Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.

Device Description

The GM Titanium Base for Bridge are prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Titanium Base for Bridge is a two-piece abutment used as a base when fabricating a CAD/CAM customized restoration. The planning and milling of the customized superstructures should be made using the validated Dental Wings Operating System (DWOS) or 3Shape Software. All digitally designed copings and/or crowns for use with the GM Titanium Base for Bridge are intended to be manufactured as a validated milling center. The limits for customization are stated in the GM Titanium Base for Bridge Instructions for Use. The superstructure produced through the CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Titanium Base for Bridge.

The main characteristics of the subject devices are the following:

Intended for single use;
Provided sterile via ethylene oxide gas;
Manufactured of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
Conical format available in different diameters, height of cementable area and gingival height;
Screw-retained;
Provided in rotational (non-indexed) version supporting multi-unit restorations;
Provided with an implant-to-abutment interface compatible with the GM implants of the Neodent Implant System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Neodent Implant System - GM Titanium Base for Bridge" and includes performance data to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria for an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission, as it concerns a dental implant abutment and not an AI/ML system.

However, I can extract the relevant performance data and acceptance criteria mentioned for the dental device.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not applicable:

Acceptance Criteria and Device Performance for Neodent Implant System - GM Titanium Base for Bridge

1. Table of acceptance criteria and the reported device performance:

Test Method	Acceptance Criteria	Reported Device Performance
Dynamic Fatigue Test (per ISO 14801)	Meet acceptance criteria	All tested restoration materials were in accordance with the acceptance criteria.
Torsion Testing	Meet acceptance criteria	The results met the acceptance criteria.
Sterilization (per ISO 11135)	Minimum Sterility Assurance Level (SAL) of 1 x 10⁻⁶	A minimum SAL of 1 x 10⁻⁶ has been validated.
Ethylene Oxide Residuals (per ISO 10993-7)	Within accepted limits	Residuals are within accepted limits.
Biological Safety Assessment (per ISO 10993-1)	Adherence to ISO 10993-1 guidance	Guided by ISO 10993-1.
Cytotoxicity Testing (per ISO 10993-5)	Meet acceptance criteria	Performed per ISO 10993-5.
Chemical Characterization (per ISO 10993-18)	Performed	Performed per ISO 10993-18.
Biocompatibility Sample Preparation (per ISO 10993-12)	Performed	Performed per ISO 10993-12.

2. Sample size used for the test set and the data provenance:

Dynamic Fatigue Test: Not explicitly stated but mentions "worst-case implant construct assembled with GM Titanium Base for Bridge," and "tested with three different restoration materials." The exact number of each construct tested is not provided.
Torsion Testing: Not explicitly stated, but performed to evaluate "Titanium Base Screws."
Data Provenance: Not specified, but the sponsor is "JJGC Indústria e Comércio de Materiais Dentários SA (dba Neodent)" based in Curitiba, Parana, Brazil. The testing appears to be lab-based performance testing rather than clinical data from human subjects.

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

Not applicable. This device is a physical dental implant abutment, and its performance is evaluated through engineering and biocompatibility testing, not expert interpretation of outputs like an AI/ML system.

4. Adjudication method for the test set:

Not applicable. See #3.

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 physical device, not an AI/ML system, so no human reader studies were conducted.

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

Not applicable. This is a physical device.

7. The type of ground truth used:

For the physical device, the "ground truth" is defined by industry standards (e.g., ISO 14801, ISO 11135, ISO 10993 series) and internal engineering specifications for mechanical strength, biocompatibility, and sterility. The results of the laboratory tests directly provide this "ground truth" data against the specified criteria.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set."

Summary of the Study:

The studies conducted for the Neodent Implant System - GM Titanium Base for Bridge were primarily laboratory-based performance tests to assess its mechanical properties (dynamic fatigue, torsion), sterilization efficacy, and biocompatibility. These tests were conducted according to recognized international standards (ISO 14801, ISO 11135, ISO 10993 series) and FDA guidance, demonstrating that the device meets the established acceptance criteria for its intended use as a dental implant abutment. The purpose of these studies was to show substantial equivalence to a previously cleared predicate device (K180536), indicating that the new device is as safe and effective as the predicate.

