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.

Device Description

The subject implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The Zygomatic Implant with an external diameter of 4.0 mm, conical apex, helical flutes, trapezoidal thread and GM prosthetic interface. Indicated for rehabilitation surgical procedures in atrophic maxilla cases, for installation in the zygomatic bone.

The subject abutment devices are single use devices, provided sterile by Ethylene Oxide, made of Titanium allov (TI6AI4V-ELI). They are 45 degrees prosthetic abutments with anti-rotational feature, anatomic gingiva region and GM prosthetic interface to be installed on the implant, offering a structure to support the prosthesis. Indicated for rehabilitation of screw-retained bridges.

AI/ML Overview

The provided text describes the acceptance criteria and the studies performed for the K190718 Zygomatic Implants. However, it does not detail any studies involving AI, human readers, ground truth establishment methods in the AI context, or sample sizes related to AI model training or testing. The document focuses on the substantial equivalence of the Zygomatic Implants and abutments to legally marketed predicate devices based on physical and performance characteristics, and biocompatibility.

Here's the information extracted from the document regarding the acceptance criteria and related studies:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with reported device performance in a quantitative format for all characteristics. Instead, it compares the subject device's characteristics to predicate devices. The "Equivalence Discussion" column in the "TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE" implicitly serves as the acceptance criteria for substantial equivalence, where "Same" or "Equivalent" signifies meeting the criteria.

Characteristic	Acceptance Criterion (Based on Predicate Device)	Reported Device Performance (Subject Device)
Indications for Use	Same as predicate K141777 and similar to K161598 (NobelZygoma 0°)	Same as predicate K141777: "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..."
Design	Threaded root-form implant with matching abutments, made of titanium grade 4. Angled abutments made of titanium alloy.	Threaded root-form implant (titanium grade 4) with matching abutments. 45° angled abutments (titanium alloy) for GM Zygomatic implants.
Reusable	No	No
Endosseous Diameter (mm)	4.4 (Primary Predicate K141777), 4.5 (Reference Predicate K161598)	4.0
Length (mm) (Implants)	Similar range as predicates (e.g., K141777: 30-52.5mm; K161598: 30-50mm)	30; 35; 37.5; 40; 42.5; 47.5; 50; 52.5; 55
Gingival Height (mm) (Abutments)	Similar range as predicates (e.g., K141777: 1.5-6mm; K161598: 6, 8, 10mm)	1.5 and 2.5
Implant platform Ø (mm)	4.1 (Primary Predicate K141777), 4.5 (Reference Predicate K161598)	4.0
Implant surfaces	Sand blasted, acid etched NeoPoros surface (Primary Predicate K141777)	Sand blasted, acid etched NeoPoros surface.
Sterilization Method	Implants: Gamma Radiation (SAL 1x10-6); Abutments: Ethylene Oxide (SAL 1x10-6)	Implants: Gamma Radiation (SAL 1x10-6); Abutments: Ethylene Oxide (SAL 1x10-6)
Sterile Barrier	Implants: PET blister with Tyvek 1059B lidding; Abutments: PET blister with Tyvek 1059B lidding	Implants: PET blister with Tyvek 1059B lidding; Abutments: PET blister with Tyvek 1059B lidding
Dynamic Fatigue (ISO 14801)	Not explicitly stated, but implied to meet standards for multi-unit prosthesis.	Testing performed; implies conformity to FDA Guidance.
Torsion Test	Not explicitly stated, but implied to show acceptable static torsional loading.	Testing performed; implies acceptable performance.
Insertion Test	Not explicitly stated, but implies acceptable insertion torque in jawbone material.	Testing performed for bone types II, III, and IV; implies acceptable performance.
Sterility (Implants)	SAL of 1x10-6 per ISO 11137-2	Validated to SAL of 1x10-6; leveraged from K141777.
Sterility (Abutments)	SAL of 1x10-6 per ISO 11135	Validated to SAL of 1x10-6; leveraged from K163194.
Ethylene Oxide Residuals	Within accepted limits per ISO 10993-7	Assessed and within accepted limits.
Biological Safety Assessment (ISO 10993-1)	Not explicitly stated, but implies meeting safety standards.	Performed; biocompatibility information leveraged from K141777 (implants) and K163194 (abutments).
Cytotoxicity (ISO 10993-5)	Not explicitly stated, but implies non-cytotoxic.	Performed.
Chemical characterization (ISO 10993-18)	Not explicitly stated, but implies acceptable chemical composition.	Performed.
Biocompatibility Sample Prep (ISO 10993-12)	Not explicitly stated, but follows established standards.	Performed.
MRI Compatibility	Leveraged from predicate K182620.	Leveraged from K182620.

