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.

Device Description

Intended for single use;
Provided sterile via gamma irradiation;
Manufactured of commercially pure titanium (Ti) grade 4 per ASTM F67;
Morse Taper prosthetic interface with internal hexagonal indexer, exclusively from the Grand Morse (GM) line;
Body center and apex with conical format;
Trapezoidal-profile double threads;
Rounded apex end;
Available in Neoporos and Acqua surfaces;
Ø7.0 mm and 8, 10, 11.5, and 13 mm lengths;
The subject devices are compatible with all the abutments of the Neodent Implant System that present the GM implant to abutment interface, previously cleared per K163194, K173902, K180536, K191191, and K1922229.

AI/ML Overview

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Neodent Implant System - GM Helix Implants 7.0. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device is a dental implant. The concept of acceptance criteria and performance related to the AI/ML device is not applicable here. The document describes different types of testing for device safety and effectiveness.

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

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

Please note that this document is for a medical device (dental implant), not an AI/ML device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical, biological, and sterilization aspects, not AI performance metrics like accuracy, sensitivity, or specificity.

Test Category	Acceptance Criteria (Implied/Standard)	Reported Device Performance
Biocompatibility	Conformance to ISO 10993 standards (e.g., ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-18).	Biological Safety Assessment guided by ISO 10993-1 performed. Cytotoxicity testing performed per ISO 10993-5. Chemical characterization performed per ISO 10993-18. Made of commercially pure titanium grade 4 (ASTM F67), same as predicate devices. The subject devices do not present a new worst case for biocompatibility; predicate device testing is relied upon.
Mechanical Testing	Equivalence to predicate devices in dynamic fatigue strength, as per ISO 14801 and FDA Guidance.	Dynamic fatigue test per ISO 14801 was performed. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices. Insertion torque testing was also performed.
Sterilization	Sterility Assurance Level (SAL) of 10^-6, validated by ISO 11137-1 and ISO 11137-2. Endotoxin limit of 20 EU/device.	Sterilized by gamma irradiation at a nominal dose of 25 kGy. Validation by VDma22 method, according to ISO 11137-1 and ISO 11137-2, achieved a SAL of 10^-6. Routine endotoxin testing performed monthly on representative samples with a test limit of 20 EU/device.
Shelf Life	Maintenance of sterile barrier after storage for the validated shelf life.	Validated for a shelf life of 5 years by accelerated aging according to ASTM F1980. Packaging validated according to ISO 11607-1 and ISTA 2A. Sealing strength (ASTM F88), Dye Penetration (ASTM F1929), and Bubble Test (ASTM F2096) were conducted to verify sterile barrier maintenance.

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

The document does not specify exact sample sizes for each test mentioned (biocompatibility, mechanical testing, sterilization validation, shelf life validation). It refers to "representative samples" for endotoxin testing and indicates that tests were "performed" (e.g., dynamic fatigue test per ISO 14801). The "data provenance" is not explicitly stated in terms of country of origin or retrospective/prospective studies for these specific tests. However, the sponsor is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) located in Curitiba, Parana, Brazil. The regulatory contact is in Andover, Massachusetts, USA.

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)

This question is not applicable as the document describes a medical device, not an AI/ML diagnostic system requiring expert interpretation for ground truth establishment. The document relies on established international standards (ISO, ASTM, USP) and FDA guidance for evaluating the physical, chemical, and biological properties of the dental implant. Expert roles would be in the design, testing, and regulatory review processes, but not in establishing "ground truth" in the diagnostic sense.

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

Not applicable. This concept is relevant for AI/ML diagnostic studies where multiple readers interpret cases and their discrepancies are resolved. The document focuses on laboratory and material testing of a physical device.

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 is a 510(k) submission for a physical medical device (dental implant), not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness analysis with human readers would have been performed or reported here.

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

Not applicable. This relates to AI/ML device performance. The described device is a physical dental implant.

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

Not applicable. For this type of physical device, "ground truth" is established by adherence to recognized standards and validated test methods (e.g., ISO 10993 for biocompatibility, ISO 14801 for mechanical fatigue, ISO 11137 for sterilization) rather than expert consensus on diagnostic images or pathology. The "truth" is whether the device meets the physical and biological specifications under test conditions.

