TMA, STMA and Flat Connection Abutments)

Feature	Subject Device	Reference Device	Reference Device	Equivalence Discussion
	Adin UniFit Dental
Implant System	Adin Touareg NP CloseFitTM
Dental Implant System	MIS MIS C1 Narrow
Platform Conical
Connection Implant
System,
MIS C1 Wide
Platform Conical
Connection Abutments
510k Number	K223714	K140293	K172505
Material	Titanium Alloy – 6Al-
4V-ELI	Titanium Alloy – 6Al-4V-ELI	Titanium Alloy – 6Al-4V-
ELI	Identical to the reference devices
Connection	Conical "star" (Torx)
internal connection	Conical hexagon	Conical with indexes (Torx)	Identical to the reference device
K172505
Diameter	4.9mm#	4.9mm	4.8mm	Identical to K140293
Gingival
Height	1.0-5.0mm	1.0-5.0mm	1.0-5.0mm	In the range of the reference devices
Angulation	Up to 30°	Up to 30°	Up to 30°	Identical to the reference devices
Sterilization	Non-sterile provided.
Sterilized by end user.#	Non-sterile provided. Sterilized
by end user.	Sterile using gamma
irradiation	Identical to K140293 (excluding
K172505, which does not affect
substantial equivalence, since both
features are feasible and cleared).

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Table 5-5: Substantial Equivalence of Adin's UniFit Dental Implants System with

Predicate Devices (UCLA Abutments, Screw or Cement Retained)

	Subject Device	Primary Predicate Device	Reference Device
Feature	Adin UniFit Dental
Implant System	Adin Touareg CloseFit™
Dental Implant System	MIS's MIS C1 Narrow
Platform Conical
Connection Implant
System, MIS C1 Wide
Platform Conical
Connection Abutments	Equivalence Discussion
	K223714	K112585	K172505
Material	Titanium Alloy (Ti-
6Al-4V-ELI) + POM-C
(burnout plastic sleeve,
Polyoxymethylene) +
Ti-6Al-4V-ELI screw	Titanium Alloy (Ti-6Al-
4V-ELI) + POM-C
(burnout plastic sleeve,
Polyoxymethylene) + Ti-
6Al-4V-ELI screw	Gold Alloy + POM (burnout
plastic sleeve,
Polyoxymethylene) + Ti-6Al-
4V-ELI screw	Identical to the primary predicate device
K112585
Connection	Conical "star" (Torx)
internal connection	Conical hexagon	Conical with indexes (Torx)	Identical to the reference device
K172505
Diameter	4.7-5.2mm#	4.7-5.2mm	3.3-5.0mm	Identical to the primary device and
within the range the comparable cleared
devices (primary predicate and reference
devices).
Gingival
Height	1.5mm	1.36-1.5mm	Information not available	In the range of the primary predicate
device
Sterilization	Non-sterile provided.
Sterilized by end user.#	Non-sterile provided.
Sterilized by end user.	Non-sterile provided.
Sterilized by end user.	Identical to the primary predicate device
and the reference device

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Table 5-6: Substantial Equivalence of Adin's UniFit Dental Implants System with Predicate Devices (Ball Attachments)

Feature	Subject Device	Primary Predicate Device	Reference Device
	Adin UniFit Dental
Implant System	Adin's Touareg CloseFitTM
Dental Implant System	MIS'S MIS C1 Narrow
Platform Conical Connection
Implant System, MIS C1
Wide
Platform Conical Connection
Abutments
510(k) Number	K223714	K112585	K172505
Material	Titanium Alloy – 6Al-
4V-ELI	Titanium Alloy – 6Al-4V-ELI	Titanium Alloy – 6Al-4V-ELI

Titanium Nitride (TiN)
coating | Identical to the primary predicate device |
| Connection | Conical "star" (Torx)
internal connection | Conical hexagon | Conical with indexes (Torx) | Identical to the reference device K172505 |
| Diameter | 3.1mm# | 3.1-3.5mm | 3.3-5.0mm | In the range of the primary predicate device
and the reference device |
| Gingival Height | 0.5-5.0mm | 0.5-5.0mm | 1-5mm | In the range of the primary predicate device
and the reference device |
| Angulation | Straight | Straight | Up to 15° | In the range of the primary predicate device
and the reference device |
| Sterilization | Non-sterile provided.
Sterilized by end user.# | Non-sterile provided. Sterilized
by end user. | Non-sterile provided. Sterilized
by end user. | Identical to the primary predicate device and
the reference device |

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Image /page/32/Picture/0 description: The image contains four icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle with a line above it inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is the letters VA inside of a circle.

