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.

AI/ML Overview

This FDA 510(k) summary describes the JDentalCare® Implant System JDIcon® and demonstrates its substantial equivalence to previously marketed predicate devices, rather than presenting a study proving performance against specific acceptance criteria.

The document focuses on comparing the proposed device's characteristics and performance to legally marketed predicate devices. It doesn't define absolute "acceptance criteria" in the sense of predefined thresholds for a new study, but rather demonstrates that the new device meets the established safety and effectiveness profile by being similar to already cleared implants.

Therefore, the requested tables and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not directly applicable or provided in this type of regulatory submission.

However, I can extract information related to how the device's performance was evaluated and how it compares to existing standards and predicate devices, which implicitly serve as "acceptance criteria" for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Implied by Comparison to Predicates):

Feature/Test	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (JDentalCare® Implant System JDIcon®)
Indications for Use	Similar to legally marketed predicate devices, for replacing missing teeth, single/multiple unit applications, delayed/immediate loading, fixed/removable bridgework, overdentures. Specific 2.75mm D implant for maxillary lateral incisors and mandibular lateral/central incisors.	Intended to replace missing masticatory functional units (teeth) within the maxilla or mandible, for single/multiple tooth restorations, delayed/immediate loading, fixed/removable bridgework, or to retain overdentures. 2.75mm D implant specifically for maxillary lateral incisors and mandibular lateral and central incisors, for single-stage or two-stage procedures, immediate implantation, or in healed alveolar ridges. Concluded as substantially equivalent.
Biocompatibility	Compliant with ISO 10993-1:2010 and related standards (cytotoxicity, intracutaneous reactivity, delayed hypersensitivity, acute systemic toxicity, bacterial reverse mutation). Materials (Titanium Grade 4/5) known for biocompatibility.	Tests performed according to ISO 10993-1:2010 for cytotoxicity, intracutaneous reactivity, delayed hypersensitivity, acute systemic toxicity, and bacterial reverse mutation. Concluded as compliant and biocompatible. (Page 6, 10)
Surface Validation	Morphological analysis and cleaning process validation expected for sandblasting and acid etching treatment to ensure removal of manufacturing residue.	Morphological SEM analysis and cleaning process validation performed show results of SEM analysis and complete removal of materials used. Surface treatment is substantially equivalent to reference device STRAUMANN Dental Implant System SLA. Concluded as validated. (Page 6, 11)
Mechanical Fatigue	Compliant with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801:2007 (dynamic fatigue test, typically 5,000,000 cycles for worst-case).	Tests performed in compliance with cited guidance and ISO 14801:2007. Demonstrated that the worst-case chosen is able to resist to 5,000,000 cycles. Specific mechanical tests performed to confirm substantial equivalence of abutments. Concluded as mechanically sound and robust. (Page 6, 10, 16)
Sterilization & Shelf Life	Sterilized with gamma radiation to achieve SAL of 10-6. Validated sterilization process. Packaging maintains sterility for 5 years.	Sterilized with gamma ray sterilization to assure a SAL level of 10-6. Validation of the sterilization process performed. Shelf life granted is 5 years. Packaging and sterilization methods are the same as predicate (K143142). Concluded as validated for sterility and shelf life. (Page 6, 12)
Materials	Use of medically accepted materials (e.g., Titanium Grade 4/5) with demonstrated biocompatibility.	Implant fixtures (3.9/4.3/5 mm) are Titanium Grade 4; 2.75 mm implant fixtures are Titanium Grade 5. Abutments are Titanium Grade 5. Both grades compliant with ASTM standards and widely recommended for biomedical applications. Concluded as using appropriate and substantially equivalent materials. (Page 4, 10, 14)
Design & Dimensions	Similar design features (threaded, root-form, tapered screw, internal hexagon connection). Dimensions (diameters, lengths) within range of predicate and reference devices. Minor differences do not impact substantial equivalence.	Tapered, threaded (fully treated or with 1.5mm collar), root-form dental implants. Conical with internal hexagon connection. Dimensions (diameters 2.75, 3.9, 4.3, 5 mm; various lengths) are presented and compared, falling within the range or being similar to predicate/reference devices. Concluded as substantially equivalent in design and dimensions. (Page 4, 9, 11, 13)

