The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Device Description

The Zirconia Base abutment is used as two-piece abutment, where the base is premanufactured from zirconia and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The top half and base pieces are cemented together to form the final abutment. This submission aims to introduce the conventional workflow for obtaining prostheses manually designed by the technician using the Zirconia Bases, already cleared under K201491. With that, the introduction of one more restoration material (IPS e.max® Press) for the top half confection is necessary. The conventional workflow, using the IPS e.max® Press as restoration material along with the suggested cement materials is equivalent to the design workflow indicated for reference device (K142890).

AI/ML Overview

The provided text describes the regulatory clearance of a dental implant system and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML device. Therefore, the information requested for an AI/ML device, such as specific acceptance criteria and detailed study designs involving test sets, ground truth establishment, and expert involvement, is not available in the provided document.

The document primarily discusses:

Device: Neodent Implant System - Zirconia Implant System, specifically the Zirconia Base abutment.
Purpose of Submission: To introduce a conventional workflow for manually designed prostheses using Zirconia Bases and to include a new restoration material (IPS e.max® Press).
Method of Proof: Substantial Equivalence to legally marketed predicate devices, as per FDA 510(k) requirements. This involves comparing indications for use, technological characteristics, materials, and manufacturing processes, supported by performance data (mechanical testing, MR compatibility, sterilization validation, biocompatibility) demonstrating that the new workflow and material do not raise new questions of safety or effectiveness.

Therefore, I cannot populate the requested tables and information as it pertains to AI/ML device acceptance criteria and study details. The document does not describe an AI/ML device or its evaluation.

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.

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: K222026

Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 14, 2023 Received: June 14, 2023

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.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K222026

Device Name

Neodent Implant System - Zirconia Implant System

Indications for Use (Describe) Indications for Use for Zirconia Bases:

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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	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	July 13, 2023
Preparer / Alternate Contact	Mariana HartmannRegulatory Affairs LeaderE-mail: mariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary NameCommon Name	Neodent Implant System - Zirconia Implant SystemEndosseous dental implant abutment
Classification Name	Endosseous dental implant abutment
Classification RegulationsProduct CodeClassification PanelReviewing Branch	21 CFR 872.3630, Class IINHADental Products PanelDental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K201491 – Neodent Implant System – Zirconia ImplantSystem, JJGC Indústria e Comércio de MateriaisDentários S.A;
Reference Device	K142890 – Institut Straumann AG – Straumann®Variobase™ AbutmentsK163194 - Neodent Implant System - GM Line, JJGCIndústria e Comércio de Materiais Dentários S.A

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K223638 - Neodent Implant System - Helix Short Implant System; JJGC Indústria e Comércio de Materiais Dentários S.A.

INDICATIONS FOR USE

Indications for Use Zirconia Bases:

SUBJECT DEVICE DESCRIPTIONS

This submission aims to introduce the conventional workflow for obtaining prostheses manually designed by the technician using the Zirconia Bases, already cleared under K201491. With that, the introduction of one more restoration material (IPS e.max® Press) for the top half confection is necessary. The conventional workflow, using the IPS e.max® Press as restoration material along with the suggested cement materials is equivalent to the design workflow indicated for reference device (K142890). The table below details the restorative material introduced and the cement materials involved in the conventional workflow for the Zirconia Bases:

	Top Half Material	Cement Material
Material Name	IPS e.max® Press	Ivoclar Multilink
Raw Material	Lithium Dissilicate	Lithium Dissilicate
510(k)	K120053	K130436

The subject and primary predicate devices (K201491) have identical Indications for Use statements, providing the support for patient-specific prosthetic restorations. They also present the same raw material, technological characteristics (design and gingival height), reuse indication, sterilization method and sterile barrier.

Regarding the restoration material, focus of this submission, the IPS e.max® Press used to create the top half under the subject device are already cleared in the same configuration under K142890 (reference device). The Ivoclar Multilink cement material has also been previously cleared to be used together with IPS e.max restoration materials, under K223638 (reference device), with the intention to prepare a prosthetic restoration under implantable devices.

The results of the comparison between the subject, predicate and reference devices using the IPS e.max restoration materials along with the cement materials demonstrate that they are substantially equivalent.

