(249 days)
No
The summary describes a traditional dental implant system and does not mention any AI or ML components.
Yes.
The device is intended to replace missing masticatory functional units (teeth) and restore chewing function, which addresses a pathological condition and restores normal function, classifying it as therapeutic.
No
The device is a dental implant system used to replace missing teeth, not to diagnose medical conditions or diseases. Its purpose is structural and restorative.
No
The device description explicitly states it is comprised of dental implant fixtures and prosthetic devices, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the JDentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices surgically placed in the jawbone to replace missing teeth. This is a surgical and prosthetic device, not a diagnostic test performed on bodily samples.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analysis of biological samples, or detection of diseases or conditions.
Therefore, the JDentalCare Dental Implant System falls under the category of a surgical and prosthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
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.
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.
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.
The device components are:
Implants:
Design: Two pieces dental implant system with internal hexagon connection.
Shape: Tapered screw implant body, cylindrical implant neck.
Materials: Diameter 3.5 – 3.7 – 3.9 – 4.0 – 4.3 – 4.5 – 5.0 – 6.0 are Titanium Grade 4.
Surface: Implants JDEvolution Plus, JDIcon, JDIcon Plus are treated through sandblasting followed by acid etching (SLA).
Neck: JDEvolution plus – Available with fully treated collar or 1.5 mm anodized collar (1.2 and 0.6 mm pitch) or 2.5 mm anodized collar (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. JDIcon plus – Available with fully treated collar (1.2 and 0.8 mm pitch) or 1.5 mm anodized collar (double thread models).
Thread: Double thread body. 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 (Only for JDIcon plus 3.5 mm, 4.0 mm, 4.5 mm).
Self-Threading Capacity: Self-threading capacity in both direction.
Implant Dimensions: Diameter From 3.5 to 6 mm, Length From 8 to 20 mm, Neck diameter From 3.7 to 6 mm.
Connection: Internal hexagon (JDEvolution Plus, JDEvolution), Conical with internal hexagon (JDIcon and JDIcon Plus).
Packaging: Blister with internal vial for implants. Materials: Blister: Tyvek CR27 / Polyester PETG, Vial: Polystyrene EMPERA 116.
Abutments:
Healing Abutment: Used in delayed loading technique for non-submerged healing. Sizes: 5mm diameter, 4, 6, 9mm gingival collar height. Material: Titanium grade 5. Available with or without anodization. "Tissue lovers" models have a concave profile and yellow anodization.
Temporary Abutment: For temporary restorations. Engaging/non-engaging variants for single/multiple-unit restorations. "Tissue lovers" models have a concave profile and yellow anodization. Sizes: 3.1mm diameter, 2mm gingival collar height, 10mm post height.
Straight Abutments: For cemented prosthesis (single/multiple units). Collar heights: 0.5, 1.5, 2, 3, 4mm, depending on soft tissues. 0.5mm collar height available in engaging/non-engaging for single/multiple-unit restorations. "Tissue lovers" models have a concave profile and yellow anodization. Sizes: 4-5mm diameter, 0.5-4mm gingival collar height, 7mm post height.
GP Abutments (engaging/non-engaging): For single/multiple implants. Can be modified with a drill for definitive use. Sizes: 4, 5, 4.5mm diameter, 1, 1.5mm gingival collar height, 10mm post height. Angulations: 0°, 15°, 25°.
Conical Abutments: For screwed-in prosthesis. Straight and angulated models, multi-unit restorations only. "Tissue lovers" models have a concave profile. Sizes: 4.8mm diameter, 1-9mm gingival collar height, 2.2mm post height. Angulations: 0°, 17°, 30°.
JDEvolution D3.25 ABUTMENTS (Conical Abutments): 4.8mm diameter, 3-3.5mm gingival collar height, 2.2mm post height. Angulations: 0°, 17°, 30°.
JDICON ABUTMENTS:
Healing Abutment: 5mm diameter, 9mm gingival collar height. Material: Titanium grade 5.
Temporary Abutment: 4.4mm diameter, 1.3mm gingival collar height, 10mm post height.
