K Number

Device Name

JDentalCare Implant System JDIcon

Manufacturer

J Dental Care S.r.l.

Date Cleared

2020-06-26

(694 days)

Product Code

DZE NHA

Regulation Number

872.3640

Intended Use

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

Device Description

JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon. Abutment and accessories are exclusive for JDentalCare® implant system JDIcon® JDentalCare® implant system JDIcon® is threaded (fully treated or with a collar of 1.5 mm), rootform dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered. Their surface is treated through sandblasting followed by acid etching treatment. JDIcon® implants may be placed in the oral cavity using either a single stage surgical procedure or a two-stage surgical procedure. If a single procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained. The available dimensions of the JDentalCare® implant system JDIcon®, considering the Fully treated collar version and the machined collar version, are shown in the table below. Note the MACHINED COLLAR referenced is not implanted in bone, making the implantable length of these implants 1.5 mm less than the total implant length listed below.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K143142

Reference Devices

K153111, K102436, K123784

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system and its mechanical and biological properties. There is no mention of AI or ML technology.

Therapeutic

Yes

The device replaces missing teeth and restores chewing function, which are therapeutic actions to alleviate or treat a condition (missing teeth).

Diagnostic

The device description indicates that the system is an implant used to replace missing teeth and provide prosthetic attachment, which is a restorative function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it is comprised of physical components (dental implant fixtures and prosthetic devices made of titanium) and undergoes physical testing (mechanical tests, surface validation, sterilization). This indicates it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for replacing missing masticatory functional units (teeth) within the maxilla or mandible. This is a surgical and prosthetic application, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a dental implant system composed of fixtures and prosthetic devices, made of titanium, and designed for surgical implantation. This aligns with a medical device used for treatment and restoration, not for in vitro diagnosis.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is a dental implant system, which falls under the category of medical devices used for surgical and restorative purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. J Dental Care® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

J Dental Care® implant system IDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon.

Abutment and accessories are exclusive for JDentalCare® implant system JDIcon®

JDentalCare® implant system JDIcon® is threaded (fully treated or with a collar of 1.5 mm), rootform dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered.

Their surface is treated through sandblasting followed by acid etching treatment.

JDIcon® implants may be placed in the oral cavity using either a single stage surgical procedure or a two-stage surgical procedure. If a single procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

The available dimensions of the JDentalCare® implant system JDIcon®, considering the Fully treated collar version and the machined collar version, are shown in the table below. Note the MACHINED COLLAR referenced is not implanted in bone, making the implantable length of these implants 1.5 mm less than the total implant length listed below.

JDentalCare® Implant System JDIcon® // FULLY TREATED COLLAR
IMPLANT DIAMETER (mm) IMPLANT LENGTHS (mm)
2.75 - 10 11.5 13 15
3.9 - 8 10 11.5 13 15
4.3 - 8 10 11.5 13 15
5 - 8 10 11.5 13 15
JDentalCare® Implant System JDIcon® // MACHINED COLLAR
IMPLANT DIAMETER (mm) IMPLANT LENGTHS (mm)
3.9 - - 10 11.5 13 15
4.3 - - 10 11.5 13 15
5 - - 10 11.5 13 15

The above listed dental implants are used with dedicated abutments, shortly described here below:

HEALING ABUTMENT: it is used in the delayed loading technique (used when there is not a good primary stability of the bone) to close the implant connection for non-submerged healing. It helps the qum to heal properly. The abutment is screwed into the implant.
-TEMPORARY ABUTMENT (engaging/non engaging): temporary abutments are used for the fabrication of temporary screw-retained restorations. Engaging and non-engaging variants are used for single- and multiple-unit restorations, respectively.
GP ABUTMENTS: these abutments are indicated for cemented temporary restorations of single and multiple implants. They can be modified with a drill or they can also be used as definitive abutment.
STRAIGHT ABUTMENTS: they are indicated for cemented prosthesis of single and multiple units. Collar height can be of 0,5 mm, 1,5 mm, 2 mm or 4 mm depending on the height of soft tissues.
ANATOMIC ABUTMENTS: these abutments are indicated for cemented prosthesis of single and multiple units. The anatomic abutment has an anatomical festoon preparation of the cervical marqin that ensure lesser need of abutment preparation.
-CONICAL ABUTMENTS: They are indicated for screwed-in prosthesis. Conical abutments are intended to be used only for multi-unit restorations, with no angulation correction.
-BALL ABUTMENTS: are indicated for overdentures with ball anchoring.
-EMI ABUTMENTS: are indicated for overdentures with hemispheric anchoring.

