JDentalCare Implant System JDIcon

K182081 · Jdentalcare Srl · DZE · Jun 26, 2020 · Dental

Device Facts

Record IDK182081
Device NameJDentalCare Implant System JDIcon
ApplicantJdentalcare Srl
Product CodeDZE · Dental
Decision DateJun 26, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Device Story

System comprises titanium dental implant fixtures and prosthetic abutments; joined by through-screw with internal hexagon connection. Fixtures are tapered, threaded, and surface-treated via sandblasting and acid etching. Used by dentists/oral surgeons in clinics for single or multiple tooth replacement. Input: surgical site preparation in maxilla/mandible. Transformation: mechanical integration of fixture into bone; prosthetic attachment provides support for restorations. Output: restored masticatory function. Clinical decision-making: clinician assesses primary stability to determine suitability for immediate loading. Benefits: restoration of chewing function and dental aesthetics.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1, -3, -5, -10, -11), surface validation (SEM analysis), and mechanical fatigue testing (ISO 14801:2007) demonstrating resistance to 5,000,000 cycles. Sterilization validated per ISO 11137.

Technological Characteristics

Materials: Titanium Grade 4 (ASTM F67) and Grade 5 (ASTM F136). Design: Tapered screw, internal hexagon connection, sandblasted/acid-etched surface. Dimensions: 2.75mm to 5.0mm diameters. Sterilization: Gamma radiation (SAL 10^-6). Connectivity: N/A (mechanical).

Indications for Use

Indicated for replacement of missing teeth in maxilla or mandible. Supports single tooth, partially or fully edentulous spans, fixed/removable bridgework, or overdentures. 2.75mm diameter implants restricted to maxillary lateral incisors and mandibular lateral/central incisors. Suitable for single-stage or two-stage procedures, immediate or delayed loading, and immediate implantation in extraction sites or healed alveolar ridges.

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. June 26, 2020 J Dental Care S.r.1. % Guido Bonapace Official Correspondent ISEMED Srl Via P. Togliatti 19X Imola, Bologna 40026 ITALY Re: K182081 Trade/Device Name: JDentalCare® Implant System JDIcon® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 19, 2020 Received: June 25, 2020 Dear Guido Bonapace: 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. for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration ## Indications for Use Device Name JDENTALCARE® Implant System JDIcon® #### Indications for Use (Describe) JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. I Dental Care® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. I Dental Care® implant system IDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Type of Use (*Select one or both, as applicable*) | <div> <span style="font-size:12px"></span> </div> | <div> <span style="font-size:12px">Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |---------------------------------------------------|-----------------------------------------------------------------------------------------------| | | <div> <span style="font-size:12px">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | 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 the JDENTALCARE Implant System This 510(k) Summary is being submitted in accordance with the requirements of the 21 CFR 807.92. | 1. General Information<br>Submitter: | J DENTAL CARE S.r.l. is located at:<br>Via del Tirassegno 41/N<br>MODENA<br>ITALY | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Guido Bonapace<br>Isemed Srl<br>Via Palmiro Togliatti 19/X<br>Imola, BO 40026 ITALY<br>Tel. +39 0542 683803<br>Fax +39 0542 698456<br>Email: regulatory@isemed.eu | | Summary Preparation Date: | June 26, 2020 | | 2. Names | | | Device Name: | JDentalCare® Implant System JDIcon® | |--------------------------|-----------------------------------------| | Classification Name: | Implant, Endosseous, Root-form abutment | | Product Code: | DZE | | Product Code (Secondary) | NHA | | Regulation number: | 21 CFR 872.3640 | | CLASS | II | - 3. Predicate Devices The JDentalCare® Implant System JDIcon® is substantially equivalent to the devices legally marketed in US listed in the tables below. For the endosseous dental implant fixtures and implant the considered "primary predicate" device is the following: | Applicant | Device name | Device Model name | 510(k)<br>Number | Product<br>code | |-------------------------|--------------------------------|-------------------|------------------|-----------------| | J Dental Care<br>S.r.l. | JDentalCare® Implant<br>System | JDEvolution | K143142 | DZE<br>NHA | {4}------------------------------------------------ Moreover, the following reference devices have been considered: | Applicant | Device name | 510(k)<br>Number | |--------------------------------------|---------------------------------------|------------------| | Adin Dental Implants<br>Systems Ltd. | TOUAREG CloseFit™ UNP 2.75mmD | K153111 | | Nobel Biocare USA LLC | Nobel Active 3.0 | K102436 | | Straumann USA LLC | Straumann® Dental Implant System SLA® | K123784 | #### 4. Device Description JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon. Abutment and accessories are exclusive for JDentalCare® implant system JDIcon® JDentalCare® implant system JDIcon® is threaded (fully treated or with a collar of 1.5 mm), rootform dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered. Their surface is treated through sandblasting followed by acid etching treatment. JDIcon® implants may be placed in the oral cavity using either a single stage surgical procedure or a two-stage surgical procedure. If a single procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained. The available dimensions of the JDentalCare® implant system JDIcon®, considering the Fully treated collar version and the machined collar version, are shown in the table below. Note the MACHINED COLLAR referenced is not implanted in bone, making the implantable length of these implants 1.5 mm less than the total implant length listed below. | JDentalCare® Implant System JDIcon® // FULLY TREATED COLLAR | | | | | | | | |-------------------------------------------------------------|-----------------------|----------------------|----|------|------|----|----| | Image: Implant | IMPLANT DIAMETER (mm) | IMPLANT LENGTHS (mm) | | | | | | | | 2.75 | - | 10 | 11.5 | 13 | 15 | | | | 3.9 | - | 8 | 10 | 11.5 | 13 | 15 | | | 4.3 | - | 8 | 10 | 11.5 | 13 | 15 | | | 5 | - | 8 | 10 | 11.5 | 13 | 15 | | JDentalCare® Implant System JDIcon® // MACHINED COLLAR | | | | | | | | | Image: Implant | IMPLANT DIAMETER (mm) | IMPLANT LENGTHS (mm) | | | | | | | | 3.9 | - | - | 10 | 11.5 | 13 | 15 | | | 4.3 | - | - | 10 | 11.5 | 13 | 15 | | | 5 | - | - | 10 | 11.5 | 13 | 15 | The above listed dental implants are used with dedicated abutments, shortly described here below: {5}------------------------------------------------ - HEALING ABUTMENT: it is used in the delayed loading technique (used when there is not a good primary stability of the bone) to close the implant connection for non-submerged healing. It helps the qum to heal properly. The abutment is screwed into the implant. - -TEMPORARY ABUTMENT (engaging/non engaging): temporary abutments are used for the fabrication of temporary screw-retained restorations. Engaging and non-engaging variants are used for single- and multiple-unit restorations, respectively. - GP ABUTMENTS: these abutments are indicated for cemented temporary restorations of single and multiple implants. They can be modified with a drill or they can also be used as definitive abutment. - STRAIGHT ABUTMENTS: they are indicated for cemented prosthesis of single and multiple units. Collar height can be of 0,5 mm, 1,5 mm, 2 mm or 4 mm depending on the height of soft tissues. - ANATOMIC ABUTMENTS: these abutments are indicated for cemented prosthesis of single and multiple units. The anatomic abutment has