(267 days)
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to restore patient esthetics and chewing function, which are therapeutic goals. It also provides support for prosthetic devices (artificial teeth) to restore chewing function.
No
This device is a dental implant system designed to support prosthetic devices, restoring chewing function and aesthetics. It is an implantable device, not one that performs diagnostic functions.
No
The device description clearly states it is an implantable device made of commercially pure titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The JDZygoma Dental implant is an implantable device made of titanium, intended to be surgically placed in the Zygomatic bone.
- Intended Use: The intended use is to provide support for prosthetic devices to restore esthetics and chewing function in patients with missing teeth. This is a surgical and restorative procedure, not a diagnostic test performed on a sample outside the body.
The device is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
JDZygoma dental implant is a JDentalCare implant system.
JDZygoma Dental implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxilla, in order to restore patient esthetics and chewing function.
The JDZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
JDZygoma dental implants are implantable devices produced in commercially pure titanium, intended to be integrated in the Zygomatic bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
The JDZygoma implant bodies are single use, gamma sterilized devices that shall be used by qualified medical personnel. The abutments are supplied non sterile and must be sterilized prior to use.
The JDZYGOMA DENTAL IMPLANTS includes 2 lines of devices with different body diameters of implants (3.9 mm and 4.3 mm) with different implant lengths:
- Diameter(mm) 3.9 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5
- Diameter(mm) 4.3 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5.
The surfaces JDZYGOMA DENTAL IMPLANTS, both 3.9 mm and 4.3 mm of diameter, is machined in the distal part of the fixture while the apical part, the threaded part, is characterized by a surface that is a SLA surface obtained through a sandblasting process followed by acid etching.
Machined surface has been analyzed form a morphological point of view using scanning electron microscope (SEM) with different level of magnification (100x, 500x, 1000x and 250x) and also performing a 3D analysis, that allow to define roughness profile with an average height of selected area (Sa) equal to 0.64 um, with a Root mean square gradient (Sdq) of 1.06 and a developed interfacial area ratio (Sdr) of 47.64%.
The abutments are made of titanium grade 5 and have the following angulations:
- 45° 52.5° and 60°
The connection implant / abutment is done through an internal hexagon.
The conical abutments surface is completely treated with anodic oxidation resulting in perception of yellow color.
The anodization process is performed by immersing the anodization solution and by providing an electrical voltage for a time necessary to activate the process with the material (titanium grade 5) and then performing washing process and drying the devices.
The result of this process has been evaluated from a morphological point of view using scanning electron microscope (SEM), measuring the roughness parameters and performing qualitative analysis of the chemical composition of the abutments surface with X-Ray detector considering and comparing both a non anodized abutments and the same anodized abutments in their finished forms.
These evaluations show a relatively uniform surface with characteristic textures of typical machined titanium, clean and free from significant residues or contaminants, with a morphology of the surface before and after anodization that doesn't show appreciable differences also for roughness and X-ray analysis identify a presence of only of Ti, Al, V, O, as expected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper jaw arch / Zygomatic bone
Indicated Patient Age Range
adult population
Intended User / Care Setting
qualified medical personnel
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)
Non-clinical Performance Studies:
A program of design verification and validation testing was performed that includes the following:
- Biocompatibility was conducted according to ISO 10993-1:2018 and ISO 10993-5
- Verification of Washing Process testing was conducted to demonstrate that no residuals substances were present on implant or abutment surface
- Packaging shelf life accelerated aging testing was conducted according to ISO 11607-1
- Comparative mechanical fatigue testing was performed according to a method modified from ISO 14801, on worst-case test articles from the subject, predicate, and reference devices, to best represent the extra-maxillary surgical method
- Gamma Ray Sterilization Validation in accordance with ISO 11137-1:2006 and ISO 11137-2: 2013
- Endotoxin tests is performed on all the batches of JDZygoma implants with the highest dental implant surface, to demonstrate that the pyrogen limit specifications through LAL test according to the United States Pharmacopeial Convention is always respected
Results of the evaluations demonstrate that the subject device demonstrated substantially equivalence performance as per its indication for use.
Clinical Performance Studies (Real World Evidence):
Two retrospective studies were provided, relevant for JDZygoma lines diameter 3.9mm and 4.3mm with follow-up after placement of 1 year and 3 years respectively.
