JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

.DentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate.

Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

JDental Care implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations

Device Description

JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery.

In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection.

JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.

The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a dental implant system. It details the device's description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about an AI/ML-enabled medical device.

Therefore, I cannot extract information related to acceptance criteria and the study proving the device meets those criteria for an AI/ML device, as the document describes a physical dental implant system and not an AI/ML product.

The sections regarding acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training sets are all relevant to the evaluation of AI/ML models. Since this document is about a physical medical device (dental implants), these concepts are not applicable in this context.

Summary

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

August 16, 2024

JDentalCare Srl % Maurizio Pantaleoni Consultant Via Borgo Santa Cristina 12 Imola, Bologna 40026 ITALY

Re: K233896

Trade/Device Name: JDental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 18, 2024 Received: July 22, 2024

Dear Maurizio Pantaleoni:

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

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

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

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

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

Sincerely,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233896

Device Name

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

Indications for Use (Describe)

JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

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

JDentalCare® Dental Implant System

This 510(k) Summary is being submitted as required by 21 CFR 807.92.

1. General Information

Regulation number:

CLASS

	Submitter:	J DENTAL CARE S.r.l. is located at:Via Dino Campana, 2MODENAITALYTel. +39 059 454255Fax +39 059 450045
	Consultant/ Contact:	Maurizio PantaleoniVia Borgo Santa Cristina 12
		40026 Imola (BO)
		Mobile: +39 348-4435155Email: maurizio.pantaleoni@gmail.com
	Summary Prepared Date:	August 16, 2024
2.	Names
	Device Name:	JDentalCare Dental Implant System:JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
	Classification Name:	Implant, Endosseous,Root-form / Endosseous dentalimplant abutment
	Product Code:	DZE
	Secondary Product Code:	NHA

872.3640

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3. Predicate Devices

The JDentalCare® Dental Implant System, is substantially equivalent to the following predicate device legally marketed in US:

Applicant	Device name	510(k) Number	Productcode
J DENTAL CARE S.r.l.	JDentalCare® Implant SystemJDIcon®	K182081	DZENHA

These predicate devices have not been subject to a design-related recall.

Reference devices that have been considered are the following:

Applicant	Device name	510(k) Number	Product code
J DENTAL CARE S.r.l.	JDentalCare® Implant SystemJDEvolution®	K143142	DZENHA
Adin Dental ImplantsSystems Ltd.	TOUAREG CloseFit™ UNP 2.75mmD	K153111	DZENHA
Nobel Biocare AB	TiUltra Implants and Xeal Abutments	K202344	DZE
Nobel Biocare AB	NobelSpeedy® Groovy	K160119	DZE
Nobel Biocare AB	Nobel Active	K142260	DZENHA
Nobel Biocare AB	Nobel Biocare Healing Cap Multi-UnitTitanium	K171142	NHA
MIS ImplantsTechnologies	MIS V3 Conical Connection Dental ImplantSystem	K163349	DZENHA

This reference devices have not been subject to a design-related recall.

4. Device Description

General

Dental implant surgery is a procedure that replaces tooth roots with metal, screwlike posts and replaces damaged or missing teeth with artificial teeth.

Dental implant surgery can offer an alternative to dentures or bridgework and can offer an option when a lack of natural teeth roots don't allow building denture or bridgework tooth replacements. How dental implant surgery is performed depends on the type of implant and the condition of the jawbone. Dental implant surgery may involve several procedures. The major benefit of implants is solid support for your new teeth - a process that requires the bone to heal tightly around the implant.

JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery.

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Implants Description

JDentalCare® Dental Implant System is a

two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.

The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.

Image /page/6/Figure/6 description: The image shows a diagram of a dental implant. The diagram shows the different parts of the implant, including the abutment, gum, endosseous dental implant, and bone. The artificial replacement tooth is placed on top of the abutment.

Endosseous dental implant and abutment will represent the support, for the dentist, for building the artificial replacement tooth.

The artificial replacement tooth component is not part of this submission.

JDentalCare® Dental Implant System
Design
General:
General Features	Two pieces dental implant system with internal hexagon connection
Shape:
Implant Body	Tapered screw
Implant Neck	Cylindrical
Implants Materials:	Diameter 3.5 – 3.7 – 3.9 – 4.0 – 4.3 –4.5 – 5.0 – 6.0	Titanium Grade 4

Abutment material:	All abutments	Titanium Grade 5
Surface:
Implant	Implants JDEvolution Plus, JDIcon, JDIcon Plus are treated throughsandblasting followed by acid etching (SLA)
Neck	JDEvolution plus – Available with:
	- fully treated collar or
	- 1.5 mm anodized collar both for model with 1.2 and 0.6 mm pitch
	- 2.5 mm anodized collar only for model with 1.2 mm pitch and 4.0 mm diameter

	JDEvolution: no new dental implants introduced, but only prosthetic
	components introduced in this submission

	JDIcon – Available with
	- fully treated collar or
	- 1.5 mm machined collar
JDentalCare® Dental Implant System
	JDIcon plus – Available with:
	- fully treated collar, both for model with 1.2 and 0.8 mm pitch or
	- 1.5 mm anodized collar only for double thread models
Abutment	Abutment surface can be:
	- Smooth/Machined (no treatment)
	- Anodized (Yellow, Green, Purple, Magenta)
	(Ref to section below about prosthetic components)
Thread:
Body	Double thread
	Pitch can be different for the different models:
	JDEvolution plus
	- Pitch 1.2 mm for fully treated collar
	- Pitch 1.2 mm for 1.5 mm and 2.5 mm anodized collar
	- Pitch 0.6 mm for 1.5 mm anodized collar (only 4.0 diameter)
	JDEvolution: no new dental implants introduced, but only prosthetic
	components introduced in this submission
	JDIcon – Available with
	- Pitch 1.2 mm for fully treated collar or
	- Pitch 1.2 mm for 1.5 mm machined collar
	JDIcon plus – Available with:
	- Pitch 1.2 mm for 1.5 mm anodized collar
	- Pitch 1.2 mm for fully treated collar,
	- Pitch 0.8 mm (single thread) and fully treated collar ( Only for JDIcon plus
	3.5 mm, 4.0 mm, 4.5 mm)
Self-ThreadingCapacity	Self-threading capacity in both direction
	Implant Dimensions (refer to tables below for more details)
Diameter	From 3.5 to 6 mm
Length	From 8 to 20 mm
Neck diameter	From 3.7 to 6 mm
Connection:
Shape	Internal hexagon (JDEvolution Plus, JDEvolution)
	Conical with internal hexagon (JDIcon and JDIcon Plus)
Packaging
Type of package	Blister with internal vial for implants
Materials:
Blister:	Tyvek CR27 / Polyester PETG
Vial:	Polystyrene EMPERA 116

The main features of the JDental Implant System added in this submission at the previous devices already cleared with K143142 and K182081 are summarized in table below:

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The specific diameter / length implant body combinations for each implant proposed in this submission are listed below:

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JDEvolution ® PLUS // FULLY TREATED + SLA + Pitch 1.2mm
Dia	Length
3.7	18
4.3	18
5.0	18

JDEvolution® PLUS // ANODIZED COLLAR (1.5mm) + SLA + Pitch 1.2mm
Dia	Length
3.7	8	10	11.5	13	15	18
4.3	8	10	11.5	13	15	18
5.0	8	10	11.5	13	15	18
6.0	8	10	11.5	13	15	/

JDEvolution® PLUS // ANODIZED COLLAR (2.5mm) + SLA + Pitch 1.2 mm
Dia	Length (mm)
4.0	11.5	13	15	18	20

JDEvolution® PLUS // ANODIZED COLLAR (1.5mm) + SLA + Pitch 0.6 mm
Dia	Length (mm)
4.0	8	10	11.5	13	15	18

JDIcon® // FULLY TREATED + Pitch 1.2 mm
Dia.	Length
3.9	18

JDIcon® // MACHINED COLLAR + Pitch 1.2 mm
Dia.	Length
3.9	18

JDIcon® PLUS // ANODIZED COLLAR (1.5 mm) + SLA + pitch 1.2 mm
Dia.	Length
3.7	8	10	11.5	13	15	18
4.3	8	10	11.5	13	15	18
5.0	8	10	11.5	13	/	/

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JDIcon® PLUS // FULLY TREATED SLA + pitch 1.2 mm
Dia.	Length
3.7	8	10	11.5	13	15	18
4.3	8	10	11.5	13	15	18
5.0	8	10	11.5	13	/	/

JDIcon® PLUS // FULLY TREATED SLA + pitch 0.8 mm (*)
Dia.		Length
3.5 (*)	/	10	11.5	13
4.0	8.5	10	11.5	13
4.5	8.5	10	11.5	13

JDIcon Plus implants with 3.5 mm diameter are intended to be used only with straight abutments.

