Adin Short Implants

K212775 · Adin Dental Implants Systems , Ltd. · DZE · Jul 8, 2022 · Dental

Device Facts

Record IDK212775
Device NameAdin Short Implants
ApplicantAdin Dental Implants Systems , Ltd.
Product CodeDZE · Dental
Decision DateJul 8, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.

Device Story

Adin Short Implants are two-piece, self-tapping, root-form screw-type dental implants. Inputs: surgical site in maxillary or mandibular arch. Transformation: mechanical fixation into bone to provide support for prosthetic devices (crowns, bridges, overdentures). Output: stable base for dental prosthetics. Used in clinical settings by dental professionals. The device is placed surgically; the provider uses the implant to restore chewing function. Benefits include restoration of oral function in edentulous or partially edentulous patients. The system includes cover screws, healing caps, and straight abutments. The device is provided sterile.

Clinical Evidence

Bench testing only. Evaluations included axial pull-out strength testing per ASTM F543, comparative bone-to-implant contact (BIC) surface area analysis, comparative surface analysis (SEM/EDS), biocompatibility testing (ISO 10993-1, ISO 10993-5, ISO 10993-11, ISO 10993-18, ISO 7405), sterilization validation (ISO 11137-2), shelf-life validation (ISO 11607-1), and non-clinical MRI safety review.

Technological Characteristics

Materials: Titanium 6AL-4V-ELI alloy (ASTM F136-13). Design: Two-piece, self-tapping, root-form screw. Surface treatments: AB/AE (Alumina Oxide Blast/Acid Etched) or OsseoFix (Calcium Phosphate). Dimensions: 6.25mm length; 4.2mm, 5.0mm, 6.0mm diameters. Connection: Internal hexagon. Sterilization: Gamma irradiation. Connectivity: None.