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)

The following tests have been performed on JDentalCare® implant system JDIcon®:
BIOCOMPATIBILITY TESTS: Performed according to ISO 10993-1:2010 "Biological Evaluation of Medical Devices" (Part 1). Tests included Cytotoxicity, Intracutaneous reactivity, Delayed Hypersensitivity, Acute Systemic Toxicity, and Bacterial Reverse Mutation.
SURFACE VALIDATION TESTS: Morphological SEM analysis and cleaning process validation were performed after sandblasting followed by acid etching treatment, and subsequent cleaning. These tests confirmed the results of SEM analysis and complete removal of manufacturing residual substances.
MECHANICAL TESTS: Performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatique test for endosseous dental implants". The tests demonstrated that the worst case chosen is able to resist to 5,000,000 cycles.
STERILIZATION AND PACKAGING SHELF LIFE: JDentalCare® implant system JDIcon® is sterilized with gamma ray sterilization to assure a SAL level of 10-6. Validation of the sterilization process was performed. Shelf life granted is 5 years. The packaging is different for dental implants and abutments. Implants are provided sterile, while abutments are not sterile and must be sterilized prior to use. The packaging and sterilization methods are the same as the predicate device JDentalCare® implant system (K143142), thus the blister validation report is considered valid for JDIcon®.
OTHER TESTS: The devices have addressed pyroqenticity information according to FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."
MECHANICAL TESTS FOR ABUTMENTS: Specific mechanical tests have been performed in order to confirm the substantial equivalence of the abutments, in compliance with ISO 14801 method, as referenced in the FDA Guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]".

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.

K143142

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.

K153111, K102436, K123784

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

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 26, 2020

J Dental Care S.r.1. % Guido Bonapace Official Correspondent ISEMED Srl Via P. Togliatti 19X Imola, Bologna 40026 ITALY

Re: K182081

Trade/Device Name: JDentalCare® Implant System JDIcon® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 19, 2020 Received: June 25, 2020

Dear Guido Bonapace:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

Device Name JDENTALCARE® Implant System JDIcon®

Indications for Use (Describe)

JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. I Dental Care® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

I Dental Care® implant system IDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for the JDENTALCARE Implant System

This 510(k) Summary is being submitted in accordance with the requirements of the 21 CFR 807.92.

| 1. General Information
Submitter: | J DENTAL CARE S.r.l. is located at:
Via del Tirassegno 41/N
MODENA
ITALY |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Guido Bonapace
Isemed Srl
Via Palmiro Togliatti 19/X
Imola, BO 40026 ITALY
Tel. +39 0542 683803
Fax +39 0542 698456
Email: regulatory@isemed.eu |
| Summary Preparation Date: | June 26, 2020 |
| 2. Names | |

Device Name:	JDentalCare® Implant System JDIcon®
Classification Name:	Implant, Endosseous, Root-form abutment
Product Code:	DZE
Product Code (Secondary)	NHA
Regulation number:	21 CFR 872.3640
CLASS	II

1. Predicate Devices
  The JDentalCare® Implant System JDIcon® is substantially equivalent to the devices legally marketed in US listed in the tables below.

For the endosseous dental implant fixtures and implant the considered "primary predicate" device is the following:

| Applicant | Device name | Device Model name | 510(k)
Number | Product
code |
|-------------------------|--------------------------------|-------------------|------------------|-----------------|
| J Dental Care
S.r.l. | JDentalCare® Implant
System | JDEvolution | K143142 | DZE
NHA |

Moreover, the following reference devices have been considered:

| Applicant | Device name | 510(k)
Number |
|--------------------------------------|---------------------------------------|------------------|
| Adin Dental Implants
Systems Ltd. | TOUAREG CloseFit™ UNP 2.75mmD | K153111 |
| Nobel Biocare USA LLC | Nobel Active 3.0 | K102436 |
| Straumann USA LLC | Straumann® Dental Implant System SLA® | K123784 |

4. Device Description

JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon.

Abutment and accessories are exclusive for JDentalCare® implant system JDIcon®

JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered.

Their surface is treated through sandblasting followed by acid etching treatment.

JDentalCare® Implant System JDIcon® // FULLY TREATED COLLAR
Image: Implant	IMPLANT DIAMETER (mm)	IMPLANT LENGTHS (mm)
	2.75	-	10	11.5	13	15
	3.9	-	8	10	11.5	13	15
	4.3	-	8	10	11.5	13	15
	5	-	8	10	11.5	13	15
JDentalCare® Implant System JDIcon® // MACHINED COLLAR
Image: Implant	IMPLANT DIAMETER (mm)	IMPLANT LENGTHS (mm)
	3.9	-	-	10	11.5	13	15
	4.3	-	-	10	11.5	13	15
	5	-	-	10	11.5	13	15

The above listed dental implants are used with dedicated abutments, shortly described here below:

