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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the UniFit Dental Implant System.

Please Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict numerical acceptance criteria against a pre-defined performance target. The studies described are primarily to ensure safety, functionality, and equivalence to already cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission focused on substantial equivalence to predicate devices rather than meeting a specific performance target for AI, the "acceptance criteria" here refer to meeting the established performance standards of the predicate devices and general safety/performance testing for the type of medical device. The document does not provide a traditional table of AI-specific acceptance criteria (e.g., sensitivity, specificity, AUC) or corresponding numerical performance for the device's AI component. Instead, it describes a series of engineering and biocompatibility tests to ensure the new device is as safe and effective as previously cleared devices.

The "device performance" reported is that the device successfully meets the internal protocols and relevant ISO/ASTM standards, indicating it performs comparably to the predicate devices and is safe for its intended use.

No AI is mentioned in the provided text for the UniFit Dental Implant System. The document describes a physical dental implant system and components, not a software or AI-driven medical device. Therefore, the subsequent questions regarding AI-specific criteria (sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable based on this document.

Test/Evaluation Category	Acceptance Criteria (Implicit from text)	Reported Device Performance
Material Biocompatibility	Compliance with ISO 10993-1, ISO 7405, FDA guidance, ISO 10993-5 (Cytotoxicity: non-cytotoxic), ISO 10993-11 (Pyrogenicity), ISO 10993-18 (Chemical extractions).	- In-vitro Cytotoxicity test met criteria (non-cytotoxic for worst-case combinations). - Pyrogenic Material-Mediated and chemical extractions conducted. - Biocompatibility tests were conducted in accordance with referenced standards.
Connection Design Effectiveness	Stable connection and all measurements within component's specification, following tolerance analysis.	All tested specimens showed stable connection and all measurements were found to be within each component's specification.
Maximal Applicable Torque Resistance (Implant)	Withstand maximal insertion torque as predefined in implant specification, considering safety margins and device design.	Test conducted in accordance with internal protocol; implies meeting criteria (no explicit numerical value reported as metric).
Tool to Implant Connection Lifetime Performance	Maximal applied torque and deformation test met predefined acceptance criteria; no mechanical or visual damages observed at end of reusable tool's recommended lifetime.	Met predefined acceptance criteria; no mechanical or visual damages observed.
Implant-Abutment Connection Degree of Rotation	Predefined acceptance criterion for degree of free rotation after applying closure torque.	All tested specimens met the predefined acceptance criterion.
Abutment Screw Performance - Maximum Applicable Torque	Torque resistance of connecting screw such that breakage occurs above acceptance criteria and at the desired location (under the screw head/groove).	All tested screws failed in values above the acceptance criteria and at the desired location.
Screw Loosening and Abutment Extraction by Retrieval Tool	Ability to screw and loosen with no deformation or fracture; abutment easily retrieved from implant under lateral pressure; screw retrieval torque withstands predefined torque.	All tested screws and abutments were successfully unscrewed and retrieved; screw retrieval torque withstood predefined torque.
Regular Platform Dynamic Loading (Fatigue)	Meet requirements of ISO 14801:2016 for fatigue load (fatigue limit) for endosseous dental implants under "worst case" conditions and prosthetic components.	All of the success criteria were met.
Torsion Testing	Meet acceptance criteria for torsional performance as per YY0315:2016 for torsional yield strength and maximum torque of worst-case implant/connecting part joints.	All tested specimens met acceptance criteria for UniFit implant system torsional performance per YY0315:2016.
6.00mm Implants Pull-Out Test	Axial pull-out strength comparable to or better than predicate devices (MIS short implants K103089), per ASTM F543.	The test met its acceptance criteria (comparison with legally marketed device).
Comparative Surface Area Analysis (before treatment)	UniFit Short Implant's actual surface area (before surface treatment) greater than or equivalent to legally marketed reference item (MIS short implants 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 (BIC) Surface Area Analysis	Test article (Adin's UniFit short implant, 6.0 mm) BIC volume and surface area comparable to or exceeding reference item (MIS SEVEN MF7-06420) for Hard Bone (Type I) and Soft Bone (Type IV) conditions.	Test article, at both conditions of the bone, exceeded the MIS reference item in terms of B.I.C. volume and surface area.
Single TMA Fatigue Rationale	Fatigue limit of Single TMA abutments assembled to designated Dental Implants (including compatible screw) conforms to ISO 14801:2016, and does not present new worst-case compared to existing and approved TMA system.	The Single TMA and designated superstructures do not present any new worst-case when compared to the existing and approved TMA system (Rationale provided).
Fatigue testing of TiBase Abutments	Worst-case combination of subject device implants, TiBase abutments, and zirconia superstructure is strong enough for clinical application per ISO 14801.	Tested according to ISO 14801; implies meeting strength requirements (no explicit numerical value reported as metric).
Gamma Irradiation Sterilization	Assurance of SAL (Sterility Assurance Level) of 10^-6 using VDmax 20kGy according to ISO 11137-2:2013 and ISO/TS 13004.	Sterilization validated in accordance with ISO 11137-2:2013, assuring SAL of 10^-6.
Cleaning and Steam Sterilization (End-User)	Assurance of SAL of 10^-6 for steam sterilization (for non-sterile components) using full cycle approach as detailed in Annex D4 of ISO 17665-1:2006, in accordance with ISO 17665-1:2006 and ISO 17665-2:2009.	Steam sterilization validated in accordance with ISO 17665-1:2006 and ISO 17665-2:2009, assuring SAL of 10^-6.
Disinfection (End-User)	Disinfection process validated in accordance with ISO 17664-1:2021 and AAMI TIR12:2020.	Disinfection process validation conducted with accordance with ISO 17664-1:2021 and AAMI TIR12:2020.
Shelf-Life, Packaging and Transportation	Ensure 5 years shelf life under accelerated and real-time aging, and confirmed sterility throughout shelf life and after packaging/transportation per ISO 11607-1.	Shelf-life tests conducted to ensure 5 years shelf life, confirming sterility after packaging and transportation.