Abutments Description

The abutments included in the JDental Implant System can be divided into the following types:

	JDEvolution Plus ABUTMENTS
SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
	HEALING ABUTMENT: used in the delayedloading technique to close the implantconnection for non-submerged healing. It helpsthe gum to heal properly. The abutment isscrewed into the implant. Available with orwithout anodization. The "tissue lovers"models are characterized by a concaveabutment profile and a yellow anodization.	5	4,6,9	/	/
	TEMPORARY ABUTMENT: (engaging / nonengaging): used for the fabrication oftemporary restorations. Engaging and non-engaging variants are used for single- andmultiple-unit restorations, respectively. The"tissue lovers" models are characterized by aconcave abutment profile and a yellowanodization.	3.1	2	10	/

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	JDEvolution Plus ABUTMENTS
SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
STRAIGHT ABUTMENTS: indicated forcemented prosthesis of single and multipleunits. Collar height can be of 0,5 mm, 1,5 mm,2 mm, 3 mm or 4 mm depending on the heightof soft tissues. Collar height of 0,5 mm availablealso in both engaging/non engaging version forsingle- and multiple-unit restorations,respectively. The "tissue lovers" models arecharacterized by a concave abutment profileand a yellow anodization.	45	0.52 - 4	77	/
GP ABUTMENTS (engaging / non engaging):indicated for restorations of single and multipleimplants. They can be modified with a drill andthey can be used as definitive abutment.	454.54.5	11.51.51.5	10101010	0°0°15°25°
CONICAL ABUTMENTS: indicated for screwed-in prosthesis. Conical abutments, available inboth straight and angulated models areintended to be used only for multi-unitrestorations. The "tissue lovers" models arecharacterized by a concave abutment profile.	4.8	1 -7 - 91.5 -3- 4- 52.5 - 3.52.5-3.5-5	2.22.22.22.2	0°0°17°30°


SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
CONICAL ABUTMENTS: indicated for screwed-inprosthesis. Conical abutments, available in bothstraight and angulated models are intended tobe used only for multi-unit restorations. The"tissue lovers" models are characterized by aconcave abutment profile.	4.8	3	2.2	0°
	4.8	3.5	2.2	17°
	4.8	3.5	2.2	30°
	4.8	1.5 - 3	2.2	0°
	4.8	2.5 – 3.5	2.2	17°
	4.8	2.5-3.5	2.2	30°

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	JDICON ABUTMENTS
SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
HEALING ABUTMENT: used in the delayedloading technique to close the implantconnection for non-submerged healing. Ithelps the gum to heal properly. The abutmentis screwed into the implant. Available with orwithout anodization. The "tissue lovers"models are characterized by a concaveabutment profile and a yellow anodization.	5	9	/	/
TEMPORARY ABUTMENT: (engaging / nonengaging): used for the fabrication oftemporary restorations. Engaging and non-engaging variants are used for single- andmultiple-unit restorations, respectively. The"tissue lovers" models are characterized by aconcave abutment profile and a yellowanodization.	4.4	1.3	10	/
ANATOMIC ABUTMENTS: indicated forcemented prosthesis of single and multipleunits. The anatomic abutment has ananatomical festoon preparation of the cervicalmargin that ensure lesser need of abutmentpreparation.	5.5	1.5 - 3	7.5	15°25°
CONICAL ABUTMENTS: indicated for screwed-in prosthesis. Conical abutments, available inboth straight and angulated are intended to beused only for multi-unit restorations. The"tissue lovers" models are characterized by aconcave abutment profile.	4.8	2.5 - 3.5	2.2	17°30°
STRAIGHT ABUTMENTS: indicated forcemented prosthesis of single and multipleunits. Collar height can be of 0,5 mm, 1,5 mm,2 mm, 3 mm or 4 mm depending on the heightof soft tissues. Collar height of 0,5 mmavailable also in both engaging/non engagingversion for single- and multiple-unitrestorations, respectively. The "tissue lovers"models are characterized by a concaveabutment profile and a yellow anodization.	3.5	1-2	7	/

	JDICON D2.75 ABUTMENTS
SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
GP ABUTMENTS (engaging / non engaging):indicated for restorations of single andmultiple implants. They can be modifiedwith a drill and they can be used as definitiveabutment.	4	1.5	10	15°

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	JDICON D2.75 ABUTMENTS
SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
CONICAL ABUTMENTS: indicated forscrewed-in prosthesis. Conical abutments,available in both straight and angulated areintended to be used only for multi-unitrestorations. The “tissue lovers” models arecharacterized by a concave abutmentprofile.	4.8	1.52.5	2.22.2	0°17°


SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
HEALING ABUTMENT: used in the delayedloading technique to close the implantconnection for non-submerged healing. Ithelps the gum to heal properly. Theabutment is screwed into the implant.Available with or without anodization. The"tissue lovers" models are characterized bya concave abutment profile and a yellowanodization.	4567.5	3-5-73-5-73-5-73-5	/	/
TEMPORARY ABUTMENT: (engaging / nonengaging): used for the fabrication oftemporary restorations. Engaging and non-engaging variants are used for single- andmultiple-unit restorations, respectively. The"tissue lovers" models are characterized bya concave abutment profile and a yellowanodization.	3.7	2	10	/
STRAIGHT ABUTMENTS: indicated forcemented prosthesis of single and multipleunits. Collar height can be of 0,5 mm, 1,5mm, 2 mm, 3 mm or 4 mm depending on theheight of soft tissues. Collar height of 0,5mm available also in both engaging/nonengaging version for single- and multiple-unit restorations, respectively. The "tissuelovers" models are characterized by aconcave abutment profile and a yellowanodization.	4.555.56.0	2 - 42 - 42 - 42 - 4	7777	/
GP ABUTMENTS (engaging / non engaging):indicated for restorations of single andmultiple implants. They can be modifiedwith a drill and they can be used as definitiveabutment.	4,5,64.54.5	1.2 -1.5 - 2.11.51.5	1110.510.5	0°15°25°

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	JDICON Plus ABUTMENTS
SHORT DESCRIPTION	DIAMETER(mm)	GINGIVALCOLLARHEIGHT (mm)	POST HEIGHT(mm)	ANGULATION
ANATOMIC ABUTMENTS: indicated forcemented prosthesis of single and multipleunits. The anatomic abutment has ananatomical festoon preparation of thecervical margin that ensure lesser need ofabutment preparation.	5	1.5 - 31.5 – 3	7.57.5	15°25°
CONICAL ABUTMENTS: indicatedforscrewed-in prosthesis. Conical abutments,available in both straight and angulatedmodels are intended to be used only formulti-unit restorations. The "tissue lovers"models are characterized by a concaveabutment profile.	4.8	1.5 -3- 42.5 - 3.52.5-3.5	2.22.22.2	0°17°30°
BALL ABUTMENTS: indicated to be directlyscrewed into the fixture placed in fullyedentulous jaws to support an overdentureretained with ball or hemi-ball anchoring.	4	1.5 -3-5	3.2	/
EMI ABUTMENTS: indicated to be directlyscrewed into the fixture placed in fullyedentulous jaws to support an overdentureretained with ball or hemi-ball anchoring	3.7	1.5 -3-5	1.6	/
OCTA ABUTMENTS: indicated for screwed-in prosthesis. Octa abutments are intendedto be used only for multi-unit restorations,with no angulation correction. Octaabutment top face is characterized by anoctagonal connection.	3.8	1.5-3-4-5-6	2	/

5. Indications for Use

JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

JDentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDental Implant System is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a onestage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

JDentalCare implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations.

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The difference in indications for use statement between subject device and primary predicate device is only related to the specification related to Implants 20 mm length; this difference is acceptable since primary predicate device didn't have implants with length of 20 mm

6. Comparison of the technological characteristics with the predicate device

The JDentalCare Dental Implant System, family names JDEvolution, JDIcon, JDIcon, JDIcon plus, are substantially equivalent to the devices legally marketed in US listed in the tables below. For the endosseous dental implant fixtures and implant abutment the considered "predicate" devices are the following:

Applicant	Device name	510(k) Number	Productcode
J DENTAL CARE S.r.l.	JDentalCare® Implant SystemJDIcon®	K182081	DZENHA

Moreover, the following reference devices have been considered:

Applicant	Device name	510(k)Number	Productcode
J DENTAL CARE S.r.l.	JDentalCare® Implant SystemJDEvolution®	K143142	DZENHA
Adin Dental ImplantsSystems Ltd.	TOUAREG CloseFit™ UNP 2.75mmD	K153111	DZENHA
Nobel Biocare AB	TiUltra Implants and Xeal Abutments	K202344	DZE
Nobel Biocare AB	NobelSpeedy® Groovy	K160119	DZE
Nobel Biocare AB	Nobel Active	K142260	DZENHA
Nobel Biocare AB	Nobel Biocare Healing Cap Multi-UnitTitanium	K171142	NHA
MIS ImplantsTechnologies	MIS V3 Conical Connection Dental ImplantSystem	K163349	DZENHA

The devices JDIcon®, has been considered as basic predicate device, because the endosseous implants and abutments have similar dimensions and features to many proposed devices; the endosseous implants have the same surface treatment (SLA) of the proposed device and, for the majority of them several other comparable components / abutment combinations.

