K Number

Device Name

JDENTALCARE Implant System

Manufacturer

J DENTAL CARE S.r.l

Date Cleared

2015-11-06

(368 days)

Product Code

DZE NHA

Regulation Number

872.3640

Intended Use

JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices. JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention 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.

Device Description

JDentalCare®implant system is composed by a fixture and an abutment, joined together by a through screw (JDEvolution). In this case the connection is done through an internal hexagon. Abutments and accessories are exclusive for JDentalCare®implant system. JDentalCare®implants are threaded, root-form 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 machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment. JDentalCare®implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K071370

Reference Devices

K102436, K051719, K073033

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML devices.

Therapeutic

Yes

This device is a dental implant system intended to restore chewing function, indicating a therapeutic purpose by improving a physiological function.

Diagnostic

Explanation: The provided text describes the JDentalCare® implant system as a device intended for surgical placement in the jaw to support prosthetic attachments and restore chewing function. Its purpose is to provide a physical means for dental reconstruction, not to identify or diagnose a disease or condition.

SaMD (Software as a Medical Device)

The device description clearly states it is comprised of physical components (fixture, abutment, screw) made of titanium, and the performance studies focus on biocompatibility, surface validation, and mechanical tests of these physical components. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a device for surgical placement in the jaw to support dental prosthetics. This is a direct intervention on the patient's body for a therapeutic purpose (restoring chewing function).
Device Description: The description details the physical components of the implant system (fixture, abutment, screw) and their material (titanium). It focuses on the mechanical and biological properties relevant to implantation.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

JDentalCare® implant system is intended for surgical placement in the upper or lower jaw.

JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices.

JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delaved 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.

IDentalCare® implant system is intended 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.

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

DZE, NHA

Device Description

JDentalCare®implants are threaded, root-form 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 machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw, mandible and maxilla

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

BIOCOMPATIBILITY according to ISO 10993-1:2010 Biological Evaluation of Medical Devices Part 1

Cytotoxicity
Intracutaneous reactivity
Delayed Hypersensitivity
Systemic Toxicity
Bacterial Reverse Mutation
The results of all the reports listed above show that the JDental implants are:
Not Cytotoxic
Satisfying the requirements for intracutaneous reactivity test
Not sensitizing
Satisfying the requirements for systemic toxicity test
Not Mutagenic

SURFACE VALIDATION TESTS
Surface treatment is performed on implants through a double acid treatment: first phase with fluoride acid etching, and a second phase of acid attack with a mixture of strong acids (solforic acid + chloridric acid). Then, there is a cleaning through a cool plasma
These tests, show the results of SEM and XPS analysis and the complete removal of materials (e.g. cutting oils or detergents) 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 fatigue test for endosseous dental implants".

STERILIZATION AND PACKAGING SHELF LIFE
JDentalCare®implant system are sterilized with gamma ray sterilization to assure a SAL level of 10-6.
Shelf life is 5 years. The packaging and shelf life were tested and validated according to applicable international standards

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K071370

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K102436, K051719, K073033

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of a human figure in profile, with three overlapping heads suggesting community and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 6, 2015

J DENTAL CARE S.r.l. % Maurizio Pantaleoni CEO ISEMED S.r.1. Via A. Bonetti 3/a Imola, BO 40026 ITALY

Re: K143142

Trade/Device Name: JDentalCare Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 28, 2015 Received: September 30, 2015

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 (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. 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 mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin |.Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143142

Device Name JDentalCare® implant system

Indications for Use (Describe)

JDentalCare® implant system is intended for surgical placement in the upper or lower jaw.

JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

510(k) SUMMARY l -

The 510(k) Summary is provided below

510(k) Summary for the K143142 JDENTALCARE Implant System

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

| Submitter: | J DENTAL CARE S.r.l. is located at:
Via del Tirassegno 41/N
MODENA
ITALY |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maurizio Pantaleoni
Isemed Srl
Via A. Altobelli Bonetti 3/A
40026 Imola (BO)
Mob.phone: +39 3484435155
Telephone: +39 0542 683803
Fax: +39 0542 698456
Email: regulatory@isemed.eu |
| Summary Preparation Date: | October 20, 2014 |

1. Names

Device Name:	JDentalCare®Implant System
Primary Classification Name:	Endosseous dental implant
Primary Product Code:	DZE
Regulation number:	872.3640
CLASS:	II
Secondary Classification Name:	Endosseous dental implant abutment
Secondary Product Code:	NHA

3. Predicate Device

The JDentalCare®Implant Systems is substantially equivalent to the following predicate device:

| Applicant | Device name | 510(k)
Number | Product
code |
|-----------------------|---------------------------------------------|------------------|-----------------|
| Nobel Biocare USA LLC | Nobel Active Internal Connection
Implant | K071370 | DZE
NHA |

Reference devices considered are listed below:

| Applicant | Device name | 510(k)
Number | Product
code |
|-----------------------------|--------------------------------------------------|------------------|-----------------|
| Nobel Biocare USA LLC | Nobel Active 3.0 | K102436 | DZE
NHA |
| A.B. Dental Devices Limited | A.B Dental Devices | K051719 | DZE |
| Implant Direct LLC | Legacy system Dental Implants With
HA Coating | K073033 | DZE |

4. Device Description

JDentalCare®implants are machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment.