Anatomic Abutments: 5.5mm diameter, 1.5-3mm gingival collar height, 7.5mm post height. Angulations: 15°, 25°.
Conical Abutments: 4.8mm diameter, 2.5-3.5mm gingival collar height, 2.2mm post height. Angulations: 17°, 30°.
Straight Abutments: 3.5mm diameter, 1-2mm gingival collar height, 7mm post height.
JDICON D2.75 ABUTMENTS:
GP Abutments: 4mm diameter, 1.5mm gingival collar height, 10mm post height. Angulation: 15°.
Conical Abutments: 4.8mm diameter, 1.5-2.5mm gingival collar height, 2.2mm post height. Angulations: 0°, 17°.
JDICON Plus ABUTMENTS:
Healing Abutment: 4, 5, 6, 7.5mm diameter, 3-7mm gingival collar height.
Temporary Abutment: 3.7mm diameter, 2mm gingival collar height, 10mm post height.
Straight Abutments: 4.5, 5, 5.5, 6mm diameter, 2-4mm gingival collar height, 7mm post height.
GP Abutments: 4, 5, 6, 4.5mm diameter, 1.2-2.1mm gingival collar height, 10.5-11mm post height. Angulations: 0°, 15°, 25°.
Anatomic Abutments: 5mm diameter, 1.5-3mm gingival collar height, 7.5mm post height. Angulations: 15°, 25°.
Conical Abutments: 4.8mm diameter, 1.5-4mm gingival collar height, 2.2mm post height. Angulations: 0°, 17°, 30°.
Ball Abutments: 4mm diameter, 1.5-5mm gingival collar height, 3.2mm post height.
EMI Abutments: 3.7mm diameter, 1.5-5mm gingival collar height, 1.6mm post height.
OCTA Abutments: 3.8mm diameter, 1.5-6mm gingival collar height, 2mm post height.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A program of design verification and validation testing was performed that includes the following:
- Biocompatibility was conducted according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and includes: o Cytotoxicity assessment according to ISO 10993-5:2009; (conducted both on implants and worst case anodized abutment) o Sensitization testing according to ISO 10993-10:2010; o Irritation testing according to ISO 10993-10:2010; o Material mediated pyrogenicity testing according to ISO 10993-11:2017; o Acute systemic toxicity testing according to ISO 10993-11:2017.
- Packaging shelf life accelerated aging tests: testing was conducted according to ISO 11607-1.Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- Surface validation test: surface treatment is identical to predicate device. The treatment performed on implants through a sandblasting treatment followed by an acid etching treatment. Then, there is a cleaning process for the removal of residual substances. A morphological SEM analysis was performed to verify roughness and cleanliness of the surface and a cleaning process validation have been performed to verify the complete removal of materials used during manufacturing process.
- Verification of Washing Process : testing was conducted to demonstrate that no residuals substances were present on implant or abutment surface.
- Mechanical Performance Tests performed according to ISO 14801 on worst case combinations of implants and abutments representative for all the products included in current submission showed comparable results between subject device and predicate / reference devices. Mechanical Testing was conducted according to ISO 14801:2016 Dentistry — Implants — Dynamic loading test for endosseous dental implants and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004).
- Gamma Ray Sterilization Validation in accordance with: o ISO 11137-1:2006, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices o ISO 11137-2: 2013, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose.
- Sterilization validation of abutments: Even though abutments are supplied not sterile, their ability to be steam sterilized before their use was verified (test performed according to ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices).