Study Details (No AI/ML Component in the Provided Text)

The document is a 510(k) summary for a dental implant system. It focuses on demonstrating "substantial equivalence" to predicate devices through design comparisons and mechanical/biological testing, not on the performance of a medical artificial intelligence/machine learning (AI/ML) device. Therefore, information related to AI-specific parameters (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance, type of ground truth for AI, training set size, and ground truth for training set) is not applicable to this document.

The studies mentioned are primarily bench testing and biological assessments:

Dynamic fatigue test per ISO 14801: To determine the fatigue strength for the implant construct.
Torsion Test: To evaluate the implant and abutment screw under static torsional loading.
Insertion Test: To evaluate the insertion torque of the implant in jawbone material (types II, III, and IV).
Sterilization Validation (Implants): Via gamma irradiation (25 kGy minimum dose) according to ISO 11137-2, achieving a minimum SAL of 1 x 10^-6. Relevant data was leveraged from K141777.
Sterilization Validation (Abutments): Via ethylene oxide gas (overkill method) according to ISO 11135, achieving a minimum SAL of 1 x 10^-6. Relevant data was leveraged from K163194.
Ethylene Oxide Residuals Assessment: Per ISO 10993-7.
Biological Safety Assessment: Guided by ISO 10993-1. Biocompatibility information for implants leveraged from K141777 and for abutments from K163194.
Cytotoxicity testing: Per ISO 10993-5.
Chemical characterization: Per ISO 10993-18.
Biocompatibility sample preparation: Per ISO 10993-12.
MRI Compatibility: Leveraged from K182620.

Regarding your specific points (since it's a non-AI device context):

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified for the bench tests. These are typically controlled laboratory tests, not clinical data. The sponsor is JJGC Indústria e Comércio de Materiais Dentários SA in Curitiba, Parana, Brazil.
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): Not applicable, as these are technical performance tests, not diagnostic or clinical evaluations requiring expert ground truth in that sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for these engineering and biological tests.
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; no AI component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; no AI component.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical tests, the "ground truth" is defined by the physical properties and failure points according to engineering standards (e.g., ISO 14801). For biological tests, it's defined by established biocompatibility assays.
The sample size for the training set: Not applicable; no AI component involved in a training set.
How the ground truth for the training set was established: Not applicable; no AI component.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 11 , 2019

JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K190718

Trade/Device Name: Zygomatic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 20, 2019 Received: March 20, 2019

Dear Jennifer Jackson:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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-regulatoryassistance/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.

for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190718

Device Name

Zygomatic Implants

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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K190718 – Neodent Implant System – Zygomatic Implants and Abutments

K190718

510(k) Summary

ADMINISTRATIVE INFORMATION
Sponsor	JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MSDirector of Regulatory Affairs,Straumann USAe-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509
Date Prepared	11/Jul/2019
Preparer / Alternate Contact	Mariana Soares HartmannRegulatory Affairs Analyste-mail: mariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary Name	Neodent Implant System - Zygomatic Implants and Abutments
Common Name	Endosseous dental implantEndosseous dental implant abutment
Classification Name	Implant, Endosseous, Root-FormEndosseous dental implant abutment
Classification Regulations	21 CFR 872.3640, Class II
Product Code	DZE/NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K141777, Neodent Implant System, JJGC Indústria e Comércio de MateriaisDentários S.A
Reference Predicate Devices	K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio deMateriais Dentários S.AK161598, NobelZygoma 0°, Nobel Biocare AB

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K182620, MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

INDICATIONS FOR 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) 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.

