JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus

K233896 · Jdentalcare Srl · DZE · Aug 16, 2024 · Dental

Device Facts

Record IDK233896
Device NameJDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
ApplicantJdentalcare Srl
Product CodeDZE · Dental
Decision DateAug 16, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. JDentalCare Dental Implant System 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. JDental 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. When a onestage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. 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.

Device Story

Two-piece endosseous dental implant system; comprises titanium fixtures and various abutments. Fixtures surgically placed in maxilla or mandible; abutments screwed into fixtures to support prosthetic restorations. Input: surgical site preparation; Output: mechanical support for artificial teeth. Used in dental clinics by dentists. System includes tapered screw fixtures with internal hexagon or conical connections; surface treated via sandblasting and acid etching (SLA). Abutments provide support for screw-retained or cemented restorations. Immediate or delayed loading protocols supported based on primary stability. Benefits: restores chewing function and esthetics; provides solid support for prosthetic teeth. System includes healing, temporary, straight, GP, conical, ball, EMI, and octa abutments. Anodized options available for specific components. Not for patient self-use.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993), mechanical dynamic loading (ISO 14801), sterilization validation (ISO 11137), and MRI safety review.

Technological Characteristics

Materials: Titanium Grade 4 (implants), Titanium Grade 5 (abutments). Design: Two-piece tapered screw with internal hexagon or conical connection. Surface: SLA (sandblasting/acid etching) or anodized. Dimensions: 3.5-6mm diameter, 8-20mm length. Sterilization: Gamma radiation (implants); steam sterilizable (abutments). Connectivity: Standalone mechanical system.

Indications for Use

Indicated for replacement of missing teeth in maxilla or mandible. Suitable for single tooth, partially or fully edentulous spans, fixed/removable bridgework, or overdentures. Supports immediate or delayed loading protocols. 20mm implants in maxilla restricted to splinted multiple-unit restorations. JDIcon 2.75mm D implants restricted to maxillary lateral incisors and mandibular lateral/central incisors.

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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. August 16, 2024 JDentalCare Srl % Maurizio Pantaleoni Consultant Via Borgo Santa Cristina 12 Imola, Bologna 40026 ITALY Re: K233896 Trade/Device Name: JDental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 18, 2024 Received: July 22, 2024 Dear Maurizio Pantaleoni: 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. {1}------------------------------------------------ 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" (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 QS 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}------------------------------------------------ For comprehensive regulatory information about mediation-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) K233896 #### Device Name JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus #### Indications for Use (Describe) JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. .DentalCare Dental Implant System 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 Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate. Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. JDental Care 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 | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---| | 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 # JDentalCare® Dental Implant System This 510(k) Summary is being submitted as required by 21 CFR 807.92. #### 1. General Information Regulation number: CLASS | | Submitter: | J DENTAL CARE S.r.l. is located at:<br>Via Dino Campana, 2<br>MODENA<br>ITALY<br>Tel. +39 059 454255<br>Fax +39 059 450045 | |----|-------------------------|----------------------------------------------------------------------------------------------------------------------------| | | Consultant/ Contact: | Maurizio Pantaleoni<br>Via Borgo Santa Cristina 12 | | | | 40026 Imola (BO) | | | | Mobile: +39 348-4435155<br>Email: maurizio.pantaleoni@gmail.com | | | Summary Prepared Date: | August 16, 2024 | | 2. | Names | | | | Device Name: | JDentalCare Dental Implant System:<br>JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | | | Classification Name: | Implant, Endosseous,<br>Root-form / Endosseous dental<br>implant abutment | | | Product Code: | DZE | | | Secondary Product Code: | NHA | 872.3640 ll {5}------------------------------------------------ #### 3. Predicate Devices The JDentalCare® Dental Implant System, is substantially equivalent to the following predicate device legally marketed in US: | Applicant | Device name | 510(k) Number | Product<br>code | |----------------------|----------------------------------------|---------------|-----------------| | J DENTAL CARE S.r.l. | JDentalCare® Implant System<br>JDIcon® | K182081 | DZE<br>NHA | These predicate devices have not been subject to a design-related recall. Reference devices that have been considered are the following: | Applicant | Device name | 510(k) Number | Product code | |--------------------------------------|----------------------------------------------------|---------------|--------------| | J DENTAL CARE S.r.l. | JDentalCare® Implant System<br>JDEvolution® | K143142 | DZE<br>NHA | | Adin Dental Implants<br>Systems Ltd. | TOUAREG CloseFit™ UNP 2.75mmD | K153111 | DZE<br>NHA | | Nobel Biocare AB | TiUltra Implants and Xeal Abutments | K202344 | DZE | | Nobel Biocare AB | NobelSpeedy® Groovy | K160119 | DZE | | Nobel Biocare AB | Nobel Active | K142260 | DZE<br>NHA | | Nobel Biocare AB | Nobel Biocare Healing Cap Multi-Unit<br>Titanium | K171142 | NHA | | MIS Implants<br>Technologies | MIS V3 Conical Connection Dental Implant<br>System | K163349 | DZE<br>NHA | This reference devices have not been subject to a design-related recall. #### 4. Device Description General Dental implant surgery is a procedure that replaces tooth roots with metal, screwlike posts and replaces damaged or missing teeth with artificial teeth. Dental implant surgery can offer an alternative to dentures or bridgework and can offer an option when a lack of natural teeth roots don't allow building denture or bridgework tooth replacements. How dental implant surgery is performed depends on the type of implant and the condition of the jawbone. Dental implant surgery may involve several procedures. The major benefit of implants is solid support for your new teeth - a process that requires the bone to heal tightly around the implant. JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery. In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection. {6}------------------------------------------------ #### Implants Description #### JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis. The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System. Image /page/6/Figure/6 description: The image shows a diagram of a dental implant. The diagram shows the different parts of the implant, including the abutment, gum, endosseous dental implant, and bone. The artificial replacement tooth is placed on top of the abutment. Endosseous dental implant and abutment will represent the support, for the dentist, for building the artificial replacement tooth. The artificial replacement tooth component is not part of this submission. | JDentalCare® Dental Implant System | | | |------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------| | Design | | | | General: | | | | General Features | Two pieces dental implant system with internal hexagon connection | | | Shape: | | | | Implant Body | Tapered screw | | | Implant Neck | Cylindrical | | | Implants Materials: | Diameter 3.5 – 3.7 – 3.9 – 4.0 – 4.3 –<br>4.5 – 5.0 – 6.0 | Titanium Grade 4 | | | | | | Abutment material: | All abutments | Titanium Grade 5 | | Surface: | | | | Implant | Implants JDEvolution Plus, JDIcon, JDIcon Plus are treated through<br>sandblasting followed by acid etching (SLA) | | | Neck | JDEvolution plus – Available with: | | | | - fully