Summary

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December 19, 2019

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

Re: K192229

Trade/Device Name: Neodent Implant System - GM Titanium Base for Bridge Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 22, 2019 Received: November 25, 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. for 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) K192229

Device Name

Neodent Implant System - GM Titanium Base for Bridge

Indications for Use (Describe)

The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.

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, 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	09/Dec/2019
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 Titanium Base for BridgeEndosseous dental implant abutment
Classification Name	Endosseous dental implant abutment
Classification RegulationsProduct Code	21 CFR 872.3630, Class IINHA
Classification PanelReviewing Branch	Dental Products PanelDental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K180536, Neodent Implant System - GM Line, JJGC Indústria eComércio de Materiais Dentários S.A
Reference Predicate Devices	K151157 - NC Straumann Variobase Abutment For Bars/Bridges,RC Straumann Variobase Abutment For Bars/Bridges, NNC

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Straumann Variobase Abutment For Bars/Bridges, RN Straumann Variobase Abutment For Bars/Bridges, WN Straumann Variobase Abutment For Bars/Bridges, STRAUMANN USA, LLC. K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

INDICATIONS FOR USE

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.

SUBJECT DEVICE DESCRIPTIONS

The main characteristics of the subject devices are the following:

Intended for single use;
Provided sterile via ethylene oxide gas;
. Manufactured of titanium alloy (Ti6Al4v-ELI) per ASTM F136;
Conical format available in different diameters, height of cementable area and gingival height;
Screw-retained;
Provided in rotational (non-indexed) version supporting multi-unit restorations;
Provided with an implant-to-abutment interface compatible with the GM implants of the Neodent Implant System.