8. The sample size for the training set

Not applicable. The concept of a "training set" refers to data used to train an AI/ML model. This document describes the validation of a physical medical device.

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

Not applicable (as above).

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.

September 4, 2020

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

Re: K201225

Trade/Device Name: Neodent Implant System - GM Helix Implants 7.0 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 12, 2020 Received: June 15, 2020

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 Part 803) for devices or post-marketing 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 (OS) 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.

for Srinivas Nandkumar, Ph.D. 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) K201225

Device Name

Neodent Implant System - GM Helix Implants 7.0

Indications for Use (Describe)

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Type of Use (Select one or both, as applicable)

Prescription Use (21 CFR Part 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, 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	03/Sep/2020
Preparer / Alternate Contact	Mariana Soares HartmannRegulatory Affairs AnalystE-mail: mariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary NameCommon Name	Neodent Implant System - GM Helix Implants 7.0Endosseous dental implant
Classification Name	Endosseous dental implant
Classification RegulationsProduct Code	21 CFR 872.3640, Class IIDZE
Classification PanelReviewing Branch	Dental Products PanelDental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K163194, Neodent Implant System – GM Line, JJGC Indústria eComércio de Materiais Dentários S.A
Reference Predicate Devices	K180536, Neodent Implant System – GM Line, JJGC Indústria eComércio de Materiais Dentários S.AK101201, KAT Implant System - KAT Implants LLC

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Legacy2, SimplyLegacy2, K192221, Legacy3, Legacy4, SimplyLegacy3 Dental Implants; Legacy2, Legacy3, Legacy4 Fixture-Mounts, Implant Direct Sybron Manufacturing, LLC K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A K193592 - Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

INDICATIONS FOR USE

SUBJECT DEVICE DESCRIPTIONS

Intended for single use;
. Provided sterile via gamma irradiation;
Manufactured of commercially pure titanium (Ti) grade 4 per ASTM F67;
. Morse Taper prosthetic interface with internal hexagonal indexer, exclusively from the Grand Morse (GM) line;
. Body center and apex with conical format;
Trapezoidal-profile double threads;
Rounded apex end;
. Available in Neoporos and Acqua surfaces;
Ø7.0 mm and 8, 10, 11.5, and 13 mm lengths;
The subject devices are compatible with all the abutments of the Neodent Implant System that present the GM implant to abutment interface, previously cleared per K163194, K173902, K180536, K191191, and K1922229.

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE
	Neodent Implant System - GM HelixImplants 7.0JJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K101201KAT Implant SystemKAT Implants LLC	K192221Legacy4Implant Direct Sybron Manufacturing LLC
Indications forUse	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, to restorechewing function. It may be used withsingle-stage or two-stage procedures,for single or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	KAT Implant System Dental Implantsare indicated for restoration ofedentulous maxilla and mandible, toprovide support for removabledentures, fixed bridges, or to be usedas a single tooth replacement. Single orsplinted implants can be immediatelyloaded if good primary stability andappropriate occlusal loading isachieved. The implants can be placedin extraction sites or healed alveolarridges. Immediate loading may not beappropriate in Type IV bone due todifficulty in achieving primary stability.	Legacy2, simplyLegacy2, Legacy3,simplyLegacy3, and Legacy4 dentalimplants are two-piece implants for one-stage or two-stage surgical procedures.These implants are intended for use inpartially and fully edentulous upper andlower jaws in support of single or multiple-unit restorations and terminal orintermediate abutment support for fixedbridgework.Implants can be indicated for immediateloading when good primary stability hasbeen achieved and with appropriateocclusal loading.Narrow (3.2mmD) implants: Indicated forsingle-tooth replacement (mandibularcentral and lateral incisors; maxillary lateralincisors), multiple-tooth replacements ordenture stabilization.Short (<10mm) 3.7mm implants: Indicatedfor single-tooth (mandibular and maxillarycentral and lateral incisors), multiple toothreplacements or denture stabilization.The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use