treated collar or | | | | - 1.5 mm anodized collar both for model with 1.2 and 0.6 mm pitch | | | | - 2.5 mm anodized collar only for model with 1.2 mm pitch and 4.0 mm diameter | | | | | | | | JDEvolution: no new dental implants introduced, but only prosthetic | | | | components introduced in this submission | | | | | | | | JDIcon – Available with | | | | - fully treated collar or | | | | - 1.5 mm machined collar | | | JDentalCare® Dental Implant System | | | | | JDIcon plus – Available with: | | | | - fully treated collar, both for model with 1.2 and 0.8 mm pitch or | | | | - 1.5 mm anodized collar only for double thread models | | | Abutment | Abutment surface can be: | | | | - Smooth/Machined (no treatment) | | | | - Anodized (Yellow, Green, Purple, Magenta) | | | | (Ref to section below about prosthetic components) | | | Thread: | | | | Body | Double thread | | | | Pitch can be different for the different models: | | | | JDEvolution plus | | | | - Pitch 1.2 mm for fully treated collar | | | | - Pitch 1.2 mm for 1.5 mm and 2.5 mm anodized collar | | | | - Pitch 0.6 mm for 1.5 mm anodized collar (only 4.0 diameter) | | | | JDEvolution: no new dental implants introduced, but only prosthetic | | | | components introduced in this submission | | | | JDIcon – Available with | | | | - Pitch 1.2 mm for fully treated collar or | | | | - Pitch 1.2 mm for 1.5 mm machined collar | | | | JDIcon plus – Available with: | | | | - Pitch 1.2 mm for 1.5 mm anodized collar | | | | - Pitch 1.2 mm for fully treated collar, | | | | - Pitch 0.8 mm (single thread) and fully treated collar ( <i>Only for JDIcon plus</i> | | | | 3.5 mm, 4.0 mm, 4.5 mm) | | | Self-Threading<br>Capacity | Self-threading capacity in both direction | | | | Implant Dimensions (refer to tables below for more details) | | | Diameter | From 3.5 to 6 mm | | | Length | From 8 to 20 mm | | | Neck diameter | From 3.7 to 6 mm | | | Connection: | | | | Shape | Internal hexagon (JDEvolution Plus, JDEvolution) | | | | Conical with internal hexagon (JDIcon and JDIcon Plus) | | | Packaging | | | | Type of package | Blister with internal vial for implants | | | Materials: | | | | Blister: | Tyvek CR27 / Polyester PETG | | | Vial: | Polystyrene EMPERA 116 | | The main features of the JDental Implant System added in this submission at the previous devices already cleared with K143142 and K182081 are summarized in table below: {7}------------------------------------------------ The specific diameter / length implant body combinations for each implant proposed in this submission are listed below: {8}------------------------------------------------ | JDEvolution ® PLUS // FULLY TREATED + SLA + Pitch 1.2mm | | |---------------------------------------------------------|--------| | Dia | Length | | 3.7 | 18 | | 4.3 | 18 | | 5.0 | 18 | | JDEvolution® PLUS // ANODIZED COLLAR (1.5mm) + SLA + Pitch 1.2mm | | | | | | | |------------------------------------------------------------------|--------|----|------|----|----|----| | Dia | Length | | | | | | | 3.7 | 8 | 10 | 11.5 | 13 | 15 | 18 | | 4.3 | 8 | 10 | 11.5 | 13 | 15 | 18 | | 5.0 | 8 | 10 | 11.5 | 13 | 15 | 18 | | 6.0 | 8 | 10 | 11.5 | 13 | 15 | / | | JDEvolution® PLUS // ANODIZED COLLAR (2.5mm) + SLA + Pitch 1.2 mm | | | | | | |-------------------------------------------------------------------|-------------|----|----|----|----| | Dia | Length (mm) | | | | | | 4.0 | 11.5 | 13 | 15 | 18 | 20 | | JDEvolution® PLUS // ANODIZED COLLAR (1.5mm) + SLA + Pitch 0.6 mm | | | | | | | |-------------------------------------------------------------------|-------------|----|------|----|----|----| | Dia | Length (mm) | | | | | | | 4.0 | 8 | 10 | 11.5 | 13 | 15 | 18 | | JDIcon® // FULLY TREATED + Pitch 1.2 mm | | |-----------------------------------------|--------| | Dia. | Length | | 3.9 | 18 | | JDIcon® // MACHINED COLLAR + Pitch 1.2 mm | | |-------------------------------------------|--------| | Dia. | Length | | 3.9 | 18 | | JDIcon® PLUS // ANODIZED COLLAR (1.5 mm) + SLA + pitch 1.2 mm | | | | | | | |---------------------------------------------------------------|--------|----|------|----|----|----| | Dia. | Length | | | | | | | 3.7 | 8 | 10 | 11.5 | 13 | 15 | 18 | | 4.3 | 8 | 10 | 11.5 | 