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 Implant System - Temporary Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

Device Description

Temporary Abutment for provisional restoration employed for up to 6 months;
Intended for single use;
Provided sterile via ethylene oxide gas;
Constructed of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
Coronal geometry has grooves to facilitate bonding of acrylic material;
Abutment is screw-retained;
Coronal geometry contains channels to facilitate reduction of abutment height;
Provided in anti-rotational and rotational versions supporting single and multi-unit restorations, respectively;
Provided in multiple gingival heights;
Implant-to-abutment interface compatible with GM implants of the Neodent Implant System.

AI/ML Overview

Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it refers to performance data used to demonstrate substantial equivalence to a predicate device. The performance data is therefore related to demonstrating features or durability comparable to established standards and the predicate.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Fatigue Strength	Sufficient to withstand dynamic loading in the oral environment, demonstrating equivalence per ISO 14801 guidelines for worst-case implant construct with temporary abutments for multi-unit restorations.	Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the worst-case implant construct assembled with GM Temporary Abutments for multi-unit restorations, according to FDA Guidance. (Specific numerical result not provided, but implies satisfactory performance to demonstrate equivalence).
Torsional Strength	Sufficient to withstand static torsional loading for abutment screws.	Torsion testing was performed to evaluate the GM Temporary Abutments Screws under static torsional loading. (Specific numerical result not provided, but implies satisfactory performance to demonstrate equivalence).
Sterility	Sterility Assurance Level (SAL) of 1 x 10^-6 via ethylene oxide gas.	Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been validated according to the requirements of ISO 1135. A minimum Sterility Assurance Level (SAL) of 1 x 10^-6 has been validated.Ethylene oxide residuals have been assessed per ISO 10993-7. Residuals are within accepted limits.
Shelf Life	At least 5 years.	Accelerated and Real Time Aging tests were performed according to ASTM F1980. The Shelf Life of the subject devices is 5-years.
Biocompatibility	Biologically safe for temporary use in the human body.	Biological Safety Assessment guided by ISO 10993-1.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. (Implies positive results showing biocompatibility and absence of cytotoxity within accepted limits).

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

The document does not specify the exact sample sizes for each of the tests (dynamic fatigue, torsion, sterility, aging, biocompatibility). It only states that the tests were performed.

The data provenance is from JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent) located in Curitiba, Parana, Brazil. The studies are prospective in nature, as they involve performing tests and gathering data specifically for this submission.

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

This information is not applicable as the studies described are performance tests (mechanical, sterilization, aging, biocompatibility) of a medical device, not diagnostic studies that require expert interpretation of results to establish ground truth (e.g., image interpretation by radiologists). The "ground truth" here is defined by objective physical and chemical standards (e.g., ISO and ASTM standards).

4. Adjudication Method for the Test Set:

This information is not applicable for the type of studies presented. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation of data is involved and discrepancies need to be resolved. The described studies are objective laboratory/engineering tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic devices (e.g., AI in radiology) to assess the impact of AI on human reader performance. The device described (Temporary Abutments) is a physical implant component, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

This question is not applicable as the device is a physical medical device (temporary abutment), not an algorithm or AI system. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance studies conducted (fatigue, torsion, sterility, etc.) are inherently "standalone" in that they test the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance studies is established by objective technical standards and regulatory guidelines. This includes:

ISO 14801 for dynamic fatigue.
ISO 1135 for sterilization validation.
ISO 10993-7 for ethylene oxide residuals.
ASTM F1980 for accelerated and real-time aging.
ISO 10993-1, 10993-5, 10993-18, 10993-12 for biocompatibility.
FDA Guidance documents for specific test methodologies.

The "ground truth" is adherence to and performance within the limits or specifications set by these recognized standards to ensure safety and effectiveness comparable to legally marketed predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI model or algorithm that requires a "training set" of data.

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

This information is not applicable for the same reason as above; there is no "training set" for physical device performance.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

December 5, 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: K191191

Trade/Device Name: Neodent Implant System - Temporary Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 1, 2019 Received: November 4, 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 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. 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) K191191

Device Name

Neodent Implant System - Temporary Abutments

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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K191191 – 510(k) Summary

ADMINISTRATIVE INFORMATION

Sponsor	JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Olivera, 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	04/Dec/2019
Preparer / Alternate Contact	Mariana Soares HartmannRegulatory Affairs AnalystE-mail: mariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary Name	Neodent Implant System - Temporary Abutments
Common Name	Endosseous dental implant abutment
Classification Name	Endosseous dental implant abutment
Classification Regulations	21 CFR 872.3630, Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental 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	K093027 - STRAUMANN RC TEMPORARY ABUTMENTSStraumann Manufacturing, INC.

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K092814 – STRAUMANN DENTAL ABUTMENTS, Straumann Manufacturing, INC.