Below the tables that compare subject and predicate devices

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JDENTALCARE® DENTAL IMPLANT SYSTEM

Table 1. Comparison Table for General Characteristics of Dental Implants and abutments

	ProposedDeviceJDentalCare®Dental ImplantSystem	PredicateDeviceJDentalCare®ImplantSystemJDIcon®(K182081)	JDentalCare®ImplantSystem(K143142)	TOUAREGCloseFit™ UNP2.75mmD(K153111)	TiUltra implants andXeal AbutmentsK202344	NobelSpeedy(K160119)	NobelActiveK142260	EquivalenceDiscussion
RegulationNumber:	872.3640 –Endosseousdental implant.	872.3640 –Endosseousdental implant.	872.3640 –Endosseousdental implant.	872.3640 –Endosseousdental implant.	872.3640 –Endosseous dentalimplant.	872.3640 –Endosseousdentalimplant.	872.3640 –Endosseousdental implant.	SameRegulationNumber
Classification:	II	II	II	II	II	II	II	SameClassification
ProductCode:	DZE (implant)NHA (Abutments)	DZE (implant)NHA (Abutments)	DZE (implant)NHA (Abutments)	DZE (implant)NHA (Abutments)	DZE (implant)NHA (Abutments)PNP (Digital Dentistryworkflow)	DZE	DZE (implant)NHA (Abutments)	SameProductCode
IntendedUse:	JDentalCare DentalImplant System,family namesJDEvolution,JDEvolution Plus,JDIcon, JDIcon Plus,is intended toreplace missingmasticatoryfunctional units(teeth) within themaxilla ormandible.JDentalCare DentalImplant System iscomprised ofdental implantfixtures anddevices	JDentalCare®Implant SystemJDIcon®is intended toreplace missingmasticatoryfunctional units(teeth) within themaxilla ormandible.JDentalCare®implant systemJDIcon® iscomprised ofdental implantfixtures andprosthetic devices.	JDental Care®implant system isintended forsurgical placementin the upper orlower jaw. JDentalCare® implantsystem iscomprised ofdental implantfixtures andprosthetic devices.JDental Care®implant systemprovides a meansfor prostheticattachment insingle tooth	TOUAREGCloseFit™ UNP2.75mmDimplants areindicated toreplace missingmasticatoryfunctional units(teeth) in single ormultiple unitapplications withinthe mandible ormaxilla. For single-stage or two-stageprocedures. Forimmediateimplantation inextraction sites or	NobelActive TiUltraNobelActive TiUltraimplants are endosseousimplants intended to besurgically placed in theupper or lower jaw bonefor anchoring orsupporting toothreplacements to restorepatient esthetics andchewing function.NobelActive TiUltraimplants are indicated forsingle or multiple unitrestorations in splinted ornon-splinted applications.This can be achieved by a2-stage or 1-stage surgical	NobelSpeedy®Groovyimplants areindicated forsingle ormultiple unitrestorations insplinted ornon-splintedapplications.NobelSpeedy®Groovyimplants 20,22, 25 mmwhen placedin the maxilla	NobelActive®implants areendosseousimplantsintended to besurgically placedin the upper orlower jaw bonefor anchoring orsupporting toothreplacements torestore patientesthetics andchewing function.	SameIntendedUse

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prosthetic devices.	provides a means	restoration and	implantation in	technique in combination	are only	NobelActive®
It provides a means	for prosthetic	partially or fully	partially healed or completely healed	with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.	indicated for multiple	implants are indicated for single or multiple
for prosthetic	attachment in single	edentulous spans with multiple single	completely healed alveolar ridge situations. When a one-stage surgical approach is applied,	protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.	unit restorations in splinted applications that utilize at least two implants.	unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
attachment in single	tooth restorations and single	teeth restorations and partially or fully	situations. When a one-stage surgical approach is applied, implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.	sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.	restorations in splinted applications that utilize at least two implants.
single tooth restorations and single	teeth utilizing delayed or	utilizing delayed or immediate	implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate. The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.	NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only.		NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.
teeth utilizing delayed or immediate loading,	utilizing delayed or immediate loading, or as a	immediate abutment for fixed or removable bridgework or to retain overdentures.	The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.	NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.		NobelActive® 3.0 implants are indicated for
delayed or immediate loading, or as a terminal or intermediary	loading, or as a terminal intermediary	abutment for fixed or removable bridgework or to retain overdentures.		NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations.
or as a terminal or intermediary abutment for fixed or removable bridgework or to retain	terminal intermediary abutment for fixed or removable bridgework or to retain	overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla.		The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC TiUltra implants can be used in splinted or non-splinted applications. The NobelReplace CC TiUltra implant may be placed
intermediary abutment for fixed or removable bridgework or to retain overdentures.	abutment for fixed or removable bridgework or to retain overdentures.	Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.		The NobelReplace CC TiUltra implants can be used in splinted or non-splinted applications. The NobelReplace CC TiUltra implant may be placed
Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla.	Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore	JDentalCare Dental Implant System is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore
JDentalCare Dental Implant System is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore	JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore

chewing function.When a one-stagesurgical approachis applied, theimplant may beimmediatelyloaded when goodprimary stability isachieved and thefunctional load isappropriate.Implants 20 mmwhen placed in themaxilla are onlyindicated formultiple unitrestorations insplintedapplications thatutilize at least twoimplants.JDentalCareimplant systemJDIcon 2.75mm DDental Implantshall only be usedto replacemaxillary lateralincisors andmandibular lateraland central incisorsfor single stage ortwo stageprocedures. It is forimmediateimplantation inextraction sites orimplantation inpartially healed orcompletely healedalveolar ridgo	in order to restorechewing function.JDentalCare®implant systemJDIcon® 2.75mmDental Implantshall onlybe used to replacemaxillary lateralincisors andmandibular lateraland centralincisors for single-stage or two-stageprocedures. It isfor immediateimplantation inextraction sites orimplantation inpartially healed orcompletely healedalveolar ridgesituations. When aone- applied, theimplant maybe immediatelyloaded when goodprimary stability isachieved and thefunctional load isappropriate.		immediately and put intoimmediate functionprovided that initialstability requirementsdetailed in the manual aresatisfied. NobelParallel CCTiUltraNobelParallel CC TiUltraimplants are endosseousimplants intended to besurgically placed in theupper or lower jaw bonefor anchoring orsupporting replacementsto restore patientesthetics and chewingfunction.NobelParallel CC TiUltraimplants are indicated forsingle or multiplerestorations in splinted ornon-splinted applications.This can be achieved by a2- stage or 1-stagesurgical techniques incombination withimmediate, early ordelayed loadingprotocols, recognizingsufficient primary stabilityand appropriate occlusalloading for the selectedtechnique. Implants with<7mm length are fordelayed loading onlywhen appropriatestability has beenachieved.MUA XealThe MUA Xeal is apromanufactured	single unitrestorations only

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situations.		prosthetic componentdirectly connected to theendosseous dentalimplant and is intendedfor use as an aid inprosthetic rehabilitation.On1 Base XealThe On1 Base Xeal deviceis a premanufacturedprosthetic componentdirectly connected to anendosseous implant and itis intended for use inprosthetic rehabilitation.The On1 UniversalAbutments consist ofthree major parts.Specifically, the On1 BaseXeal, the On1 UniversalAbutment, and themesostructurecomponents make up amulti-piece abutment.The system integratesmultiplecomponents ofthe digital dentistryworkflow: scan files fromIntra-Oral Scanners, CADsoftware, CAM software,ceramic material, millingmachine and associatedtooling and accessories

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Table 2 - Comparison Table for Endosseous Implants fixture of JDentalCare® Dental Implant System family named JDEvolution®Plus