13 | 15 | 18 | | 5.0 | 8 | 10 | 11.5 | 13 | / | / | {9}------------------------------------------------ | JDIcon® PLUS // FULLY TREATED SLA + pitch 1.2 mm | | | | | | | |--------------------------------------------------|--------|----|------|----|----|----| | Dia. | Length | | | | | | | 3.7 | 8 | 10 | 11.5 | 13 | 15 | 18 | | 4.3 | 8 | 10 | 11.5 | 13 | 15 | 18 | | 5.0 | 8 | 10 | 11.5 | 13 | / | / | | JDIcon® PLUS // FULLY TREATED SLA + pitch 0.8 mm (*) | | | | | | | |------------------------------------------------------|-----|--------|------|----|--|--| | Dia. | | Length | | | | | | 3.5 (*) | / | 10 | 11.5 | 13 | | | | 4.0 | 8.5 | 10 | 11.5 | 13 | | | | 4.5 | 8.5 | 10 | 11.5 | 13 | | | JDIcon Plus implants with 3.5 mm diameter are intended to be used only with straight abutments. #### Abutments Description The abutments included in the JDental Implant System can be divided into the following types: | | JDEvolution Plus ABUTMENTS | | | | | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------|------------|---| | SHORT DESCRIPTION | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | | | HEALING ABUTMENT: used in the delayed<br>loading technique to close the implant<br>connection for non-submerged healing. It helps<br>the gum to heal properly. The abutment is<br>screwed into the implant. Available with or<br>without anodization. The "tissue lovers"<br>models are characterized by a concave<br>abutment profile and a yellow anodization. | 5 | 4,6,9 | / | / | | | TEMPORARY ABUTMENT: (engaging / non<br>engaging): used for the fabrication of<br>temporary restorations. Engaging and non-<br>engaging variants are used for single- and<br>multiple-unit restorations, respectively. The<br>"tissue lovers" models are characterized by a<br>concave abutment profile and a yellow<br>anodization. | 3.1 | 2 | 10 | / | {10}------------------------------------------------ | | JDEvolution Plus ABUTMENTS | | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------|--------------------------|------------------------|--| | SHORT DESCRIPTION | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | | STRAIGHT ABUTMENTS: indicated for<br>cemented prosthesis of single and multiple<br>units. Collar height can be of 0,5 mm, 1,5 mm,<br>2 mm, 3 mm or 4 mm depending on the height<br>of soft tissues. Collar height of 0,5 mm available<br>also in both engaging/non engaging version for<br>single- and multiple-unit restorations,<br>respectively. The "tissue lovers" models are<br>characterized by a concave abutment profile<br>and a yellow anodization. | 4<br>5 | 0.5<br>2 - 4 | 7<br>7 | / | | | GP ABUTMENTS (engaging / non engaging):<br>indicated for restorations of single and multiple<br>implants. They can be modified with a drill and<br>they can be used as definitive abutment. | 4<br>5<br>4.5<br>4.5 | 1<br>1.5<br>1.5<br>1.5 | 10<br>10<br>10<br>10 | 0°<br>0°<br>15°<br>25° | | | CONICAL ABUTMENTS: indicated for screwed-<br>in prosthesis. Conical abutments, available in<br>both straight and angulated models are<br>intended to be used only for multi-unit<br>restorations. The "tissue lovers" models are<br>characterized by a concave abutment profile. | 4.8 | 1 -7 - 9<br>1.5 -3- 4- 5<br>2.5 - 3.5<br>2.5-3.5-5 | 2.2<br>2.2<br>2.2<br>2.2 | 0°<br>0°<br>17°<br>30° | | | | JDEvolution D3.25 ABUTMENTS | | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------|-----------------------------------|---------------------|------------| | SHORT DESCRIPTION | | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | CONICAL ABUTMENTS: indicated for screwed-in<br>prosthesis. Conical abutments, available in both<br>straight and angulated models are intended to<br>be used only for multi-unit restorations. The<br>"tissue lovers" models are characterized by a<br>concave abutment profile. | | 4.8 | 3 | 2.2 | 0° | | | | 4.8 | 3.5 | 2.2 | 17° | | | | 4.8 | 3.5 | 2.2 | 30° | | | | 4.8 | 1.5 - 3 | 2.2 | 0° | | | | 4.8 | 2.5 – 3.5 | 2.2 | 17° | | | | 4.8 | 2.5-3.5 | 2.2 | 30° | {11}------------------------------------------------ | | JDICON ABUTMENTS | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------------------------|---------------------|------------| | SHORT DESCRIPTION | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | HEALING