2. Sample Size Used for the Test Set and Data Provenance

As no AI component is described, this question is not directly applicable. The performance data section describes various engineering tests.

Test Set Description: The "test set" for the engineering evaluations consists of physical samples of the UniFit Dental Implant System.
Sample Sizes:
- For most tests (connection design effectiveness, torque resistance, tool life, rotation, screw performance, screw loosening/extraction, torsion testing, fatigue testing of TiBase abutments), the document states "All tested specimens" or "All tested screws," implying all manufactured or a representative sample of components tested met the criteria. It does not provide specific numerical counts for these "specimens" or "screws."
- For the UniFit 6.00mm Implants Pull-Out test, comparison was made to "proposed predicate devices MIS short implants (K103089)." The sample size for UniFit is not explicitly stated but implies sufficient numbers for comparison.
- For Comparative Surface Area Analysis and Comparative Bone to Implant Contact Surface Area Analysis, comparison was made against "legally marketed devices (MIS short implants cleared under 510(k) K103089) at worst case implant variation" and "MIS's SEVEN MF7-06420." Again, specific sample sizes for the UniFit components are not given, but "tested items" is used.
Data Provenance: The data comes from internal testing conducted by Adin Dental Implant Systems Ltd. (implied by "Adin internal protocol") and potentially external accredited labs for biocompatibility and sterilization (e.g., "Tests have been conducted at MDT Medical Device Testing GmbH"). The tests are in accordance with international standards (ISO, ASTM, YY) and FDA guidance. The implants are compared to predicate devices already marketed in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the document does not describe the use of experts to establish a "ground truth" for an AI algorithm's performance on a test set. The validation is through engineering, materials, and biocompatibility testing against established standards and comparisons to predicate devices, which generally do not involve human "experts" establishing ground truth in the AI sense.

4. Adjudication Method for the Test Set

Not applicable, as there is no AI component or subjective human interpretation of results requiring adjudication for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable, as no AI component is described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable, as no AI component is described.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, "ground truth" is established through:

Compliance with International Standards: Adherence to ISO and ASTM standards for material properties, mechanical performance, fatigue, sterility, and biocompatibility.
Comparison to Predicate Devices: Performance characteristics (e.g., implant design, connection types, material, dimensions, sterilization methods, clinical indications) are compared against several legally marketed predicate and reference devices (e.g., Adin's Touareg™ CloseFit Dental Implant System, MIS C1 implants, Straumann BLX System, etc.). The "ground truth" implicitly aligns with the documented safety and effectiveness of these predicate devices.
Internal Protocols: Performance data is generated and evaluated against Adin's internal protocols and specifications.