	Proposed Device	Predicate device	Reference device	Reference Device	Reference device	ReferenceDevice
	JDentalCare® DentalImplant SystemJDEvolution® Plus	JDentalCare®JDIcon®(K182081)	JDentalCare®JDEvolution(K143142)	Nobel Active(K142260)	TiUltra implantsand XealAbutments(K202344)	NobelSpeedy(K160119)	EquivalenceDiscussion
Indication	Immediate ordelayed load	Immediate ordelayed load	Immediate ordelayed load	Immediate ordelayed load	Immediate ordelayed load	Immediateor delayedload	SameIndication
Placementmethod	Dual or single stagesurgery	Dual or singlestage surgery	Dual or singlestage surgery	Dual or singlestage surgery	Dual or singlestage surgery	Dual orsingle stagesurgery	SamePlacementMethod
Materials	Titanium grade 4	Titanium grade 4Titanium grade 5 (forØ2.75 mm)	Titanium grade 4Titanium grade 5(for Ø 3.25mm)	Titanium grade 4Titanium grade 5	Titanium grade 4Titanium grade 5	Titanium	SameMaterials
DesignMechanicalfeatures
Shape	Two piecesTapered screwInternal Hexagon	Two piecesTapered screwConical with InternalHexagon	Two piecesTapered screwInternal Hexagon	Two piecesTapered screwConical with InternalHexagon	Two piecesTapered screwConical with InternalHexagon	Two piecesTapered screwExternalHexagon	Same shape ofpredicatedeviceSimilar shapeof referencedevice
Thread ofthe body	Double ThreadLead 1.2mmLead 0.6mmoutline: trapezoidal	Double ThreadLead 1.2mm(thread space)outline: trapezoidal	Double ThreadLead 1.2mm(thread space)outline: trapezoidal	Tapered implantwith back-taperedcoronal design,reverse-cuttingflutes and doublelead threads	Tapered implantwith back-taperedcoronal design,reverse-cuttingflutes and doublelead threads	Single leadthread withgroove	Same threadof predicateand referencedevices
Neckfeatures	Collar withCrestal grooves lead0.3 mm	Collar with crestalgrooves lead0.25mm(for Ø2.75mm)	Collar withCrestal grooves lead0.3 mm	Crestal grooves	Crestal grooves	No crestalgrooves	Same neckfeatures ofpredicatedevices
	Proposed Device	Predicate device	Reference device	Reference Device	Reference device	Reference Device	Equivalence Discussion
	JDentalCare® DentalImplant SystemJDEvolution® Plus	JDentalCare®JDIcon®(K182081)	JDentalCare®JDEvolution(K143142)	Nobel Active(K142260)	TiUltra implantsand XealAbutments(K202344)	NobelSpeedy(K160119)
DesignSurfacefeatures
Body	SLA (Sandblastingfollowed by acidetching)	SLA (Sandblastingfollowed by acidetching)	DAE (Double AcidEtching)	Ti Unite surfaceTreatment	Ti Ultra	Ti UnitesurfaceTreatment	Similar surfacetreatment ofpredicatedevice
Neck	Fully SLA treated oranodization (1.5 mmor 2.5 mm)	SLA treatment orMachined	N/A	Ti Unite surfaceTreatment	Anodic oxidation oncollar and inside theconnection	Ti UnitesurfaceTreatment	Same necktreatment(SLA) ofreferencedevice JDIcon(K182081)Same necktreatment(anodization)of referencedevice
DesignDimensions
	Proposed Device	Predicate device	Reference device	Reference Device	Reference device	ReferenceDevice
	JDentalCare® DentalImplant SystemJDEvolution® Plus	JDentalCare®JDIcon®(K182081)	JDentalCare®JDEvolution(K143142)	Nobel Active(K142260)	TiUltra implantsand XealAbutments(K202344)	NobelSpeedy(K160119)	EquivalenceDiscussion
Diameter(mm)	Fully Treated3.7/4.3/5Anodized Collar(1.5mm) + Pitch 1.23.7/4.3/5/6Anodized Collar(2.5mm) + Pitch 1.24Anodized Collar(1.5mm) + Pitch 0.64	2.75/3.9/4.3/5	3.25/3.7/4.3/5/6	3.0, 3.5, 4.3, 5.0, 5.5	TiUltra3.0, 3.5, 4.3, 5.0,5.5	4	Similardiameters ofpredicatedevices (noworst casedimensions)
Length(*)	Fully Treated18Anodized Collar(1.5mm) + Pitch 1.28/10/11.5/13/15/18Anodized Collar(2.5mm) + Pitch 1.211.5/13/15/18/20Anodized Collar(1.5mm) + Pitch 0.68/10/11.5/13/15/18	8/10/11.5/13/15	8/10/11.5/13/15	7.0, 8.5, 10.0, 11.5,13.0, 15.0, 18.0	TiUltra7.0, 8.5, 10.0, 11.5,13.0, 15.0, 18.0	20/22/25	Same length ofpredicate /referencedevices
DesignConnectionSystem
	Proposed Device	Predicate device	Reference device	Reference Device	Reference device	Reference Device	Equivalence Discussion
	JDentalCare® DentalImplant SystemJDEvolution® Plus	JDentalCare®JDIcon®(K182081)	JDentalCare®JDEvolution(K143142)	Nobel Active(K142260)	TiUltra implantsand XealAbutments(K202344)	NobelSpeedy(K160119)
Type	Internal Hexagon	Conical connectionwith internalhexagon	Internal Hexagon	Internal conicalconnectionwith hex interface	Internal conicalconnectionwith hex interface	ExternalHexagon	Sameconnection ofpredicatedevice
Platformsize /Abutmentinterface(mm)	Ab.Int. / Diameter3.4 / 3.73.4 / 4.03.4 / 4.83.4 / 5.03.4 / 6.0	Ab Int / Diameter2.3 / 2.753.4 / 3.903.4 / 4.303.4 / 5.00	Ab.Int. / Diameter3.4 / 3.73.4 / 4.33.4 / 5.03.4 / 6.0	Ab.Int. /Diameter2.5 / 3.03.0 / 3.53.4 / 4.33.4 / 4.94.4 / 5.5	Ab.Int. /Diameter2.5 / 3.03.0 / 3.53.4 / 4.33.4 / 5.04.4 / 5.5	Ab Int /Diameter4.1 / 4	Same platformsize /abutmentinterface ofpredicatedevices
Packagingkind ofpackage	plastic vial + blister	plastic vial + blister	plastic vial + blister	Polyethyleneterephthalate (PET)vial with highdensity polyethylene (HDPE) cap(1st sterilebarrier) placed in apolyethyleneterephthalateglycol (PETG) blister(2nd sterile barrier)inside a cardboardbox (protectivepackaging).	Polyethyleneterephthalate (PET)vial with highdensity polyethylene (HDPE) cap(1st sterilebarrier) placed in apolyethyleneterephthalateglycol (PETG) blister(2nd sterile barrier)inside a cardboardbox (protectivepackaging).	Polyethyleneterephthalate(PET) vial withhighdensity polyethylene(HDPE) cap(1st sterilebarrier) placedin apolyethyleneterephthalateglycol (PETG)blister (2ndsterile barrier)inside acardboard box(protectivepackaging)	Samepackaging ofpredicatedevice
	Proposed Device	Predicate device	Reference device	Reference Device	Reference device	Reference Device	Equivalence Discussion
	JDentalCare® DentalImplant SystemJDEvolution® Plus	JDentalCare®JDIcon®(K182081)	JDentalCare®JDEvolution(K143142)	Nobel Active(K142260)	TiUltra implantsand XealAbutments(K202344)	Nobel Speedy(K160119)
Sterile	YesGamma Radiation	YesGamma Radiation	YesGamma Radiation	Gamma Radiation(SAL 10-6)	Gamma Radiation(SAL 10-6)	Gamma Radiation (SAL 10-6)	Same sterilization of predicate device