an anatomical festoon preparation of the cervical marqin that ensure lesser need of abutment preparation. - -CONICAL ABUTMENTS: They are indicated for screwed-in prosthesis. Conical abutments are intended to be used only for multi-unit restorations, with no angulation correction. - -BALL ABUTMENTS: are indicated for overdentures with ball anchoring. - -EMI ABUTMENTS: are indicated for overdentures with hemispheric anchoring. #### 5. Indications for Use JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. {6}------------------------------------------------ #### Performance data 6. Dimensions, materials and technical features are substantially equivalent to those claimed by the predicate and the references devices. The following tests have been performed on JDentalCare® implant system JDIcon®: ## BIOCOMPATIBILITY TESTS Performed according to ISO 10993-1:2010 "Biological Evaluation of Medical Devices" (Part 1) - Cytotoxicity ● - Intracutaneous reactivity ● - Delayed Hypersensitivity - Acute Systemic Toxicity - Bacterial Reverse Mutation ## SURFACE VALIDATION TESTS Surface treatment is performed on implants through a sandblasting treatment followed by an acid etching treatment. Then, there is a cleaning process for the removal of manufacturing residual substances. A morphological SEM analysis and a cleaning process validation have been performed. These tests show the results of SEM analysis and the complete removal of materials used during manufacturing process. ### MECHANICAL TESTS The Mechanical test were performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatique test for endosseous dental implants". The tests demonstrated that the worst case chosen is able to resist to 5.000.000 cycles. ### STERILIZATION AND PACKAGING SHELF LIFE JDentalCare® implant system JDIcon® is sterilized with gamma ray sterilization to assure a SAL level of 106. The validation of the sterilization process has been performed. Shelf life granted is 5 years. The packaging is different for dental implants and abutments. The implants are provided sterile, while the abutments are not sterile and have to be sterilized prior to use. The packaging of the implants and abutments are exactly the same used for the predicate device JDentalCare® implant system (K143142), the sterilization methods are the same, thus JDENTAL considered that the blister validation report validating the packaging used for dental implants is still valid. ### OTHER TESTS The devices have addressed pyroqenticity information according to FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." {7}------------------------------------------------ ## 7. Substantial Equivalence Discussion: ## COMPARISON TABLE FOR GENERAL FEATURES | Item | Proposed device | Predicate device | Reference devices | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | JDENTALCARE®<br>JDIcon®<br>Implant System<br>(K182081) | JDENTALCARE®<br>Implant System<br>(K143142) | ADIN-TOUAREG<br>CloseFit™<br>UNP 2.75mmD<br>(K153111) | NOBEL BIOCARE<br>NobelActive 3.0<br>(K102436) | STRAUMANN<br>DENTAL Implant<br>System SLA<br>(K123784) | | | Indication<br>for Use | JDentalCare® implant<br>system JDIcon® is intended<br>to replace missing<br>masticatory functional<br>units (teeth) within the<br>maxilla or mandible.<br>JDentalCare® implant<br>system JDIcon® is<br>comprised of dental<br>implant fixtures and<br>prosthetic devices. It<br>provides a means for<br>prosthetic attachment in<br>single tooth restorations<br>and partially or fully<br>edentulous spans with<br>multiple single teeth<br>utilizing delayed or<br>immediate loading, or as a<br>terminal or intermediary<br>abutment for fixed or<br>removable bridgework or<br>to retain overdentures.<br>Prosthetic devices provide<br>support and retention for<br>screw-retained or<br>cemented restorations in<br>mandible and maxilla.<br>JDentalCare® implant<br>system is intended for<br>immediate function on<br>single tooth and/or<br>multiple tooth applications<br>when good primary<br>stability is achieved, with<br>appropriate occlusal<br>loading, in order to restore<br>chewing function.