HEALING ABUTMENT: it is used in the delayed loading technique (used when there is not a good primary stability of the bone) to close the implant connection for non-submerged healing. It helps the qum to heal properly. The abutment is screwed into the implant.
-TEMPORARY ABUTMENT (engaging/non engaging): temporary abutments are used for the fabrication of temporary screw-retained restorations. Engaging and non-engaging variants are used for single- and multiple-unit restorations, respectively.
GP ABUTMENTS: these abutments are indicated for cemented temporary restorations of single and multiple implants. They can be modified with a drill or they can also be used as definitive abutment.
STRAIGHT ABUTMENTS: they are indicated for cemented prosthesis of single and multiple units. Collar height can be of 0,5 mm, 1,5 mm, 2 mm or 4 mm depending on the height of soft tissues.
ANATOMIC ABUTMENTS: these abutments are indicated for cemented prosthesis of single and multiple units. The anatomic abutment has an anatomical festoon preparation of the cervical marqin that ensure lesser need of abutment preparation.
-CONICAL ABUTMENTS: They are indicated for screwed-in prosthesis. Conical abutments are intended to be used only for multi-unit restorations, with no angulation correction.
-BALL ABUTMENTS: are indicated for overdentures with ball anchoring.
-EMI ABUTMENTS: are indicated for overdentures with hemispheric anchoring.

5. Indications for Use

JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Performance data 6.

Dimensions, materials and technical features are substantially equivalent to those claimed by the predicate and the references devices.

The following tests have been performed on JDentalCare® implant system JDIcon®:

BIOCOMPATIBILITY TESTS

Performed according to ISO 10993-1:2010 "Biological Evaluation of Medical Devices" (Part 1)

Cytotoxicity ●
Intracutaneous reactivity ●
Delayed Hypersensitivity
Acute Systemic Toxicity
Bacterial Reverse Mutation

SURFACE VALIDATION TESTS

Surface treatment is performed on implants through a sandblasting treatment followed by an acid etching treatment. Then, there is a cleaning process for the removal of manufacturing residual substances. A morphological SEM analysis and a cleaning process validation have been performed. These tests show the results of SEM analysis and the complete removal of materials used during manufacturing process.

MECHANICAL TESTS

The Mechanical test were performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatique test for endosseous dental implants". The tests demonstrated that the worst case chosen is able to resist to 5.000.000 cycles.

STERILIZATION AND PACKAGING SHELF LIFE

JDentalCare® implant system JDIcon® is sterilized with gamma ray sterilization to assure a SAL level of 106. The validation of the sterilization process has been performed.

Shelf life granted is 5 years. The packaging is different for dental implants and abutments.

The implants are provided sterile, while the abutments are not sterile and have to be sterilized prior to use. The packaging of the implants and abutments are exactly the same used for the predicate device JDentalCare® implant system (K143142), the sterilization methods are the same, thus JDENTAL considered that the blister validation report validating the packaging used for dental implants is still valid.

OTHER TESTS

The devices have addressed pyroqenticity information according to FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."

7. Substantial Equivalence Discussion:

COMPARISON TABLE FOR GENERAL FEATURES

Item	Proposed device	Predicate device	Reference devices
	JDENTALCARE®
JDIcon®
Implant System
(K182081)	JDENTALCARE®
Implant System
(K143142)	ADIN-TOUAREG
CloseFit™
UNP 2.75mmD
(K153111)	NOBEL BIOCARE
NobelActive 3.0
(K102436)	STRAUMANN
DENTAL Implant
System SLA
(K123784)
	Indication
for Use	JDentalCare® implant
system JDIcon® is intended
to replace missing
masticatory functional
units (teeth) within the
maxilla or mandible.
JDentalCare® implant
system JDIcon® is
comprised of dental
implant fixtures and
prosthetic devices. It
provides a means for
prosthetic attachment in
single tooth restorations
and partially or fully
edentulous spans with
multiple single teeth
utilizing delayed or
immediate loading, or as a
terminal or intermediary
abutment for fixed or
removable bridgework or
to retain overdentures.
Prosthetic devices provide
support and retention for
screw-retained or
cemented restorations in
mandible and maxilla.
JDentalCare® implant
system is intended for
immediate function on
single tooth and/or
multiple tooth applications
when good primary
stability is achieved, with
appropriate occlusal
loading, in order to restore
chewing function.
JDentalCare® implant
system JDicon® 2.75mm D
Dental Implant shall only
be used to replace
maxillary lateral incisors
and mandibular lateral
and central incisors for
single-stage or two-stage
procedures. It is for
immediate implantation in
extraction sites or
implantation in partially
healed or completely
healed alveolar ridge
situations.	JDENTALCARE®
implant system is
intended for
surgical placement
in the upper or
lower jaw.
JDentalCare®
implant system is
comprised of
dental implant
fixtures and
prosthetic devices.
JDentalCare®
implant system
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
abutment 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	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
implantation in
partially healed or
completely healed
alveolar ridge
situations. When a
one-stage surgical
approach is
applied, the
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.	The NobelActive
3.0mm implant is
indicated for use in
the treatment of
missing maxillary
lateral incisors or
the mandibular
central and lateral
incisors to support
prosthetic devices,
such as artificial
teeth, in order to
restore chewing
function in partially
edentulous patients.
The NobelActive 3.0
implants may be put
into immediate
function provided
that stability
requirements
detailed in the
manual are satisfied.
stage surgical approach is
applied, the implant may
be immediately loaded
when good primary
stability is achieved and
the functional load is
appropriate.	order to restore
chewing function.