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								Table 3 - Comparison Table for Abutments of JDental Implant System family named JDEvolution®Plus
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	Proposed device	Reference device	Reference device	Reference device	Reference Device	Reference Device
Features	JDentalCare®Dental ImplantSystemJDEvolution®Plus	JDentalCare®Implant SystemJDEvolution(K143142)	TiUltra implantsand XealAbutments(K202344)	Nobel BiocareHealing CapMulti-UnitTitanium(K171142	NobelActive(K142260)	MIS V3 ConicalConnection DentalImplant System(K163349)	Equivalence Discussion
Design
Healingabutment	Ø5 - height: 4,6,9mmMaterial: Titaniumgrade 5	Ø4 - height: 3,5,7mmØ5 - height: 3,5,7mmØ6 - height: 3,5,7mmMaterial: Titaniumgrade 5	N/A	N/A	Ø3.2 – 6 mmheight: 3,5,7mmMaterial: Titaniumgrade 5	N/A	Same dimension, geometry andmaterial for subject and predicatedevice (K143142)The healing abutment Height 9 mmcan be considered a non-significantmodification since this height is notrelevant for loading
Surfacetreatment	Anodization	No treatment	N/A	N/A	Anodization	N/A	Same surface treatment betweensubject and reference device NobelActive (K142260)The anodization does not impactbiocompatibility
Temporaryabutments(nonrotating /rotating)	Temporaryabutments engagingand non-engagingmodels	Available both nonrotating / rotatingmodels	N/A	N/A	Temporaryabutments engagingand non-engagingmodelsØ not published -height 10 mmMaterial: Titaniumgrade 5	N/A	Same dimension, geometry andmaterial for subject and predicatedevice (K143142) and reference deviceNobel Active (K142260)
Surfacetreatment	Anodization	No treatment	N/A	N/A	Anodization	N/A	Same surface treatment betweensubject and reference device NobelActive (K142260)
	Proposed device	Reference device	Reference device	Reference device	Reference Device	Reference Device
Features	JDentalCare®Dental ImplantSystemJDEvolution®Plus	JDentalCare®Implant SystemJDEvolution(K143142)	TiUltra implantsand XealAbutments(K202344)	Nobel BiocareHealing CapMulti-UnitTitanium(K171142	NobelActive(K142260)	MIS V3 ConicalConnection DentalImplant System(K163349)	Equivalence Discussion
Straightabutment	Ø5 mmCollar height 2 - 4mmØ4 mmCollar height 0.5 mm	Ø4, 5, 6 mmCollar height 2 - 4mmMaterial: Titaniumgrade 5	N/A	N/A	StraightØ not publishedCollar Height 0,5 – 1- 1,5 - 2 - 3 - 4,5mmMaterial: titaniumgrade 5	N/A	Same dimension, geometry andmaterial for subject and predicatedevice(K143142)Similar dimension, geometry andmaterialfor subject and reference device NobelActive (K142260)Comparable results for mechanicaltests
Surfacetreatment	Anodization (bothabutment andprostethic screw oronly prostheticscrew)	No treatment	N/A	N/A	Anodization	N/A	Same surface treatment betweensubject and reference device NobelActive (K142260)
GP Abutment	GP abutmentsstraight (Ø4,5mm)15°, 25° angled(Ø4.5mm)Height 10 mmMaterial: Titaniumgrade 5	GP abutmentsstraight (Ø4, 5, 6mm)Height 7 mmMaterial: titaniumgrade 5	N/A	N/A	15° angledØ not publishedHeight: 8, 8.5,9.5, 10,11 mmMaterial: titaniumgrade 5	25° angledabutment (Ø4.8,5.5, 5.8 mm)Height (gingival) 1– 2 – 3 mmMaterial: titaniumgrade 5	Straight GP AbutmentSame dimension, geometry andmaterial for subject and predicatedevice (K143142)Angled GP AbutmentSame dimension, geometry andmaterial for subject and referencedevices NobelActive (K142260) andMIS V3 (K163349)Comparable results for mechanicaltests
	Proposed device	Reference device	Reference device	Reference device	Reference Device	Reference Device
Features	JDentalCare®Dental ImplantSystemJDEvolution®Plus	JDentalCare®Implant SystemJDEvolution(K143142)	TiUltra implantsand XealAbutments(K202344)	Nobel BiocareHealing CapMulti-UnitTitanium(K171142	NobelActive(K142260)	MIS V3 ConicalConnection DentalImplant System(K163349)	Equivalence Discussion
Surfacetreatment	Anodization only forprosthetic screw	No treatment	N/A	N/A	Anodization on thetop	Anodization	Same surface treatment betweensubject and reference devicesNobelActive (K142260) and MIS V3(K163349)
ConicalAbutments	Ø4.8mmAngle 0° - collarheight 1-7-9mmAngle 0° anodized-collar height1.5-3-4 - 5mmAngle 17° anodized-collar height2.5-3.5mmAngle 30° anodized-collar height2.5 - 3.5 - 5 mmMaterial: Titaniumgrade 5	Ø4.8mmAngles 0 - 17° - 30°angle 0° - collarheight1,5 - 2 - 3 - 4 mmangle 17° - collarheight 2,5 - 3,5 mmangle 30° - collarheight 2,5 - 3,5 mmMaterial: Titaniumgrade 5	MUA XealØ not publishedAngles 0 - 17° - 30°Angle 0°collar height:1.5, 2.5, 3.5, 4.5Angle 17° -collar height:2.5, 3.5Angle 30° -collar height: 3.5,4.5Material: Titaniumgrade 5	N/A	N/A	N/A	Same dimension, geometry andmaterial for subject and predicatedevice(K143142)Similar dimension, geometry andmaterialfor subject and reference deviceTiUltra implants and Xeal abutments(K202344)Comparable results for mechanicaltests
Surfacetreatment	No treatment oranodization	No treatment	Anodization	N/A	N/A	N/A	Same surface treatment betweensubject and reference device TiUltraimplants and Xeal abutments(K202344)
Features	Proposed deviceJDentalCare®Dental ImplantSystemJDEvolution®Plus	Reference deviceJDentalCare®Implant SystemJDEvolution(K143142)	Reference deviceTiUltra implantsand XealAbutments(K202344)	Reference deviceNobel BiocareHealing CapMulti-UnitTitanium(K171142	Reference DeviceNobelActive(K142260)	Reference DeviceMIS V3 ConicalConnection DentalImplant System(K163349)	Equivalence Discussion
Healing CAP	Ø5 mmAvailable in 2heights:6 - 9 mmMaterial: Titaniumgrade 5Surface treatment:Anodization	Ø4.8 mmHeight: 3 mmMaterial: Titaniumgrade 5Surface treatment:No treatment	N/A	Available in 2diameters: 5 - 6 mmAvailable in 2heights: 4.1 - 5.5mmMaterial: Titaniumgrade 5Surface treatment:No treatment	N/A	N/A	Same geometry and material forsubject andPredicate device (K143142)Same dimension, geometry andmaterial for subject device andReference device (K171142)The healing cap Height 9 mm can beconsidered a non-significantmodification since this height is notrelevant for loadingAnodization does not impactbiocompatibility
Materials
Materials	Titanium grade 5	Titanium grade 5	N/A	Titanium grade 5	N/A	N/A	Same material
Packaging
Sterility	Non sterile	Non Sterile	Sterile	Sterile	Sterile	Non sterile	Not sterile both subject and predicatedevice (K143142)

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Table 4 - Comparison Table for Abutments of JDentalCare® Dental Implant System families named JDEvolution (related to 3.25mm Implants)
Features	Proposed deviceJDentalCare® Dental Implant SystemJDEvolution (3.25mm)	Reference deviceJDentalCare®Implant SystemJDEvolution (K143142)	Reference deviceTiUltra implants and Xeal Abutments(K202344)	Equivalence Discussion
Design
ConicalAbutments	Ø4.8mmAngle 0° - collar height 3 mmAngle 17° - collar height 3.5 mmAngle 30° - collar height 3.5 mmANODIZED:Angle 0° - collar height 1.5 - 3 mmAngle 17° - collar height 2.5 –3.5 mmAngle 30° - collar height 2.5 - 3.5mmMaterial: Titanium grade 5	Ø4.8mmAngles 0 - 17° - 30°Height from 1 to 4 mm depending onthe model.In detail:angle 0° - collar height 1,5 - 2 - 3 - 4mmangle 17° - collar height 2,5 – 3,5 mmangle 30° - collar height 2,5 – 3,5 mm	Ø not publishedMUA XealAngle 0° - collar height: 1.5, 2.5,3.5, 4.5Angle 17° - collar height: 2.5, 3.5Angle 30° - collar height: 3.5, 4.5Material: Titanium grade 5	Same dimension, geometry andmaterial for subject and predicatedevice(K143142)Same dimension, geometry andmaterial for subject and referencedevice(K202344)Comparable results for mechanicaltests
Surface treatment	No treatment or anodization (bothabutment and prosthetic screw oronly prosthetic screw)	No treatment	Anodization	Same surface treatment aspredicate / reference device
Materials
Materials	Titanium grade 5	Titanium grade 5	Titanium (commercially pure)	Same materiale
Packaging
Sterility	Non sterile	Non Sterile	Sterile	Not sterile both subject and predicatedevice(K143142)
	Proposed Device	Predicate device	Reference device
	JDentalCare® Dental Implant System	JDentalCare® Implant System	TiUltra implants and Xeal Abutment	Equivalence Discussion
	Family JDIcon	JDIcon® (K182081)	(K202344)
Indication	Immediate or delayed load	Immediate or delayed load	Immediate or delayed load	Same Indication of predicate device
Placementmethod	Dual or single stage surgery	Dual or single stage surgery	Dual or single stage surgery	Same Placement Method ofpredicate device
Materials	Titanium grade 4	Titanium grade 4Titanium grade 5 (for Ø2.75mm)	Titanium grade 4Titanium grade 5	Same Materials of predicate device
DesignMechanicalfeatures
Shape	Two piecesTapered screwConical with Internal Hexagon	Two piecesTapered screwConical with Internal Hexagon	Two piecesTapered screwConical with Internal Hexagon	Same Shape of predicate deviceSimilar shape of reference device
Thread ofthe body	Double ThreadLead 1,2mm(thread space)outline: trapezoidal	Double ThreadLead 1,2mm(thread space)outline: trapezoidal	Tapered implant with back-taperedcoronal design, reverse-cutting flutesand double lead threads	Same thread of predicate devicesSimilar thread of reference device
Neckfeatures	No crestal grooves for diametersincluded in this submission	Collar with crestal grooves lead 0,25mm (for Ø2.75 mm)No crestal grooves for other diameters	Crestal grooves	Same neck features of predicatedevices
DesignSurfacefeatures
Body	SLA (Sandblasting followed by acidetching)	SLA (Sandblasting followed by acidetching)	Ti Ultra treatment on body	Same surface treatment of predicatedevice
Neck	SLA or Machined	SLA or Machined	Anodic oxidation on collar and insidethe connection	Same neck treatment (SLA ormachined) of predicate device
DesignDimensions
Diameter(mm)	3.9	2.75/3.9/4.3/5	3.0, 3.5, 4.3, 5.0, 5.5	Same diameter of predicate device
	Proposed Device	Predicate device	Reference device	Equivalence Discussion
	JDentalCare® Dental Implant System	JDentalCare® Implant System	TiUltra implants and Xeal Abutment(K202344)
	Family JDIcon	JDIcon® (K182081)
Length	18	8/10/11.5/13/15	7.0, 8.5, 10.0, 11.5, 13.0,15.0, 18.0	Same length of reference device for 18 mm
Design-ConnectionSystem
Type	Conical connection with internal hexagon	Conical connection with internal hexagon	Internal conicalconnectionwith hex interface	Same connection of predicate device
Platformsize /Abutmentinterface(mm)	Ab.Int. / Diameter3.43.90	Ab.Int. / Diameter2.3 2.753.4 3.903.4 4.303.4 5.00	Ab.Int. / Diameter2.5 3.03.0 3.53.4 3.94.4 5.1	Same platform size / abutmentinterface of predicate device
Packagingkind ofpackage	plastic vial + blister	plastic vial + blister	plastic vial + blister	Same packaging of predicate device
Sterile	YesGamma Radiation	YesGamma Radiation	YesGamma Radiation	Same sterilization of predicate device