Regarding the specific numbered questions:

A table of acceptance criteria and the reported device performance
- This has been provided above, interpreting the comparison to predicate devices and standards as the implicit "acceptance criteria" for substantial equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document is a 510(k) summary, which inherently relies on demonstrating substantial equivalence to already legally marketed devices. It describes engineering tests and biocompatibility assessments, rather than clinical trial data with patient samples.
- Sample Size: Not specified in the document for any particular test. These are typically bench tests following standardized methodologies.
- Data Provenance: Not explicitly stated as "country of origin for data." The tests are performed "according to ISO" or "in compliance with FDA guidance," implying standard laboratory or testing facility setups. There is no mention of human subject data, therefore, no retrospective or prospective study is described in this context for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document does not describe a clinical study where ground truth is established by experts (e.g., for diagnostic accuracy). The "ground truth" here is compliance with engineering standards and demonstration of similar functional characteristics and safety profiles to existing devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this document does not describe a clinical study requiring adjudication of expert interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a dental implant system (a physical medical device), not an AI algorithm for image interpretation or diagnosis. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical dental implant system, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is established by:
  - Standardized Test Methods: Adherence to international standards like ISO 14801 (mechanical fatigue), ISO 10993 (biocompatibility), ISO 11137 (sterilization), and ASTM F67/F136 (materials).
  - Comparison to Legally Marketed Predicate Devices: The key "ground truth" for a 510(k) is that the device is substantially equivalent in safety and effectiveness to a device already cleared by the FDA. This relies on the established safety and effectiveness of the predicate.
  - Internal Validation: Surface validation and cleaning process validation are internally conducted and documented.
The sample size for the training set
- Not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."
How the ground truth for the training set was established
- Not applicable, as there is no training set for a physical dental implant.

Summary

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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.

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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

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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 InformationSubmitter:	J DENTAL CARE S.r.l. is located at:Via del Tirassegno 41/NMODENAITALY
Contact Person:	Guido BonapaceIsemed SrlVia Palmiro Togliatti 19/XImola, BO 40026 ITALYTel. +39 0542 683803Fax +39 0542 698456Email: 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	Productcode
J Dental CareS.r.l.	JDentalCare® ImplantSystem	JDEvolution	K143142	DZENHA

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Moreover, the following reference devices have been considered:

Applicant	Device name	510(k)Number
Adin Dental ImplantsSystems 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:

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

5. Indications for Use

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

JDentalCare® implant system JDicon® 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.

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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."

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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-TOUAREGCloseFit™UNP 2.75mmD(K153111)	NOBEL BIOCARENobelActive 3.0(K102436)	STRAUMANNDENTAL ImplantSystem SLA(K123784)
	Indicationfor Use	JDentalCare® implantsystem JDIcon® is intendedto replace missingmasticatory functionalunits (teeth) within themaxilla or mandible.JDentalCare® implantsystem JDIcon® iscomprised of dentalimplant fixtures andprosthetic devices. Itprovides a means forprosthetic attachment insingle tooth restorationsand partially or fullyedentulous spans withmultiple single teethutilizing delayed orimmediate loading, or as aterminal or intermediaryabutment for fixed orremovable bridgework orto retain overdentures.Prosthetic devices providesupport and retention forscrew-retained orcemented restorations inmandible and maxilla.JDentalCare® implantsystem is intended forimmediate function onsingle tooth and/ormultiple tooth applicationswhen good primarystability is achieved, withappropriate occlusalloading, in order to restorechewing function.JDentalCare® implantsystem JDicon® 2.75mm DDental Implant shall onlybe used to replacemaxillary lateral incisorsand mandibular lateraland central incisors forsingle-stage or two-stageprocedures. It is forimmediate implantation inextraction sites orimplantation in partiallyhealed or completelyhealed alveolar ridgesituations.	JDENTALCARE®implant system isintended forsurgical placementin the upper orlower jaw.JDentalCare®implant system iscomprised ofdental implantfixtures andprosthetic devices.JDentalCare®implant systemprovides a meansfor prostheticattachment insingle toothrestorations andpartially or fullyedentulous spanswith multiplesingle teethutilizing delayed orimmediateloading, or as aterminal orintermediaryabutment for fixedor removablebridgework or toretainoverdentures.Prosthetic devicesprovide supportand retentionabutment forscrew-retained orcementedrestorations inmandible andmaxilla.JDENTALCARE®implant system isintended forimmediate functionon single toothand/or multipletooth applicationswhen good primarystability is achieved,with appropriateocclusal loading in	TOUAREGCloseFit™ UNP2.75mmD implantsare indicated toreplace missingmasticatoryfunctional units(teeth) in single ormultiple unitapplications withinthe mandible ormaxilla.For single-stage ortwo-stageprocedures. Forimmediateimplantation inextraction sites orimplantation inpartially healed orcompletely healedalveolar ridgesituations. When aone-stage surgicalapproach isapplied, theimplant maybeimmediatelyloaded when goodprimary stability isachieved and thefunctional load isappropriate.The TOUAREGCloseFit™ UNP2.75mmDDentalImplant shall onlybe used to replacemaxillary lateralincisors andmandibular lateraland central incisors.	The NobelActive3.0mm implant isindicated for use inthe treatment ofmissing maxillarylateral incisors orthe mandibularcentral and lateralincisors to supportprosthetic devices,such as artificialteeth, in order torestore chewingfunction in partiallyedentulous patients.The NobelActive 3.0implants may be putinto immediatefunction providedthat stabilityrequirementsdetailed in themanual are satisfied.
stage surgical approach isapplied, the implant maybe immediately loadedwhen good primarystability is achieved andthe functional load isappropriate.	order to restorechewing function.