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
	Neodent Implant System – Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K201491Neodent Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K142890Straumann® Variobase™ AbutmentsInstitut Straumann AG
Indications for Use	The Zirconia Base is an abutment placed overNeodent Zirconia Implants in order to providesupport for patient-specific prosthetic restorations,such as copings or crowns. It may be used forcement- or screw retained single unit restorations.All digitally designed copings and/or crowns to beused with the Neodent Zirconia Base AbutmentSystem are intended to be sent to Straumann formanufacture at a validated milling center.	The Zirconia Base is an abutment placed over NeodentZirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings orcrowns. It may be used for cement- or screw retainedsingle unit restorations. All digitally designed copingsand/or crowns to be used with the Neodent ZirconiaBase Abutment System are intended to be sent toStraumann for manufacture at a validated milling center.		Identical
Implant toabutment interface	Straight internal connectionindexing features (Zilock)	Straight internal connectionindexing features (Zilock)		Identical
Gingival Height	1.5 and 2.5 mm	1.5 and 2.5 mm		Identical
Reusable	No	No		Identical
Material	Zirconia Base: Yttrium-stabilized zirconium dioxide(Y-TZP).Screw: Titanium alloy, according to ASTM F136standard.	Zirconia Base: Yttrium-stabilized zirconium dioxide (Y-TZP).Screw: Titanium alloy, according to ASTM F136 standard.		Identical
Design workflow	Digital Workflow: Zirconia Base library on DentalWings and 3Shape.Conventional Workflow: manually designed by thetechnician	Digital Workflow: Zirconia Base library on Dental Wingsand 3Shape.	Digital Workflow: CARES® Visual.Conventional Workflow: manually designed by thetechnician	EquivalentThe digital workflow remains thesame and the conventional workflowis done manually as the referencepredicate device.
Manufacturingworkflow	Digital Workflow: Straumann Milling CenterConventional Workflow: in-lab (traditionalpressing)	Digital Workflow: Straumann Milling Center	Digital Workflow: Straumann Milling CenterConventional Workflow: in-lab (traditional casting orpressing)	EquivalentThe digital workflow remains thesame and the conventional workflow(subject of this submission) is thesame of the reference predicatedevice (traditional pressing).

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Traditional 510(k) Submission

K222026 - Neodent Implant System – Zirconia Implant System

	SUBJECT DEVICE		PRIMARY PREDICATE DEVICE		REFERENCE DEVICE		EQUIVALENCE DISCUSSION
	Neodent Implant System – Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K201491Neodent Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.		K142890Straumann® Variobase™ AbutmentsInstitut Straumann AG		Equivalent
Restoration Material	Digital Workflow:	Digital Workflow:	Digital Workflow:	The digital workflow remains thesame when compared to primarypredicate device. The change of thissubmission is related toconventional workflow andinclusion of IPS e.max Pressindication to Zirconia Bases.However, when compared toreference predicate device, therestorative material (IPS e.maxPress) is equivalent.
	Material	Minimum wallthickness	Minimumangulation	Maximumangulation	Material	Minimum wallthickness	Minimumangulation	Maximumangulation	Material	Minimum wallthickness	Minimumangulation	Maximumangulation
	3M ESPE LavaPlus Zirconia	0.7 mm			3M ESPE Lava PlusZirconia	0.7 mm			Zerion	0.4 mm
	Zirconia (ZerionLT)	0.4 mm	0°	30°	Zirconia (Zerion LT)	0.4 mm	0°	30°	IPS e.max CAD	0.9 mm	0°	30°
	Zirconia (ZerionUTML)	0.5 mm			Zirconia (ZerionUTML)	0.5 mm			Coron	0.3 mm		30°
									Polycon ae	0.5 mm
	Conventional Workflow:					Conventional Workflow:
	Material	Minimum wallthickness	Minimumangulation	Maximumangulation		Material	Minimum wallthickness	Minimumangulation	Maximumangulation
	IPS e.max Press	0.9 mm	0°	30°		IPS e.max Press (in-lab pressing)	0.9 mm	0°	30°
						Type 4 dentalmetals (ISO 22674)(In-lab casting).	0.5 mm	0°	30°
Sterilization Method	Provided sterile via Ethylene Oxide to an SAL of 10-6.End user sterilized via moist heat followingcementation of coping and before use.				Provided sterile via Ethylene Oxide to an SAL of 10-6. Enduser sterilized via moist heat following cementation ofcoping and before use.				Identical

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PERFORMANCE DATA

Mechanical testing

In order to demonstrate the substantial equivalence regarding the mechanical strength of the system, the dynamic fatigue test was performed using the new restoration material, in accordance with ISO 14801 and FDA guidance document "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The performance bench test carried out with the Zirconia Bases and IPS e.max Press demonstrates that the new material is substantially equivalent to the previously cleared materials.

MR Compatibility testing

The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for primary predicate devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per primary predicate devices.

Sterilization validation

Sterilization of the Zirconia Abutments via ethylene oxide gas using the overkill method has been performed according to the requirements of ISO 11135-1 Sterilization of Health Care Products -Ethylene Oxide - Part 1: Requirements For Development, Validation and Routine Control of a Sterilization Process For Medical Devices. A minimum Sterility Assurance Level (SAL) of 1 x 10° has been validated.

Steam sterilization have been performed according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The worst case device in conjunction with lithum dissilicate restoration material (IPS) was already validated for steam sterilization, using the parameters described in IFU, under reference device evaluation (K163194).

Biocompatibility

A biological assessment was performed according to ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016. No new issues of biocompatibility are raised for the Zirconia Bases when compared to primary predicate and restoration and cement materials when compared to reference devices (K223638). Therefore, no additional biocompatibility testing was required.

CONCLUSION

The results of the comparison between the subject and predicates devices demonstrate that they are substantially equivalent.

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.)