- MRI environment: Non-clinical worst-case MRI review was performed to evaluate the JDENTALCARE IMPLANT SYSTEM devices in the MRI environment using scientific rationale and published literature, based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K143142, K153111, K202344, K160119, K142260, K171142, K163349
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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) |
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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:
Via Dino Campana, 2
MODENA
ITALY
Tel. +39 059 454255
Fax +39 059 450045 |
|----|-------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | Consultant/ Contact: | Maurizio Pantaleoni
Via Borgo Santa Cristina 12 |
| | | 40026 Imola (BO) |
| | | Mobile: +39 348-4435155
Email: maurizio.pantaleoni@gmail.com |
| | Summary Prepared Date: | August 16, 2024 |
| 2. | Names | |
| | Device Name: | JDentalCare Dental Implant System:
JDEvolution; JDEvolution plus; JDIcon; JDIcon plus |
| | Classification Name: | Implant, Endosseous,
Root-form / Endosseous dental
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
code |
|----------------------|----------------------------------------|---------------|-----------------|
| J DENTAL CARE S.r.l. | JDentalCare® Implant System
JDIcon® | K182081 | DZE
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 | ||
| JDEvolution® | K143142 | DZE | |
| NHA | |||
| Adin Dental Implants | |||
| Systems Ltd. | TOUAREG CloseFit™ UNP 2.75mmD | K153111 | DZE |
| 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 |
| NHA | |||
| Nobel Biocare AB | Nobel Biocare Healing Cap Multi-Unit | ||
| Titanium | K171142 | NHA | |
| MIS Implants | |||
| Technologies | MIS V3 Conical Connection Dental Implant | ||
| System | K163349 | DZE | |
| 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 – | |
| 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 | |
| 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 ( Only for JDIcon plus | ||
| 3.5 mm, 4.0 mm, 4.5 mm) | ||
| Self-Threading | ||
| 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 | ||||
| (mm) | GINGIVAL | ||||
| COLLAR | |||||
| HEIGHT (mm) | POST HEIGHT | ||||
| (mm) | ANGULATION | ||||
| HEALING ABUTMENT: used in the delayed | |||||
| loading technique to close the implant | |||||
| connection for non-submerged healing. It helps | |||||
| the gum to heal properly. The abutment is | |||||
| screwed into the implant. Available with or | |||||
| without anodization. The "tissue lovers" | |||||
| models are characterized by a concave | |||||
| abutment profile and a yellow anodization. | 5 | 4,6,9 | / | / | |
| TEMPORARY ABUTMENT: (engaging / non | |||||
| engaging): used for the fabrication of | |||||
| temporary restorations. Engaging and non- | |||||
| engaging variants are used for single- and | |||||
| multiple-unit restorations, respectively. The | |||||
| "tissue lovers" models are characterized by a | |||||
| concave abutment profile and a yellow | |||||
| anodization. | 3.1 | 2 | 10 | / |
10
| JDEvolution Plus ABUTMENTS | |||||
|---|---|---|---|---|---|
| SHORT DESCRIPTION | DIAMETER | ||||
| (mm) | GINGIVAL | ||||
| COLLAR | |||||
| HEIGHT (mm) | POST HEIGHT | ||||
| (mm) | ANGULATION | ||||
| STRAIGHT ABUTMENTS: indicated for | |||||
| cemented prosthesis of single and multiple | |||||
| units. Collar height can be of 0,5 mm, 1,5 mm, | |||||
| 2 mm, 3 mm or 4 mm depending on the height | |||||
| of soft tissues. Collar height of 0,5 mm available | |||||
| also in both engaging/non engaging version for | |||||
| single- and multiple-unit restorations, | |||||
| respectively. The "tissue lovers" models are | |||||
| characterized by a concave abutment profile | |||||
| and a yellow anodization. | 4 | ||||