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	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE
	Neodent Implant System - GM HelixImplants 7.0JJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K101201KAT Implant SystemKAT Implants LLC	K192221Legacy4Implant Direct Sybron Manufacturing LLCwith the corresponding dental implants(Legacy2, Legacy3, and Legacy4,respectively). The fixture-mounts canfunction as an abutment. As an abutment,fixture-mounts are intended for use withdental implants in the maxillary and/ormandibular arches to provide support forcrowns or bridges for edentulous orpartially edentulouspatients.Fixture-mounts as an abutment for narrow(3.2mmD) implants: Indicated for single-tooth replacement of mandibular centraland lateral incisors and maxillary lateralincisors.Fixture-mounts as an abutment for short(8mm) 3.7mmD implants: Indicated fortooth replacement of mandibular andmaxillary central and lateral incisors.Legacy2, simplyLegacy2, Legacy3,simplyLegacy3, and Legacy4 implants arecompatible with the following abutments.Manufacturer AbutmentLine PlatformDiameter(mm) Implant Direct Legacy 3.0, 3.5,4.5, 5.7
Implant-Abutmentinterface	GM	GM	1.5° torque-activated locking taperconnection
Design	Body center and apex with conicalformatRounded apexTrapezoidal profile double threads	Body center and apex with conicalformatRounded apexTrapezoidal profile double threads	Root-form implant;Endosseous screw type with acontinuous thread and horizontalcircumferential fins	Body and apex straight, lower portiontapered with progressively deeperbuttress-threads

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	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE
	Neodent Implant System - GM HelixImplants 7.0JJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K101201KAT Implant SystemKAT Implants LLC	K192221Legacy4Implant Direct Sybron Manufacturing LLC
Reusable	No	No	No	No
Length (mm)	8; 10; 11.5; 13	8; 10; 11.5; 13; 16; 18	6; 8; 10	6; 8; 10; 11.5; 13; 16
Diameter (Ø)(mm)	7.0	3.5; 3.75; 4.0; 4.3; 5.0	6.0; 7.0. 8.0	3.2; 3.7; 4.2; 4.7; 5.2; 5.7; 7.0
Material	Commercially pure Titanium grade 4(ASTM F67)	Commercially pure Titanium grade 4(ASTM F67)	Titanium alloy (ASTM F136)	Titanium alloy
SterilizationMethod	Gamma irradiation to a SAL of 1x10-6	Gamma irradiation to a SAL of 1x10-6	Gamma irradiation to a SAL of 1x10-6	Gamma irradiation

The subject devices and the primary predicate device K163194 have the same design, similar range of lengths, same raw material and same sterlization method. The subject devices is within the range of the reference predicate devices (K101201). The subject devices and reference predicate devices (K101201 and K192221) are indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

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PERFORMANCE DATA

Biocompatibility

Biocompatibility sample preparation was made according to ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1, Cytotoxicity testing was performed per ISO 10993-5 and Chemical characterization was performed per ISO 10993-18. The subject implants are made of unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), the same type of titanium used for fabrication of the predicate devices cleared under K163194 and K180536. The subject devices undergo to the same manufacturing processes to the cited predicate devices. The subject devices do not present a new worst case for biocompatibility and therefore, the predicate and reference device testing are relied upon for determining substantial equivalence.

Mechanical testing

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the dental implant system, according to FDA Guidance. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.

Insertion torque testing was also performed to determine insertion torque for the dental implants in Type III and Type IV bone.

Sterilization Validation

The subject implants are sterilized by ℃o gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization has been validated by the VDma22 method, according to ISO 11137-1 and ISO 11137-2. The method achieved a Sterility Assurance Level 10-6.

The Subject devices are not represented to be "pyrogen free". Routine endotoxin testing for NeoPoros and Acqua implants are performed monthly on representative samples of this group of products. The test limit is 20 EU/device as recommended by USP <161>.

The sterilization method presented for the subject devices is the same as for the predicate devices and has been previously reviewed under K163194 and K180536.

Shelf Life Validation

The subject implants have a shelf life of 5 years that was validated by accelerated aging according to ASTM F1980. The packaging was validated according to ISO 11607-1 and ISTA 2A. Sealing strength (ASTM F88), Dye Penetration (ASTM F1929), and Bubble Test (ASTM F2096) were conducted to verify the maintenance of the sterile barrier after storage.

CONCLUSION

The subject devices and the primary predicate devices K163194 have the same intended use, same design and technological characteristics, similar range of length, same sterilization method and are made of the same materials. The subject devices present a diameter that is contained within the range of diameters of the reference predicate devices. 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.