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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.

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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
Placementmethod	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 acidetching	Double Acid Etching	OsseoFix™ andanodized
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
XLength	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 connectionwith internal hexagon	Internal Hexagon	Conical - Hex connection
Platformsize /Abutmentinterface(mm)	Plat / Diameter2.33.43.43.4	Plat / Diameter2.753.904.305.00	Plat / Diameter3.43.43.43.4
		3.74.35.0	2.252.75
kind ofpackage	Plastic vial + blister	Plastic vial + blister	Double vial
Sterile	YesGamma Radiation	YesGamma Radiation	YesGamma Radiation

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(*) 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.

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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.

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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.

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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
Healingabutment	Available in 3 height: 3, 5 and 7 mmMaterial: Titanium Grade 5		Available in 3 height: 3,5,7mmMaterial: Titanium Grade 5		Ref from UNP0046 to UNP0050Ref from UNP0004 to UNP0013Material Ti 6Al 4V ELI		Ref. models 36794-36795-36796.Available in 3 height: 3,5,7mmMaterial: 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
Temporaryabutments	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

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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)
GPAbutment	Material: Titanium Grade 5Abutment screw: included		Material: Titanium Grade 5Abutment screw: included			Narrow profile abutments.Ref. codes 36781 - 36780Material: Titanium Grade 5Abutment 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 7.0/9.03.0
	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
FixedProsthesis	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
Straightabutment	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)
FixedProsthesisAnatomicAbutments	Collar height: 1.5 – 3 mmStraightMaterial: Titanium Grade 5		Collar height 1,5 – 3StraightMaterial: Titanium Grade 5		//		//
	Dia x Collar Height xAngle	Implant Diameter	Dia x Collar Height xAngle	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
FixedprosthesisConicalAbutments	Straight (Angle 0°)Material: Titanium Grade 5		Straight (Angle 0°)Material: Titanium Grade 5		//		//
	Dia x Collar Height xAngle	Implant Diameter	Dia x Collar Height xAngle	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
OverdentureBallAbutments	Height: 1.5 - 3 - 5 mmMaterial: Titanium Grade 5		Height: 1.5 – 3 – 5 mmMaterial: Titanium Grade 5		Height 0.5-1.0-2.0-3.0-4.0-5.0Material: 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
OverdentureEmiAbutments	Height: 1.5 - 3 - 5 mmMaterial: Titanium Grade 5		Height: 1.5 – 3 – 5 mmMaterial: 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

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JDentalCare® IMPLANT SYSTEM JDICON®

{16}------------------------------------------------

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

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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).

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.