General features comparison description.

The indication for use of the JDentalCare® Implant System JDIcon® is similar to the one declared by the predicate device JDentalCare® implant system (K143142), because JDIcon® implant systems are new fixtures of dental implants manufactured by J Dental Care S.r.l.

Differences are related to the specific application intended for JDentalCare® JDIcon® Implant System 2,75 mm. For this particular indication for use, the proposed Device Family JDentalCare® JDIcon® Implant System declares the same specific use (JDIcon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors) to the one declared by the reference device ADIN TOUAREG CloseFit™ UNP 2.75mmD (K153111), which propose implant fixture having the same diameter and length. Specifically, both 2.75 mm Implant fixture devices are intended for single or multiple unit applications, and for single-stage or twostage procedures, just to replace maxillary lateral incisors and mandibular lateral and central incisors.

The indication for use of the proposed device JDentalCare® Implant System JDIcon® can also be considered equivalent to the indication for use of the other reference devices because all the reference devices are designed to be surgically placed in upper or lower jaw or, in other words, in the bone of the mandible and/or maxillary.

Particularly, the JDentalCare® Implant System JDIcon®, as the predicate device JDentalCare® implant system (K143142), the reference devices ADIN TOUAREG CloseFit™ UNP 2.75mmD (K153111) / NOBEL BIOCARE NobelActive 3.0 (K102436), are complete implant system, fixtures and abutments with different fixture models.

The device STRAUMANN Dental Implant System SLA cleared in K123784, has been considered as reference device because it has the same surface treatment of the proposed device.

Therefore, in terms of indications for use, the JDentalCare® Implant System JDIcon® devices can be considered substantially equivalent to the identified predicate and reference devices.

The JDentalCare® Implant System JDIcon® is compliant to the same standards which have been applied by the predicate device JDentalCare® Implant System JDIcon® (K143142).

Conclusion – General Features

In light of evidence discussed above, considering the general features of the device, the proposed JDentalCare® implant system JDIcon® may be found substantially equivalent compared to the identified predicate and reference devices.

COMPARISON TABLE FOR ENDOSSEOUS IMPLANTS FIXTURE

	Proposed device	Predicate device	Reference device
	JDIcon®	JDENTALCARE®	ADIN - TOUAREG CloseFit™ UNP
	Implant System	Implant System	2.75mmD
	(K182081))	(K143142)	(K153111)
Indication	Immediate or delayed load	Immediate or delayed load	Immediate or delayed load
Placement
method	Dual or single stage surgery	Dual or single stage surgery	Dual or single stage surgery
	Titanium Grade 5	Titanium Grade 5
Materials	Ø2.75 mm	Ø 3,25mm	Titanium Grade 23
	Titanium Grade 4	Titanium Grade 4	Ti 6AL-4V ELI
Design - Mechanical features	Ø 3.9 / 4.3 / 5 mm	Ø 3.7 / 4.3 / 5 / 6 mm
	Two pieces	Two pieces	Two pieces
Shape	Tapered screw	Tapered screw	Tapered screw
	Conical with Internal Hexagon	Internal Hexagon	Conical-Hex connection
	Double Thread	Double Thread
Thread of	Lead 1,2mm	Lead 1,2 mm	Triple Lead thread with 3 mm
the body	(thread space)	(thread space)	pitch
	outline: trapezoidal	outline: trapezoidal
Neck	Collar with crestal grooves lead	Collar with
features	0,25 mm (for Ø2,75 mm)	Crestal grooves	Collar with crestal grooves lead
		lead 0,3 mm
Design - Surface features
Body	Sandblasting followed by acid
etching	Double Acid Etching	OsseoFix™ and
anodized
Neck	Sandblasting followed by acid	N/A	OsseoFix™ and
	etching (for fully threated version)		anodized
Design - Dimensions
	NC 2.75 x 10		NC 2.75 x 10
Diameter	NC 2.75 x 11.5		NC 2.75 x 11.5
X
Length	NC 2.75 x 13		NC 2.75 x 13
(mm)	NC 2.75 x 15		NC 2.75 x 16
	NC 3.9 x 8	NC 3.7 x 8
C -	NC 3.9 x 10	NC 3.7 x 10
Machined	NC 3.9 x 11.5	NC 3.7 x 11.5
Collar	NC 3.9 x 13	NC 3.7 x 13
	NC 3.9 x 15	NC 3.7 x 15
NC -
Fully treated
(Not	C 3.9 x 10 (*)	NC 3.7 x 8
machined	C 3.9 x 11.5 (*)	NC 3.7 x 10
Collar)	C 3.9 x 13 (*)	NC 3.7 x 11.5
	C 3.9 x 15 (*)	NC 3.7 x 13