<br>JDentalCare® implant<br>system JDicon® 2.75mm D<br>Dental Implant shall only<br>be used to replace<br>maxillary lateral incisors<br>and mandibular lateral<br>and central incisors for<br>single-stage or two-stage<br>procedures. It is for<br>immediate implantation in<br>extraction sites or<br>implantation in partially<br>healed or completely<br>healed alveolar ridge<br>situations. | JDENTALCARE®<br>implant system is<br>intended for<br>surgical placement<br>in the upper or<br>lower jaw.<br>JDentalCare®<br>implant system is<br>comprised of<br>dental implant<br>fixtures and<br>prosthetic devices.<br>JDentalCare®<br>implant system<br>provides a means<br>for prosthetic<br>attachment in<br>single tooth<br>restorations and<br>partially or fully<br>edentulous spans<br>with multiple<br>single teeth<br>utilizing delayed or<br>immediate<br>loading, or as a<br>terminal or<br>intermediary<br>abutment for fixed<br>or removable<br>bridgework or to<br>retain<br>overdentures.<br>Prosthetic devices<br>provide support<br>and retention<br>abutment for<br>screw-retained or<br>cemented<br>restorations in<br>mandible and<br>maxilla.<br>JDENTALCARE®<br>implant system is<br>intended for<br>immediate function<br>on single tooth<br>and/or multiple<br>tooth applications<br>when good primary<br>stability is achieved,<br>with appropriate<br>occlusal loading in | TOUAREG<br>CloseFit™ UNP<br>2.75mmD implants<br>are indicated to<br>replace missing<br>masticatory<br>functional units<br>(teeth) in single or<br>multiple unit<br>applications within<br>the mandible or<br>maxilla.<br>For single-stage or<br>two-stage<br>procedures. For<br>immediate<br>implantation in<br>extraction sites or<br>implantation in<br>partially healed or<br>completely healed<br>alveolar ridge<br>situations. When a<br>one-stage surgical<br>approach is<br>applied, the<br>implant maybe<br>immediately<br>loaded when good<br>primary stability is<br>achieved and the<br>functional load is<br>appropriate.<br>The TOUAREG<br>CloseFit™ UNP<br>2.75mmDDental<br>Implant shall only<br>be used to replace<br>maxillary lateral<br>incisors and<br>mandibular lateral<br>and central incisors. | The NobelActive<br>3.0mm implant is<br>indicated for use in<br>the treatment of<br>missing maxillary<br>lateral incisors or<br>the mandibular<br>central and lateral<br>incisors to support<br>prosthetic devices,<br>such as artificial<br>teeth, in order to<br>restore chewing<br>function in partially<br>edentulous patients.<br>The NobelActive 3.0<br>implants may be put<br>into immediate<br>function provided<br>that stability<br>requirements<br>detailed in the<br>manual are satisfied. | | stage surgical approach is<br>applied, the implant may<br>be immediately loaded<br>when good primary<br>stability is achieved and<br>the functional load is<br>appropriate. | order to restore<br>chewing function. | | | | | {8}------------------------------------------------ General features comparison description. The indication for use of the JDentalCare® Implant System JDIcon® is similar to the one declared by the predicate device JDentalCare® implant system (K143142), because JDIcon® implant systems are new fixtures of dental implants manufactured by J Dental Care S.r.l. Differences are related to the specific application intended for JDentalCare® JDIcon® Implant System 2,75 mm. For this particular indication for use, the proposed Device Family JDentalCare® JDIcon® Implant System declares the same specific use (JDIcon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors) to the one declared by the reference device ADIN TOUAREG CloseFit™ UNP 2.75mmD (K153111), which propose implant fixture having the same diameter and length. Specifically, both 2.75 mm Implant fixture devices are intended for single or multiple unit applications, and for single-stage or twostage procedures, just to replace maxillary lateral incisors and mandibular lateral