Indications for Use

Indicated for fully or partially edentulous patients requiring surgical placement of dental implants in the maxillary or mandibular arch to support crowns, bridges, or overdentures and restore chewing function. May be immediately loaded given good primary stability and appropriate occlusal loading. Restricted to use with straight abutments.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Adin Dental Implants Systems Ltd. % Tali Hazan RA Consultant Talmed Ltd Ramot-Naftali, M.P. Upper Galilee 1383000 ISRAEL Re: K212775 Trade/Device Name: Adin Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 4, 2022 Received: June 9, 2022 Dear Tali Hazan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212775 Device Name Adin Short Implants ### Indications for Use (Describe) Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <label><input checked="checked" type="checkbox"/> Residential Use (R1-SFR, R1-Duplex)</label> | |-----------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> On-Site Composting (R1-SFR only)</label> | 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." {3}------------------------------------------------ # 510(K) SUMMARY FOR ADIN SHORT IMPLANTS K212775 ### DATE PREPARED: JULY 07, 2022 #### 1. 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: +972-4-642-6732 Email: ilana.lutvak@adin-implants.com Contact person name: Tali Hazan, RA Consultant, Talmed Ltd. Phone: +972-50-5292304, Fax: +972-72-2448981, Email: tali.hazan@talmed.co.il. #### 2. DEVICE NAME - 2.1 Device's Trade name: Adin Short Implants - 2.2 Classification Name: Implant, Dental, Endosseous, Root-Form - 2.3 Device's Common Name: Endosseous dental implant - 2.4 Regulation Number: 21 CFR 872.3640 - 2.5 Class: II - 2.6 Product Code: DZE ### 3. PREDICATE DEVICES Adin Short Implants are substantially equivalent to the following Predicate Devices: - 3.1 Primary predicate device: Adin's Dental Implants System, cleared under 510(k) number K081751 on December 19, 2008. - 3.2 Reference device: Adin's Touareg CloseFit™ Dental Implant System, cleared under 510(k) number K112585 on May 24, 2012. - 3.3 Reference device: MIS's Short Implants, cleared under 510(k) number K103089 on September 15, 2011. - 3.4 Reference device: Blue Sky Bio's Dental Implant System, cleared under 510(k) number K102034 on April 19, 2011. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains four icons inside of circles. The first icon is a purple hexagon. The second icon is a blue triangle pointing downwards. The third icon is a green six-pointed star. The fourth icon is a gray symbol that looks like the letters VA. #### 4. DEVICE DESCRIPTION Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows: The Touareg™-S and Swell™ short implants with internal hexagon in 6.25mm length are available in diameters of 4.20mm, 5.0 mm and 6.0mm. The implants surface treatment is AB/AE (Alumina Oxide Blast/Acid Etched) for both of them. The Touareg-S short implant has a spiral tapered design and the Swell™ short implant has a straight, parallel walled, slightly tapered V-shape thread design. The Touareg-OS short implant with internal hexagon in 6.25mm length is available in diameters of 4.20mm, 5.0mm and 6.0mm. The implants surface treatment is OsseoFix™ (Calcium Phosphate). The Touareg™-OS short implant has the same design as the Touareg 10-S. The only difference between them is the surface treatment. As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. Body contact materials were evaluated for biocompatibility in accordance with FDA's Guidance document for Use of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing with a Risk Management Process, dated September 4, 2020 together with ISO 10993-1:2018 and ISO 7405:2018 standards. #### 5. INTENDED USE Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments. {5}------------------------------------------------ Image /page/5/Figure/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 green six-pointed star inside of a circle. The fourth icon is a gray symbol inside of a circle. #### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6. Adin Short Implants have the same intended use as the MIS short implants that were cleared under 510(k) K103089, Adin's Touareg™-S and Swell™ implants cleared under 510(k) number K081751, Adin's Touareg CloseFit™ K112585 and Blue Sky Bio's Dental Implant System cleared under 510(k) number K102034 (excluding the one-piece implant model). Adin Short Implants are available in three models: Touareg™-S, Touareg™-OS and Swell™. Two types of surface treatments are utilized for the short implants: AB/AE (Alumina Oxide Blast/Acid Etched), also used for Touareg™-S and Swell™ cleared implants and; OsseoFix™ (Calcium Phosphate), as cleared under 510(k) K112585, for Adin's Touareg CloseFit™ Dental Implant System. For the purpose of substantial equivalency, the Touareg™-S, Touareg™-OS and Swell™ short implants are supported by Adin's 510(k) K081751 while the Touareg™-OS is further supported by 510(k) K112585 only to cover the OsseoFix™ surface treatment method. The MIS short implants cleared under K103089 support the 6.25mm length dimension of all Adin Short Implants' models. The Blue Sky Bio Dental Implant System cleared under 510(k) K102034, was used for additional support of Adin's Swell™ pullout force. The subject device and its predicate devices have the same technology and basic performance characteristics. Except for the length dimensions, the design of the subject Touareg-STM and Swell™ short implants are exactly the same as the cleared Touareg-STM and Swell™ implants. The subject and predicate devices are manufactured from the same biocompatible Titanium alloy and undergo same machining, surface treatment and sterilization processes. It was therefore concluded that Adin Short Implants are substantially equivalent to the predicate devices. ### NON-CLINICAL PERFORMANCE DATA 7. A series of safety and performance tests and evaluations were performed to demonstrate that Adin Short Implants do not raise any new issues of safety and effectiveness to support substantial equivalence with the predicate devices. These evaluations included: {6}------------------------------------------------ Image /page/6/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 with a line above it inside of a circle. The third icon is a green six-pointed star inside of a circle. The fourth icon is a gray symbol that looks like two letter V's inside of a circle. ### a) Pull-Out Testing The test was performed to determining the axial pull-out strength of the Adin Short Implants as compared to the proposed predicate devices: MIS short implants (K103089) for the Touareg™-S and OS short implants and Blue Sky Bio Dental Implant System (K102034) for the Swell™ short implant. The test was performed according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device. ### b) Comparative Bone to Implant Contact Surface Area Analysis- Contact surface area was analyzed in comparison to both legally marketed devices (MIS short implants and Blue Sky Bio Dental Implant System, cleared under 510(k) K103089 and K102034, respectively), at worst case implant variation. ### c) Comparative Surface Analysis Before Surface Treatment - Implant actual surface area before surface treatment was compared to both legally marketed devices (MIS short implants and Blue Sky Bio Dental Implant System, cleared under 510(k) K103089 and K102034, respectively), at worst case implant variation. ## d) 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 using representative final implants with both surface treatments which went through Adin's entire production process, including packaging and sterilization (Gamma irradiation). ## e) Surface Analysis After Surface Treatment - The implants' surface after surface treatments was tested for each surface treatment type (AB/EA and OsseoFix™) using the SEM/EDS (Scanning Electron Microscope / Energy Dispersive X-ray Spectroscopy) which are valid, conventional and known methods to evaluate the quality of the treated surface area. {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 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 VA inside of a circle. #### Gamma sterilization validation f) Sterilization validation was conducted with successful results, using Gamma Irradiation according to VDmax method in accordance with ISO 11137-2 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 10-6. The sterilization validation includes both the implants and the cover screw. ### g) Shelf-life validation - Shelf-life validation was 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 standard. This validation confirmed that the sterility of Adin's sterile products will remain throughout the device shelf life. ### h) MR Environment Condition - Non-clinical worst-case MRI review was performed to evaluate the metallic Adin Short Implants in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices", Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. All performance tests' results and worst-case MRI review, support Adin's labeling claims in order to establish substantial equivalency with the selected predicate devices. #### 8. SUBSTANTIAL EQUIVALENCE Adin Short Implants are substantial 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. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains four different symbols inside circles. The first symbol is a purple hexagon. The second symbol is a teal triangle pointing downwards. The third symbol is a green six-pointed star. The fourth symbol is a gray abstract symbol. The Substantial equivalent decision was received based on the following comparison with the predicate devices: | Feature | Adin Short<br>Implants<br>(Touareg-STM,<br>TouaregTM-OS,<br>SwellTM) | Adin's Touareg-S<br>and SwellTM<br>Dental Implants,<br>cleared under<br>K081751 | Adin's<br>CloseFitTM<br>Dental Implant<br>System, cleared<br>under K112585 | MIS'S MIS<br>Short<br>Implants,<br>cleared under<br>K103089 | Blue Sky Bio's<br>Dental Implant<br>System, cleared<br>under K102034 | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | - Subject Device - | - Primary<br>Predicate Device - | - Reference<br>Device - | - Reference<br>Device - | - Reference<br>Device - | | 510(k) number | K212775 | K081751 | K112585 | K103089 | K102034 | | Classification | Class: II<br>Product code:<br>DZE<br>Regulation No.:<br>872.3640 | Class: II<br>Product code:<br>DZE (primary)<br>NHA (secondary)<br>Regulation No.:<br>872.3640 | Class: II<br>Product code:<br>DZE<br>(primary),<br>NHA<br>(secondary)<br>Regulation<br>No.: 872.3640 | Class: II<br>Product code:<br>DZE<br>(primary),<br>NHA<br>(secondary)<br>Regulation<br>No.: 872.3640 | Class: II<br>Product code:<br>DZE (primary),<br>NHA<br>(secondary)<br>Regulation No.:<br>872.3640 | | Indications For<br>Use | Adin Dental<br>Implants are<br>intended for<br>surgical<br>placement in the<br>maxillary and/or<br>mandibular arch<br>to support crowns,<br>bridges, or<br>overdentures in<br>fully or partially<br>edentulous<br>patients in order<br>to restore a<br>patient's chewing<br>function. Adin<br>Dental Implants<br>may be<br>immediately<br>loaded when good<br>primary stability<br>is achieved and<br>with appropriate<br>occlusal loading.<br>Adin short<br>implants are to be<br>used only with<br>straight<br>abutments. | Adin Dental<br>Implants are<br>intended for<br>surgical placement<br>in the maxillary<br>and/or mandibular<br>arch to support<br>crowns, bridges, or<br>overdentures in<br>edentulous or<br>partially<br>edentulous<br>patients.<br>Adin Dental<br>Implants may be<br>immediately<br>loaded when good<br>primary stability is<br>achieved and with<br>appropriate<br>occlusal loading. | Touareg<br>CloseFitTM<br>Dental<br>Implants are<br>intended for<br>surgical<br>placement in<br>the maxillary<br>and/or<br>mandibular<br>arch to support<br>crowns,<br>bridges, or<br>overdentures<br>in edentulous<br>or<br>partially<br>edentulous<br>patients.<br>Touareg<br>CloseFitTM<br>Dental<br>Implants may<br>be<br>immediately<br>loaded when<br>good primary<br>stability is<br>achieved and | MIS dental<br>implants are<br>intended to be<br>surgically<br>placed in the<br>bone of the<br>upper or lower<br>jaw arches to<br>provide<br>support for<br>prosthetic<br>devices, such<br>as artificial<br>teeth, in order<br>to restore a<br>patient's<br>chewing<br>function.<br>When a one<br>stage surgical<br>procedure is<br>applied, the<br>implant may be<br>immediately<br>loaded when<br>good primary<br>stability is<br>achieved and<br>the occlusal | Intended Use for<br>Two-Piece<br>Implant<br>Systems:<br>• For<br>implantation<br>into any area of<br>the fully<br>edentulous<br>maxilla and<br>mandible for<br>the support of a<br>removable or<br>fixed dental<br>prosthesis<br>• For single<br>tooth or<br>multiple unit<br>prosthesis<br>• For single<br>stage or two<br>stage surgical<br>procedure<br>• For immediate<br>placement and<br>immediate<br>function when<br>multiple units<br>are splinted | | Feature | Adin Short<br>Implants<br>(Touareg-STM,<br>TouaregTM-OS,<br>SwellTM)<br>- Subject Device - | Adin's Touareg-S<br>and SwellTM<br>Dental Implants,<br>cleared under<br>K081751<br>- Primary<br>Predicate Device - | Adin's<br>CloseFitTM<br>Dental Implant<br>System, cleared<br>under K112585<br>- Reference<br>Device -<br>with<br>appropriate<br>occlusal<br>loading. | MIS'S MIS<br>Short<br>Implants,<br>cleared under<br>K103089<br>- Reference<br>Device -<br>load is<br>appropriate.<br>MIS short<br>implants are to<br>be used only<br>with straight<br>abutments. | Blue Sky Bio's<br>Dental Implant<br>System, cleared<br>under K102034<br>- Reference<br>Device -<br>and for single<br>units when<br>adequate initial<br>stability is<br>achieved in<br>type I or type II<br>bone and under<br>appropriate<br>occlusal<br>loading.