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JDENTALCARE® DENTAL IMPLANT SYSTEM

Table 5 - Comparison Table for Endosseous Implants fixture of JDental Implant System family named JDIcon

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JDENTALCARE® DENTAL IMPLANT SYSTEM

Table 6 - Comparison Table for Abutments of JDental Implant System families named JDIcon

	Proposed device	Predicate device	Reference device	Reference Device	Reference Device
Features	JDentalCare® DentalImplant SystemFamily JDIcon(added abutments)	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®Implant SystemJDEvolution(K143142)	TiUltra implantsand XealAbutments(K202344)	MIS V3 ConicalConnection DentalImplant System(K163349)	Equivalence Discussion
Design
Healingabutment	Ø5 - height: 9 mmMaterial: Titaniumgrade 5	Ø4 - height: 3,5,7 mmØ5 - height: 3,5,7 mmØ6 - height: 3,5,7 mmMaterial: Titanium grade 5	/	/	/	Same geometry and material for subjectand predicate device(K182081)The healing abutment Height 9 can beconsidered a non-significantmodification since this height is notrelevant for loading
Surfacetreatment	No treatment	No treatment	/	/	/	Same surface treatment for subject andpredicate device(K182081)
Temporaryabutments(non rotating/ rotating)	Temporary AbutmentNon Engaging for WeldingJDIconØ4.4 – Height 10mmMaterial: Titaniumgrade 5	Temporary abutmentsengaging and non-engaging modelsØ3.8 – Height 10mmMaterial: Titanium grade 5	/	/	/	Similar dimension, same geometry andmaterial for subject and predicate device(K182081)
Surfacetreatment	No treatment	No treatment	/	/	/	Same surface treatment for subject andpredicate device(K182081)
	Proposed device	Predicate device	Reference device	Reference Device	Reference Device	Equivalence Discussion
Features	JDentalCare® DentalImplant SystemFamily JDIcon(added abutments)	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®Implant SystemJDEvolution(K143142)	TiUltra implantsand XealAbutments(K202344)	MIS V3 ConicalConnection DentalImplant System(K163349)
Anatomicabutment	Ø5.5mm	/	Ø5.5mm	/	Angled 25°Angulatedabutment(Ø4.8, 5.5, 5.8 mm)Height (gingival) 1 – 2 - 3 mmMaterial: Titaniumgrade 5	Angulated 15°Same dimension, geometry andmaterial for subject and referencedevice(K143142)Angulated 25°Same dimension, geometry andmaterial for subject and referencedevice MIS V3 (K163349)Comparable results for mechanicaltests
	Angulated 15°:Collar height 1,5-3mm		Angulated 15°:Collar height 1,5-3mm
	Angulated 25°:Collar height 1,5-3mm
	Material: Titanium grade5		Material: Titaniumgrade 5

Surfacetreatment	No treatment	/	No treatment	/	Anodization	Same surface treatment betweensubject reference device (K143142)
	Proposed device	Predicate device	Reference device	Reference Device	Reference Device	Equivalence Discussion
Features	JDentalCare® DentalImplant SystemFamily JDIcon(added abutments)	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®Implant SystemJDEvolution(K143142)	TiUltra implantsand XealAbutments(K202344)	MIS V3 ConicalConnection DentalImplant System(K163349)
		/		MUA Xeal	/	Same dimension, geometry and materialfor subject and reference device(K143142)Comparable results for mechanicaltests
	Ø4.8mmAngle 17° - collar height2.5-3.5 mmAngle 30° - collar height2.5 - 3.5mmMaterial: Titanium grade5	/	Ø4.8mmAngle 0° - collarheight1,5 – 2 – 3 – 4 mmAngle 17° - collarheight 2,5 – 3,5 mmAngle 30° - collarheight 2,5 – 3,5 mmMaterial: Titaniumgrade 5	Ø not publishedAngles 0 – 17° –30°Angle 0°collar height:1.5, 2.5, 3.5, 4.5Angle 17° -collar height:2.5, 3.5Angle 30° -collar height:3.5, 4.5Material:Titanium grade5	/
Surfacetreatment	No treatment	/	No treatment	/	/	Same surface treatment betweensubject and reference device(K143142)
	Proposed device	Predicate device	Reference device		Reference Device
				Reference Device
Features	JDentalCare® DentalImplant SystemFamily JDIcon(added abutments)	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®Implant SystemJDEvolution(K143142)	TiUltra implantsand XealAbutments(K202344)	MIS V3 ConicalConnection DentalImplant System(K163349)	Equivalence Discussion
StraightAbutments	Ø3.5 mmCollar height 1-2 mm	(straight abutments)Ø4, 5, 6 mmCollar height 2 - 4 mmMaterial: Titanium grade 5	/	/	/	Similar dimension, geometry andmaterialfor subject and predicate device JDIcon(K182081)Comparable results for mechanicaltests
Surfacetreatment	No treatment	No treatment	/	/	/	Same surface treatment as predicatedevice
Materials
Materials	Titanium grade 5	Titanium grade 5	Titanium grade 5	Titanium grade 5	/	Same material between subject andpredicate / reference devices
Packaging						/
Sterility	Non sterile	Non Sterile	Non Sterile	Sterile	Non Sterile	Not sterile both subject and predicate/ reference devices

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JDENTALCARE® DENTAL IMPLANT SYSTEM

Table 7 - Comparison Table for Abutments of JDental Implant System families named JDIcon 2.75