and central incisors. The indication for use of the proposed device JDentalCare® Implant System JDIcon® can also be considered equivalent to the indication for use of the other reference devices because all the reference devices are designed to be surgically placed in upper or lower jaw or, in other words, in the bone of the mandible and/or maxillary. Particularly, the JDentalCare® Implant System JDIcon®, as the predicate device JDentalCare® implant system (K143142), the reference devices ADIN TOUAREG CloseFit™ UNP 2.75mmD (K153111) / NOBEL BIOCARE NobelActive 3.0 (K102436), are complete implant system, fixtures and abutments with different fixture models. The device STRAUMANN Dental Implant System SLA cleared in K123784, has been considered as reference device because it has the same surface treatment of the proposed device. Therefore, in terms of indications for use, the JDentalCare® Implant System JDIcon® devices can be considered substantially equivalent to the identified predicate and reference devices. The JDentalCare® Implant System JDIcon® is compliant to the same standards which have been applied by the predicate device JDentalCare® Implant System JDIcon® (K143142). ### Conclusion – General Features In light of evidence discussed above, considering the general features of the device, the proposed JDentalCare® implant system JDIcon® may be found substantially equivalent compared to the identified predicate and reference devices. {9}------------------------------------------------ ## COMPARISON TABLE FOR ENDOSSEOUS IMPLANTS FIXTURE | | Proposed device | Predicate device | Reference device | |-----------------------------------------------------|---------------------------------------------|-------------------------------------------------|---------------------------------------------| | | JDIcon® | JDENTALCARE® | ADIN - TOUAREG CloseFit™ UNP | | | Implant System | Implant System | 2.75mmD | | | (K182081)) | (K143142) | (K153111) | | Indication | Immediate or delayed load | Immediate or delayed load | Immediate or delayed load | | Placement<br>method | Dual or single stage surgery | Dual or single stage surgery | Dual or single stage surgery | | | Titanium Grade 5 | Titanium Grade 5 | | | Materials | Ø2.75 mm | Ø 3,25mm | Titanium Grade 23 | | | Titanium Grade 4 | Titanium Grade 4 | Ti 6AL-4V ELI | | Design - Mechanical features | Ø 3.9 / 4.3 / 5 mm | Ø 3.7 / 4.3 / 5 / 6 mm | | | | Two pieces | Two pieces | Two pieces | | Shape | Tapered screw | Tapered screw | Tapered screw | | | Conical with Internal Hexagon | Internal Hexagon | Conical-Hex connection | | | Double Thread | Double Thread | | | Thread of | Lead 1,2mm | Lead 1,2 mm | Triple Lead thread with 3 mm | | the body | (thread space) | (thread space) | pitch | | | outline: trapezoidal | outline: trapezoidal | | | Neck | Collar with crestal grooves lead | Collar with | | | features | 0,25 mm (for Ø2,75 mm) | Crestal grooves | Collar with crestal grooves lead | | | | lead 0,3 mm | | | Design - Surface features | | | | | Body | Sandblasting followed by acid<br>etching | Double Acid Etching | OsseoFix™ and<br>anodized | | Neck | Sandblasting followed by acid | N/A | OsseoFix™ and | | | etching (for fully threated version) | | anodized | | Design - Dimensions | | | | | | NC 2.75 x 10 | | NC 2.75 x 10 | | Diameter | NC 2.75 x 11.5 | | NC 2.75 x 11.5 | | X<br>Length | NC 2.75 x 13 | | NC 2.75 x 13 | | (mm) | NC 2.75 x 15 | | NC 2.75 x 16 | | | NC 3.9 x 8 | NC 3.7 x 8 | | | C - | NC 3.9 x 10 | NC 3.7 x 10 | | | Machined | NC 3.9 x 11.5 | NC 3.7 x 11.5 | | | Collar | NC 3.9 x 13 | NC 3.7 x 13 | | | | NC 3.9 x 15 | NC 3.7 x 15 | | | NC -<br>Fully treated | | | | | (Not | C 3.9 x 10 (*) | NC 3.7 x 8 | | | machined | C 3.9 x 11.5 (*) | NC 3.7 x 10 | | | Collar) | C 3.9 x 13 (*) | NC 3.7 x 11.5 | | | | C 3.9 x 15 (*) | NC 3.7 x 13 | | | | | | | | | NC 4.3 x 8 | NC 4.3 x 8 | | | | NC 4.3 x 10 | NC 4.3 x 10 | | | | NC 4.3 x 11.5 | NC 4.3 x 11.5 | | | | NC 4.3 x 13 | NC 4.3 x 13 | | | | NC 