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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the JDZygoma dental implants, which is a medical device. This type of document is a submission to the FDA demonstrating that the device is as safe and effective as a legally marketed predicate device. The information required in the prompt (acceptance criteria, study details, etc.) is typically found in performance studies used to support substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics with corresponding reported values in a pass/fail format. However, it describes several performance tests and their outcomes:

Performance Test / Criterion Type	Reported Device Performance (Implied Acceptance)
Biocompatibility	Conducted according to ISO 10993-1:2018 and ISO 10993-5. (Implies compliance with these standards, meaning the device is biocompatible).
Washing Process	Demonstrated that no residual substances were present on implant or abutment surface. (Implies successful cleaning and absence of harmful residuals).
Packaging Shelf Life	Accelerated aging testing conducted according to ISO 11607-1. (Implies meeting the shelf-life requirements of this standard).
Mechanical Fatigue	Comparative mechanical fatigue testing was performed according to a method modified from ISO 14801. Results confirm that fatigue performances of the subject device are comparable to or better than both predicate and reference Devices. (Implies the device meets or exceeds the mechanical durability of predicate/reference devices).
Gamma Ray Sterilization	Validation in accordance with ISO 11137-1:2006 and ISO 11137-2: 2013. (Implies effective sterilization and compliance with these standards).
Endotoxin Tests	Performed on all batches to demonstrate that pyrogen limit specifications through LAL test according to the United States Pharmacopeial Convention is always respected. (Implies the device is non-pyrogenic).
Clinical Survival Rate	Survival rates of the 3.9mm and 4.3mm implants which met the criteria for successful implant osseointegration, were 100% for both studies. (Implied acceptance based on comparison with existing clinical expectations for dental implants. High survival rates are a key indicator of clinical success).
Clinical Complications	No differences were registered among clinical indices related to the different abutments inclinations (modified Plaque Index (mPLI), modified Bleeding Index (mBI), Mucosal Seal Efficacy Evaluation (MSEE) and Zygomatic Implants Classification Level (ZICL)). (Implies that different abutment angles do not lead to increased complications).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Clinical): 143 JDZygoma dental implants in a total of 66 patients.
Data Provenance: The studies were retrospective studies. The country of origin of the data is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. It states that "Outcome measures were evaluated," but doesn't specify who performed these evaluations or their credentials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for the clinical study outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is Not Applicable to the provided document. The JDZygoma dental implant is a physical medical device (dental implant and abutments), not an AI/software device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is Not Applicable for the same reasons as point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical studies, the ground truth was outcomes data including:

Implant/abutment success (defined by criteria for successful implant osseointegration)
Prosthetic survival
General postoperative complications
Secondary outcomes: Modified Plaque Index (mPLI), modified Bleeding Index (mBI), Mucosal Seal Efficacy Evaluation (MSEE), and Zygomatic Implants Classification Level (ZICL).

8. The sample size for the training set

The document refers to retrospective studies and does not mention a separate "training set" in the context of device development or validation. The "143 JDZygoma dental implants in a total of 66 patients" represent the clinical data used for validation, not a separate training set as would be typical for AI/machine learning.

9. How the ground truth for the training set was established

As there is no described "training set" in the context of AI/machine learning, this point is Not Applicable. The clinical "ground truth" (outcomes data) for the retrospective studies was established by evaluating the performance of the implants in patients post-surgically, as described in point 7.

Summary

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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.

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

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

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

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

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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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240143

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.

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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, 2MODENAITALYTel. +39 059 454255Fax +39 059 450045
Consultant/ Contact:	Maurizio PantaleoniVia Borgo Santa Cristina 1240026 Imola (BO)

Summary Prepared Date:

October 11, 2024

Mobile: +39 348-4435155

Email: maurizio.pantaleoni@gmail.com

1. Names

Device Name:	JDZYGOMA DENTAL IMPLANTS
Classification Name:	Implant, Endosseous, Root-form
Product Code:	DZE
Secondary Product Code:	NHA
Regulation number:	872.3640
CLASS	==============================================================================================================================================================================

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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

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 .

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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.

5. Indications for Use

JDZygoma Dental implant is a JDentalCare implant system.