<br>Multiple units<br>may be<br>splinted with a<br>bar. In<br>edentulous<br>cases restored<br>with a fixed<br>prosthesis, four<br>or more<br>implants must<br>be used. | | Patient<br>population | Edentulous or<br>partially<br>edentulous<br>patients | Edentulous or<br>partially<br>edentulous patients | Edentulous or<br>partially<br>edentulous<br>patients | Edentulous or<br>partially<br>edentulous<br>patients | Edentulous or<br>partially<br>edentulous<br>patients | | Sterility | Sterile using<br>Gamma<br>Irradiation | Sterile using<br>Gamma Irradiation | Sterile using<br>Gamma<br>Irradiation | Sterile using<br>Gamma<br>Irradiation | Sterile using<br>Gamma<br>Irradiation | | Nature of body<br>contact | Implant in<br>bone/tissue<br>contact for long<br>term duration<br>(>30 d) | Implant in<br>bone/tissue contact<br>for long term<br>duration (>30 d) | Implant in<br>bone/tissue<br>contact for long<br>term duration<br>(>30 d) | Implant in<br>bone/tissue<br>contact for long<br>term duration<br>(>30 d) | Implant in<br>bone/tissue<br>contact for long<br>term duration<br>(>30 d) | | Prescription or<br>Over-the-<br>Counter (OTC) | Prescription | Prescription | Prescription | Prescription | Prescription | | Single use | Yes | Yes | Yes | Yes | Yes | | Operation<br>Principle | Single or Two-<br>Stages procedure<br>(immediate or<br>delayed loading) | Single or Two-<br>Stages procedure<br>(immediate or<br>delayed loading) | Single or Two-<br>Stages<br>procedure<br>(immediate or | Single or Two-<br>Stages<br>procedure<br>(immediate or | Single or Two-<br>Stages<br>procedure | | Feature | Adin Short<br>Implants<br>(Touareg-STM,<br>TouaregTM-OS,<br>SwellTM)<br>- Subject Device - | Adin's Touareg-S<br>and SwellTM<br>Dental Implants,<br>cleared under<br>K081751<br>- Primary Predicate Device - | Adin's<br>CloseFitTM<br>Dental Implant<br>System, cleared<br>under K112585<br>- Reference Device - | MIS'S MIS<br>Short<br>Implants,<br>cleared under<br>K103089<br>- Reference Device - | Blue Sky Bio's<br>Dental Implant<br>System, cleared<br>under K102034<br>- Reference Device - | | Placement<br>Method | Placing the<br>implant in the jaw<br>bone immediately<br>after drilling | Placing the implant<br>in the jaw bone<br>immediately after<br>drilling | Placing the<br>implant in the<br>jaw bone<br>immediately<br>after drilling | Placing the<br>implant in the<br>jaw bone<br>immediately<br>after drilling | Placing the<br>implant in the<br>jaw bone<br>immediately<br>after drilling | | Self-Tapping | Yes | Yes | Yes | Yes | Yes | | Implant<br>Material | Titanium Alloy -<br>6Al-4V-ELI | Titanium Alloy -<br>6Al-4V-ELI | Titanium<br>Alloy -<br>6Al-4V-ELI | Titanium Alloy<br>- 6A1-4V-ELI | Titanium Alloy<br>- 6Al-4V | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible | Biocompatible | | Shape | Screw type | Screw type | Screw type | Screw type | Screw type | | Connection | Internal hexagon | Internal hexagon | Conical<br>hexagon | Internal<br>hexagon | Internal hexagon<br>with taper,<br>Internal Square<br>with taper (anti-<br>rotational<br>feature) | | Surface<br>Treatment | AB/AE and<br>OsseoFixTM | AB/AE | OsseoFixTM<br>Calcium<br>Phosphate | Sand blasting<br>& Acid<br>Etching | Blasted with<br>resorbable<br>medium or<br>Aluminum<br>Oxide and Acid<br>Etched | | Implanted<br>Length | 6.25 mm | 8, 10, 11.5, 13, 16,<br>18 mm | 8, 10, 11.5, 13,<br>16, 18 mm | 6.0 mm | 6-16 mm | | Outer Diameter<br>(OD) | 4.2, 5, 6 mm | Swell Implant<br>Model: 3.30, 3.75,<br>4.2, 5, 6mm<br>Touareg-S Model:<br>3.5, 3.75, 4.2, 5,<br>6mm | 3.5, 3.75, 4.2,<br>5, 6mm | 4.2, 5, 6 mm | 3.25-5.0 mm | | Abutment<br>Angulation | Straight abutment<br>only | Straight and up to<br>25° | Straight and up<br>to 25° | Straight<br>abutment only | Straight and up<br>to 30° | | Packaging<br>(Microbial<br>Barrier) | Sterile barrier<br>Protective Tube | Sterile barrier<br>Protective Tube | Sterile barrier<br>Protective<br>Tube | Sterile barrier<br>Protective<br>Tube | Sterile barrier | | Feature | Adin Short<br>Implants<br>(Touareg-STM,<br>TouaregTM-OS,<br>SwellTM) | Adin's Touareg-S<br>and SwellTM<br>Dental Implants,<br>cleared under<br>K081751 | Adin's<br>CloseFitTM<br>Dental Implant<br>System, cleared<br>under K112585 | MIS's MIS<br>Short<br>Implants,<br>cleared under<br>K103089 | Blue Sky Bio's<br>Dental Implant<br>System, cleared<br>under K102034 | | | - Subject Device - | - Primary<br>Predicate Device - | - Reference<br>Device - | - Reference<br>Device - | - Reference<br>Device - | | Shelf-Life | 5 years | 5 years…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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