	NC 4.3 x 8	NC 4.3 x 8
	NC 4.3 x 10	NC 4.3 x 10
	NC 4.3 x 11.5	NC 4.3 x 11.5
	NC 4.3 x 13	NC 4.3 x 13
	NC 4.3 x 15	NC 4.3 x 15

	Proposed device	Predicate device	Reference device
	JDIcon®	JDENTALCARE®	ADIN - TOUAREG CloseFit™ UNP
	Implant System	Implant System	2.75mmD
	(K182081)	(K143142)	(K153111)
	C 4.3 x 10 (*)	NC 4.3 x 8
	C 4.3 x 11.5 (*)	NC 4.3 x 10
	C 4.3 x 13 (*)	NC 4.3 x 11.5
	C 4.3 x 15 (*)	NC 4.3 x 13
	-	-
	NC 5.0 x 8	NC 5.0 x 8
	NC 5.0 x 10	NC 5.0 x 10
	NC 5.0 x 11.5	NC 5.0 x 11.5
	NC 5.0 x 13	NC 5.0 x 13
	NC 5.0 x 15	NC 5.0 x 15
	-	-
	C 5.0 x 10 (*)	NC 5.0 x 8
	C 5.0 x 11.5 (*)	NC 5.0 x 10
	C 5.0 x 13 (*)	NC 5.0 x 11.5
	C 5.0 x 15 (*)	NC 5.0 x 13
Type	Conical connection
with internal hexagon	Internal Hexagon	Conical - Hex connection
Platform
size /
Abutment
interface
(mm)	Plat / Diameter
2.3
3.4
3.4
3.4	Plat / Diameter
2.75
3.90
4.30
5.00	Plat / Diameter
3.4
3.4
3.4
3.4
		3.7
4.3
5.0	2.25
2.75
kind of
package	Plastic vial + blister	Plastic vial + blister	Double vial
Sterile	Yes
Gamma Radiation	Yes
Gamma Radiation	Yes
Gamma Radiation

(*) see collar comparison description

Endosseous implant fixtures comparison description.

JDentalCare® Implant System JDIcon® and the predicate device JDentalCare® Implant System (K143142) and reference devices (K15311) are indicated for delayed or immediate loading, with the warning that for the immediate loading a good primary stability shall be achieved. JDentalCare® Implant System JDIcon®, can be used both for dual or single stage surgery, like the predicate device (K143142) and reference devices (K153111).

The materials used to manufacture the JDentalCare® Implant System JDIcon® Endosseus dental implants are Titanium Grade 4 (implant fixtures diameters 3.9 / 4.3 / 5 mm) and Titanium Grade 5 for implant fixtures diameter 2.75 mm. The predicate device uses the same materials for similar components: Titanium Grade 4 (diameters 3.7 / 4.3 / 5 / 6 mm) and Titanium Grade 5 for dental implants with the smaller diameter (3,25 mm for the predicate K143142).

Both Titanium Grade 4 (compliant to the ASTM F67) and Titanium Grade 5 (compliant to the ASTM F136) are widely recommended in biomedical applications, such as implantable components, due to their biocompatibility with human tissue. The biocompatibility of the proposed devices has been verified by means of specific tests, according to ISO 10993-1 and related standards.

Moreover, the mechanical difference between Titanium Grade 5 and titanium Grade 23 adopted by the reference devices (K153111) have been addressed and justified by means of mechanical test according to ISO standard 14801:2007.

The shape of the fixtures, the shape of the neck and the kind of thread and/or micro-thread used to manufacture the fixtures included in the JDentalCare® implant system JDIcon® are very similar to the mechanical solution adopted by the predicate devices and reference devices.

(*) Implant bodies with collar version (1.5 mm for diameters 3.9 / 4.3 / 5.0). The mechanical features for this solution can be considered the same if compared to the fully treated version having similar implantable length. Particularly, considering that the implantable section of a collar versions is equal to the total length reduced by the collar dimension (L – 1,5 mm) similar implantable length have been taken into account while comparing the predicate devices JDentalCare® (JDEvolution -K143142).

About biocompatibility, we can consider the Titanium Grade 4 and 5 property and similitude claimed for surface treatment with reference device STRAUMANN Dental Implant System SLA (K123784).

The surface treatment of the subject device JDentalCare® implant system JDIcon® is substantially equivalent to the surface of the reference device K123784.