K103084 - Neodent Graft Screw, JJGC Indústria e Comércio de Materiais Dentários S.A.

INDICATIONS FOR USE

SUBJECT DEVICE DESCRIPTIONS

Temporary Abutment for provisional restoration employed for up to 6 months;
Intended for single use;
Provided sterile via ethylene oxide gas;
Constructed of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
Coronal geometry has grooves to facilitate bonding of acrylic material;
Abutment is screw-retained;
. Coronal geometry contains channels to facilitate reduction of abutment height;
Provided in anti-rotational and rotational versions supporting single and multi-unit restorations, respectively;
. Provided in multiple gingival heights;
Implant-to-abutment interface compatible with GM implants of the Neodent Implant System.

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Neodent Implant System	K163194Neodent Implant System - GM Line	EQUIVALENCE DISCUSSION
Indicationsfor Use	The Neodent Implant System is intendedto be surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices such as artificial teeth,to restore chewing function. It may beused with single-stage or two-stageprocedures, for single or multiple unitrestorations, and may be loadedimmediately when good primary stabilityis achieved and with appropriate occlusalloading. The Neodent Implant System -Temporary Abutments are indicated tobe used on Neodent implants to providetemporary support for prosthesisstructure for up to 6 months.	Indications for Use for GM implants andconventional abutments:The Neodent Implant System is intendedto be surgically placed in the bone of theupper or lower jaw to provide supportfor prosthetic devices such as artificialteeth, to restore chewing function. Itmay be used with single-stage or two-stage procedures, for single or multipleunit restorations, and may be loadedimmediately when good primary stabilityis achieved and with appropriate occlusalloading.Indications for Use for GM Titanium Baseabutments:Titanium Base Abutment is a titaniumbase placed onto Neodent dentalimplants to provide support for	EquivalentThe subject device is a temporaryabutment for use with GM implants,therefore only the first paragraph of theIndications of the primary predicate arerelevant. The subject submission doesnot include Titanium Base Abutments orProPEEK Abutments.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	EQUIVALENCE DISCUSSION
	Neodent Implant System	K163194Neodent Implant System - GM Line
		customized prosthetic restorations. It isused with a coping and crown, or crownalone, and is indicated for cement-retained single or multi-unitrestorations, or screw-retained singlerestorations.
		All digitally designed copings and/orcrowns for use with the NeodentTitanium Base Abutment System areintended to be sent to Straumann formanufacture at a validated millingcenter.
		Indications for Use for GM Pro PeekAbutments:
		The Pro PEEK Abutments are indicated tobe used on Neodent implants to providetemporary support for prosthesisstructure for up to 6 months. They canbe used in one or two stage proceduresand also immediate load when there isgood primary stability.
Interface	GM	GM	Same
Design	Straight, cylindrical with retention rings	Straight and cylindrical	Equivalent
Reusable	No	No	Same
Gingival Height	0.8; 1.5; 2.5 and 3.5 mm	0.8; 1.5; 2.5; 3.5; 4.5 and 5.5 mm	EquivalentSubject devices within range establishedby predicate devices
Diameter ( $Ø$ )	3.5 and 4.5 mm	3.3 and 4.5 mm	Equivalent
Angulation	Straight	Straight, 17° and 30°	SameSubject devices are straight which is thesame as the straight predicate devices.
Material	TAV (ASTM F136)	Implants:Titanium grade 4Conventional abutments:Titanium alloy Ti-6Al-4V ELICAD/CAM abutments:Titanium alloy Ti-6Al-4V ELITemporary abutments:Titanium alloy Ti-6Al-4V PEEK	SameSubject devices are the same material asthe TAV predicate devices.
Duration of use(maximum)	180 days	Lifetime	EquivalentSubject devices within range establishedby primary predicate. Subject devicessame as for reference predicates perK093027 and K092814
SterilizationMethod	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Same

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The subject devices and the primary predicate device K163194 have equivalent Indications for Use, similar design, range of gingival height, same raw material and same sterilization method.

PERFORMANCE DATA

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the worst-case implant construct assembled with GM Temporary Abutments for multi-unit restorations, according to FDA Guidance.

Torsion testing was performed to evaluate the GM Temporary Abutments Screws under static torsional loading.

Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been validated according to the requirements of ISO 1135. A minimum Sterility Assurance Level (SAL) of 1 x 106 has been validated.

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

Accelerated and Real Time Aging tests were performed according to ASTM F1980. The Shelf Life of the subject devices is 5-years.

Biological Safety Assessment guided by ISO 10993-1.

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.

CONCLUSION

The subject devices and the primary predicate devices K163194 have the same intended use, similar designs and technological characteristics, and are made of the same materials. The data included in this submission demonstrate that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)