8. The Sample Size for the Training Set

Not applicable, as no AI component or machine learning model is described that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no AI component or machine learning model is described that would require a training set with established ground truth.

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 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.	Panel
Endosseous dental implant	DZE(Primary)	872.3640	Dental
Endosseous dental implantabutment	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

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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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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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	PrimaryPredicateDevice	Reference Device	Reference Device	ReferenceDevice	Reference Device
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFitTMDentalImplantSystem,	Adin DentalImplants System	MIS'S MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem	EquivalenceDiscussion
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
Classification	Class: IIProduct code: DZE(primary)NHA (secondary)Regulation No.:872.3640	Class: IIProduct code:DZE (primary)NHA(secondary)RegulationNo.: 872.3640	Class: IIProduct code:DZE (primary)NHA (secondary)Regulation No.:872.3640	Class: IIProduct code:DZE (primary)NHA (secondary)Regulation No.:872.3640	Class: IIProduct code:DZERegulationNo.: 872.3640	Class: IIProduct code:DZE (primary)NHA (secondary)Regulation No.:872.3640
Indications ForUse	UniFit DentalImplants areintended for surgicalplacement in themaxillary and/ormandibular arch to	TouaregCloseFitTMDental Implantsare intended forsurgicalplacement in	Adin DentalImplants areintended forsurgicalplacement in themaxillary and/or	MIS dental implantsystem isintended to besurgically placedin the bone of theupper or	MIS dentalimplants areintended to besurgicallyplaced in thebone of the	Straumann® BLXImplants aresuitable forendostealimplantation inthe upper and	The subjectdevice has thesameindication asthe primarypredicate
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device	EquivalenceDiscussion
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFitTMDentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
	support crowns,bridges, oroverdentures inpartially orcompletelyedentulous patientsin order to restoremasticatoryfunction. UniFitDental Implants maybe immediatelyloaded when goodprimary stability isachieved and withappropriate occlusalloading.	the maxillaryand/ormandibulararch to supportcrowns,bridges, oroverdentures inedentulous orpartiallyedentulouspatients.TouaregCloseFitTMDental Implantsmay beimmediately	mandibular archto support crowns,bridges, oroverdentures inedentulous orpartiallyedentulouspatients.Adin DentalImplants may beimmediatelyloaded when goodprimary stabilityis achieved andwith appropriateocclusal loading.	lower jaw arches toprovidesupport forprosthetic devices,such as artificialteeth, in order torestore masticatoryfunction. When aone-stage surgicalprocedure is applied,the implant may beimmediately loadedwhen good primarystability is achievedand the occlusal loadis appropriate.	upper or lowerjaw arches toprovidesupport forprostheticdevices, suchas artificialteeth, in orderto restore apatient'schewingfunction.When a onestage surgicalprocedure isapplied, the	lower jaw and forthe functional andesthetic oralrehabilitation ofedentulous andpartiallyedentulouspatients. BLXimplants can beplaced withimmediatefunction onsingle-toothapplications whengood primarystability is	device and thereferencedevices, withonly minordifferences inwordingwhich do notaffect theindications foruse and doesnot raise newsafety issues.Limitationexists for MISnarrowimplants in
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device	EquivalenceDiscussion
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFitTMDentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
	UniFit shortimplants are to beused only withstraight abutments.All digitallydesigned customabutments for usewith Ti Baseabutments or Pre-milled Blankabutments are to besent to an AdinDental validatedmilling center formanufacture.	loaded whengood primarystability isachieved andwithappropriateocclusalloading.		Narrow implants(Ø3.3mm & UNO)are indicated for usein surgical andrestorativeapplications forplacement only inthe mandibularcentral, lateralincisor and maxillarylateral incisorregions of partiallydentulous jaws, toprovide support forprosthetic devicessuch as artificial	implant may beimmediatelyloaded whengood primarystability isachieved andthe occlusalload isappropriate.MIS shortimplants are tobe used onlywith straightabutments.	achieved and withappropriateocclusal loadingto restore chewingfunction. Theprostheticrestorations areconnected to theimplants throughthe correspondingabutmentcomponents.	OD of 3.3mm(K172505)does not applyto the UniFitimplant sincethe lowest ODis 3.5mm.
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	ReferenceDevice	Reference Device
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFit™DentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem	EquivalenceDiscussion
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
				teeth, in order torestore the patientchewing function.Mandibular centraland lateral incisorsmust be splinted ifusing two or morenarrow implantsadjacent to oneanother.
Patientpopulation	Edentulous orpartially edentulouspatients	Edentulous orpartiallyedentulouspatients	Edentulous orpartiallyedentulouspatients	Edentulous orpartially edentulouspatients	Edentulous orpartiallyedentulouspatients	Edentulous orpartiallyedentulouspatients	Identical tothe primarypredicatedevice and thereferencedevices
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFit™DentalImplantSystem,	Adin DentalImplants System	MIS'S MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem	EquivalenceDiscussion
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