| 5 | 0.5 | ||||
| 2 - 4 | 7 | ||||
| 7 | / | ||||
| GP ABUTMENTS (engaging / non engaging): | |||||
| indicated for restorations of single and multiple | |||||
| implants. They can be modified with a drill and | |||||
| they can be used as definitive abutment. | 4 | ||||
| 5 | |||||
| 4.5 | |||||
| 4.5 | 1 | ||||
| 1.5 | |||||
| 1.5 | |||||
| 1.5 | 10 | ||||
| 10 | |||||
| 10 | |||||
| 10 | 0° | ||||
| 0° | |||||
| 15° | |||||
| 25° | |||||
| CONICAL ABUTMENTS: indicated for screwed- | |||||
| in prosthesis. Conical abutments, available in | |||||
| both straight and angulated models are | |||||
| intended to be used only for multi-unit | |||||
| restorations. The "tissue lovers" models are | |||||
| characterized by a concave abutment profile. | 4.8 | 1 -7 - 9 | |||
| 1.5 -3- 4- 5 | |||||
| 2.5 - 3.5 | |||||
| 2.5-3.5-5 | 2.2 | ||||
| 2.2 | |||||
| 2.2 | |||||
| 2.2 | 0° | ||||
| 0° | |||||
| 17° | |||||
| 30° |
| JDEvolution D3.25 ABUTMENTS | |||||
|---|---|---|---|---|---|
| SHORT DESCRIPTION | DIAMETER | ||||
| (mm) | GINGIVAL | ||||
| COLLAR | |||||
| HEIGHT (mm) | POST HEIGHT | ||||
| (mm) | ANGULATION | ||||
| CONICAL ABUTMENTS: indicated for screwed-in | |||||
| prosthesis. Conical abutments, available in both | |||||
| straight and angulated models are intended to | |||||
| be used only for multi-unit restorations. The | |||||
| "tissue lovers" models are characterized by a | |||||
| 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 | |||
| (mm) | GINGIVAL | |||
| COLLAR | ||||
| HEIGHT (mm) | POST HEIGHT | |||
| (mm) | ANGULATION | |||
| HEALING ABUTMENT: used in the delayed | ||||
| loading technique to close the implant | ||||
| connection for non-submerged healing. It | ||||
| helps the gum to heal properly. The abutment | ||||
| is screwed into the implant. Available with or | ||||
| without anodization. The "tissue lovers" | ||||
| models are characterized by a concave | ||||
| abutment profile and a yellow anodization. | 5 | 9 | / | / |
| TEMPORARY ABUTMENT: (engaging / non | ||||
| engaging): used for the fabrication of | ||||
| temporary restorations. Engaging and non- | ||||
| engaging variants are used for single- and | ||||
| multiple-unit restorations, respectively. The | ||||
| "tissue lovers" models are characterized by a | ||||
| concave abutment profile and a yellow | ||||
| anodization. | 4.4 | 1.3 | 10 | / |
| ANATOMIC ABUTMENTS: indicated for | ||||
| cemented prosthesis of single and multiple | ||||
| units. The anatomic abutment has an | ||||
| anatomical festoon preparation of the cervical | ||||
| margin that ensure lesser need of abutment | ||||
| preparation. | 5.5 | 1.5 - 3 | 7.5 | 15° |
| 25° | ||||
| CONICAL ABUTMENTS: indicated for screwed- | ||||
| in prosthesis. Conical abutments, available in | ||||
| both straight and angulated are intended to be | ||||
| used only for multi-unit restorations. The | ||||
| "tissue lovers" models are characterized by a | ||||
| concave abutment profile. | 4.8 | 2.5 - 3.5 | 2.2 | 17° |
| 30° | ||||
| STRAIGHT ABUTMENTS: indicated for | ||||
| cemented prosthesis of single and multiple | ||||
| units. Collar height can be of 0,5 mm, 1,5 mm, | ||||
| 2 mm, 3 mm or 4 mm depending on the height | ||||
| of soft tissues. Collar height of 0,5 mm | ||||
| available also in both engaging/non engaging | ||||
| version for single- and multiple-unit | ||||
| restorations, respectively. The "tissue lovers" | ||||
| models are characterized by a concave | ||||
| abutment profile and a yellow anodization. | 3.5 | 1-2 | 7 | / |
| JDICON D2.75 ABUTMENTS | ||||
|---|---|---|---|---|
| SHORT DESCRIPTION | DIAMETER | |||
| (mm) | GINGIVAL | |||
| COLLAR | ||||
| HEIGHT (mm) | POST HEIGHT | |||
| (mm) | ANGULATION | |||
| GP ABUTMENTS (engaging / non engaging): | ||||