4.3 x 15 | NC 4.3 x 15 | | | | | | | | | Proposed device | Predicate device | Reference device | | | JDIcon® | JDENTALCARE® | ADIN - TOUAREG CloseFit™ UNP | | | Implant System | Implant System | 2.75mmD | | | (K182081) | (K143142) | (K153111) | | | C 4.3 x 10 (*) | NC 4.3 x 8 | | | | C 4.3 x 11.5 (*) | NC 4.3 x 10 | | | | C 4.3 x 13 (*) | NC 4.3 x 11.5 | | | | C 4.3 x 15 (*) | NC 4.3 x 13 | | | | - | - | | | | NC 5.0 x 8 | NC 5.0 x 8 | | | | NC 5.0 x 10 | NC 5.0 x 10 | | | | NC 5.0 x 11.5 | NC 5.0 x 11.5 | | | | NC 5.0 x 13 | NC 5.0 x 13 | | | | NC 5.0 x 15 | NC 5.0 x 15 | | | | - | - | | | | C 5.0 x 10 (*) | NC 5.0 x 8 | | | | C 5.0 x 11.5 (*) | NC 5.0 x 10 | | | | C 5.0 x 13 (*) | NC 5.0 x 11.5 | | | | C 5.0 x 15 (*) | NC 5.0 x 13 | | | Type | Conical connection<br>with internal hexagon | Internal Hexagon | Conical - Hex connection | | Platform<br>size /<br>Abutment<br>interface<br>(mm) | Plat / Diameter<br>2.3<br>3.4<br>3.4<br>3.4 | Plat / Diameter<br>2.75<br>3.90<br>4.30<br>5.00 | Plat / Diameter<br>3.4<br>3.4<br>3.4<br>3.4 | | | | 3.7<br>4.3<br>5.0 | 2.25<br>2.75 | | kind of<br>package | Plastic vial + blister | Plastic vial + blister | Double vial | | Sterile | Yes<br>Gamma Radiation | Yes<br>Gamma Radiation | Yes<br>Gamma Radiation | {10}------------------------------------------------ (*) see collar comparison description Endosseous implant fixtures comparison description. JDentalCare® Implant System JDIcon® and the predicate device JDentalCare® Implant System (K143142) and reference devices (K15311) are indicated for delayed or immediate loading, with the warning that for the immediate loading a good primary stability shall be achieved. JDentalCare® Implant System JDIcon®, can be used both for dual or single stage surgery, like the predicate device (K143142) and reference devices (K153111). The materials used to manufacture the JDentalCare® Implant System JDIcon® Endosseus dental implants are Titanium Grade 4 (implant fixtures diameters 3.9 / 4.3 / 5 mm) and Titanium Grade 5 for implant fixtures diameter 2.75 mm. The predicate device uses the same materials for similar components: Titanium Grade 4 (diameters 3.7 / 4.3 / 5 / 6 mm) and Titanium Grade 5 for dental implants with the smaller diameter (3,25 mm for the predicate K143142). Both Titanium Grade 4 (compliant to the ASTM F67) and Titanium Grade 5 (compliant to the ASTM F136) are widely recommended in biomedical applications, such as implantable components, due to their biocompatibility with human tissue. The biocompatibility of the proposed devices has been verified by means of specific tests, according to ISO 10993-1 and related standards. Moreover, the mechanical difference between Titanium Grade 5 and titanium Grade 23 adopted by the reference devices (K153111) have been addressed and justified by means of mechanical test according to ISO standard 14801:2007. {11}------------------------------------------------ The shape of the fixtures, the shape of the neck and the kind of thread and/or micro-thread used to manufacture the fixtures included in the JDentalCare® implant system JDIcon® are very similar to the mechanical solution adopted by the predicate devices and reference devices. (*) Implant bodies with collar version (1.5 mm for diameters 3.9 / 4.3 / 5.0). The mechanical features for this solution can be considered the same if compared to the fully treated version having similar implantable length. Particularly, considering that the implantable section of a collar versions is equal to the total length reduced by the collar dimension (L – 1,5 mm) similar implantable length have been taken into account while comparing the predicate devices JDentalCare® (JDEvolution -K143142). About biocompatibility, we can consider the Titanium Grade 4 and 5 property and similitude claimed for surface treatment with reference device STRAUMANN Dental Implant System SLA (K123784). The surface treatment of the subject device JDentalCare® implant system JDIcon® is substantially