Sterilization	Gamma Irradiation(implants and coverscrew only)	GammaIrradiation(implants andcover screwonly)	GammaIrradiation(implants andcover screw only)	Gamma Irradiation(implants and coverscrew)	GammaIrradiation(implants andcover screw)	GammaIrradiation(implants)	Identical tothe primarypredicatedevice and thereferencedevices.
Nature of bodycontact	Implant inbone/tissue contactfor long termduration (>30 d)	Implant inbone/tissuecontact for longterm duration(>30 d)	Implant inbone/tissuecontact for longterm duration(>30 d)	Implant inbone/tissue contactfor long termduration (>30 d)	Implant inbone/tissuecontact forlong termduration (>30d)	Implant inbone/tissuecontact for longterm duration(>30 d)	Identical tothe primarypredicatedevice and thereferencedevices.
Prescription orOver-the-Counter (OTC)	Prescription	Prescription	Prescription	Prescription	Prescription	Prescription	Identical tothe primarypredicatedevice and the
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFit™DentalImplantSystem,	Adin DentalImplants System	MIS'S MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem	EquivalenceDiscussion
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
							referencedevices.
Single use	Yes	Yes	Yes	Yes	Yes	Yes	Identical tothe primarypredicatedevice and thereferencedevices.
OperationPrinciple	Single or Two-Stages procedure(immediate ordelayed loading)	Single or Two-Stagesprocedure(immediate ordelayedloading)	Single or Two-Stages procedure(immediate ordelayed loading)	Single or Two-Stages procedure(immediate ordelayed loading)	Single or Two-Stagesprocedure(immediate ordelayedloading)	Single or Two-Stages procedure(immediate, early,or lateimplantation)(Appendix F,page 2, frompublished	Identical tothe primarypredicatedevice and thereferencedevices.
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device	EquivalenceDiscussion
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFit™DentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961Instructions forUse, Section 3.Pg. 2)
PlacementMethod	Placing the implantin the jaw boneimmediately afterdrilling	Placing theimplant in thejaw boneimmediatelyafter drilling	Placing theimplant in the jawbone immediatelyafter drilling	Placing the implantin the jaw boneimmediately afterdrilling	Placing theimplant in thejaw boneimmediatelyafter drilling	Placing theimplant in the jawbone immediatelyafter drilling	Identical tothe primarypredicatedevice and thereferencedevices.
Self-Tapping	Yes	Yes	Yes	Yes	Yes	Information notavailable	Identical tothe primarypredicatedevice and thereferencedevices
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFitTMDentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem	EquivalenceDiscussion
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
Material	Titanium Alloy –6Al-4V-ELI	Titanium Alloy– 6Al-4V-ELI	Titanium Alloy –6Al-4V-ELI	Titanium Alloy –6Al-4V-ELI	Titanium Alloy– 6Al-4V-ELI	Titanium-13Zirconium alloy(Roxolid®)	(excludingK173961).Identical tothe primarypredicatedevice and thereferencedevices(excludingK173961).
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible	Biocompatible	Biocompatible	Identical tothe primarypredicatedevice and thereferencedevices.
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device	EquivalenceDiscussion
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFitTMDentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961
Shape	Screw type	Screw type	Screw type	Screw type	Screw type	Screw type(Appendix F,page 113, whichis the publishedTechnicalInformation forStraumann,section 2, page 6)	Identical tothe primarypredicatedevice and thereferencedevices.
Connection	Conical "star"(Torx) internalconnection	Conicalhexagon	Internal hexagon	Conical with indexes	Internalhexagon	Conical Torxinternalconnection	Identical tothe referencedevicesK172505 andK173961.
SurfaceTreatment	OsseoFixTMCalcium Phosphate	OsseoFixTMCalciumPhosphate	AB/AE	Anodized, sandblasted and acidetched	Sand blasting& acid etching	HydrophilicSLActive®	Identical tothe primarypredicate
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	Reference Device	Reference Device
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFit™DentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem	EquivalenceDiscussion
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961	deviceK112585.
Length	3.5mmD: 8, 10,11.5, 13, 16, 18mm.3.75mmD: 8, 10,11.5, 13, 16, 18 mm.4.3, 5mmD: 6, 8, 10,11.5, 13, 16, 18 mm.6mmD: 6, 8, 10,11.5, 13mm.	3.5, 4.3,5mmD: 8, 10,11.5, 13, 15, 18mm	3.5, 3.75, 4.2, 5,6mmD: 8, 10,11.5, 13, 16,18mm	3.3mmD: 10, 11.5,13 and 16 mm	4.2, 5, 6mmD:6.0 mm	4.5mmD: 6, 8, 10,12, 14, 16, 18 mm5.5, 6.5mmD: 6,8, 10, 12 mm	In the range ofdiameters ofthe primarypredicatedevice and thereferencedevices.
Outer Diameter(OD)	3.5, 3.75, 4.3, 5,6mm	RP 3.5mmWP 4.3, 5mm	Touareg-S Model:3.5, 3.75, 4.2, 5,6mm	3.3mm	4.2, 5, 6mm	4.5, 5.5, 6.5mm	In the range ofdiameters ofthe primarypredicatedevice and the
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	ReferenceDevice	Reference Device
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFitTMDentalImplantSystem,	Adin DentalImplants System	MIS's MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem	EquivalenceDiscussion
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961	referencedevices.
Packaging(MicrobialBarrier)	Sterile barrierProtective Tube	Sterile barrierProtective Tube	Sterile barrierProtective Tube	Information notavailable	Informationnot available	Information notavailable	Identical tothe primarypredicatedevice and thereferencedevices (forwhichinformation isavailable).
	Subject Device	PrimaryPredicateDevice	Reference Device	Reference Device	ReferenceDevice	Reference Device	EquivalenceDiscussion
Feature	Adin UniFit DentalImplant System	Adin TouaregCloseFit™DentalImplantSystem,	Adin DentalImplants System	MIS'S MIS C1Narrow PlatformConical ConnectionImplant System,MIS C1 WidePlatform ConicalConnectionAbutments	MISMIS ShortImplants	StraumannBLX ImplantSystem
510(k) Number	K223714	K112585	K081751	K172505	K103089	K173961	Identical tothe primarypredicatedevice and thereferencedevices (forwhichinformation isavailable)
Shelf-Life	5 years	5 years	5 years	5 years	Informationnot available	5 years