| indicated for restorations of single and | ||||
| multiple implants. They can be modified | ||||
| with a drill and they can be used as definitive | ||||
| abutment. | 4 | 1.5 | 10 | 15° |
12
| JDICON D2.75 ABUTMENTS | ||||
|---|---|---|---|---|
| SHORT DESCRIPTION | DIAMETER | |||
| (mm) | GINGIVAL | |||
| COLLAR | ||||
| HEIGHT (mm) | POST HEIGHT | |||
| (mm) | ANGULATION | |||
| CONICAL ABUTMENTS: indicated for | ||||
| screwed-in prosthesis. Conical abutments, | ||||
| available in both straight and angulated are | ||||
| intended to be used only for multi-unit | ||||
| restorations. The “tissue lovers” models are | ||||
| characterized by a concave abutment | ||||
| profile. | 4.8 | 1.5 | ||
| 2.5 | 2.2 | |||
| 2.2 | 0° | |||
| 17° |
| JDICON Plus ABUTMENTS | |||||
|---|---|---|---|---|---|
| SHORT DESCRIPTION | DIAMETER | ||||
| (mm) | GINGIVAL | ||||
| COLLAR | |||||
| HEIGHT (mm) | POST HEIGHT | ||||
| (mm) | ANGULATION | ||||
| HEALING ABUTMENT: used in the delayed | |||||
| loading technique to close the implant | |||||
| connection for non-submerged healing. It | |||||
| helps the gum to heal properly. The | |||||
| abutment is screwed into the implant. | |||||
| Available with or without anodization. The | |||||
| "tissue lovers" models are characterized by | |||||
| a concave abutment profile and a yellow | |||||
| anodization. | 4 | ||||
| 5 | |||||
| 6 | |||||
| 7.5 | 3-5-7 | ||||
| 3-5-7 | |||||
| 3-5-7 | |||||
| 3-5 | / | / | |||
| TEMPORARY ABUTMENT: (engaging / non | |||||
| engaging): used for the fabrication of | |||||
| temporary restorations. Engaging and non- | |||||
| engaging variants are used for single- and | |||||
| multiple-unit restorations, respectively. The | |||||
| "tissue lovers" models are characterized by | |||||
| a concave abutment profile and a yellow | |||||
| anodization. | 3.7 | 2 | 10 | / | |
| STRAIGHT ABUTMENTS: indicated for | |||||
| cemented prosthesis of single and multiple | |||||
| units. Collar height can be of 0,5 mm, 1,5 | |||||
| mm, 2 mm, 3 mm or 4 mm depending on the | |||||
| height of soft tissues. Collar height of 0,5 | |||||
| mm available also in both engaging/non | |||||
| engaging version for single- and multiple- | |||||
| unit restorations, respectively. The "tissue | |||||
| lovers" models are characterized by a | |||||
| concave abutment profile and a yellow | |||||
| anodization. | 4.5 | ||||
| 5 | |||||
| 5.5 | |||||
| 6.0 | 2 - 4 | ||||
| 2 - 4 | |||||
| 2 - 4 | |||||
| 2 - 4 | 7 | ||||
| 7 | |||||
| 7 | |||||
| 7 | / | ||||
| GP ABUTMENTS (engaging / non engaging): | |||||
| indicated for restorations of single and | |||||
| multiple implants. They can be modified | |||||
| with a drill and they can be used as definitive | |||||
| abutment. | 4,5,6 | ||||
| 4.5 | |||||
| 4.5 | 1.2 -1.5 - 2.1 | ||||
| 1.5 | |||||
| 1.5 | 11 | ||||
| 10.5 | |||||
| 10.5 | 0° | ||||
| 15° | |||||
| 25° |
13
| JDICON Plus ABUTMENTS | ||||
|---|---|---|---|---|
| SHORT DESCRIPTION | DIAMETER | |||
| (mm) | GINGIVAL | |||
| COLLAR | ||||
| HEIGHT (mm) | POST HEIGHT | |||
| (mm) | ANGULATION | |||
| ANATOMIC ABUTMENTS: indicated for | ||||
| cemented prosthesis of single and multiple | ||||
| units. The anatomic abutment has an | ||||
| anatomical festoon preparation of the | ||||
| cervical margin that ensure lesser need of | ||||
| abutment preparation. | 5 | 1.5 - 3 | ||
| 1.5 – 3 | 7.5 | |||
| 7.5 | 15° | |||
| 25° | ||||
| CONICAL ABUTMENTS: indicated | ||||
| for | ||||
| screwed-in prosthesis. Conical abutments, | ||||
| available in both straight and angulated | ||||
| models are intended to be used only for | ||||
| multi-unit restorations. The "tissue lovers" | ||||
| models are characterized by a concave | ||||
| abutment profile. | 4.8 | 1.5 -3- 4 | ||
