Who is the manufacturer of UniFit Dental Implant System?

Adin Dental Implant Systems , Ltd. filed the 510(k) submission for UniFit Dental Implant System (K223714).

What is the FDA product code for UniFit Dental Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for UniFit Dental Implant System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like UniFit Dental Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

UniFit Dental Implant System

Q: What are the predicate devices for UniFit Dental Implant System?

Adin Touareg CloseFit Dental Implant System (K112585).

K223714 · Adin Dental Implant Systems , Ltd. · DZE · Dec 29, 2023 · Dental

Device Facts

Record ID	K223714
Device Name	UniFit Dental Implant System
Applicant	Adin Dental Implant Systems , Ltd.
Product Code	DZE · Dental
Decision Date	Dec 29, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

UniFit Dental Implant System consists of tapered core endosseous dental implants, screws, and prosthetic components (abutments, Ti bases, Ti blanks) for CAD/CAM restorations. Implants feature a spiral tap, dome apex, and double lead thread design with OsseoFix calcium phosphate blast surface treatment. Used in dental clinics by clinicians for surgical placement in maxillary/mandibular bone to support prosthetic devices. Implants are placed via drilling; immediate loading is permitted given sufficient primary stability. Prosthetic components connect to implants to support crowns, bridges, or overdentures. System includes specific components for CAD/CAM workflows, requiring validated milling centers for custom abutment manufacture. Benefits include restoration of masticatory function in edentulous/partially edentulous patients.

Clinical Evidence

Bench testing only. Testing included connection effectiveness, torque resistance, fatigue loading (ISO 14801:2016), torsional yield strength (YY0315:2016), pull-out strength (ASTM F543), and comparative surface area/bone-to-implant contact (B.I.C.) analysis. Biocompatibility evaluated per ISO 10993-1, ISO 7405, and ISO 10993-5/11/18. Sterilization validated per ISO 11137-2 and ISO 17665-1.

Technological Characteristics

Materials: 6Al-4V-ELI Titanium alloy (ASTM F136-13, ISO 5832-3). Surface: OsseoFix Calcium Phosphate blast. Connection: Conical 'star' (Torx) internal connection. Form factor: Tapered core implants (3.5-6.0mm diameter, 6-18mm length). Sterilization: Gamma irradiation (implants/cover screws); steam sterilization (abutments). Connectivity: Compatible with CAD/CAM digital workflows.

Indications for Use

Indicated for partially or completely edentulous patients requiring surgical placement of dental implants in the maxillary or mandibular arch to support crowns, bridges, or overdentures to restore masticatory function.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Adin Touareg CloseFit Dental Implant System (K112585)

Reference Devices

Imagine Milling Technologies, LLC's MIST IC abutments (PREFIT) (K182246)
Adin Dental Implants System (K081751)
MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments (K172505)
MIS Short Implants (K103089)
Straumann BLX Implant System (K173961)
Adin Touareg NP CloseFit Dental Implant System (K140293)
MIS CONNECT Superstructures (Cementing Caps) (K173326)
Neobiotech Co., Ltd. IS Multi-Unit Abutment System (Multi-Unit Abutment Cylinder) (K210903)
TruAbutment Inc., URIS OMNI Narrow System & Prosthetic (Multi-unit Base) (K200817)
DESS Dental, Smart Solutions Terrats Medical SL, DESS Aurum Base (K212628)

Related Devices

K200586 — Straumann TLX Implant System · Institut Straumann AG · Aug 20, 2020
K193234 — NUVO IF Implant System · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jun 18, 2020
K240262 — BTI Interna 3.0 Dental Implant System UnicCa® · B.T.I. Biotechnology Institute, Sl. · Oct 10, 2024
K231566 — ICX-Implant System · Medentis Medical GmbH · Sep 5, 2024
K151757 — IMMEDIATELOAD Dental Implant System · Immediateload S.A. · Aug 3, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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. {2}------------------------------------------------ 3 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 {3}------------------------------------------------ ### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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 implant abutment | NHA (Secondary) | 872.3630 | | {5}------------------------------------------------ #### 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. {6}------------------------------------------------ #### 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: ● {7}------------------------------------------------ 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. {8}------------------------------------------------ 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. {9}------------------------------------------------ Image /page/9/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 down 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. 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, {10}------------------------------------------------ Image /page/10/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 yellow star inside of a circle. The fourth icon is the letters VA inside of a circle. 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. - 2) 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. - 3) 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. - 4) 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. - 5) 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 {11}------------------------------------------------ Image /page/11/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 inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is a gray image of the letters VA inside of a circle. acceptance criteria and at the desired location (weak-point). The test was conducted in accordance with Adin internal protocol. - 6) 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. - 7) 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. - 8) 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. - 9) 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. - 10) 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. - 11) ) 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) {12}------------------------------------------------ Image /page/12/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, and the fourth icon is a gray symbol that looks like two triangles inside of a circle. 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. - 12) 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. - 13) 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° {13}------------------------------------------------ Image /page/13/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 a gray waveform inside of a circle. 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: {14}------------------------------------------------ Image /page/14/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 a gray symbol that looks like the letters VA inside of a circle. # 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. 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. | loaded when good primary stability is achieved and with appropriate occlusal loading. | | Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially dentulous jaws, to provide support for prosthetic devices such as artificial | implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. MIS short implants are to be used only with straight abutments. | achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components. | OD of 3.3mm (K172505) does not apply to the UniFit implant since the lowest OD is 3.5mm. | | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | | | Feature | Adin UniFit Dental Implant System | Adin Touareg CloseFit™ 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 | | | | | | | teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. | | | | | Patient population | Edentulous or partially edentulous patients | Edentulous or partially edentulous patients | Edentulous or partially edentulous patients | Edentulous or partially edentulous patients | Edentulous or partially edentulous patients | Edentulous or partially edentulous patients | Identical to the primary predicate device and the reference devices | | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | | | Feature | Adin UniFit Dental Implant System | Adin Touareg CloseFit™ 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 | | | Sterilization | Gamma Irradiation (implants and cover screw only) | Gamma Irradiation (implants and cover screw only) | Gamma Irradiation (implants and cover screw only) | Gamma Irradiation (implants and cover screw) | Gamma Irradiation (implants and cover screw) | Gamma Irradiation (implants) | Identical to the primary predicate device and the reference devices. | | Nature of body contact | Implant in bone/tissue contact for long term duration (>30 d) | Implant in bone/tissue contact for long term duration (>30 d) | Implant in bone/tissue contact for long term duration (>30 d) | Implant in bone/tissue contact for long term duration (>30 d)…