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Image /page/26/Picture/0 description: The image contains four circular icons. The first icon contains a hexagon shape. The second icon contains a triangle shape. The third icon contains a star shape. The fourth icon contains a squiggly line shape.

	Subject Device	PrimaryPredicate Device	ReferenceDevice	Reference Device
Feature	Adin UniFitDental ImplantSystem	Adin TouaregCloseFit™ DentalImplant System	Adin DentalImplantsSystem	StraumannBLX ImplantSystem	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 thereference devices (excluding K173961)
Connection	Conical "star"(Torx) internalconnection	Conical hexagon	Internal hexagon	Conical Torxinternalconnection	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 therange of all the comparable cleared devices(primary predicate and reference devices).
Height aboveimplant connection	2.0-6.0mm#	2.0-6.0mm	2.0-6.0mm	2.75-7.5mm	Identical to the primary and Adin's referencedevice and within the range of all the comparablecleared devices (primary predicate and referencedevices).
Sterilization	Non-sterileprovided.Sterilized by enduser.#	Non-sterileprovided.Sterilized by enduser.	Non-sterileprovided.Sterilized by enduser.	Sterile usinggamma irradiation	Identical to the primary predicate device and thereference devices (excluding K173961, whichdoes not affect substantial equivalence, since bothfeatures are feasible and cleared).