Features	Proposed deviceJDentalCareJDIcon (2.75mm)(added abutments)	Predicate deviceJDentalCare®Implant SystemJDIcon (K182081)	Reference deviceAdin Dental Implants.TOUAREG CloseFit™ UNP2.75mmD (K153111)	Equivalence Discussion
Design
GPabutment	Ø4.0 mmHeigth 10 mmAngulated 15°:Material: Titaniumgrade 5	Ø3.2, 4.0 mmHeigth 10 mmMaterial:Titanium grade 5	UNP Angled Abutment 15°No End LineØ, height not publishedAngled 15°Material: Titanium grade 5	Similar dimension, geometry and material for subject and reference device (K153111)Comparable results for mechanical tests
Surfacetreatment	No treatment	No treatment	No treatment	Same surface treatment between subject and predicate / reference devices
ConicalAbutments	Ø4.8 mmAngle 0° - collar height1.5Angle 17° - collar height2.5- mmMaterial: Titaniumgrade 5	/	UNP Straight SlimAbutment No End LineUNP Angled Abutment 15°No End LineØ, height not publishedAngled 0° - 15°Material: Titanium grade 5	Similar dimension, geometry and material for subject and reference deviceComparable results for mechanical tests
Surfacetreatment	No treatment	/	No treatment	Same surface treatment between subject and reference devices
Materials	Titanium grade 5	Titanium grade 5	Titanium grade 5	Same material between subject and predicate / reference devices
Packaging
	Proposed device	Predicate device	Reference device
Features	JDentalCareJDIcon (2.75mm)(added abutments)	JDentalCare®Implant SystemJDIcon (K182081)	Adin Dental Implants.TOUAREG CloseFit™ UNP2.75mmD (K153111)	Equivalence Discussion
Sterility	Non sterile	Non Sterile	Non Sterile	Not sterile both subject and predicate / reference devices
	Proposed DeviceJDentalCare® Dental ImplantSystem JDIcon® Plus	Predicate deviceJDentalCare® ImplantSystem JDIcon (K182081)	Reference DeviceNobel Active(K142260)	Reference deviceTiUltra implants and XealAbutments (K202344)	Equivalence Discussion
Indication	Immediate or delayed load	Immediate or delayed load	Immediate or delayed load	Immediate or delayed load	Same Indication
Placementmethod	Dual or single stage surgery	Dual or single stage surgery	Dual or single stage surgery	Dual or single stage surgery	Same Placement Method
Materials	Titanium grade 4	Titanium grade 5 (for Ø2.75 mm)Titanium grade 4	Titanium grade 4Titanium grade 5	Titanium grade 4Titanium grade 5	Same Materials
DesignMechanicalfeatures
Shape	Two piecesTapered screwConical with Internal Hexagon	Two piecesTapered screwConical with Internal Hexagon	Two piecesTapered screwConical with Internal Hexagon	Two piecesTapered screwConical with Internal Hexagon	Similar shape of predicate and referencedevices
Thread ofthe body	Double ThreadLead 1,2mm (for diameter 3.7 -4.3 – 5.0)Single ThreadLead 0,8mm (for diameter 3.5-4.0 – 4.5)(thread space)outline: trapezoidal	Double ThreadLead 1,2mm(thread space)outline: trapezoidal	Tapered implant with back-tapered coronal design,reverse-cutting flutes anddouble lead threads	Tapered implant with back-tapered coronal design,reverse-cutting flutes anddouble lead threads	Same thread of predicate devices (for 1.2mm lead)Similar thread of predicate and referencedevice
Neckfeatures	Collar with crestal grooves lead0,3mm for diameter 3.7 - 4.3 –5.0 and thread for diameters3.5 - 4.0 - 4.5	Collar with crestal grooves lead0.25 mm(for Ø2.75 mm)	Crestal grooves	Anodic oxidation on collar andinside the connection	Same neck features of predicate devices(for fully treated)Similar neck features of reference device(for anodized neck)
DesignSurfacefeatures
Body	Sandblasting followed byacid etching	Sandblasting followed by acidetching	Ti Unite surface Treatment	Ti Ultra	Same surface treatment of predicatedevice
	Proposed Device	Predicate device	Reference Device	Reference device	Equivalence Discussion
	JDentalCare® Dental Implant	JDentalCare® Implant	Nobel Active	TiUltra implants and Xeal
	System JDIcon® Plus	System JDIcon (K182081)	(K142260)	Abutments (K202344)
	Anodization or Fully treatedSLA	Sandblasting followed by acidetching (for fully threatedversion)	Ti Unite surface Treatment	Anodic oxidation on collar andinside the connection	Same neck treatment (SLA) of predicatedeviceSimilar neck treatment (anodization) ofreference device
Neck
DesignDimensions
Diameter(mm)	3.7/4.3/53.5/4/4.5	2.75/3.9/4.3/5	3.0, 3.5, 4.3, 5.0, 5.5	3.0, 3.5, 4.3, 5.0, 5.5mm	Similar dimensions of predicate devices(no worst case dimensions)
Length(*)	8/10/11.5/13/15/188.5/10/11.5/13	8/10/11.5/13/15	7.0, 8.5, 10.0, 11.5, 13.0,15.0, 18.0	7.0, 8.5, 10.0, 11.5, 13.0,15.0, 18.0mm	Same length of predicate and referencedevices
DesignConnectionSystem
Type	Conical connection withinternal hexagon	Conical connection withinternal hexagon	Internal conicalconnectionwith hex interface	Internal conicalconnectionwith hex interface	Same connection of predicate device
Platformsize /Abutmentinterface(mm)	Ab.Int. / Diameter3.1 3.403.1 3.603.1 3.763.1 4.003.1 4.80	Ab.Int. / Diameter2.32.753.4 3.903.4 4.303.4 5.00	Ab.Int. / Diameter2.5 / 3.03.0 / 3.53.4 / 4.33.4 / 4.94.4 / 5.5	Ab.Int. / diameter2.5 3.03.0 3.53.4 3.94.4 5.1	similar platform size / abutment interfaceof predicate device
Packaging
	Proposed Device	Predicate device	Reference Device	Reference device	Equivalence Discussion
	JDentalCare® Dental ImplantSystem JDIcon® Plus	JDentalCare® ImplantSystem JDIcon (K182081)	Nobel Active(K142260)	TiUltra implants and XealAbutments (K202344)
kind ofpackage	plastic vial + blister	plastic vial + blister	Polyethylene terephthalate(PET) vial with highdensity poly ethylene (HDPE)cap (1st sterilebarrier) placed in apolyethylene terephthalateglycol (PETG) blister (2nd sterilebarrier) inside a cardboard box(protective packaging).	Double vial	Same packaging of predicate device
Sterile	YesGamma Radiation	YesGamma Radiation	Gamma Radiation (SAL 10-6)	YesGamma Radiation	Same sterilization of predicate device

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JDENTALCARE® DENTAL IMPLANT SYSTEM

Table 8 - Comparison Table for Endosseous Implants fixture of family named JDIcon® Plus

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JDENTALCARE® DENTAL IMPLANT SYSTEM

Table 9 - Comparison Table for Abutments of family named JDIcon® Plus

	Proposed device	Predicate device	Referencedevice	Referencedevice	ReferenceDevice	Reference device	ReferenceDevice
Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)	Equivalence Discussion
Design
Healingabutment	Ø4 - height: 3,5,7 mmØ5 - height: 3,5,7 mmØ6 - height: 3,5,7 mmØ7.5 - height: 3,5 mmMaterial: Titaniumgrade 5	Ø4 - height: 3,5,7 mmØ5 - height: 3,5,7 mmØ6 - height: 3,5,7 mmMaterial: Titaniumgrade 5	/	Ø3.2 – 6 mmheight: 3,5,7Material:Titanium grade 5	/	/	N/A	Same geometry and material forsubject and predicate device(K182081) and reference device(K142260)The healing abutment diameter7.5 can be considered a non-significant modification since theheight is not relevant for loading
Surfacetreatment	Anodization	No treatment	/	Anodization	/	/	/	Same surface treatmentbetween subject and referencedeviceAnodization does not impactsince biocompatibility testsshowed that anodization isbiocompatible

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	Proposed device	Predicate device	Referencedevice	Referencedevice	ReferenceDevice	Reference device	ReferenceDevice
Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)	Equivalence Discussion
Temporaryabutments(nonrotating /rotating)	Temporary abutmentsengaging and non-engaging modelsØ3.7 – Height 10mmMaterial: Titaniumgrade 5	Temporary abutmentsengaging and non-engaging modelsØ3.8 – Height 10mmMaterial: Titaniumgrade 5	/	Temporaryabutmentsengaging andnon-engagingmodelsØ not published -height 10 mmMaterial:Titanium grade5	/	/	/	Same dimension, geometry andmaterial for subject andpredicate device(K182081) and reference device(K142260)
Surfacetreatment	Anodization	No treatment	/	Anodization	/	/	/	Same surface treatmentbetween subject and NobelActive (K142260) referencedeviceAnodization does not impactperformances sincebiocompatibility tests showedthat anodization isbiocompatible
	Proposed device	Predicate device	Referencedevice	Referencedevice	ReferenceDevice	Reference device	ReferenceDevice

Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)	Equivalence Discussion
Straightabutment	Ø4.5, 5.0, 5.5, 6.0 mmCollar height 2 - 4 mmMaterial: Titaniumgrade 5	Ø4, 5, 6 mmCollar height 2 - 4 mmMaterial: Titaniumgrade 5	/	StraightØ not publishedCollar Height0,5 - 1 - 1,5 - 2 -3 – 4,5 mmMaterial: titaniumgrade 5	/	/	/	Same dimension, geometry andmaterial for subject andpredicate device(K182081)Similar dimension, geometry andmaterialfor subject and reference deviceComparable results formechanical tests
Surfacetreatment	Anodization	No treatment	/	Anodization	/	/	/	Same surface treatmentbetween subject and NobelActive (K142260) referencedeviceAnodization does not impactperformances sincebiocompatibility tests showedthat anodization isbiocompatible
GP Abutment	GP abutments straight(Ø4, 5, 6 mm) andangled 15°, 25°(Ø4.5 mm)Height 10.5, 11mmMaterial: Titaniumgrade 5	GP abutments straight(Ø3.2, 4, 5, 6 mm)Height 10, 10.5mmMaterial: Titaniumgrade 5	/	15° angledØ not publishedHeight: 8, 8.5,9.5,10, 11 mmMaterial:titanium grade5	/	/	25° angledabutment(Ø4.8, 5.5,5.8 mm)Height(gingival) 1 –2 - 3 mm	Straight GP AbutmentSame dimension, geometry andmaterial for subject andpredicate device(K182081)Angled GP AbutmentSame dimension, geometry andmaterial for subject and
	Proposed device	Predicate device	Reference device	Reference device	Reference Device	Reference device	Reference Device
Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)	Equivalence Discussion
Surfacetreatment	Anodization	No treatment	/	Anodization	/	/	Anodization	Same surface treatment betweensubject and Nobel Active (K142260)reference deviceAnodization does not impactperformances since biocompatibilitytests showed that anodization isbiocompatible
AnatomicAbutments	Ø5 mmAngulated 15°:Collar height 1,5-3mmAngulated 25°:Collar height 1,5-3mmMaterial: Titaniumgrade 5	/	Ø5.5mmStraight:Collar height1,5-3mmAngulated15°:Collar height1,5-3mmAngle 0° - 15°Material:Titanium grade5	/	/	/	25° angledabutment(Ø4.8, 5.5,5.8 mm)Height(gingival) 1 -2-3 mm	Same dimension, geometry andmaterial for subject andreference device(K143142)Angled Anatomic AbutmentSame dimension, geometry andmaterial for subject andreference device (K163349)Comparable results formechanical tests
		Proposed device	Predicate device	Reference device	Reference device	Reference Device	Reference device	Reference Device
	Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)	Equivalence Discussion
	Surfacetreatment	Anodization	/	No treatment	/	/	/	Anodization	Same surface treatmentbetween subject and NobelActive (K142260) referencedeviceAnodization does not impactperformances sincebiocompatibility tests showedthat anodization isbiocompatible
	ConicalAbutments	Ø4.8 mm	Ø4.8 mm	/	/	MUA XealØ notpublished	/	/	Similar dimension, geometry andmaterial for subject andpredicate device (K143142)and reference deviceComparable results formechanical tests
		Angle 0° - collar height 1.5- 3 - 4 mmAngle 17° - collar height2.5 - 3.5 mmAngle 30° - collar height2.5 - 3.5 mmMaterial: Titaniumgrade 5	Angle 0° - collar height1.5-3 mmMaterial: Titaniumgrade 5	/	/	Angles 0 – 17°– 30°Angle 0° -collarheight:1.5, 2.5, 3.5,4.5Angle 17° -collarheight:2.5, 3.5Angle 30° -galler
	Proposed device	Predicate device	Reference device	Reference device	Reference Device	Reference device	Reference Device

Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)	Equivalence Discussion
Surfacetreatment	Anodization	No treatment	/	/	Anodization	/	/	Same surface treatmentbetween subject and referencedevice (K202344)Anodization does not impactperformances sincebiocompatibility tests showedthat anodization isbiocompatible
BallAbutments	Ø4 mmHeight: 1.5 – 3 – 5 mmMaterial: Titaniumgrade 5	Ø3.7 mmHeight: 1.5 – 3 – 5 mmMaterial: Titanium	Ø4 mmHeight: 1.5 – 3– 5 mmMaterial:Titanium grade5	/	height: 3.5,4.5Material:Titaniumgrade 5	/	Height: 1 – 2 –3 – 4 – 5 mmMaterial:Titanium gr 5	Similar dimension, samegeometry and material forsubject andpredicate device (K182081)Same dimension, same geometryand material for subject andreference device (K143142)
Surfacetreatment	No treatment	No treatment	No treatment	/	/	/	TiN Coating	Same surface treatment aspredicate device (K182081)
	Proposed device	Predicate device	Referencedevice	Referencedevice	ReferenceDevice	Reference device	ReferenceDevice	Equivalence Discussion

Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)
EmiAbutments	Ø3.7 mm	Ø3.7 mm	Ø3.7 mm	/	/	/	Height: 1 – 2 –3 -4 - 5 mmMaterial:Titanium gr 5	Same dimension, geometry andmaterial for subject andpredicate device (K182081)and Reference device (K143142)
	Height: 1.5 - 3 - 5 mmMaterial: Titaniumgrade 5	Height: 1.5 – 3 – 5 mmMaterial: Titanium	Height: 1.5 – 3- 5 mmMaterial:Titanium gr 5
Surfacetreatment	No treatment	No treatment	No treatment	/	/	/	TiN Coating	Same surface treatment aspredicate device (K182081)
OctaAbutments	Ø3.8 mm	/	/	/	MUA XealØ notpublished	/	/	Same dimension, geometry andmaterial for subject andReference device (K202344)
	Available in 5 heights: 1.5— 3- 4 — 5 — 6 mmMaterial: Titanium grade5Surface treatment:Anodization				Available in 4heights: 1.5-2.5-3.5-4.5mmMaterial:Titaniumgrade 5
HealingCAP	Available in 2 diameters:4 – 5 mmAvailable in 2 heights: 4 -5 mmMaterial: Titanium gr 5Surface treatment:No treatment	/	Ø4.8 mmHeight: 3 mmMaterial:Titanium grade5Surfacetreatment:No treatment	/	/	Available in 2diameters: 5 – 6 mmAvailable in 2 heights:4.1 – 5.5 mmMaterial: Titaniumgrade 5Surface treatment:No treatment	/	Same dimension, geometry andmaterial for subject andReference device (K171142)
	Proposed device	Predicate device	Reference device	Reference device	Reference Device	Reference device	Reference Device
Features	JDentalCare® DentalImplant SystemFamily JDIcon® Plus	JDentalCare® ImplantSystem JDIcon®(K182081)	JDentalCare®ImplantSystemJDEvolution(K143142)	NobelActive(K142260)	TiUltraimplants andXealAbutments(K202344)	Nobel BiocareHealing Cap Multi-Unit(K171142)	MIS V3ConicalConnection(K163349)	Equivalence Discussion
Materials	Titanium grade 5	/	Titaniumgrade 5	/	/	Titanium grade 5	/	Same material for subject andreference devices
Packaging
Sterility	Non sterile	Non sterile	Non sterile	Sterile	Sterile	Sterile	Non sterile	Same material for subject,predicate and reference devices

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7. Performance Data (non clinical)

A program of design verification and validation testing was performed that includes the following:

Biocompatibility was conducted according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and includes: o Cytotoxicity assessment according to ISO 10993-5:2009; (conducted both on implants and worst case anodized abutment)
o Sensitization testing according to ISO 10993-10:2010;

o Irritation testing according to ISO 10993-10:2010;

o Material mediated pyrogenicity testing according to ISO 10993-11:2017;
o Acute systemic toxicity testing according to ISO 10993-11:2017.

• Packaging shelf life accelerated aging tests: testing was conducted according to ISO 11607-1. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

• Surface validation test: surface treatment is identical to predicate device. The treatment performed on implants through a sandblasting treatment followed by an acid etching treatment. Then, there is a cleaning process for the removal of residual substances. A morphological SEM analysis was performed to verify roughness and cleanliness of the surface and a cleaning process validation have been performed to verify the complete removal of materials used during manufacturing process.

• Verification of Washing Process : testing was conducted to demonstrate that no residuals substances were present on implant or abutment surface.

• Mechanical Performance Tests performed according to ISO 14801 on worst case combinations of implants and abutments representative for all the products included in current submission showed comparable results between subject device and predicate / reference devices. Mechanical Testing was conducted according to ISO 14801:2016 Dentistry — Implants — Dynamic loading test for endosseous dental implants and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004).

Gamma Ray Sterilization Validation in accordance with:
o ISO 11137-1:2006, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices o ISO 11137-2: 2013, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

• Sterilization validation of abutments

Even though abutments are supplied not sterile, their ability to be steam sterilized before their use was verified (test performed according to ISO 17665-1:2006 Sterilization of health care products -

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Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices)

· MRI environment

Non-clinical worst-case MRI review was performed to evaluate the JDENTALCARE IMPLANT SYSTEM devices in the MRI environment using scientific rationale and published literature, based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque

8. Clinical data

N/A

9. Conclusions

The JDENTALCARE® DENTAL IMPLANT SYSTEM were evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data, the JDENTALCARE® DENTAL IMPLANT SYSTEM have been shown to be substantially equivalent to the predicate devices

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.