Sample Size: 143 JDZygoma dental implants planted in a total of 66 patients (male and female adult population).
Outcome measures: Implant/abutment success, prosthetic survival, general postoperative complications. Secondary outcomes: Iso Modified Plaque Index (mPLI), modified Bleeding Index (mBI), Mucosal Seal Efficacy Evaluation (MSEE) and Zygomatic Implants Classification Level (ZICL).
Key Results: The survival rates of the 3.9mm and 4.3mm implants which met the criteria for successful implant osseointegration, were 100% for both studies. No differences were registered among clinical indices related to the different abutments inclinations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Survival rates of 100% for both 3.9mm and 4.3mm implants in clinical studies.
Predicate Device(s)
Reference Device(s)
K210356, K152093, K052885, K173343, K182081
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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October 11, 2024
JDentalCare Srl % Pantaleoni Maurizio Consultant Maurizio Pantaleoni Via Borgo Santa Cristina 12 Imoa, 40026 ITALY
Re: K240143
Trade/Device Name: JDZygoma dental implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 16, 2024 Received: September 16, 2024
Dear Pantaleoni Maurizio:
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/cdrb/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.
1
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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-regulatory
2
assistance/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,
Sherrill Lathrop Blitzer
for Andrew 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
JDZygoma dental implants
Indications for Use (Describe)
JDZygoma Dental implant is a JDentalCare implant system.
JDZvgoma Dental implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxilla, in order to restore patient esthetics and chewing function.
The JDZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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:
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4
510(k) Summary JDZYGOMA DENTAL IMPLANTS
This 510(k) Summary is being submitted per 21 CFR 807.92.
1. General Information
| Submitter: | J DENTAL CARE S.r.l. is located at:
Via Dino Campana, 2
MODENA
ITALY
Tel. +39 059 454255
Fax +39 059 450045 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Consultant/ Contact: | Maurizio Pantaleoni
Via Borgo Santa Cristina 12
40026 Imola (BO) |
Summary Prepared Date:
October 11, 2024
Mobile: +39 348-4435155
Email: maurizio.pantaleoni@gmail.com
-
- Names
| Device Name: | JDZYGOMA DENTAL IMPLANTS |
|---|---|
| Classification Name: | Implant, Endosseous, Root-form |
| Product Code: | DZE |
| Secondary Product Code: | NHA |
| Regulation number: | 872.3640 |
| CLASS | ============================================================================================================================================================================== |
5
3. Predicate and Reference Devices
The JDZYGOMA DENTAL IMPLANTS, is substantially equivalent to the following predicate device legally marketed in US:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| Noris Medical | Noris Medical Dental Implants System | |
| (Primary Predicate device) | K151909 |
Reference devices that have been used for comparison of technological features are the following:
| Applicant | Device name | 510(k)
Number |
|--------------------------------|--------------------------------------|------------------|
| Noris Medical | Noris Medical Dental Implants System | K210356 |
| Nobel Biocare AB | NobelZygoma 45° | K152093 |
| Nobel Biocare AB | Zygoma Angled Abutments | K052885 |
| Southern Implants (Pty)
Ltd | Zygomatic Implant System
(ZYGAN) | K173343 |
| J DENTAL CARE S.r.l. | JDIcon | K182081 |
4. Device Description
JDZygoma dental implants are implantable devices produced in commercially pure titanium, intended to be integrated in the Zygomatic bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
The JDZygoma implant bodies are single use, gamma sterilized devices that shall be used by qualified medical personnel. The abutments are supplied non sterile and must be sterilized prior to use.
The JDZYGOMA DENTAL IMPLANTS includes 2 lines of devices with different body diameters of implants (3.9 mm and 4.3 mm) with different implant lengths:
- Diameter(mm) 3.9 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5 ●
- Diameter(mm) 4.3 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5 .
The surfaces JDZYGOMA DENTAL IMPLANTS, both 3.9 mm and 4.3 mm of diameter, is machined in the distal part of the fixture while the apical part, the threaded part, is characterized by a surface that is a SLA surface obtained through a sandblasting process followed by acid etching.