ABUTMENT: used in the delayed<br>loading technique to close the implant<br>connection for non-submerged healing. It<br>helps the gum to heal properly. The abutment<br>is screwed into the implant. Available with or<br>without anodization. The "tissue lovers"<br>models are characterized by a concave<br>abutment profile and a yellow anodization. | 5 | 9 | / | / | | TEMPORARY ABUTMENT: (engaging / non<br>engaging): used for the fabrication of<br>temporary restorations. Engaging and non-<br>engaging variants are used for single- and<br>multiple-unit restorations, respectively. The<br>"tissue lovers" models are characterized by a<br>concave abutment profile and a yellow<br>anodization. | 4.4 | 1.3 | 10 | / | | ANATOMIC ABUTMENTS: indicated for<br>cemented prosthesis of single and multiple<br>units. The anatomic abutment has an<br>anatomical festoon preparation of the cervical<br>margin that ensure lesser need of abutment<br>preparation. | 5.5 | 1.5 - 3 | 7.5 | 15°<br>25° | | CONICAL ABUTMENTS: indicated for screwed-<br>in prosthesis. Conical abutments, available in<br>both straight and angulated are intended to be<br>used only for multi-unit restorations. The<br>"tissue lovers" models are characterized by a<br>concave abutment profile. | 4.8 | 2.5 - 3.5 | 2.2 | 17°<br>30° | | STRAIGHT ABUTMENTS: indicated for<br>cemented prosthesis of single and multiple<br>units. Collar height can be of 0,5 mm, 1,5 mm,<br>2 mm, 3 mm or 4 mm depending on the height<br>of soft tissues. Collar height of 0,5 mm<br>available also in both engaging/non engaging<br>version for single- and multiple-unit<br>restorations, respectively. The "tissue lovers"<br>models are characterized by a concave<br>abutment profile and a yellow anodization. | 3.5 | 1-2 | 7 | / | | | JDICON D2.75 ABUTMENTS | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------|---------------------|------------| | SHORT DESCRIPTION | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | GP ABUTMENTS (engaging / non engaging):<br>indicated for restorations of single and<br>multiple implants. They can be modified<br>with a drill and they can be used as definitive<br>abutment. | 4 | 1.5 | 10 | 15° | {12}------------------------------------------------ | | JDICON D2.75 ABUTMENTS | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------|---------------------|------------| | SHORT DESCRIPTION | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | CONICAL ABUTMENTS: indicated for<br>screwed-in prosthesis. Conical abutments,<br>available in both straight and angulated are<br>intended to be used only for multi-unit<br>restorations. The “tissue lovers” models are<br>characterized by a concave abutment<br>profile. | 4.8 | 1.5<br>2.5 | 2.2<br>2.2 | 0°<br>17° | | | JDICON Plus ABUTMENTS | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------|-----------------------------------|---------------------|------------------| | SHORT DESCRIPTION | | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | HEALING ABUTMENT: used in the delayed<br>loading technique to close the implant<br>connection for non-submerged healing. It<br>helps the gum to heal properly. The<br>abutment is screwed into the implant.<br>Available with or without anodization. The<br>"tissue lovers" models are characterized by<br>a concave abutment profile and a yellow<br>anodization. | | 4<br>5<br>6<br>7.5 | 3-5-7<br>3-5-7<br>3-5-7<br>3-5 | / | / | | TEMPORARY ABUTMENT: (engaging / non<br>engaging): used for the fabrication of<br>temporary restorations. Engaging and non-<br>engaging variants are used for single- and<br>multiple-unit restorations, respectively. The<br>"tissue lovers" models are characterized by<br>a concave abutment profile and a yellow<br>anodization. | | 3.7 | 2 | 10 | / | | STRAIGHT ABUTMENTS: indicated for<br>cemented prosthesis of single and multiple<br>units. Collar height can be of 0,5 mm, 1,5<br>mm, 2 mm, 3 mm or 4 mm depending on the<br>height of soft tissues. Collar height of 0,5<br>mm available also in both engaging/non<br>engaging version for single- and multiple-<br>unit restorations, respectively. The "tissue<br>lovers" models are characterized by a<br>concave abutment profile and a yellow<br>anodization. | | 