equivalent to the surface of the reference device K123784. About dimensions, the comparison table shows that dimensions are similar between the proposed device JDentalCare® implant system JDIcon® and its predicate/references devices and any remaining small differences do not impact substantial equivalence. ### Particularly: Dimensions combinations 2.75 x 10 / 11.5 / 13 are the same proposed by the reference device TOUAREG CloseFit™ 2.75mmD - (K153111). The dimension combination 2.75 x 15 results within the range of the reference device (K153111 - 2.75 x 16 mm). We believe that it can be considered structurally able to perform the expected performances, according to "Class II Specials Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Even if not all combinations are identical, the proposed dimensions are all within the same diameter x length range of the primary predicate and reference devices, thus can be considered substantially equivalent. ### Connection system. JDentalCare® implant system JDIcon®, similarly to the predicate device JDentalCare® implant system (JDEvolution – K143142) and the reference devices (K153111) have a connection solution with internal hexagon. Particularly, the connection system for the two-pieces JDentalCare® Implant System JDIcon® 2.75 mm implants is conical with internal Hexagon, as the reference device TOUAREG CloseFit™ 2.75mmD (K153111). For the small implant diameter (2.75 mm) the platform size and abutment interface ratio are similar to the one proposed by the reference device (K153111). The platform size and abutment interface for proposed diameters 3.9 / 4.3 / 5.0 mm are very similar to the ones adopted by the predicate device JDentalCare® implant system (JDEvolution -K143142) having diameters 3.7 / 4.3 and 5.0 mm. To verify the mechanical design of the connection system JDentalCare® has performed specific mechanical tests, in compliance with ISO 14801 method. Thus, the methods of connection used by the JDentalCare® implant system JDIcon® are substantially equivalent to the connection methods used by the predicate and reference devices. Packaging. {12}------------------------------------------------ The JDentalCare® Implant System JDIcon® fixtures are sold in sterile condition, into a double package composed by a plastic vial inserted into a blister. Sterilization is done through gamma rays. This kind of packaging and sterilization method is exactly the same used for the predicate device JDentalCare® implant system (K143142). The sterilization method has been and the related validation protocol and report have already been submitted to the Agency. The packaging of the JDentalCare® Implant System JDIcon® fixtures is exactly the same of the packaging used for the predicate device JDentalCare® implant system (K143142), thus the validation of packaging and shelf life, in order to maintain the sterility condition for 5 years can be considered valid also for the JDIcon® implants. ### Conclusion - Endosseous implant fixtures In light of evidence discussed above, materials, shape, surface treatment, dimensions, connection system, packaging and sterilization method may be found substantially equivalent compared to the identified predicate and reference devices. {13}------------------------------------------------ ## JDentalCare® IMPLANT SYSTEM JDICON® ## COMPARISON TABLE FOR ABUTMENTS FEATURES | | Proposed device | | Predicate device | | Reference device | | | | | |------------------------|--------------------------------------------------------------------|------------------|---------------------------------------------------------------|------------------|--------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------|------------------|--| | Features | JDIcon® Implant System<br>(K182081) | | JDENTALCARE® Implant System<br>(K143142) | | ADIN - TOUAREG CloseFit™<br>UNP 2.75mmD (K153111) | NOBEL BIOCARE NobelActive 3.0<br>(K102436) | | | | | Design | | | | | | | | | | | Healing<br>abutment | Available in 3 height: 3, 5 and 7 mm<br>Material: Titanium Grade 5 | | Available in 3 height: 3,5,7mm<br>Material: Titanium Grade 5 | | Ref from UNP0046 to UNP0050<br>Ref from UNP0004 to UNP0013<br>Material Ti 6Al 4V ELI | | Ref. models 36794-36795-36796.