| 2.5 - 3.5 | ||||
| 2.5-3.5 | 2.2 | |||
| 2.2 | ||||
| 2.2 | 0° | |||
| 17° | ||||
| 30° | ||||
| BALL ABUTMENTS: indicated to be directly | ||||
| screwed into the fixture placed in fully | ||||
| edentulous jaws to support an overdenture | ||||
| retained with ball or hemi-ball anchoring. | 4 | 1.5 -3-5 | 3.2 | / |
| EMI ABUTMENTS: indicated to be directly | ||||
| screwed into the fixture placed in fully | ||||
| edentulous jaws to support an overdenture | ||||
| retained with ball or hemi-ball anchoring | 3.7 | 1.5 -3-5 | 1.6 | / |
| OCTA ABUTMENTS: indicated for screwed- | ||||
| in prosthesis. Octa abutments are intended | ||||
| to be used only for multi-unit restorations, | ||||
| with no angulation correction. Octa | ||||
| abutment top face is characterized by an | ||||
| 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
code |
|----------------------|----------------------------------------|---------------|-----------------|
| J DENTAL CARE S.r.l. | JDentalCare® Implant System
JDIcon® | K182081 | DZE
NHA |
Moreover, the following reference devices have been considered:
| Applicant | Device name | 510(k)
Number | Product
code |
|--------------------------------------|----------------------------------------------------|------------------|-----------------|
| J DENTAL CARE S.r.l. | JDentalCare® Implant System
JDEvolution® | K143142 | DZE
NHA |
| Adin Dental Implants
Systems Ltd. | TOUAREG CloseFit™ UNP 2.75mmD | K153111 | DZE
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
NHA |
| Nobel Biocare AB | Nobel Biocare Healing Cap Multi-Unit
Titanium | K171142 | NHA |
| MIS Implants
Technologies | MIS V3 Conical Connection Dental Implant
System | K163349 | DZE
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
Device
JDentalCare®
Dental Implant
System | Predicate
Device
JDentalCare®
Implant
System
JDIcon®
(K182081) | JDentalCare®
Implant
System
(K143142) | TOUAREG
CloseFit™ UNP
2.75mmD
(K153111) | TiUltra implants and
Xeal Abutments
K202344 | Nobel
Speedy
(K160119) | NobelActive
K142260 | Equival
ence
Discussion |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Regulation
Number: | 872.3640 –
Endosseous
dental implant. | 872.3640 –
Endosseous
dental implant. | 872.3640 –
Endosseous
dental implant. | 872.3640 –
Endosseous
dental implant. | 872.3640 –
Endosseous dental
implant. | 872.3640 –
Endosseous
dental
implant. | 872.3640 –
Endosseous
dental implant. | Same
Regulation
Number |
| Classification: | II | II | II | II | II | II | II | Same
Classification |
| Product
Code: | DZE (implant)
NHA (Abutments) | DZE (implant)
NHA (Abutments) | DZE (implant)
NHA (Abutments) | DZE (implant)
NHA (Abutments) | DZE (implant)
NHA (Abutments)
PNP (Digital Dentistry
workflow) | DZE | DZE (implant)
NHA (Abutments) | Same
Product
Code |
| Intended
Use: | JDentalCare Dental
Implant System,
family names
JDEvolution,
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
devices | 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. | JDental Care®
implant system is
intended for
surgical placement
in the upper or
lower jaw. JDental
Care® implant
system is
comprised of
dental implant
fixtures and
prosthetic devices.
JDental Care®
implant system
provides a means
for prosthetic
attachment in
single tooth | TOUAREG
CloseFit™ UNP
2.75mmD
implants are
indicated to
replace missing
masticatory
functional units
(teeth) in single or
multiple unit
applications within
the mandible or
maxilla. For single-
stage or two-stage
procedures. For
immediate
implantation in
extraction sites or | NobelActive TiUltra
NobelActive TiUltra
implants are endosseous
implants intended to be
surgically placed in the
upper or lower jaw bone
for anchoring or
supporting tooth
replacements to restore
patient esthetics and
chewing function.
