Zygomatic Implants are indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Zygomatic Implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Zygomatic Implants may be loaded immediately when stability is achieved and with appropriate occlusal loading.

Device Description

This submission includes threaded root-form dental implants designed for placement into the zygomatic bone with either an external hexagon abutment interface, or a Morse taper abutment interface. Both implant designs are provided with a thread major diameter of 4.4 mm at the coronal end of the implant (over a length of 10 mm), which tapers to a thread major diameter of 3.9 mm for the remaining implant length. Both implant designs are provided in multiple threaded lengths ranging from 30 mm to 52.5 mm. All implants are made of commercially pure titanium, Grade 4, conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

This submission includes transepithelial abutments with external hexagon or Morse taper interfaces for connection to the zygomatic implants. The external hexagon abutments have a platform diameter of 4.1 mm and are provided in gingival heights of 3, 4, or 5 mm. The Morse taper transepithelial abutments also have a platform diameter of 4.1 mm and are provided in gingival heights of 1.5, 2, 3, 4, or 5 mm.

This submission also includes a Protection Cylinder that is used to protect the abutment during healing of the gingival tissue. The Protection Cylinder may be installed on either abutment design (external hexagon or Morse taper) with the corresponding Protection Cylinder Screw.

All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All zygomatic implants are packaged assembled with the corresponding implant mount and provided sterilized by gamma irradiation. All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are provided sterilized by exposure to ethylene oxide.

AI/ML Overview

The provided text describes a submission for a Neodent Implant System to the FDA for 510(k) clearance, asserting its substantial equivalence to previously marketed predicate devices. This type of submission focuses on comparing a new device to existing ones rather than proving the device meets specific acceptance criteria through a clinical trial with a defined ground truth and expert adjudication.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a study, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for the training set.

Instead, the document details:

Non-clinical data: Biocompatibility, engineering analysis, dimensional analysis, and dynamic compression-bending testing according to ISO 14801. These are physical and material property tests to ensure the device meets certain strength and safety standards, but are not "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for an AI/algorithm-based device.
Clinical literature data: This is a review of existing data rather than a prospective study designed to meet specific performance criteria for the subject device.

Here's what can be extracted, acknowledging the limitations regarding "acceptance criteria" in the AI/algorithm sense:

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

The document does not specify "acceptance criteria" for performance in the typical sense of metrics like sensitivity, specificity, accuracy, etc., for a diagnostic or AI device. Instead, the "performance" demonstrated is a comparison to predicate devices, where the primary outcome considered is implant survival rates.

Performance Metric	Reported Device Performance (Subject Device)	Reported Predicate Device Performance (K070182)
Zygomatic Implant Survival	100% (after immediate loading at 12 months)	100% (with delayed loading, 6-36 months follow-up)
Conventional Implant Survival	100% (after immediate loading at 12 months)	85.7% to 100% (6-36 months follow-up)

2. Sample sizes used for the test set and the data provenance

Subject device (test set, as per clinical literature):
- Sample Size: 16 subjects with a total of 37 zygomatic implants.
- Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.
Predicate device (comparison in clinical literature):
- Sample Size: 45 subjects with a total of 90 zygomatic implants and 165 conventional dental implants.
- Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a review of clinical literature data focusing on implant survival, not an expert-adjudicated test of an AI/algorithm's performance. The "ground truth" would implicitly be the observed clinical outcome (implant survival/failure) as reported in the literature, which is based on clinical assessment by treating physicians.

4. Adjudication method for the test set

Not applicable, as it's a review of clinical literature data, not an expert adjudication process for algorithmic output.

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

Not applicable. This submission is for a physical medical device (dental implants), not an AI/algorithm where human reader performance would be a relevant metric.

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

Not applicable. This is not an AI/algorithm device.

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

The "ground truth" implicitly used for the clinical literature data was outcomes data (implant survival/failure) as observed and reported in the clinical studies.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm and therefore does not have a "training set."

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

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.

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

July 20, 2015

JJGC Industria e Comercio de Materiais Dentarios SA c/o Mr. Kevin Thomas PaxMed International, LLC 12264 El Camino Real, Ste 400 San Diego, California 92130

Re: K141777

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 15, 2015 Received: June 16, 2015

Dear Mr.Thomas,

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 may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

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

Sincerely yours,

Tina
Kiang -S

for 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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Indications for Use

510(k) Number (if known) K141777

Device Name

Neodent Implant System

Indications for Use (Describe)

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 JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System K141777

July 1, 2015

Manufacturer Name	JJGC Indústria e Comércio de Materiais Dentários S.A.Av. Juscelino Kubitschek de Oliveira, 3291 - CICCuritiba, Paraná, 81270-200, BrazilTelephone: +55 41 2169 1003Fax: +55 41 2169 1043
Official Contact	Jacson CambruzziHead of Quality and Regulatory Affairs
Representative/Consultant	Kevin A. Thomas, PhDFloyd G. LarsonPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 (858) 792-1235Fax +1 (858) 792-1236Email kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Neodent Implant System
Common Name	Endosseous dental implantEndosseous dental implant abutment
Classification Regulations	21 CFR 872.3640
Product Code	DZENHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

INTENDED USE

Zygomatic Implants are indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Zygomatic Implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Zygomatic Implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

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DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, dimensional analysis, and dynamic compressionbending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.