<br>Available in 3 height: 3,5,7mm<br>Material: Titanium Grade 5 | | | | | Diameter x Height | Implant Diameter | Diameter x Height | Implant Diameter | Diameter x Height | Implant Diameter | | | | | | 3.2 x 3/5/7 (mm) | 2.75 (mm) | // | | 2.75 x 3/5/7 (mm) | 2.75 (mm) | 3.2 x 3/5/7 (mm) | 3.00 (mm) | | | | 4.0 x 3/5/7 (mm) | 2.75 (mm) | | | 4.0 x 3/5/7 (mm) | 2.75 (mm) | 3.8 x 3/5/7 (mm) | 3.00 (mm) | | | | 4.0 x 3/5/7 (mm) | 3,9 (mm) | 4.0 x 3/5/7 (mm) | 3,7 | // | | // | | | | | 4.0 x 3/5/7 (mm) | 4,3/5 (mm) | 4.0 x 3/5/7 (mm) | 4,3/5 | | | | | | | | 5.0 x 3/5/7 (mm) | 3,9 (mm) | 5.0 x 3/5/7 (mm) | 3,7 | | | | | | | | 5.0 x 3/5/7 (mm) | 4,3/5 (mm) | 5.0 x 3/5/7 (mm) | 4,3/5 | | | | | | | | | | 5.0 x 9 (mm) | 3.7/4.3/5.0 | | | | | | | | 6.0 x 3/5/7 (mm) | 3.9 | 6.0 x 3/5/7 (mm) | 3.7 | | | | | | | | 6.0 x 3/5/7 (mm) | 4.3/5.0 | 6.0 x 3/5/7 (mm) | 4.3/5.0 | | | | | | | Temporary<br>abutments | Engaging / Non-Engaging models.<br>Material: Titanium Grade 5 | | Engaging / Non-Engaging models.<br>Material: Titanium Grade 5 | | Engaging / Non-Engaging models.<br>Material: Ti 6Al 4V ELI | | Engaging / Non-Engaging models.<br>Ref. model 36779 (Engaging)<br>Material: Titanium Grade 5 | | | | | Exagon/Diameter | Implant Diameter | Exagon/Diameter | Implant Diameter | Exagon/Diameter | Implant Diameter | Exagon | Implant Diameter | | | | 1.8 mm Eng. | 2.75 | // | | 1.9 mm Eng. | 2.75 | 1.5 mm Eng. | 3.0 | | | | - | - | | | Non engaging | 2.75 | | | | | | 2.65 mm Eng. | 3.9 | 2.65 mm Eng. | 3.7 | | | | | | | | 2.65 mm Eng. | 4.3 / 5.0 | 2.65 mm Eng. | 4.3 / 5.0 / 6.0 | // | | | //// | | | | 3.3 mm Non Eng. | 3.9 | 3.3 Non Eng. | 3.7 | | | | | | | | 3.3 mm Non Eng. | 4.3 / 5.0 | 3.3 Non Eng. | 4.3 / 5.0 / 6.0 | | | | | | {14}------------------------------------------------ ## JDentalCare® IMPLANT SYSTEM JDICON® | | Proposed device | | Predicate device | | Reference device | | | |----------------------------------------------|---------------------------------------------------------------------|------------------|-----------------------------------------------------------------|------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------| | Features | JDIcon® Implant System<br>(K182081) | | JDENTALCARE® Implant System<br>(K143142) | | ADIN - TOUAREG CloseFit™<br>UNP 2.75mmD (K153111) | NOBEL BIOCARE NobelActive 3.0<br>(K102436) | | | GP<br>Abutment | Material: Titanium Grade 5<br>Abutment screw: included | | Material: Titanium Grade 5<br>Abutment screw: included | | | Narrow profile abutments.<br>Ref. codes 36781 - 36780<br>Material: Titanium Grade 5<br>Abutment screw: included | | | | Diameter x height | Implant Diameter | Diameter x height | Implant Diameter | Diameter x height | Implant Diameter | | | | 3.2/4.0 mm x 10 | 2.75 | | | | 3.2 mm x 7.0/9.0<br>3.0 | | | | 4.0/5.0 mm x 10.5 | 3.9 | 4.0/5.0 mm x 10.5 | 3.7 | // | | | | | 6.0 mm x 10.5 | 3.9 | 6.0 mm x 10.5 | 3.7 | | | | | | 4.0/5.0 mm x 10.5 | 4.3/5.0 | 4.0/5.0 mm x 10.5 | 4.3/5.0 | // | | | | | 6.0 mm x 10.5 | 4.3/5.0 | 6.0 mm x 10.5 | 4.3/5.0 | | | | | Fixed<br>Prosthesis | Material: Titanium Grade 5 | | Material: Titanium Grade 5 | | Collar Height 1.0-2.0-3.0 mm Straight<br>(Ref. Code UNP0019-0011-0064)<br>Material: Ti 6Al 4V ELI | Collar Height 1.5-3-4.5 mm Straight<br>(Ref. Code 36782 – 36783 - 36814)<br>Material: Titanium Grade 5 | | | Straight<br>abutment | Dia x Collar Height | Implant Diameter | Dia x Collar Height | Implant Diameter | Dia x Collar Height | Implant Diameter | | | | // | | | | 4.0 x 1 | 2.75 | | | | 4.0 x 2 mm | 2.75 | // | | 4.0 x 2 | 2.75 | | | | 4.0 x 4 mm | 2.75 | | | 4.0 x 3 | 2.75 | | | | 4.5 x 2 mm | 3.9 | 4.5 x 2 mm | 3.7 | // | | | | | 4.5 x 4 mm | 3.9…
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