In the following table there are the dimensions for all the JDENTALCARE Implants:

| JDENTALCARE implant system :

JDEvolution dental implant dimensions
IMPLANT DIAMETER	IMPLANT LENGTHS
3,25	8	10	11,5	13	15
3,7	8	10	11,5	13	15
4,3	8	10	11,5	13	15
5	8	10	11,5	13	15
6	8	10	11,5	13	15

Below a short description of all the abutments included in this submission:

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 gum to heal properly. The abutment is screwed into the implant.

HEALING ABUTMENT BI COMPONENT: 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 nonsubmerged healing. It helps the gum to heal properly. The abutment is screwed into the implant with a screw.

TEMPORARY ABUTMENT (engaging / not 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 implant restorations, respectively

GP ABUTMENTS: is indicated for cemented temporary restorations of single and multiple implants. It can be modified with a drill or it can be used as definitive abutment.

STRAIGHT ABUTMENTS: it is indicated for cemented prosthesis of single or multiple units. Collar height can vary from 1mm to 4 mm depending on the height of soft tissues

ANATOMIC ABUTMENTS: it is indicated for cemented prosthesis of single or multiple units. The anatomic abutment has an anatomical festoon preparation of the cervical margin that ensure lesser need of abutment preparation.

CONICAL ABUTMENT: is indicated for screwed-in prosthesis. Conical abutments are intended to be used only for multi-unit restorations, with not angulation correction.

BALL ABUTMENTS: it is indicated for overdentures with ball anchoring

EMI ABUTMENTS: it is indicated for overdentures with emispheric anchoring

5. Indications for Use

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.

6. Performance data

Dimensions, materials and surface treatments are substantially equivalent to those of predicate devices. Also, J DENTALCARE performed the following tests on JDentalCare®implant system:

BIOCOMPATIBILITY according to ISO 10993-1:2010 Biological Evaluation of Medical Devices Part 1

Cytotoxicity
Intracutaneous reactivity
Delayed Hypersensitivity
Systemic Toxicity
Bacterial Reverse Mutation

The results of all the reports listed above show that the JDental implants are:

Not Cytotoxic
Satisfying the requirements for intracutaneous reactivity test
Not sensitizing
Satisfying the requirements for systemic toxicity test
Not Mutagenic

SURFACE VALIDATION TESTS

Surface treatment is performed on implants through a double acid treatment: first phase with fluoride acid etching, and a second phase of acid attack with a mixture of strong acids (solforic acid + chloridric acid). Then, there is a cleaning through a cool plasma

These tests, show the results of SEM and XPS analysis and the complete removal of materials (e.g. cutting oils or detergents) 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 fatigue test for endosseous dental implants".

STERILIZATION AND PACKAGING SHELF LIFE

JDentalCare®implant system are sterilized with gamma ray sterilization to assure a SAL level of10°.

Shelf life is 5 years. The packaging and shelf life were tested and validated according to applicable international standards

7. Substantial Equivalence Discussion:

COMPARATIVE TABLE FOR IMPLANTS

The indications for use of the JDentalCare® implant system devices can be considered substantially equivalent to the identified predicate devices.

The material, shape, the dimensions and the connection are equivalent to that of the predicate devices as shown in the table below:

	JDENTALCARE Implant System Implants	Predicate Devices
	JDEvolution
(K143142)	A.B Dental Devices
(K051719)	Nobel Active
(K071370) (K102436)	Implant Direct Legacy
(K073033)
Intended Use
Intended
Use	JDentalCare® implant system is intended for
surgical placement in the upper or lower jaw.
JDentalCare® implant system is comprised of
dental implant fixtures and prosthetic devices.
JDentalCare® implant system provides a means
for prosthetic attachment in single tooth
restorations and partially or fully edentulous
spans with multiple single teeth utilizing delayed
or immediate loading, or as a terminal or
intermediary abutment for fixed or removable
bridgework or to retain overdentures. Prosthetic
devices provide support and retention 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.	A.B. Dental Devices' implants
are intended for surgical
placement in the maxillary
and/or mandibular arch to
support crowns, bridges, or
overdentures in edentulous or
partially edentulous patients.
Two-piece implants –
I1, I2, I2b & I5:
Two-stage implants - I2, I2b &
I5 implants:
One-stage implants - I1
One piece implants - I6, I7
Implants for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading
I2, I2b, I5, I6 & I7	The NobelActive 3.0 mm
implant is indicated for use
in the treatment of missing
maxillary lateral incisors or
the mandibular central and
lateral incisors to support
prosthetic devices, such as
artificial teeth, in order to
restore chewing function in
partially edentulous
patients. The NobelActive
3.0 implant may be put into
immediate function
provided that stability
requirements detailed in
the manual are satisfied.	These implants are two-piece
implants for single-stage or two-
stage surgical procedures. The
Legacy implants are intended
for use in the mandible and
maxilla, in support of single or
multipleunit cement or screw
receiving fixed restorations and
for retention and support of
overdentures. The implants are
intended for immediate
placement and function for
support of single tooth and/or
multiple tooth restorations,
recognizing bone stability and
appropriate occlusal load
requirements.
Indication	Immediate load	I5: immediate loading	Immediate load	Immediate Load
Placement
method	Dual or single stage surgery	I5: two stage implant	Dual or single stage
surgery	Dual or single stage surgery
	Design - Mechanical features
Shape	Two pieces
Tapered screw
Internal Hexagon	I5: two pieces
Tapered screw
Internal Hexagon	Two pieces
Tapered screw
Internal Hexagon	Two pieces
Tapered screw
Internal Hexagon
Thread of
the body
Materials	Double Thread
outline: trapezoidal
Titanium grade 4
Titanium grade 5 (for Ø 3,25mm)	I5: double thread
outline: trapezoidal
Titanium alloy (Ti6AL-4V ELI)
grade 5	Double Thread
outline: trapezoidal
Titanium grade 4	Double thread
outline: trapezoidal
Titanium alloy (Ti6AL-4V ELI)
(→grade 5)
	Design - Dimensions
Diameter
(mm)	3.25/3.7/4.3/5/6	I5:3.5/3.75/4.2/4.5/5/6/7/8	3/3.5/4.3/5	3.2/3.7/4.2/4.7/5.2/5.7/7
Length	8/10/11.5/13/15	I5: 6/8/10/11.5/13/16	8.5/10/11.5/13/15/18	6/8/10/11.5/13/16
	Design - Connection System
Type	Internal Hexagon	I5: internal hexagon	internal Hexagon	Internal Hexagon
	Packaging
Package	plastic vial + blister	Double packaging	vial + blister	vial + blister
Sterile	Yes
Gamma Radiation	Yes
Method unknown	Yes
Gamma Radiation	Yes
Gamma Radiation

COMPARATIVE TABLE FOR ABUTMENTS:

The intended use for abutments of JDentalCare® implant system is identical to the predicate devices. The abutments have the same material composition and connection to the implants. The main design features of the abutments are identical to the predicate devices as shown in the table below:

	JDENTALCARE® Implant System	Predicate Devices
Features	Abutments	Nobel Active (K102436)	A.B DENTAL (K051719)
Healing abutment
Healing Abutment
bicomponent	Available in 3 height: 3,5,7mm
Material: Titanium	Available in 3 height: 3,5,7mm
Material: Titanium	N/A
Temporary abutments	Temporary abutments
non rotating / rotating models
Material: Titanium	Temporary abutment
non rotating and rotating
Material: titanium or plastic	N/A
GP Abutment	GP abutment
Height: 7 mm
Material: titanium
Abutment screw: included	Narrow profile abutments.
Height: 7mm
Material: titanium
Abutment screw: included	N/A
Straight abutment	Straight abutment
Collar height 1 - 2 - 3 - 4 mm
Material: titanium	N/A	Anatomic abutment
Collar height 1 - 2 - 3 - 4 mm
Material: titanium
Anatomic Abutments	Anatomic abutments
Collar height 1,5 - 3
Straight - angled 15°	Esthetic abutment
Straight with Collar height 1,5 - 3 - 4,5
Angled 15°with Collar height 1,5 - 3 - 4,5	Anatomic angular abutment with shoulder
Conical Abutments	Conical abutments
angle 0° - collar height 1,5 - 2 - 3 - 4 mm
angle 17° - collar height 2,5 - 3,5 mm
angle 30° - collar height 2,5 - 3,5 mm	Multi unit abutment
Straight - collar height 1,5-2,5-3.5-4.5mm
Angle 17° - collar height 2,5 - 3,5 mm
Angle 30°- collar height 3,5 - 4,5 mm	N/A
Ball Abutments	Ball abutments
Material: titanium	Ball Abutment .
Material: titanium	N/A
Emi Abutments	Material: titanium	N/A	LOW Connector
Material	Titanium gr.5	Titanium (commercially pure)	Titanium gr.5
Sterility	Not Sterile	Sterile	Not Sterile

8. Applicable Standards:

The Family of JDentalCare®Implant Systems have 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: 2007 - Dynamic fatigue 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

ASTM 1980 "Standard Guide For Accelerated Aging of Sterile Medical Devices Packages".

ISO 10993-1:2010 Biological Evaluation of Medical Devices Part 1.

9. Conclusions

Based on technological characteristics (intended use, material used, dimensions and features) and performance data (mechanical tests, biocompatibility tests, sterilization and shelf life) included in this submission, the JDentalCare® implant system has been shown to be substantially equivalent to the listed predicate device