Clinical literature data were submitted in this premarket notification including reports of 45 subjects treated with a total of 90 predicate device (K070182) zygomatic implants in combination with 165 conventional dental implants, and 16 subjects treated with a total of 37 subject device zygomatic implants in combination with 58 conventional dental implants. All subjects were treated for rehabilitation of maxillary atrophy for restoration of aesthetics and chewing function. The subjects who received the predicate zygomatic implants were treated by a

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delayed loading protocol in 44 of 45 cases (1 case of immediate loading); all subjects who received the subject device zygomatic implants had immediate loading (within 48 hours of surgical placement). Follow-up time periods for all subjects ranged from 6 to 36 months. For the subjects who received the predicate zygomatic implants, survival of the zygomatic implants was 100% and survival of the conventional implants ranged from 85.7 to 100%. Subjects who received the subject device zygomatic implants had 100% survival of all implants (zygomatic and conventional) after immediate loading at 12 months. These clinical data demonstrate the subject device is as safe, as effective and performs as well as the predicate device in the atrophic maxilla.

EQUIVALENCE TO MARKETED DEVICES

Neodent Implant System is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Nobel Biocare USA, LLC, Zygoma Implant, K070182;

JJGC Indústria e Comércio de Materiais Dentários SA, Neodent Implant System, K133510; and

JJGC Indústria e Comércio de Materiais Dentários SA, Neodent Implant System, K123022.

The primary predicate device is K070182. The reference predicate devices are K133510 and K123022. A comparison of the technological characteristics of the subject device and the primary predicate device K070182 is provided in the following table.

	Subject Device	Primary Predicate Device
Comparison	JJGC Indústria e Comércio de MateriaisDentários SANeodent Implant SystemK141777	Nobel Biocare USA, LLCZygoma ImplantK070182
Indications for Use	Zygomatic Implants are indicated for surgicalinstallation in the zygoma region, in cases of severe jawresorption, in order to restore patient esthetics andchewing function. Zygomatic Implants arerecommended for the posterior (pre-molar/molar)region, one implant on each side, with at least twostandard dental implants in the anterior region tosupport a fixed restoration. Zygomatic Implants may beloaded immediately when good primary stability isachieved and with appropriate occlusal loading.	Nobel Biocare's Zygoma implants are endosseousdental implants intended to be surgically placed inthe bone of the upper jaw arches to provide supportfor prosthetic devices, such as artificial teeth, inorder to restore patient esthetics and chewingfunction. The Zygoma Implants may be put intoimmediate function provided that stabilityrequirements detailed in the manual are satisfied.
Implants
Design	Threaded root-form implant to be used withmating abutments	External hex threaded root-form implant to beused with mating abutments
Platform (Ø)	4.1 mm	4.1 mm
Thread (major Ø)	4.4 mm tapering to 3.9 mm	4.4 mm tapering to 3.9 mm
Length, mm	External hex: 30, 35, 40, 45, 47.5, 50, 52.5	30, 35, 40, 45, 47.5, 50, 52.5
	Morse taper: 30, 35, 40, 42.5, 45, 47.5, 50, 52.5	n/a
Type	External hex and Morse taper	External hex
Implant Head Angle	45°	45°
Implant Surface	Machined	Machined

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	Subject Device	Primary Predicate Device
Comparison	JJGC Indústria e Comércio de MateriaisDentários SANeodent Implant SystemK141777	Nobel Biocare USA, LLCZygoma ImplantK070182
Abutments
Platform (Ø)	4.1 mm	4.1 mm
Abutment Angle	0° (straight)	0° and 17°
Gingival Height	External hex: 3, 4, 5 mm	External hex: 2, 3, 5 mm
	Morse taper: 1.5, 2, 3, 4, 5 mm	n/a
Materials
Implants	F67 commercially pure titanium, grade 4	Commercially pure titanium
Implant Mount	F136 Ti-6Al-4V ELI	Not stated
Implant Mount Screw	F136 Ti-6Al-4V ELI	Not stated
Abutments	F136 Ti-6Al-4V ELI	F136 Ti-6Al-4V ELI
Abutment Screws	External hex: F136 Ti-6Al-4V ELI	Not stated
Protection Cylinders	F136 Ti-6Al-4V ELI	n/a
Protection Cylinder Screws	F136 Ti-6Al-4V ELI	n/a

The subject device and the primary predicate K070182 have substantially equivalent indications for use, including restoration of patient esthetics and chewing function, and immediate loading when used with standard dental implants placed in the anterior region to support a fixed restoration. The implants of the subject device and the predicate device K070182 have similar designs, dimensions, materials, and machined surface finish. The abutments of the subject device have similar designs, similar dimensions, and are made from similar or identical materials as those cleared under K070182, K133510, and K123022. The subject device includes both external hexagon and Morse taper abutment-implant interface connections, whereas the K070182 predicate device includes only external hexagon connections. The subject device includes only straight abutments, whereas the K070182 predicate device abutments are provided in both straight and 17° angled designs. The subject device external hexagon abutments are provided in gingival heights of 3, 4, and 5 mm, whereas the K070182 predicate device external hexagon abutments are provided in gingival heights of 2, 3, and 5 mm.

The subject device has similar packaging and is sterilized using the same materials and processes as the predicate devices in K133510, and K123022.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, gingival height, and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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.