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 ImplantsSystem (K151909)	Nobel Zygoma 45°(K152093)
RegulationNumber:	872.3640 - Endosseous dentalimplant	872.3640 - Endosseous dental implant.	872.3640 - Endosseousdental implant.
Classification	II	II	II
Product Code	DZE (implant)	DZE (implant)	DZE (implant)
	NHA (Abutments)	NHA (Abutments)	NHA (Abutments)
	JDZygoma dental implant is aJDentalCare implant system.JDZygoma Dental implant Systemis intended to be implanted in theupper jaw arch to provide support	Noris Medical Dental Implants System isintended to replace missing tooth/teeth ineither jaw for supporting prosthetic devicesthat may aid in restoring the patient'schewing function. The procedure can beaccomplished in a one-stage or two-stagesurgical operation. All implants areappropriate for immediate loading whengood primary stability is achieved and withappropriate occlusal loading.Noris Medical Zygomatic Dental ImplantSystem is intended to be implanted in the	Nobel Biocare's Zygomaimplants are endosseous dentalimplants intended to besurgically placed in the bone ofthe upper jaw arches to providesupport for prosthetic devicessuch as artificial teeth, in orderto restore patient estheticsand chewing function.
IntendedUse	for fixed or removable prostheticdevices in patients with partiallyor fully edentulousmaxillae, in order to restorepatient esthetics and chewingfunction.The JDZygoma Implants are		The Zygoma Implants may beput into immediate function

6. Comparison of the technological characteristics with the predicate and reference devices

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JDENTALCARE®S.R.L. Traditional 510(k) Submission

	appropriate forimmediateloading when good primarystability is achieved and withappropriate occlusal loading.	upper jaw arch to provide support for fixedor removable prosthetic devices in patientswith partially or fully edentulousmaxillae.	provided that stabilityrequirements detailed in thedirections for use are satisfied.
Indication	Immediate or delayed load	Immediate or delayed load	Immediate or delayed load
Placementmethod	Extra maxillary	Extra maxillary	Inside or outside the maxillarysinus

Table 1 - Regulatory Comparison Table

	Subject deviceJDENTALCARE		Primary Predicate deviceNoris Medical	Reference deviceNobel Biocare AB
	Implant SystemJDZygomaDiameter 3.9	Implant SystemJDZygomaDiameter 4.3	Noris MedicalZygomatic ImplantsSystem (K151909)	Nobel Zygoma 45°(K152093)
Design & Mechanical features
Materials	Titanium grade 4Two pieces	Titanium grade 4Two pieces	Titanium alloy (Grade 5)Two pieces	Titanium grade 4Two pieces
Shape	Cylindrical screwstraight 0°	Cylindrical screwstraight 0°	Cylindrical screwstraight 0°	Cylindrical screwpreangled 45°
Connections	Internal HexagonConical connectionPlatform Diam: 3.4 mmInt. Hex Diam: 2,425mm	Internal HexagonConical connectionPlatform Diam: 3.4 mmInt. Hex Diam: 2,425mm	Internal HexagonConical connectionPlatform Diam: 3,75 mmInt. Hex Diam: 2,42mm	External Hexagon
Diameters (mm)	4.35 max diameter(at platform level)3.9 body3.9 apex	4.5 max diameter(at platform level)4.3 body4.3 apex	4.2 max diameter3.75mm platform4.2 body3.5 apex	4.5 platform-4.0 body3.9 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 4.230 / 35 / 37.5 / 40 / 42.5/45 / 47.5 / 50 / 52.5/ 55/57.5	Diameter 4.030 / 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 ofK052885)
Design of the Thread
Thread Length(starts at apexand extendscoronally	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

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	Subject deviceJDENTALCARE		Primary PredicatedeviceNoris Medical	Reference deviceNobel Biocare AB
	Implant SystemJDZygomaDiameter 3.9	Implant SystemJDZygomaDiameter 4.3	Noris MedicalZygomatic ImplantsSystem (K151909)	Nobel Zygoma 45°(K152093)
Apex parts	Sandblasting followedby acid etching	Sandblasting followed byacid etching	RBM(Resorbable BlastMedia)	TiUnite
Treatedsurface height	18 mm	18 mm	16 mm	TiUnite
Crestal part ofthe implant	Machined	Machined	Machined	TiUnite
Design - Dimensions (mm)
Packaging
kind ofpackage	plastic vial + blister	plastic vial + blister	plastic vial + blister	plastic vial + blister
Sterile	YesGamma Radiation	YesGamma Radiation	YesGamma Radiation	YesGamma Radiation

Table 2 - Comparison Table for Endosseous Implants fixtures

	Subject deviceJDENTALCARE	Primary Predicate deviceNoris Medical	Reference device
Features	Implant System JDZygoma	Noris Medical ZygomaticImplants System (K151909 +K210356)	Zygoma Angled Abutments(K052885)
Design
Images ofangulatedabutments	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° withthe implant)
AbutmentsHeight	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:

1. 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.
1. 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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1. 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.
1. 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.

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.