4.5<br>5<br>5.5<br>6.0 | 2 - 4<br>2 - 4<br>2 - 4<br>2 - 4 | 7<br>7<br>7<br>7 | / | | GP ABUTMENTS (engaging / non engaging):<br>indicated for restorations of single and<br>multiple implants. They can be modified<br>with a drill and they can be used as definitive<br>abutment. | | 4,5,6<br>4.5<br>4.5 | 1.2 -1.5 - 2.1<br>1.5<br>1.5 | 11<br>10.5<br>10.5 | 0°<br>15°<br>25° | {13}------------------------------------------------ | | JDICON Plus ABUTMENTS | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------------|---------------------|------------------| | SHORT DESCRIPTION | DIAMETER<br>(mm) | GINGIVAL<br>COLLAR<br>HEIGHT (mm) | POST HEIGHT<br>(mm) | ANGULATION | | ANATOMIC ABUTMENTS: indicated for<br>cemented prosthesis of single and multiple<br>units. The anatomic abutment has an<br>anatomical festoon preparation of the<br>cervical margin that ensure lesser need of<br>abutment preparation. | 5 | 1.5 - 3<br>1.5 – 3 | 7.5<br>7.5 | 15°<br>25° | | CONICAL ABUTMENTS: indicated<br>for<br>screwed-in prosthesis. Conical abutments,<br>available in both straight and angulated<br>models are intended to be used only for<br>multi-unit restorations. The "tissue lovers"<br>models are characterized by a concave<br>abutment profile. | 4.8 | 1.5 -3- 4<br>2.5 - 3.5<br>2.5-3.5 | 2.2<br>2.2<br>2.2 | 0°<br>17°<br>30° | | BALL ABUTMENTS: indicated to be directly<br>screwed into the fixture placed in fully<br>edentulous jaws to support an overdenture<br>retained with ball or hemi-ball anchoring. | 4 | 1.5 -3-5 | 3.2 | / | | EMI ABUTMENTS: indicated to be directly<br>screwed into the fixture placed in fully<br>edentulous jaws to support an overdenture<br>retained with ball or hemi-ball anchoring | 3.7 | 1.5 -3-5 | 1.6 | / | | OCTA ABUTMENTS: indicated for screwed-<br>in prosthesis. Octa abutments are intended<br>to be used only for multi-unit restorations,<br>with no angulation correction. Octa<br>abutment top face is characterized by an<br>octagonal connection. | 3.8 | 1.5-3-4-5-6 | 2 | / | #### 5. Indications for Use JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. JDentalCare Dental Implant System 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. JDental 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. When a onestage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. 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. {14}------------------------------------------------ The difference in indications for use statement between subject device and primary predicate device is only related to the specification related to Implants 20 mm length; this difference is acceptable since primary predicate device didn't have implants with length of 20 mm #### 6. Comparison of the technological characteristics with the predicate device The JDentalCare Dental Implant System, family names JDEvolution, JDIcon, JDIcon, JDIcon plus, are substantially equivalent to the devices legally marketed in US listed in the tables below. For the endosseous dental implant fixtures and implant abutment the considered "predicate" devices are the following: | Applicant | Device name | 510(k) Number | Product<br>code | |----------------------|----------------------------------------|---------------|-----------------| | J DENTAL CARE S.r.l. | JDentalCare® Implant System<br>JDIcon® | K182081 | DZE<br>NHA | Moreover, the following reference devices have been considered: | Applicant | Device name | 510(k)<br>Number | Product<br>code | |--------------------------------------|----------------------------------------------------|------------------|-----------------| | J DENTAL CARE S.r.l. | JDentalCare® Implant System<br>JDEvolution® | K143142 | DZE<br>NHA | | Adin Dental Implants<br>Systems Ltd. | TOUAREG CloseFit™ UNP 2.75mmD | K153111 | DZE<br>NHA | | Nobel Biocare AB | TiUltra Implants and Xeal Abutments | K202344 | DZE | | Nobel Biocare AB | NobelSpeedy® Groovy | K160119 | DZE | | Nobel Biocare AB | Nobel Active | K142260 | DZE<br>NHA | | Nobel Biocare AB | Nobel Biocare Healing Cap Multi-Unit<br>Titanium | K171142 | NHA | | MIS Implants<br>Technologies | MIS V3 Conical Connection Dental Implant<br>System | K163349 | DZE<br>NHA | The devices JDIcon®, has been considered as basic predicate