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

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@ @ @ @ @

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

Predicate Devices (Cement Retained Abutments)

	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
Feature	Adin UniFitDental ImplantSystem	Adin TouaregCloseFit™ DentalImplant System	Adin DentalImplants System	MISMIS C1 Narrow PlatformConical ConnectionImplant System, MIS C1WidePlatform ConicalConnection 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 predicatedevice and the reference devices(excluding K173961).
Connection	Conical "star"(Torx) internalconnection	Conical hexagon	Internal hexagon	Conical with indexes (Torx)	Identical to the reference deviceK172505.
Diameter	4.0-5.5mm#	4.0-5.5mm	3.9-5.0mm	3.3-5.0mm	Identical to the primary deviceand within the range of all thecomparable cleared devices(primary predicate and referencedevices).
Gingival Height	1.0-3.0mm	1.0-3.0mm	0.6-4.0mm	Information not available	In the range of the primarypredicate device and the referencedevices (excluding K172505).

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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 primarypredicate device and within therange of all the comparablecleared devices (primary predicateand reference devices).
Sterilization	Non-sterileprovided. Sterilizedby end user.#	Non-sterileprovided. Sterilizedby end user.	Non-sterileprovided. Sterilizedby end user.	Non-sterile provided.Sterilized by end user.	Identical to the primary predicatedevice and the reference devices

Subject Device

Adin UniFit

Dental Implant

System

Feature

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

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(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 DentalImplant System	Adin Touareg NP CloseFitTMDental Implant System	MIS MIS C1 NarrowPlatform ConicalConnection ImplantSystem,MIS C1 WidePlatform ConicalConnection 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 deviceK172505
Diameter	4.9mm#	4.9mm	4.8mm	Identical to K140293
GingivalHeight	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. Sterilizedby end user.	Sterile using gammairradiation	Identical to K140293 (excludingK172505, which does not affectsubstantial equivalence, since bothfeatures are feasible and cleared).

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Image /page/30/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 pointing downwards inside of a circle. The third icon is a yellow star inside of a circle, and the fourth icon is a gray icon with the letters VA inside of a circle.

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 DentalImplant System	Adin Touareg CloseFit™Dental Implant System	MIS's MIS C1 NarrowPlatform ConicalConnection ImplantSystem, MIS C1 WidePlatform ConicalConnection 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 (burnoutplastic sleeve,Polyoxymethylene) + Ti-6Al-4V-ELI screw	Identical to the primary predicate deviceK112585
Connection	Conical "star" (Torx)internal connection	Conical hexagon	Conical with indexes (Torx)	Identical to the reference deviceK172505
Diameter	4.7-5.2mm#	4.7-5.2mm	3.3-5.0mm	Identical to the primary device andwithin the range the comparable cleareddevices (primary predicate and referencedevices).
GingivalHeight	1.5mm	1.36-1.5mm	Information not available	In the range of the primary predicatedevice
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 deviceand the reference device

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Image /page/31/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 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 5-6: Substantial Equivalence of Adin's UniFit Dental Implants System with Predicate Devices (Ball Attachments)