Machined surface has been analyzed form a morphological point of view using scanning electron microscope (SEM) with different level of magnification (100x, 500x, 1000x and 250x) and also performing a 3D analysis, that allow to define roughness profile with an average height of selected area (Sa) equal to 0.64 um, with a Root mean square gradient (Sdq) of 1.06 and a developed interfacial area ratio (Sdr) of 47.64%.
6
The abutments are made of titanium grade 5 and have the following angulations:
- . 45° 52.5° and 60°
The connection implant / abutment is done through an internal hexagon.
The conical abutments surface is completely treated with anodic oxidation resulting in perception of yellow color.
The anodization process is performed by immersing the anodization solution and by providing an electrical voltage for a time necessary to activate the process with the material (titanium grade 5) and then performing washing process and drying the devices.
The result of this process has been evaluated from a morphological point of view using scanning electron microscope (SEM), measuring the roughness parameters and performing qualitative analysis of the chemical composition of the abutments surface with X-Ray detector considering and comparing both a non anodized abutments and the same anodized abutments in their finished forms.
These evaluations show a relatively uniform surface with characteristic textures of typical machined titanium, clean and free from significant residues or contaminants, with a morphology of the surface before and after anodization that doesn't show appreciable differences also for roughness and X-ray analysis identify a presence of only of Ti, Al, V, O, as expected.
5. Indications for Use
JDZygoma Dental implant is a JDentalCare implant system.
JDZygoma Dental implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxilla, in order to restore patient esthetics and chewing function.
The JDZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| Subject device | Primary Predicate device | Reference device | |
|---|---|---|---|
| JDENTALCARE | Noris Medical | Nobel Biocare AB | |
| Implant System JDZygoma | Noris Medical Zygomatic Implants | ||
| System (K151909) | Nobel Zygoma 45° | ||
| (K152093) | |||
| Regulation | |||
| Number: | 872.3640 - Endosseous dental | ||
| implant | 872.3640 - Endosseous dental implant. | 872.3640 - Endosseous | |
| dental implant. | |||
| Classification | II | II | II |
| Product Code | DZE (implant) | DZE (implant) | DZE (implant) |
| NHA (Abutments) | NHA (Abutments) | NHA (Abutments) | |
| JDZygoma dental implant is a | |||
| JDentalCare implant system. | |||
| JDZygoma Dental implant System | |||
| is intended to be implanted in the | |||
| upper jaw arch to provide support | Noris Medical Dental Implants System is | ||
| intended to replace missing tooth/teeth in | |||
| either jaw for supporting prosthetic devices | |||
| that may aid in restoring the patient's | |||
| chewing function. The procedure can be | |||
| accomplished in a one-stage or two-stage | |||
| surgical operation. All implants are | |||
| appropriate for immediate loading when | |||
| good primary stability is achieved and with | |||
| appropriate occlusal loading. | |||
| Noris Medical Zygomatic Dental Implant | |||
| System is intended to be implanted in the | Nobel Biocare's Zygoma | ||
| implants are endosseous dental | |||
| implants intended to be | |||
| surgically placed in the bone of | |||
| the upper jaw arches to provide | |||
| support for prosthetic devices | |||
| such as artificial teeth, in order | |||
| to restore patient esthetics | |||
| and chewing function. | |||
| Intended | |||
| Use | for fixed or removable prosthetic | ||
| devices in patients with partially | |||
| or fully edentulous | |||
| maxillae, in order to restore | |||
| patient esthetics and chewing | |||
| function. | |||
| The JDZygoma Implants are | The Zygoma Implants may be | ||
| put into immediate function |
6. Comparison of the technological characteristics with the predicate and reference devices
7
JDENTALCARE®S.R.L. Traditional 510(k) Submission
| | appropriate for
immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading. | upper jaw arch to provide support for fixed
or removable prosthetic devices in patients
with partially or fully edentulous
maxillae. | provided that stability
requirements detailed in the
directions for use are satisfied. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indication | Immediate or delayed load | Immediate or delayed load | Immediate or delayed load |