SUBJECT DEVICE DESCRIPTIONS

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Neodent Implant System - ZygomaticImplants and AbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	K141777Neodent Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K161598NobelZygoma 0°Nobel Biocare AB	EQUIVALENCE DISCUSSION
Indicationsfor Use	Zygomatic Implants are indicated forsurgical installation in the zygoma region,in cases of severe jaw resorption, in orderto restore patient esthetics and chewingfunction.ZygomaticImplantsarerecommended for the posterior (pre-molar/molar) region, one implant on eachside, with at least two standard dentalimplants in the anterior region to supporta fixed restoration. Zygomatic Implantsmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading.	Zygomatic Implants are indicated forsurgical installation in the zygoma region,in cases of severe jaw resorption, in orderto restore patient esthetics and chewingfunction.ZygomaticImplantsarerecommended for the posterior (pre-molar/molar) region, one implant on eachside, with at least two standard dentalimplants in the anterior region to supporta fixed restoration. Zygomatic Implantsmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading.	NobelZygoma implants are endosseousdental implants intended to be surgicallyplaced in the bone of the upper jaw archto provide support for prosthetic devices,such as artificial teeth, in order to restorepatient esthetics and chewing function.TheNobelZygomaImplantsareappropriate for immediate loading whengood primary stability is achieved and withappropriate occlusal loading.	SameThe subject devices and the primarypredicate devices have the sameIndications for Use.
Design	Threaded root-form implant to be usedwith matching abutments, made oftitanium grade 445° angled abutments made of titaniumalloy, intended exclusively for use withthe GM Zygomatic implants	Threaded root-form implant to be usedwith matching abutments, made oftitanium grade 4Angled abutments made of titaniumalloy	Tapered with cut out flutes45° and 60° angled abutments made oftitanium alloy	EquivalentFor the predicate, the coronal aspect ofthe implant incorporated the 45° angleand the abutments were straight. For thesubject devices, this is reversed. Thesubject abutments present the sameangulation as the reference predicatedevices K161598 (45°)The design of the subject device isequivalent to that of the reference deviceK163194.
Reusable	No	No	No	Same
EndosseousDiameter (mm)	4.0	4.4	4.5	EquivalentThe difference is insignificant.
Length (mm)(Implants)	30; 35; 37.5; 40; 42.5; 47.5; 50; 52.5; 55	External hex: 30; 35; 40; 45; 47.5; 50;52.5Morse Taper: 30; 35; 40; 42.5; 45; 47.5;50; 52.5	30, 35, 37.5, 40, 42.5, 45, 47.5, 50	EquivalentSimilar range of sizes.
Gingival Height (mm)(Abutments)	1.5 and 2.5	1.5; 2; 3; 4; 5; and 6.	6, 8; 10	EquivalentSimilar range of sizes, having the predicate the biggest range, covering the subject devices sizes.
Implant platform Ø (mm)	4.0	4.1	4.5	EquivalentThe difference is insignificant.
Implant surfaces	Sand blasted, acid etched NeoPoros surface.	Sand blasted, acid etched NeoPoros surface.	TiUnite	SameThe subject devices and the primary predicate devices present the same implant surfaces.
Sterilization Method	ImplantsGamma Radiation to an SAL of 1x10-6AbutmentsEthylene Oxide to an SAL of 1x10-6	ImplantsGamma Radiation to an SAL of 1x10-6AbutmentsEthylene Oxide to an SAL of 1x10-6	ImplantsGamma IrradiationAbutmentsGamma Irradiation	SameThe subject devices and the primary predicate devices present the same Sterilization Methods.
Sterile Barrier	ImplantsPET blister with Tyvek 1059B liddingAbutmentsPET blister with Tyvek 1059B lidding	ImplantsPET blister with Tyvek 1059B liddingAbutmentsPET blister with Tyvek 1059B lidding	N/A	SameThe subject devices and the primary predicate devices present the same Sterile Barrier.

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The subject devices and the primary predicate device K141777 have the same intended use and Indications for Use statements. The subject device and the primary predicate device K141777 have implants with similar platform and endosseous diameter, similar lengths, same surface treatment, same sterilization methods and same sterile barrier. The subject devices and the primary predicate device have abutments with similar range of Gingival Height, same raw material, same sterilization method and same sterile barrier.

PERFORMANCE DATA

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for implant construct assembled with prosthetic abutment for multi-unit prosthesis, assembled with GM Zygomatic Implants, according to FDA Guidance.

Torsion Test was performed to evaluate the GM Zygomatic Implant and the screw of GM Exact Mini Conical Abutment (45 Degrees) under static torsional loading.

Insertion test was performed to evaluate the insertion torque of the GM Zygomatic Implant when inserted into jawbones material representing bone type II, III and IV.

Sterilization of the subject implants via gamma irradiation using a protocol of 25 kGy minimum dose has been performed according to the requirements stablished by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 106 has been validated. The sterility information and the sterile barrier validation was leveraged from K141777 for the implants.

Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been performed according to the requirements of ISO 11135. A minimum Sterility Assurance Level (SAL) of 1 x 10 6 has been validated. The sterility information and the sterile barrier validation was leveraged from K163194 for the abutments.

Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.

Biological Safety Assessment guided by ISO 10993-1, was performed for GM Zygomatic and GM Exact Mini Conical Abutment.

Cytotoxicity testing was performed per ISO 10993-5.

Chemical characterization was performed per ISO 10993-18.

Biocompatibility sample preparation was performed per ISO 10993-12. The biocompatibility information for implants was leveraged from K141777 and for abutments was leveraged from K163194.

The MRI labeling was leveraged from K182620.

CONCLUSION

The subject device and the primary predicate device K141777 have the same intended use, have similar designs and technological characteristics, and are materials. The data included in this submission demonstrate that the subject device is substantially equivalent to the 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.