About dimensions, the comparison table shows that dimensions are similar between the proposed device JDentalCare® implant system JDIcon® and its predicate/references devices and any remaining small differences do not impact substantial equivalence.

Particularly:

Dimensions combinations 2.75 x 10 / 11.5 / 13 are the same proposed by the reference device TOUAREG CloseFit™ 2.75mmD - (K153111). The dimension combination 2.75 x 15 results within the range of the reference device (K153111 - 2.75 x 16 mm). We believe that it can be considered structurally able to perform the expected performances, according to "Class II Specials Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

Even if not all combinations are identical, the proposed dimensions are all within the same diameter x length range of the primary predicate and reference devices, thus can be considered substantially equivalent.

Connection system.

JDentalCare® implant system JDIcon®, similarly to the predicate device JDentalCare® implant system (JDEvolution – K143142) and the reference devices (K153111) have a connection solution with internal hexagon. Particularly, the connection system for the two-pieces JDentalCare® Implant System JDIcon® 2.75 mm implants is conical with internal Hexagon, as the reference device TOUAREG CloseFit™ 2.75mmD (K153111).

For the small implant diameter (2.75 mm) the platform size and abutment interface ratio are similar to the one proposed by the reference device (K153111).

The platform size and abutment interface for proposed diameters 3.9 / 4.3 / 5.0 mm are very similar to the ones adopted by the predicate device JDentalCare® implant system (JDEvolution -K143142) having diameters 3.7 / 4.3 and 5.0 mm.

To verify the mechanical design of the connection system JDentalCare® has performed specific mechanical tests, in compliance with ISO 14801 method. Thus, the methods of connection used by the JDentalCare® implant system JDIcon® are substantially equivalent to the connection methods used by the predicate and reference devices.

Packaging.

The JDentalCare® Implant System JDIcon® fixtures are sold in sterile condition, into a double package composed by a plastic vial inserted into a blister. Sterilization is done through gamma rays. This kind of packaging and sterilization method is exactly the same used for the predicate device JDentalCare® implant system (K143142).

The sterilization method has been and the related validation protocol and report have already been submitted to the Agency.

The packaging of the JDentalCare® Implant System JDIcon® fixtures is exactly the same of the packaging used for the predicate device JDentalCare® implant system (K143142), thus the validation of packaging and shelf life, in order to maintain the sterility condition for 5 years can be considered valid also for the JDIcon® implants.

Conclusion - Endosseous implant fixtures

In light of evidence discussed above, materials, shape, surface treatment, dimensions, connection system, packaging and sterilization method may be found substantially equivalent compared to the identified predicate and reference devices.

JDentalCare® IMPLANT SYSTEM JDICON®

COMPARISON TABLE FOR ABUTMENTS FEATURES

	Proposed device		Predicate device		Reference device
Features	JDIcon® Implant System
(K182081)		JDENTALCARE® Implant System
(K143142)		ADIN - TOUAREG CloseFit™
UNP 2.75mmD (K153111)	NOBEL BIOCARE NobelActive 3.0
(K102436)
Design
Healing
abutment	Available in 3 height: 3, 5 and 7 mm
Material: Titanium Grade 5		Available in 3 height: 3,5,7mm
Material: Titanium Grade 5		Ref from UNP0046 to UNP0050
Ref from UNP0004 to UNP0013
Material Ti 6Al 4V ELI		Ref. models 36794-36795-36796.
Available in 3 height: 3,5,7mm
Material: Titanium Grade 5
	Diameter x Height	Implant Diameter	Diameter x Height	Implant Diameter	Diameter x Height	Implant Diameter
	3.2 x 3/5/7 (mm)	2.75 (mm)	//		2.75 x 3/5/7 (mm)	2.75 (mm)	3.2 x 3/5/7 (mm)	3.00 (mm)
	4.0 x 3/5/7 (mm)	2.75 (mm)			4.0 x 3/5/7 (mm)	2.75 (mm)	3.8 x 3/5/7 (mm)	3.00 (mm)
	4.0 x 3/5/7 (mm)	3,9 (mm)	4.0 x 3/5/7 (mm)	3,7	//		//
	4.0 x 3/5/7 (mm)	4,3/5 (mm)	4.0 x 3/5/7 (mm)	4,3/5
	5.0 x 3/5/7 (mm)	3,9 (mm)	5.0 x 3/5/7 (mm)	3,7
	5.0 x 3/5/7 (mm)	4,3/5 (mm)	5.0 x 3/5/7 (mm)	4,3/5
			5.0 x 9 (mm)	3.7/4.3/5.0
	6.0 x 3/5/7 (mm)	3.9	6.0 x 3/5/7 (mm)	3.7
	6.0 x 3/5/7 (mm)	4.3/5.0	6.0 x 3/5/7 (mm)	4.3/5.0
Temporary
abutments	Engaging / Non-Engaging models.
Material: Titanium Grade 5		Engaging / Non-Engaging models.
Material: Titanium Grade 5		Engaging / Non-Engaging models.
Material: Ti 6Al 4V ELI		Engaging / Non-Engaging models.
Ref. model 36779 (Engaging)
Material: Titanium Grade 5
	Exagon/Diameter	Implant Diameter	Exagon/Diameter	Implant Diameter	Exagon/Diameter	Implant Diameter	Exagon	Implant Diameter
	1.8 mm Eng.	2.75	//		1.9 mm Eng.	2.75	1.5 mm Eng.	3.0
	-	-			Non engaging	2.75
	2.65 mm Eng.	3.9	2.65 mm Eng.	3.7
	2.65 mm Eng.	4.3 / 5.0	2.65 mm Eng.	4.3 / 5.0 / 6.0	//			////
	3.3 mm Non Eng.	3.9	3.3 Non Eng.	3.7
	3.3 mm Non Eng.	4.3 / 5.0	3.3 Non Eng.	4.3 / 5.0 / 6.0

