The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

Device Description

The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The GM Helix LG Implant is a long conical implant with external diameters of 3.75 and 4.0 mm and lengths of 20, 22.5 and 25 mm. It has trapezoidal threads, conical apex with spherical tip and helical chambers, cylindrical body and Grand Morse prosthetic interface. The GM Helix LG implants share the same design characteristics as the existing GM Helix but are longer than the previously cleared range of implants. Indicated to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

The provided text, a 510(k) summary for the Neodent Implant System, does not describe the acceptance criteria and study that proves the device meets clinical performance criteria in the way a traditional clinical study report would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance tests.

Therefore, many of the requested elements for a clinical study analysis (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not explicitly stated in this type of regulatory submission. The goal of a 510(k) is to show that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance and a comparison of technological characteristics.

However, I can extract the relevant information regarding the performance data and how it supports the claim of substantial equivalence.

Acceptance Criteria and Device Performance (as inferred from the 510(k) summary)

The "acceptance criteria" in this context are not explicitly listed with numerical targets as they would be for a direct clinical performance claim. Instead, the acceptance criteria are implicitly met by demonstrating that the subject device performs equivalently to or satisfactorily when compared to the predicate device or established standards, based on the performed in vitro tests.

Here's a table summarizing the performance evaluations described:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Test Type	Inferred Acceptance Criteria	Reported Device Performance and Support for Equivalence
Dynamic Fatigue Test (ISO 14801)	Determine fatigue strength for implant-prosthetic construct for multi-unit prosthesis, according to FDA Guidance. (Implied: performance comparable to predicate or acceptable for intended use.)	Performed to determine the fatigue strength for implant construct assembled with prosthetic abutment for multi-unit prosthesis, assembled with GM Helix LG Implants, according to FDA Guidance. (No specific numerical results are provided in this summary, but the completion of the test meeting guidance implies acceptable performance.)
Torsion Test	Evaluate the GM Helix LG Implant under static torsional loading. (Implied: Pass established thresholds for static torsional strength, demonstrating structural integrity.)	Performed to evaluate the GM Helix LG Implant under static torsional loading. (The submission states this supports the change in technology, implying acceptable performance.)
Insertion Test	Evaluate the insertion torque when inserted into sawbones (bone type II, III, IV). (Implied: Demonstrate controlled and effective insertion performance across various bone densities.)	Performed to evaluate the insertion torque of the GM Helix LG Implant when inserted into sawbones material representing bone type II, III, and IV. (Completion of test implies acceptable insertion characteristics.)
Pull-out Testing	Compare axial pull-out strength between the subject devices and predicate devices. (Implied: Demonstrate comparable or superior pull-out strength to the predicate device.)	Performed to compare the Axial Pull-out Strength between the subject devices and the predicate devices. (The submission states this supports the change in technology, implying comparable or acceptable performance to the predicate.)
Sterilization	Achieve a minimum Sterility Assurance Level (SAL) of 1 x 10⁻⁶ via gamma irradiation (25 kGy minimum dose) according to ISO 11137-2.	"Sterilization... has been performed according to the requirements established by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10⁻⁶ has been validated." (Explicitly states criteria met.)
Biocompatibility (ISO 10993)	Assess biological safety, cytotoxicity, and chemical characterization in accordance with relevant ISO 10993 standards. (Implied: Demonstrate acceptable biocompatibility.)	Biological Safety Assessment guided by ISO 10993-1, Cytotoxicity guided by ISO 10993-5 and Chemical characterization guided by ISO 10993-18 were performed. Biocompatibility sample preparation was performed per ISO 10993-12. (Completion implies acceptable biocompatibility.)

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated for any of the performance tests. These are typically in vitro (laboratory) tests, not human subject studies.
Data Provenance: The tests are in vitro engineering/materials tests performed in a laboratory setting, not derived from patient data (retrospective or prospective). The location of the test performance is not specified beyond being part of the submission from "JJGC Indústria e Comércio de Materiais Dentários SA" (dba Neodent) in Brazil.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. For in vitro performance testing of a dental implant, "ground truth" as it pertains to clinical outcomes or expert interpretation of patient data is not established. Performance is measured against engineering standards and internal specifications.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where subjective assessments (e.g., image interpretation) require consensus among experts. This is not relevant for the in vitro mechanical and material tests described.

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

No. An MRMC study is a type of clinical study involving multiple human readers assessing cases, often with and without AI assistance, to measure diagnostic performance. This submission does not describe such a study. The device is a physical dental implant, not a diagnostic AI system.

6. Standalone (Algorithm Only) Performance Study:

No. A "standalone performance study" typically refers to the algorithmic performance of an AI diagnostic device without human interaction. This is not applicable to a dental implant device.

7. Type of Ground Truth Used:

Engineering Standards and Specifications. The "ground truth" for the in vitro tests is based on established engineering standards (e.g., ISO 14801, ISO 11137-2, ISO 10993 series) and the internal specifications of the device, often benchmarked against the predicate device's performance characteristics. Pathology or outcomes data are not used for these in vitro tests.