device, because the endosseous implants and abutments have similar dimensions and features to many proposed devices; the endosseous implants have the same surface treatment (SLA) of the proposed device and, for the majority of them several other comparable components / abutment combinations. Below the tables that compare subject and predicate devices {15}------------------------------------------------ #### JDENTALCARE® DENTAL IMPLANT SYSTEM #### Table 1. Comparison Table for General Characteristics of Dental Implants and abutments | | Proposed<br>Device<br>JDentalCare®<br>Dental Implant<br>System | Predicate<br>Device<br>JDentalCare®<br>Implant<br>System<br>JDIcon®<br>(K182081) | JDentalCare®<br>Implant<br>System<br>(K143142) | TOUAREG<br>CloseFit™ UNP<br>2.75mmD<br>(K153111) | TiUltra implants and<br>Xeal Abutments<br>K202344 | Nobel<br>Speedy<br>(K160119) | NobelActive<br>K142260 | Equival<br>ence<br>Discussion | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Regulation<br>Number: | 872.3640 –<br>Endosseous<br>dental implant. | 872.3640 –<br>Endosseous<br>dental implant. | 872.3640 –<br>Endosseous<br>dental implant. | 872.3640 –<br>Endosseous<br>dental implant. | 872.3640 –<br>Endosseous dental<br>implant. | 872.3640 –<br>Endosseous<br>dental<br>implant. | 872.3640 –<br>Endosseous<br>dental implant. | Same<br>Regulation<br>Number | | Classification: | II | II | II | II | II | II | II | Same<br>Classification | | Product<br>Code: | DZE (implant)<br>NHA (Abutments) | DZE (implant)<br>NHA (Abutments) | DZE (implant)<br>NHA (Abutments) | DZE (implant)<br>NHA (Abutments) | DZE (implant)<br>NHA (Abutments)<br>PNP (Digital Dentistry<br>workflow) | DZE | DZE (implant)<br>NHA (Abutments) | Same<br>Product<br>Code | | Intended<br>Use: | JDentalCare Dental<br>Implant System,<br>family names<br>JDEvolution,<br>JDEvolution Plus,<br>JDIcon, JDIcon Plus,<br>is intended to<br>replace missing<br>masticatory<br>functional units<br>(teeth) within the<br>maxilla or<br>mandible.<br>JDentalCare Dental<br>Implant System is<br>comprised of<br>dental implant<br>fixtures and<br>devices | JDentalCare®<br>Implant System<br>JDIcon®<br>is intended to<br>replace missing<br>masticatory<br>functional units<br>(teeth) within the<br>maxilla or<br>mandible.<br>JDentalCare®<br>implant system<br>JDIcon® is<br>comprised of<br>dental implant<br>fixtures and<br>prosthetic devices. | JDental Care®<br>implant system is<br>intended for<br>surgical placement<br>in the upper or<br>lower jaw. JDental<br>Care® implant<br>system is<br>comprised of<br>dental implant<br>fixtures and<br>prosthetic devices.<br>JDental Care®<br>implant system<br>provides a means<br>for prosthetic<br>attachment in<br>single tooth | TOUAREG<br>CloseFit™ UNP<br>2.75mmD<br>implants are<br>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. For single-<br>stage or two-stage<br>procedures. For<br>immediate<br>implantation in<br>extraction sites or | NobelActive TiUltra<br>NobelActive TiUltra<br>implants are endosseous<br>implants intended to be<br>surgically placed in the<br>upper or lower jaw bone<br>for anchoring or<br>supporting tooth<br>replacements to restore<br>patient esthetics and<br>chewing function.<br>NobelActive TiUltra<br>implants are indicated for<br>single or multiple unit<br>restorations in splinted or<br>non-splinted applications.<br>This can be achieved by a<br>2-stage or 1-stage surgical | NobelSpeedy®<br>Groovy<br>implants are<br>indicated for<br>single or<br>multiple unit<br>restorations in<br>splinted or<br>non-splinted<br>applications.<br>NobelSpeedy®<br>Groovy<br>implants 20,<br>22, 25 mm<br>when placed<br>in the maxilla | NobelActive®<br>implants are<br>endosseous<br>implants<br>intended to be<br>surgically placed<br>in the upper or<br>lower jaw bone<br>for anchoring or<br>supporting tooth<br>replacements to<br>restore patient<br>esthetics and<br>chewing function. | Same<br>Intended<br>Use | {16}------------------------------------------------ | prosthetic devices. | provides a means | restoration and | implantation in | technique in combination | are only | NobelActive® | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | It provides a means…
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