JDentalCare® IMPLANT SYSTEM JDICON®

	Proposed device		Predicate device		Reference device
Features	JDIcon® Implant System
(K182081)		JDENTALCARE® Implant System
(K143142)		ADIN - TOUAREG CloseFit™
UNP 2.75mmD (K153111)	NOBEL BIOCARE NobelActive 3.0
(K102436)
GP
Abutment	Material: Titanium Grade 5
Abutment screw: included		Material: Titanium Grade 5
Abutment screw: included			Narrow profile abutments.
Ref. codes 36781 - 36780
Material: Titanium Grade 5
Abutment screw: included
	Diameter x height	Implant Diameter	Diameter x height	Implant Diameter	Diameter x height	Implant Diameter
	3.2/4.0 mm x 10	2.75				3.2 mm x 7.0/9.0
3.0
	4.0/5.0 mm x 10.5	3.9	4.0/5.0 mm x 10.5	3.7	//
	6.0 mm x 10.5	3.9	6.0 mm x 10.5	3.7
	4.0/5.0 mm x 10.5	4.3/5.0	4.0/5.0 mm x 10.5	4.3/5.0	//
	6.0 mm x 10.5	4.3/5.0	6.0 mm x 10.5	4.3/5.0
Fixed
Prosthesis	Material: Titanium Grade 5		Material: Titanium Grade 5		Collar Height 1.0-2.0-3.0 mm Straight
(Ref. Code UNP0019-0011-0064)
Material: Ti 6Al 4V ELI	Collar Height 1.5-3-4.5 mm Straight
(Ref. Code 36782 – 36783 - 36814)
Material: Titanium Grade 5
Straight
abutment	Dia x Collar Height	Implant Diameter	Dia x Collar Height	Implant Diameter	Dia x Collar Height	Implant Diameter
	//				4.0 x 1	2.75
	4.0 x 2 mm	2.75	//		4.0 x 2	2.75
	4.0 x 4 mm	2.75			4.0 x 3	2.75
	4.5 x 2 mm	3.9	4.5 x 2 mm	3.7	//
	4.5 x 4 mm	3.9	4.5 x 4 mm	3.7
	4.5 x 2 mm	4.3/5	4.5 x 2 mm	4.3/5
	4.5 x 4 mm	4.3/5	4.5 x 4 mm	4.3/5	//
	5.0 x 2 mm	3.9	5.0 x 2 mm	3.7
	5.0 x 4 mm	3.9	5.0 x 4 mm	3.7
	5.0 x 2 mm	4.3/5	5.0 x 2 mm	4.3/5
	5.0 x 4 mm	4.3/5	5.0 x 4 mm	4.3/5	//
	6.0 x 2 mm	3.9	6.0 x 2 mm	3.7
	6.0 x 4 mm	3.9	6.0 x 4 mm	3.7
	6.0 x 2 mm	4.3/5	6.0 x 2 mm	4.3/5
	6.0 x 4 mm	4.3/5	6.0 x 4 mm	4.3/5
	Proposed device		Predicate device		Reference device
Features	JDIcon® Implant System
(K182081)		JDENTALCARE® Implant System
(K143142)		ADIN - TOUAREG CloseFit™
UNP 2.75mmD (K153111)		NOBEL BIOCARE NobelActive 3.0
(K102436)
Fixed
Prosthesis
Anatomic
Abutments	Collar height: 1.5 – 3 mm
Straight
Material: Titanium Grade 5		Collar height 1,5 – 3
Straight
Material: Titanium Grade 5		//		//
	Dia x Collar Height x
Angle	Implant Diameter	Dia x Collar Height x
Angle	Implant Diameter
	5.0 x 1.5 x Straight	3.9	5.0 x 1.5 x Straight	3.7
	5.0 x 3.0 x Straight	3.9	5.0 x 3.0 x Straight	3.7
	5.0 x 1.5 x Straight	4.3 / 5.0	5.0 x 1.5 x Straight	4.3 / 5.0
	5.0 x 3.0 x Straight	4.3 / 5.0	5.0 x 3.0 x Straight	4.3 / 5.0
Fixed
prosthesis
Conical
Abutments	Straight (Angle 0°)
Material: Titanium Grade 5		Straight (Angle 0°)
Material: Titanium Grade 5		//		//
	Dia x Collar Height x
Angle	Implant Diameter	Dia x Collar Height x
Angle	Implant Diameter
	4.8 x 1.5 / 3.0 x 0°	3.9	4.8 x 1.5 / 3.0 x 0°	3.7
	4.8 x 1.5 / 3.0 x 0°	4.3 / 5.0	4.8 x 1.5 / 3.0 x 0°	4.3 / 5.0
Overdenture
Ball
Abutments	Height: 1.5 - 3 - 5 mm
Material: Titanium Grade 5		Height: 1.5 – 3 – 5 mm
Material: Titanium Grade 5		Height 0.5-1.0-2.0-3.0-4.0-5.0
Material: Ti 6Al 4V ELI
	Collar Height	Implant Diameter	Collar Height	Implant Diameter	Collar Height	Implant Diameter
	1.5 / 3.0 / 5.0	2.75	//		1.5 / 3.0 / 5.0	2.75
	1.5 / 3.0 / 5.0	3.9	1.5 / 3.0 / 5.0	3.7	//
	1.5 / 3.0 / 5.0	4.3 / 5.0	1.5 / 3.0 / 5.0	4.3 / 5.0
Overdenture
Emi
Abutments	Height: 1.5 - 3 - 5 mm
Material: Titanium Grade 5		Height: 1.5 – 3 – 5 mm
Material: Titanium Grade 5		//		//
	Collar Height	Implant Diameter	Collar Height	Implant Diameter
	1.5 / 3.0 / 5.0	3.9	1.5 / 3.0 / 5.0	3.7
	1.5 / 3.0 / 5.0	4.3 / 5.0	1.5 / 3.0 / 5.0	4.3 / 5.0
Materials	Titanium Grade 5		Titanium Grade 5		Titanium Alloy Ti 6Al 4V ELI (Grade 23)		Titanium Grade 5
Sterility	Non sterile		Non sterile		Sterile		Sterile