8. Sample Size for the Training Set:

Not Applicable. The device is a physical dental implant, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary, which aims to demonstrate substantial equivalence of a new medical device to a legally marketed predicate. The "studies" described are primarily in vitro engineering and materials performance tests designed to show that the new device shares similar technological characteristics and performs equivalently to the predicate, ensuring it is as safe and effective. It is not a clinical study report with human subjects, associated ground truth establishment by experts, or AI performance metrics.

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.

November 9, 2019

JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer M. Jackson Director Regulatory Affairs Straumann 60 Minuteman Road Andover, Massachusetts 01810

Re: K190958

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: October 10, 2019 Received: October 11, 2019

Dear Jennifer M. 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 medical devices and radiation-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,

Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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

510(k) Number (if known) K190958

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
ADMINISTRATIVE INFORMATION
Sponsor	JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Paraná, 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	08/Nov/2019
Preparer / Alternate Contact	Mariana Soares HartmannRegulatory Affairs Analystmariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary NameCommon Name	Neodent Implant SystemEndosseous dental implant
Classification Name	Implant, Endosseous, Root-Form
Classification RegulationsProduct Code	21 CFR 872.3640, Class IIDZE
Classification PanelReviewing Branch	Dental Products PanelDental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K160119, NobelSpeedy® Groovy, Nobel Biocare AB
Reference Devices	K163194, Neodent Implant System - GM Line, JJGC Indústriae Comércio de Materiais Dentários S.AK180536, Neodent Implant System - GM Line, JJGC IndústriaComércio de Materiais Dentários S.AK190718, Neodent GM Zygomatic Implants – GM Line, JJGCIndústria e Comércio de Materiais Dentários S.A

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INDICATIONS FOR USE

SUBJECT DEVICE DESCRIPTIONS

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	GM Helix LG (K190958)Neodent Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K160119NobelSpeedy® Groovy NobelBiocare AB
Indications forUse	The Neodent Implant System is intended to be surgicallyplaced in the bone of the upper or lower jaw to providesupport for prosthetic devices, such as artificial teeth, torestore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unitrestorations, and may be loaded immediately when goodprimary stability is achieved and with appropriate occlusalloading. The Neodent GM Helix LG implants can be placedbicortically in cases of reduced bone density. The NeodentGM Helix LG implants are only indicated for multiple unitrestorations in splinted applications that utilize at leasttwo implants.	NobelSpeedy® Groovy implants are endosseous implantsintended to be surgically placed in the upper or lower jaw bonefor anchoring or supporting tooth replacements to restorepatient esthetics and chewing function. NobelSpeedy® Groovyimplants are indicated for single or multiple unit restorations insplinted or non- splinted applications. This can be achieved by a2- stage or 1-stage surgical technique in combination withimmediate, early or delayed loading protocols, recognizingsufficient primary stability and appropriate occlusal loading forthe selected technique. Implants allow also for bi-corticalanchorage in cases of reduced bone density NobelSpeedy®Groovy implants 20, 22, 25 mm when placed in the maxilla areonly indicated for multiple unit restorations in splintedapplications that utilize at least two implants.
Design	Threaded root-form implant with internal GM Morse taperconnection with internal hex.	Single lead thread with groove, tapered apex with bonecutting flutes and external hex.
Device Material	Commercially Pure Titanium (ASTM F67)	Commercially Pure Titanium
Reusable	No	No
PlatformDiameter	3.75; 4.0 mm	4.0 mm
Length	20; 22.5; 25 mm	20; 22; 25 mm
Surface	Machined, acid-etched NeoPoros surface.	TiUnite

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

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	Sterilization Method	Gamma Irradiation to an SAL of 1x10-6	Gamma Irradiation
Placement	Single or Bicortically in mandible or maxilla	Single or Bicortically in mandible or maxilla

SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject devices and the primary predicate device have equivalent intended use and Indications for Use statements. Both can be placed single or bicortically in mandible or maxilla. The subject devices and the primary predicate devices also share the same material of composition, the same sterilization method and range of length and present similar designs and platform diameter. The difference between the subject devices and the predicate devices is the Ø3.75 mm device. This change in technology is supported by the torsion test and pull out test, both included as appendices of this submission. The subject devices have the same thread design and the same implant-to-abutment interface design as the reference predicate devices.

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 Helix LG Implants, according to FDA Guidance.

Torsion Test was performed to evaluate the GM Helix LG Implant under static torsional loading. Insertion test was performed to evaluate the insertion torque of the GM Helix LG Implant when inserted into sawbones material representing bone type II, III and IV.

Pull-out testing was performed to compare the Axial Pull-out Strength between the subject devices and the predicate devices.

Sterilization of the subject implants via gamma irradiation using a protocol of 25 kGy minimum dose has been performed according to the requirements established by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10 ° has beenvalidated.

Biological Safety Assessment guided by ISO 10993-1, Cytotoxicity guided by ISO 10993-5 and Chemical characterization guided by ISO 10993-18 were performed for GM Helix LG implants. Biocompatibility sample preparation was performed per ISO 10993-12.

CONCLUSION

The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.

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.