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
Indications for Use	K192229Neodent Implant System - GM TitaniumBase for BridgeJJGC Indústria e Comércio de MateriaisDentários S.A.	K180536Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K151157NC Straumann Variobase Abutment ForBars/Bridges, RC Straumann VariobaseAbutment For Bars/Bridges, NNCStraumann Variobase Abutment ForBars/Bridges, RN Straumann VariobaseAbutment For Bars/Bridges, WNStraumann Variobase Abutment ForBars/BridgesStraumann USA, LLC	EquivalentThe subject devices bring specificinformation regarding the restorationtype indicated to be used with them butthe general indications are the same forboth subject and the GM Exact TitaniumBase abutments of the predicate device.
	Titanium Base Abutment is a titaniumbase placed onto Neodent dentalimplants to provide support forcustomized prosthetic restorations. It isused with a coping and crown, or crownalone, and is indicated for cement-retained single or multi-unit restorationsor screw-retained single restorations. Alldigitally designed copings and/or crownsto be used with the Neodent TitaniumBase Abutment System are intended tobe sent to Straumann for manufacture ata validated milling center.The GM Titanium Base for Bridge isindicated for cement or screw-retainedmulti-unit restorations.	GM Helix Implants and conventionalabutments: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.GM Exact Titanium Block for MedentikaHolder:GM Exact Titanium Block for MedentikaHolder is a titanium abutment to be usedin fabricating a full custom abutment andplaced onto Neodent dental implants toprovide support for customizedprosthetic restorations. The GM ExactTitanium Block for Medentika Holderabutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.All digitally designed abutments for usewith the GM Exact Titanium Block forMedentika Holder are intended to besent to Straumann for manufacture at avalidated milling center.	Straumann® Variobase™ prostheticcomponents directly connected to theendosseous dental implants areindicated for use as an aid in prostheticrehabilitations. The prostheticrestoration (bridge or overdenture) canbe cemented on the Straumann®Variobase™ prosthetic components. Atemporary restoration can be used priorto the insertion of the final componentsto maintain, stabilize and form the softtissue during the healing phase. Theymay not be placed into occlusion. Finalabutments and restorations may beplaced into occlusion when the implant isfully osseointegrated.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K192229Neodent Implant System - GM TitaniumBase for BridgeJJGC Indústria e Comércio de MateriaisDentários S.A.	K180536Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K151157NC Straumann Variobase Abutment ForBars/Bridges, RC Straumann VariobaseAbutment For Bars/Bridges, NNCStraumann Variobase Abutment ForBars/Bridges, RN Straumann VariobaseAbutment For Bars/Bridges, WNStraumann Variobase Abutment ForBars/BridgesStraumann USA, LLC	EQUIVALENCE DISCUSSION
		GM Exact Titanium Base abutments:
		Titanium Base Abutment is a titaniumbase placed onto Neodent dentalimplants to provide support forcustomized prosthetic restorations. It isused with a coping and crown, or crownalone, and is indicated for cement-retained single or multi-unit restorations,or screw-retained single restorations. Alldigitally designed copings and/or crownsfor use with the Neodent Titanium BaseAbutment System are intended to besent to Straumann for manufacture at avalidated milling center.Titanium Base C for GM Exact
		abutments:The Titanium Base C for GM Exactabutments is a titanium component thatis placed over Neodent implants toprovide support for custom prostheticrestorations, such as copings or crowns.It is indicated for single-tooth screw-retained restorations. All digitallydesigned copings and/or crowns for usewith the Titanium Base C for GM Exactabutments are to be designed usingSirona inLab software or Sirona CERECSoftware and manufactured using aSirona CEREC or inLab MC X or MC XLmilling unit.
Implant-Abutmentinterface	GM	GM	N/A	Same as Primary Predicate
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K192229Neodent Implant System - GM TitaniumBase for BridgeJJGC Indústria e Comércio de MateriaisDentários S.A.	K180536Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K151157NC Straumann Variobase Abutment ForBars/Bridges, RC Straumann VariobaseAbutment For Bars/Bridges, NNCStraumann Variobase Abutment ForBars/Bridges, RN Straumann VariobaseAbutment For Bars/Bridges, WNStraumann Variobase Abutment ForBars/BridgesStraumann USA, LLC	EQUIVALENCE DISCUSSION
	Straight	Straight	Straight	Equivalent
Design	Conical upper portionHelical micro grooves in the cementableportion	Cylindrical upper portionHelical micro grooves in the cementableportion	Conical upper portionHelical micro grooves in the cementableportion	The coronal design of the subject deviceis equivalent to that of the referencedevice K151157.
Reusable	No	No	No	Same
Diameter (Ø)	3.5, 4.5, and 5.5 mm	5.5 mm	3.3 mm	EquivalentThe reference devices (K151157) have aminimum diameter of 3.3 mm which issimilar to the subject devices. Dynamicfatigue testing was performed with thenew worst-case design of the subjectdevices, the results indicate performancesuitable for the intended use.
Gingival Height(mm)	0.8, 1.5, 2.5, 3.5, and 4.5	0.8, 1.5, 2.5, 3.5, 4.5, and 5.5	N/A	EquivalentSubject devices are within the rangeestablished by the primary predicate.
MaximumAngulation	30°	30°	30°	Same
Abutment Height	4 mm	4 mm	3.5 – 5.2 mm	Same as Primary Predicate
Material	TAV (ASTM F136)	TAV (ASTM F136)	Ti-6Al-7Nb (TAN)	Same as Primary Predicate
SterilizationMethod	Ethylene Oxide to an SAL of 1x10-6	Ethylene Oxide to an SAL of 1x10-6	Non-Sterile	Same as Primary Predicate

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The subject devices and the primary predicate device (K180536) have the same Indications for Use, similar design, similar 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 Titanium Base for Bridge, according to FDA Guidance. The abutments were tested with three different restoration materials and all of them are in accordance with the acceptance criteria.

Torsion testing was performed to evaluate the Titanium Base Screws under static torsional loading. The results met the acceptance criteria.

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 10th has been validated.

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

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 K180536 have the same intended use, similar designs and technological characteristics, similar range of gingival height, same sterilization method 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.)