Feature	Subject Device	Primary Predicate Device	Reference Device	Equivalence Discussion
	Adin UniFit DentalImplant System	Adin's Touareg CloseFitTMDental Implant System	MIS'S MIS C1 NarrowPlatform Conical ConnectionImplant System, MIS C1WidePlatform Conical ConnectionAbutments
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 deviceand the reference device
Gingival Height	0.5-5.0mm	0.5-5.0mm	1-5mm	In the range of the primary predicate deviceand the reference device
Angulation	Straight	Straight	Up to 15°	In the range of the primary predicate deviceand the reference device
Sterilization	Non-sterile provided.Sterilized by end user.#	Non-sterile provided. Sterilizedby end user.	Non-sterile provided. Sterilizedby end user.	Identical to the primary predicate device andthe 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 DentalImplant System	MIS CONNECTSuperstructures(Cementing Caps)	Neobiotech Co.,Ltd., IS Multi-UnitAbutment System(Multi-UnitAbutment Cylinder)	TruAbutment Inc.,URIS OMNINarrow 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'sScrew RetainedAbutments (TMA,STMA) mounted onan Adin UnifitConical ConnectionImplant	Connects to MISCONNECTabutment mountedon a MIS ConicalConnection DentalImplant	Connected with MultiUnit Abutment withCylinder Screw	Not mentioned inthe summary	Identical to the reference deviceK173326
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-sterileprovided. Sterilizedby end user.	End-User Moist HeatSterilization	End-User MoistHeat Sterilization	Identical to the reference devices
	Subject Device	Reference Device	Reference Device
Feature	Adin UniFit Dental ImplantSystem	DESS DentalSmart SolutionsTerrats Medical SL, DESSAurum Base(Information also obtained fromcompany IFU FDA version)	MIS's MIS C1 Narrow PlatformConical Connection ImplantSystem, MIS C1 WidePlatform Conical ConnectionAbutments, cleared under	EquivalenceDiscussion
510(k) Number	K223714	K212628	K172505
Material	Ti-6Al-4V-ELI, Argen ZUltra Zirconia, Panavia V5Cement	Ti-6Al-4V ELI, Y-TZP per ISO13356, Ivoclar Vivadent Multi-Link cement	Titanium Grade 4	Same as ReferenceDevice clearedunder K212628
Connection	Conical “star” (Torx) internalconnection	Internal Hex Conical	Conical with indexes (Torx)	Same as ReferenceDevice clearedunder K172505
Diameter	4.5-6.5mm	4.5 – 6.5mm	3.3-5.0mm	In range of thereference devices
Sterilization	Non-sterile/End usersterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Identical to thereference device
Design limits	Minimum wall thickness –0.5 mmMinimum post height forsingle-unit restorations – 4.0mmgingival height – 1-4 mm	Minimum wall thickness – 0.4 mmMinimum post height for single-unit restorations – 4.0 mmgingival height – 0.5-6.0 mm	Not Applicable, since notcustomizable but serves to supportthe specification limits.	In range of theReference Devicecleared underK212628
Feature	Subject Device	Reference Device	Reference Device	Reference Device	Equivalence Discussion
	Adin UniFit DentalImplant System	Imagine MillingTechnologies, LLC'sMIST IC abutments(PREFIT)	DESS DentalSmart SolutionsTerrats Medical SL, Pre-milledBlank Ti(Information also obtained fromcompany IFU FDA version)	MIS'S MIS C1 NarrowPlatform Conical ConnectionImplant System, MIS C1Wide Platform ConicalConnection 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 Devicecleared under K212628
Connection	Conical "star"(Torx) internalconnection	Not mentioned in thesummary	Conical internal hex connection	Conical with indexes (Torx)	Same as Reference Devicecleared under K172505
Implant/AbutmentconnectionDiameter	2.9mm	3.5-5.0mm	2.3-6.0	3.3-5.0mm	In range of the referencedevices
Design limits					In range of the referencedevices
MinimumAbutment wallthickness	0.5mm	0.5mm	0.45 mm	Not Applicable, since notcustomizable but serves tosupport the specification limits.
Maximum Milledabutment height	10	Not mentioned in thesummary	19
MaximumEmergence profilediameter	13	Not mentioned in thesummary	14
	Subject Device	Reference Device	Reference Device	Reference Device
Feature	Adin UniFit DentalImplant System	Imagine MillingTechnologies, LLC'sMIST IC abutments(PREFIT)	DESS DentalSmart SolutionsTerrats Medical SL, Pre-milledBlank Ti(Information also obtained fromcompany IFU FDA version)	MIS'S MIS C1 NarrowPlatform Conical ConnectionImplant System, MIS C1Wide Platform ConicalConnection Abutments	Equivalence Discussion
	K223714	K18224	K212628	K172505
MaximumAbutmentangulation	20°	30°	Straight
Minimum postheight for single-unit restoration	4.0	4.0	4.0
MaximumEmergence profileheight/Maximumgingival height	6.0	5.0	6.0
Minimumgingival height	0.5 mm	0.5 mm	0.5 mm
Sterilization	Non-sterile/End usersterilized	Non-sterile/End usersterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized

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

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

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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.

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.