JDentalCare® IMPLANT SYSTEM JDICON®

Abutments comparison description.

The abutments included in the submission are designed to allow the user to perform a complete restorative process as the abutments included in the predicate device JDentalCare® implant system (K143142) and reference devices (K153111) and (K102436).

As shown in the comparison table, the design characteristics of JDentalCare® implant system JDIcon® abutments are very similar to the design of the abutments of predicate and reference devices. They have similar material, similar connection system to the implant and similar design features of the abutments related to the predicate and the reference devices.

Remaining small differences do not impact the substantial equivalence of the device.

Considering the FDA Guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", specific mechanical tests have been performed in order to confirm the substantial equivalence of the abutments.

Conclusion – Abutments

In light of evidence above, materials, shape, surface treatment, dimensions and connection system may be found substantially equivalent compared to the identified predicate and reference devices.

Applicable Standards: 8.
The Family of JDentalCare® Implant System JDIcon® has been developed and tested according to the following international standards:
ASTM F67 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications
ASTMF136 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications
ISO 14801 Dynamic fatique test for endosseous dental implants ●
ISO 11137-1 Sterilization of health care products -- Radiation -- Part 1: Requirements for ● development, validation and routine control of a sterilization process for medical device
ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ASTM F1980 - Standard Guide For Accelerated Aging of Sterile Medical Devices Packages.
. ISO 10993-1 - Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process
ISO 10993-3 Biological Evaluation of Medical Devices Part 3: Tests for genotoxicity, ● carcinogenicity and reproductive toxicity
ISO 10993-5 - Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 - Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11 - Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity
ISO 22674 - Dentistry -- Metallic materials for fixed and removable restorations and appliances

ISO 5832-2 Implants For Surgery Metallic Materials Part 2: Unalloyed Titanium ●
ISO 5832-3 Implants For Surgery -- Metallic Materials -- Part 3: Wrought Titanium 6-● Aluminium 4-Vanadium Alloy

9. Conclusions

Considering technological characteristics (indication for use, material used, dimensions and features) and performance data (mechanical tests, biocompatibility tests, sterilization and shelf life), the proposed device JDentalCare® implant system JDIcon® family, may be found substantially equivalent compared to the identified primary predicate devices (K143142) and to the reference devices (K153111 - K102436 - K123784).