| Placement
method | Extra maxillary | Extra maxillary | Inside or outside the maxillary
sinus |
Table 1 - Regulatory Comparison Table
| | Subject device
JDENTALCARE | | Primary Predicate device
Noris Medical | Reference device
Nobel Biocare AB |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | Implant System
JDZygoma
Diameter 3.9 | Implant System
JDZygoma
Diameter 4.3 | Noris Medical
Zygomatic Implants
System (K151909) | Nobel Zygoma 45°
(K152093) |
| Design & Mechanical features | | | | |
| Materials | Titanium grade 4
Two pieces | Titanium grade 4
Two pieces | Titanium alloy (Grade 5)
Two pieces | Titanium grade 4
Two pieces |
| Shape | Cylindrical screw
straight 0° | Cylindrical screw
straight 0° | Cylindrical screw
straight 0° | Cylindrical screw
preangled 45° |
| Connections | Internal Hexagon
Conical connection
Platform Diam: 3.4 mm
Int. Hex Diam: 2,425mm | Internal Hexagon
Conical connection
Platform Diam: 3.4 mm
Int. Hex Diam: 2,425mm | Internal Hexagon
Conical connection
Platform Diam: 3,75 mm
Int. Hex Diam: 2,42mm | External Hexagon |
| Diameters (mm) | 4.35 max diameter
(at platform level)
3.9 body
3.9 apex | 4.5 max diameter
(at platform level)
4.3 body
4.3 apex | 4.2 max diameter
3.75mm platform
4.2 body
3.5 apex | 4.5 platform-
4.0 body
3.9 apex |
| Lengths | 30 / 35 / 37.5 / 40 /
42.5 / 45 / 47.5 / 50 /
52.5/ 55 / 57.5 | 30 / 35 / 37.5 / 40 / 42.5 /
45 / 47.5 / 50 / 52.5/ 55/
57.5 | Diameter 4.2
30 / 35 / 37.5 / 40 / 42.5/
45 / 47.5 / 50 / 52.5/ 55/
57.5 | Diameter 4.0
30 / 35 / 37.5 / 40 / 42.5
/ 45 / 47.5 / 50 / 52.5 |
| Abutment | 45°; 52.5°; 60° | 45°; 52.5°; 60° | 17°, 30°, 45°
(Extended at 52° and 60°
with K210356) | 45°, 62°
(62° with the use of
K052885) |
| Design of the Thread | | | | |
| Thread Length
(starts at apex
and extends
coronally | 16 mm | 18 mm | 13 mm | 18 mm |
| Thread design | Double lead | Double lead | Double lead | Single lead |
| Thread Pitch | 1.295mm | 0.645mm | 1.295mm | 0.600mm |
| Thread Depth | 0.400mm (mean) | 0.330mm (mean) | 0.500mm (mean) | 0.320mm |
| Thread Width | 0.200mm | 0.100mm | 0.200mm | 0.100mm |
| Design of the surfaces | | | | |
8
| | Subject device
JDENTALCARE | | Primary Predicate
device
Noris Medical | Reference device
Nobel Biocare AB |
|--------------------------------|--------------------------------------------|--------------------------------------------|---------------------------------------------------------|--------------------------------------|
| | Implant System
JDZygoma
Diameter 3.9 | Implant System
JDZygoma
Diameter 4.3 | Noris Medical
Zygomatic Implants
System (K151909) | Nobel Zygoma 45°
(K152093) |
| Apex parts | Sandblasting followed
by acid etching | Sandblasting followed by
acid etching | RBM
(Resorbable Blast
Media) | TiUnite |
| Treated
surface height | 18 mm | 18 mm | 16 mm | TiUnite |
| Crestal part of
the implant | Machined | Machined | Machined | TiUnite |
| Design - Dimensions (mm) | | | | |
| Packaging | | | | |
| kind of
package | plastic vial + blister | plastic vial + blister | plastic vial + blister | plastic vial + blister |
| Sterile | Yes
Gamma Radiation | Yes
Gamma Radiation | Yes
Gamma Radiation | Yes
Gamma Radiation |
Table 2 - Comparison Table for Endosseous Implants fixtures
| | Subject device
JDENTALCARE | Primary Predicate device
Noris Medical | Reference device |
|-------------------------------------|--------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------|
| Features | Implant System JDZygoma | Noris Medical Zygomatic
Implants System (K151909 +
K210356) | Zygoma Angled Abutments
(K052885) |
| Design | | | |
| Images of
angulated
abutments | Image: angulated abutments for JDENTALCARE | Image: angulated abutments for Noris Medical | Image: angulated abutments for Zygoma |
| Angles | 45°, 52.5°, 60° | 17°, 30°, 45°, 52° (), 60° () | 0°, 17°
(work angle from 45° to 62° with
the implant) |
| Abutments
Height | 4.5 and 5.0mm | 2, 5 mm | 2, 3, 5 mm |
| Materials | | | |
| Materials | Titanium grade 5 | Titanium grade 5 | Titanium grade 5 |
| Packaging | | | |
| Sterility | Non sterile | Non Sterile | Non Sterile |
Table 3 - Comparison Table for Abutments
The fixtures included in the JDentalCare implant system JDZygoma are considered substantially equivalent to the predicate and reference devices due to the following:
-
- the difference in material respect to the primary predicate device (titanium grade 4 vs 5) doesn't affect the safety and effectiveness of the device, and material is the same material of the reference device.