NobelActive TiUltra
implants are indicated for
single or multiple unit
restorations in splinted or
non-splinted applications.
This can be achieved by a
2-stage or 1-stage surgical | NobelSpeedy®
Groovy
implants are
indicated for
single or
multiple unit
restorations in
splinted or
non-splinted
applications.
NobelSpeedy®
Groovy
implants 20,
22, 25 mm
when placed
in the maxilla | NobelActive®
implants are
endosseous
implants
intended to be
surgically placed
in the upper or
lower jaw bone
for anchoring or
supporting tooth
replacements to
restore patient
esthetics and
chewing function. | Same
Intended
Use |
16
| prosthetic devices. | provides a means | restoration and | implantation in | technique in combination | are only | NobelActive® |
|---|---|---|---|---|---|---|
| It provides a means | for prosthetic | partially or fully | partially healed or completely healed | with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. | indicated for multiple | implants are indicated for single or multiple |
| for prosthetic | attachment in single | edentulous spans with multiple single | completely healed alveolar ridge situations. When a one-stage surgical approach is applied, | protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. | unit restorations in splinted applications that utilize at least two implants. | unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. |
| attachment in single | tooth restorations and single | teeth restorations and partially or fully | situations. When a one-stage surgical approach is applied, implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate. | sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. | restorations in splinted applications that utilize at least two implants. | |
| single tooth restorations and single | teeth utilizing delayed or | utilizing delayed or immediate | implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate. The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors. | NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only. | NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. | |
| teeth utilizing delayed or immediate loading, | utilizing delayed or immediate loading, or as a | immediate abutment for fixed or removable bridgework or to retain overdentures. | The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors. | NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. | NobelActive® 3.0 implants are indicated for | |
| delayed or immediate loading, or as a terminal or intermediary | loading, or as a terminal intermediary | abutment for fixed or removable bridgework or to retain overdentures. | NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. | |||
| or as a terminal or intermediary abutment for fixed or removable bridgework or to retain | terminal 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. | The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC TiUltra implants can be used in splinted or non-splinted applications. The NobelReplace CC TiUltra implant may be placed | |||
| intermediary abutment for fixed or removable bridgework or to retain overdentures. | 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 and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. | The NobelReplace CC TiUltra implants can be used in splinted or non-splinted applications. The NobelReplace CC TiUltra implant may be placed | |||
| Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. | 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 | JDentalCare Dental 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 | ||||
| JDentalCare Dental 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 | 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. | ||||||
| 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. | ||||||
| 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 ridgo | in order to restore | |||||
| chewing function. | ||||||
| JDentalCare® | ||||||
| implant system | ||||||
| JDIcon® 2.75mm | ||||||
| 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- applied, the | ||||||
| implant may | ||||||
| be immediately | ||||||
| loaded when good | ||||||
| primary stability is | ||||||
| achieved and the | ||||||
| functional load is | ||||||
| appropriate. | immediately and put into | |||||
| immediate function | ||||||
| provided that initial | ||||||
| stability requirements | ||||||
| detailed in the manual are | ||||||
| satisfied. NobelParallel CC | ||||||
| TiUltra | ||||||
| NobelParallel CC TiUltra | ||||||
| implants are endosseous | ||||||
| implants intended to be | ||||||
| surgically placed in the | ||||||
| upper or lower jaw bone | ||||||
| for anchoring or | ||||||
| supporting replacements | ||||||
| to restore patient | ||||||
| esthetics and chewing | ||||||
| function. | ||||||
| NobelParallel CC TiUltra | ||||||
| implants are indicated for | ||||||
| single or multiple | ||||||
| restorations in splinted or | ||||||
| non-splinted applications. | ||||||
| This can be achieved by a | ||||||
| 2- stage or 1-stage | ||||||
| surgical techniques in | ||||||
| combination with | ||||||
| immediate, early or | ||||||
| delayed loading | ||||||
| protocols, recognizing | ||||||
| sufficient primary stability | ||||||
| and appropriate occlusal | ||||||
| loading for the selected | ||||||
| technique. Implants with |