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.

AI/ML Overview

This document is a 510(k) Summary for the JDentalCare® Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/CAD system would. Therefore, much of the requested information (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available from this document.

However, I can extract the acceptance criteria as described for the device's characteristics and the "study" (which are performance tests and validation activities) demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this document is a 510(k) summary for a dental implant system (a physical medical device, not an AI/CAD software), the "acceptance criteria" are related to its physical, material, and functional properties being equivalent to legally marketed predicate devices, and demonstrating safety and effectiveness through various tests.

Acceptance Criteria (Demonstrated Equivalence / Performance)	Reported Device Performance (JDentalCare® Implant System)
Intended Use Equivalence	Intended use is substantially equivalent to predicate devices for surgical placement in the upper or lower jaw, prosthetic attachment in single tooth restorations, partially or fully edentulous spans (delayed/immediate loading), and as an abutment for bridgework or overdentures. Immediate function for single/multiple tooth applications with good primary stability and appropriate occlusal loading.
Material Composition	Machined from Grade 4 or Grade 5 Titanium (for Ø 3.25mm) for implants; abutments are Titanium (Gr.5). This is equivalent to or the same as predicate devices (e.g., Nobel Active uses Titanium Grade 4, Implant Direct Legacy uses Titanium alloy (Ti6AL-4V ELI) (Grade 5)).
Design and Mechanical Features (Shape, Thread, Connection)	Two pieces, tapered screw, internal hexagon with double trapezoidal thread. This is consistent with predicate devices.
Dimensions (Diameter, Length)	Implants available in diameters: 3.25, 3.7, 4.3, 5, 6 mm and lengths: 8, 10, 11.5, 13, 15 mm. These dimensions fall within the range or are comparable to the dimensions offered by predicate devices. Abutment heights also consistent with predicate devices.
Surface Treatment	Double acid etched treatment (fluoride acid etching, then strong acids sulfuric + hydrochloric acid), followed by cool plasma cleaning. Surface validation tests (SEM, XPS) confirm complete removal of manufacturing materials.
Biocompatibility (ISO 10993-1:2010 Part 1)	Tested for Cytotoxicity, Intracutaneous reactivity, Delayed Hypersensitivity, Systemic Toxicity, Bacterial Reverse Mutation. Results: Not Cytotoxic, Satisfying requirements for intracutaneous reactivity, Not sensitizing, Satisfying requirements for systemic toxicity, Not Mutagenic.
Mechanical Performance (ISO 14801:2007)	Dynamic fatigue tests performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatigue test for endosseous dental implants". The document states tests were performed in compliance, but specific quantitative acceptance criteria or results are not listed in this summary. The implication is that they meet acceptable engineering standards.
Sterilization & Packaging Shelf Life (ISO 11137-1, ASTM 1980)	Sterilized with gamma ray sterilization to assure a SAL level of 10⁻⁶. Shelf life is 5 years. Packaging and shelf life were tested and validated according to applicable international standards. The packaging type (plastic vial + blister) and method of sterilization (Gamma Radiation) are consistent with predicate devices. Abutments are noted as not sterile, consistent with one predicate, while another predicate's abutments are sterile. This difference is considered in the context of substantial equivalence.
Packaging	Plastic vial + blister, sterile. Consistent with predicate devices.

2. Sample Size for Test Set and Data Provenance

This document does not describe a clinical study in the format of an AI/CAD device. Instead, "tests" refer to laboratory-based performance testing of the physical implant device and its materials. Therefore, there are no "test sets" of patient data in the conventional sense.

Sample Size for Test Set: Not applicable. Tests involve physical samples of the implant devices and materials. The number of samples for each mechanical or biocompatibility test is not specified in this summary but would be standard for such device testing.
Data Provenance: Not applicable for patient data. The tests are laboratory-based, performed on manufactured devices.

3. Number of Experts and their Qualifications for Ground Truth

Not applicable. Ground truth for a physical medical device like a dental implant is established through validated laboratory tests against engineering standards and material specifications, not through expert clinical consensus on patient data.

4. Adjudication Method

Not applicable. No clinical expert adjudication is mentioned or relevant for the types of tests described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a physical dental implant, not an AI/CAD system, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical dental implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device, which refers to its performance and safety, is established through:

Compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 14801 for mechanical fatigue).
Material specifications (e.g., ASTM F67 for Titanium Grade 4, ASTM F136 for Titanium-6Aluminum-4Vanadium ELI Alloy).
Laboratory test results (e.g., cytotoxicity, fatigue strength, surface analysis).
Comparison to predicate devices with an established history of safe and effective use.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/CAD system that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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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

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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

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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.

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.