-
- are two-pieces implants with a cylindrical shape, straight 0° platform exactly as the primary predicate device Noris Medical Zygomatic Implants System (K151909).
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-
- has a conical connection with internal hexagon, exactly as the primary predicate device with an internal Diameter of the hexagon very similar to the one of the primary predicate device.
- diameter, length and work angles are within the range of the predicate devices and/or of the 4) reference device.
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- the thread of JDentalCare implant system JDZygoma can be considered substantially equivalent to the thread of the predicate and reference devices.
- ର) the surface treatment used in JDentalCare implant system JDZygoma doesn't introduce any new issues related to safety and effectiveness of the devices
Finally, where differences are present these are supported also by the availability of the reference devices and by the results of:
- The comparative mechanical fatigue test executed on the worst cases configuration in comparison . with the predicate and reference device, that confirms that fatigue performances of the subject device are comparable to or better than both predicate and reference Devices.
- Real World Evidence
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 and ISO 10993-5
- Verification of Washing Process testing was conducted to demonstrate that no residuals substances were present on implant or abutment surface
- Packaging shelf life accelerated aging testing was conducted according to ISO 11607-1
- Comparative mechanical fatigue testing was performed according to a method modified from ISO 14801, on worst-case test articles from the subject, predicate, and reference devices, to best represent the extra-maxillary surgical method
- . Gamma Ray Sterilization Validation in accordance with ISO 11137-1:2006 and ISO 11137-2: 2013
- . Endotoxin tests is performed on all the batches of JDZygoma implants with the highest dental implant surface, to demonstrate that the pyrogen limit specifications through LAL test according to the United States Pharmacopeial Convention is always respected
Results of the evaluations demonstrate that the subject device demonstrated substantially equivalence performance as per its indication for use.
8. Clinical data
To support the use of the JDZygoma dental system, including different proposed angulations, implant diameter, and length for use with the extra-maxillary surgical method, real world evidence was provided in the form of two retrospective studies, respectively relevant for JDZygoma lines diameter 3.9mm and 4.3mm with follow-up after placement of 1 year and 3 years.
143 JDZygoma dental implants of the two diameters and different lengths were placed in male and female adult population for a total of 66 patients. Distribution of the site, position, length, and diameter varied. Implant/abutment success, prosthetic survival, general postoperative complications have been evaluated as Iso Modified Plaque Index (mPLI), modified Bleeding Index (mBI), Mucosal Seal Efficacy Evaluation (MSEE) and Zygomatic Implants Classification Level (ZICL), as secondary outcomes.
Outcome measures were evaluated, for the 3.9mm JDZygoma implants at 1 year post-surgery and for 4.3mm implants at 3 years post-surgery.
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Based on results of these studies, the survival rates of the 3.9mm and 4.3mm implants which met the criteria for successful implant osseointegration, were 100% for both the studies and no differences were registered among clinical indices related to the different abutments inclinations.
9. Conclusions
The JDZYGOMA DENTAL IMPLANTS was evaluated for substantial equivalence using standards, comparative testing and real world evidences.
The totality of information combined between the real world evidence and bench testing was provided to support the performance of the implant-abutment configuration up to 60° with lengths of 55mm and 57.5mm for the diameter of 3.9mm for the demonstration of substantial equivalence.