Table 5-7: Substantial Equivalence of Adin's UniFit Dental Implants System with Predicate Devices (TMA and STMA Cementing Cone)

	Subject Device	Reference Device	Reference Device	Reference Device	Equivalence Discussion
Feature	Adin UniFit Dental
Implant System	MIS CONNECT
Superstructures
(Cementing Caps)	Neobiotech Co.,
Ltd., IS Multi-Unit
Abutment System
(Multi-Unit
Abutment Cylinder)	TruAbutment Inc.,
URIS OMNI
Narrow System &
Prosthetic (Multi-
unit Base)
510(k) Number	K223714	K173326	K210903	K200817
Material	Titanium Alloy –
6Al-4V-ELI	Titanium Alloy –
6Al-4V-ELI	Titanium Alloy –
6Al-4V-ELI	Titanium Alloy –
6Al-4V-ELI	Identical to the reference devices
Connection	Connect to Adin's
Screw Retained
Abutments (TMA,
STMA) mounted on
an Adin Unifit
Conical Connection
Implant	Connects to MIS
CONNECT
abutment mounted
on a MIS Conical
Connection Dental
Implant	Connected with Multi
Unit Abutment with
Cylinder Screw	Not mentioned in
the summary	Identical to the reference device
K173326
Diameter	4.9mm#	4.8mm	4.8mm	5.0mm	In range of the reference devices
Length	4.9mm	3.3mm	5.0mm	5.0mm	In range of the reference devices
Angulation	Straight	Straight	Straight	Straight	Identical to the reference devices
Sterilization	Non-sterile provided.
Sterilized by end user.#	Non-sterile
provided. Sterilized
by end user.	End-User Moist Heat
Sterilization	End-User Moist
Heat Sterilization	Identical to the reference devices
	Subject Device	Reference Device	Reference Device
Feature	Adin UniFit Dental Implant
System	DESS Dental
Smart Solutions
Terrats Medical SL, DESS
Aurum Base
(Information also obtained from
company IFU FDA version)	MIS's MIS C1 Narrow Platform
Conical Connection Implant
System, MIS C1 Wide
Platform Conical Connection
Abutments, cleared under	Equivalence
Discussion
510(k) Number	K223714	K212628	K172505
Material	Ti-6Al-4V-ELI, Argen Z
Ultra Zirconia, Panavia V5
Cement	Ti-6Al-4V ELI, Y-TZP per ISO
13356, Ivoclar Vivadent Multi-
Link cement	Titanium Grade 4	Same as Reference
Device cleared
under K212628
Connection	Conical “star” (Torx) internal
connection	Internal Hex Conical	Conical with indexes (Torx)	Same as Reference
Device cleared
under K172505
Diameter	4.5-6.5mm	4.5 – 6.5mm	3.3-5.0mm	In range of the
reference devices
Sterilization	Non-sterile/End user
sterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Identical to the
reference device
Design limits	Minimum wall thickness –
0.5 mm
Minimum post height for
single-unit restorations – 4.0
mm
gingival height – 1-4 mm	Minimum wall thickness – 0.4 mm
Minimum post height for single-
unit restorations – 4.0 mm
gingival height – 0.5-6.0 mm	Not Applicable, since not
customizable but serves to support
the specification limits.	In range of the
Reference Device
cleared under
K212628
Feature	Subject Device	Reference Device	Reference Device	Reference Device	Equivalence Discussion
	Adin UniFit Dental
Implant System	Imagine Milling
Technologies, LLC's
MIST IC abutments
(PREFIT)	DESS Dental
Smart Solutions
Terrats Medical SL, Pre-milled
Blank Ti
(Information also obtained from
company IFU FDA version)	MIS'S MIS C1 Narrow
Platform Conical Connection
Implant System, MIS C1
Wide Platform Conical
Connection Abutments
	K223714	K18224	K212628	K172505
Material	Titanium Alloy –
6Al-4V-ELI	Titanium Alloy, Zirconia	Titanium alloy (Ti-6Al-4V)	Titanium Grade 4	Same as Reference Device
cleared under K212628
Connection	Conical "star"
(Torx) internal
connection	Not mentioned in the
summary	Conical internal hex connection	Conical with indexes (Torx)	Same as Reference Device
cleared under K172505
Implant/Abutment
connection
Diameter	2.9mm	3.5-5.0mm	2.3-6.0	3.3-5.0mm	In range of the reference
devices
Design limits					In range of the reference
devices
Minimum
Abutment wall
thickness	0.5mm	0.5mm	0.45 mm	Not Applicable, since not
customizable but serves to
support the specification limits.
Maximum Milled
abutment height	10	Not mentioned in the
summary	19
Maximum
Emergence profile
diameter	13	Not mentioned in the
summary	14
	Subject Device	Reference Device	Reference Device	Reference Device
Feature	Adin UniFit Dental
Implant System	Imagine Milling
Technologies, LLC's
MIST IC abutments
(PREFIT)	DESS Dental
Smart Solutions
Terrats Medical SL, Pre-milled
Blank Ti
(Information also obtained from
company IFU FDA version)	MIS'S MIS C1 Narrow
Platform Conical Connection
Implant System, MIS C1
Wide Platform Conical
Connection Abutments	Equivalence Discussion
	K223714	K18224	K212628	K172505
Maximum
Abutment
angulation	20°	30°	Straight
Minimum post
height for single-
unit restoration	4.0	4.0	4.0
Maximum
Emergence profile
height/Maximum
gingival height	6.0	5.0	6.0
Minimum
gingival height	0.5 mm	0.5 mm	0.5 mm
Sterilization	Non-sterile/End user
sterilized	Non-sterile/End user
sterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized

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Image /page/33/Picture/0 description: The image contains four icons in a horizontal row. The first icon is a purple hexagon inside of a circle. The second icon is a blue triangle pointing downwards inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is a white symbol that looks like two lines connected by a curve inside of a circle.

Table 5-8: Substantial Equivalence of Adin's UniFit Dental Implants System with Predicate Device (Ti Bases)

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Image /page/34/Picture/0 description: The image contains four icons arranged horizontally. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle pointing downwards inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is the letters VA inside of a circle.

Table 5-9: Substantial Equivalence of Adin's UniFit Dental Implants System with Predicate Device (Ti Blank)

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Image /page/35/Picture/0 description: The image contains four icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle pointing downwards inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is the letters VA inside of a circle.

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Image /page/36/Picture/0 description: The image contains four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle with a line above it inside of a circle. The third icon is a yellow six-pointed star inside of a circle. The fourth icon is the letters VA inside of a circle.

Substantial Equivalence Discussion:

The proposed Adin UniFit Dental Implant System has the same indications for use, technological characteristics, mode of operation and performance specifications as the above identified Predicate and Reference devices. The proposed device has the same intended use as the Predicate and Reference devices and is placed using the same methodology as all selected predicate devices. The proposed and Predicate and Reference devices all function in the same manner providing support for prosthetic devices in the upper or lower jaw. Similarities and differences were addressed by Adin. It can be seen that certain differences presented in the comparison table are all within the range of one or more Predicate or Reference device(s). Therefore, it was concluded that Adin UniFit Dental Implant System and the predicate devices are substantially equivalent.

9. CONCLUSIONS

Adin UniFit Dental Implant System, which is the subject of this 510(k) Submission, is substantially equivalent to the predicate device indicated above. The device has met its requirements and labeling claims per its intended use. The device does not introduce new risks and does not present any new adverse health effects or safety potential risks to patients when used as intended.

Therefore, it was concluded that the overall evaluation of the device performance demonstrates that it is as safe and as effective as the predicate devices and therefore substantially equivalent.