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 l -

The 510(k) Summary is provided below

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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/NMODENAITALY
Contact Person:	Maurizio PantaleoniIsemed SrlVia A. Altobelli Bonetti 3/A40026 Imola (BO)Mob.phone: +39 3484435155Telephone: +39 0542 683803Fax: +39 0542 698456Email: 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	Productcode
Nobel Biocare USA LLC	Nobel Active Internal ConnectionImplant	K071370	DZENHA

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Reference devices considered are listed below:

Applicant	Device name	510(k)Number	Productcode
Nobel Biocare USA LLC	Nobel Active 3.0	K102436	DZENHA
A.B. Dental Devices Limited	A.B Dental Devices	K051719	DZE
Implant Direct LLC	Legacy system Dental Implants WithHA Coating	K073033	DZE

4. 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

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

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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.

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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

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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
IntendedUse	JDentalCare® implant system is intended forsurgical placement in the upper or lower jaw.JDentalCare® implant system is comprised ofdental implant fixtures and prosthetic devices.JDentalCare® implant system provides a meansfor prosthetic attachment in single toothrestorations and partially or fully edentulousspans with multiple single teeth utilizing delayedor immediate loading, or as a terminal orintermediary abutment for fixed or removablebridgework or to retain overdentures. Prostheticdevices provide support and retention for screw-retained or cemented restorations in mandibleand maxilla.JDentalCare® implant system is intended forimmediate function on single tooth and/ormultiple tooth applications when good primarystability is achieved, with appropriate occlusalloading, in order to restore chewing function.	A.B. Dental Devices' implantsare intended for surgicalplacement in the maxillaryand/or mandibular arch tosupport crowns, bridges, oroverdentures in edentulous orpartially edentulous patients.Two-piece implants –I1, I2, I2b & I5:Two-stage implants - I2, I2b &I5 implants:One-stage implants - I1One piece implants - I6, I7Implants for immediateloading when good primarystability is achieved and withappropriate occlusal loadingI2, I2b, I5, I6 & I7	The NobelActive 3.0 mmimplant is indicated for usein the treatment of missingmaxillary lateral incisors orthe mandibular central andlateral incisors to supportprosthetic devices, such asartificial teeth, in order torestore chewing function inpartially edentulouspatients. The NobelActive3.0 implant may be put intoimmediate functionprovided that stabilityrequirements detailed inthe manual are satisfied.	These implants are two-pieceimplants for single-stage or two-stage surgical procedures. TheLegacy implants are intendedfor use in the mandible andmaxilla, in support of single ormultipleunit cement or screwreceiving fixed restorations andfor retention and support ofoverdentures. The implants areintended for immediateplacement and function forsupport of single tooth and/ormultiple tooth restorations,recognizing bone stability andappropriate occlusal loadrequirements.
Indication	Immediate load	I5: immediate loading	Immediate load	Immediate Load
Placementmethod	Dual or single stage surgery	I5: two stage implant	Dual or single stagesurgery	Dual or single stage surgery
	Design - Mechanical features
Shape	Two piecesTapered screwInternal Hexagon	I5: two piecesTapered screwInternal Hexagon	Two piecesTapered screwInternal Hexagon	Two piecesTapered screwInternal Hexagon
Thread ofthe bodyMaterials	Double Threadoutline: trapezoidalTitanium grade 4Titanium grade 5 (for Ø 3,25mm)	I5: double threadoutline: trapezoidalTitanium alloy (Ti6AL-4V ELI)grade 5	Double Threadoutline: trapezoidalTitanium grade 4	Double threadoutline: trapezoidalTitanium 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	YesGamma Radiation	YesMethod unknown	YesGamma Radiation	YesGamma 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:

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	JDENTALCARE® Implant System	Predicate Devices
Features	Abutments	Nobel Active (K102436)	A.B DENTAL (K051719)
Healing abutmentHealing Abutmentbicomponent	Available in 3 height: 3,5,7mmMaterial: Titanium	Available in 3 height: 3,5,7mmMaterial: Titanium	N/A
Temporary abutments	Temporary abutmentsnon rotating / rotating modelsMaterial: Titanium	Temporary abutmentnon rotating and rotatingMaterial: titanium or plastic	N/A
GP Abutment	GP abutmentHeight: 7 mmMaterial: titaniumAbutment screw: included	Narrow profile abutments.Height: 7mmMaterial: titaniumAbutment screw: included	N/A
Straight abutment	Straight abutmentCollar height 1 - 2 - 3 - 4 mmMaterial: titanium	N/A	Anatomic abutmentCollar height 1 - 2 - 3 - 4 mmMaterial: titanium
Anatomic Abutments	Anatomic abutmentsCollar height 1,5 - 3Straight - angled 15°	Esthetic abutmentStraight with Collar height 1,5 - 3 - 4,5Angled 15°with Collar height 1,5 - 3 - 4,5	Anatomic angular abutment with shoulder
Conical Abutments	Conical abutmentsangle 0° - collar height 1,5 - 2 - 3 - 4 mmangle 17° - collar height 2,5 - 3,5 mmangle 30° - collar height 2,5 - 3,5 mm	Multi unit abutmentStraight - collar height 1,5-2,5-3.5-4.5mmAngle 17° - collar height 2,5 - 3,5 mmAngle 30°- collar height 3,5 - 4,5 mm	N/A
Ball Abutments	Ball abutmentsMaterial: 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

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.