Indications for Use for Zirconia Implants, Cover Screw and Healing Abutment:
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 singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for Zirconia Bases:
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

Intended for single use;
Zirconia implants provided sterile via Ethylene Oxide; Zirconia Base abutments are provided sterile but require end user sterilization via moist heat following cementation of the restoration and before use
All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide), except for the Zirconia Implant Cover Screw and the Basal Screw, which is manufactured of titanium alloy according to ASTM F136 standard;
ZiLock prosthetic interface with internal indexer;
Apically tapered implant with trapezoidal thread profile;
Implant provided with sand-blasted, acid etched surface finish to facilitate osseointegration.
The final finished Zirconia Base abutments are two-piece abutments composed of a zirconia base bottom-half bonded to a CAD-CAM zirconia top-half.

AI/ML Overview

The provided text describes a medical device submission (K201491) for the Neodent Implant System - Zirconia Implant System to the FDA. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance results for a new AI/software device.

Therefore, the requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies cannot be extracted from this document as it pertains to a different type of medical device submission (dental implants and their components) and regulatory pathway (510(k) for substantial equivalence).

The document details the comparison of the subject device (Neodent Implant System - Zirconia Implant System) to predicate and reference devices in terms of indications for use, technological characteristics, and performance data from various tests. However, these are evaluations against established standards and comparisons to existing devices, not metrics of an AI's performance.

Here's what can be extracted, though it doesn't directly answer the detailed questions about AI performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria for software performance in the typical sense (e.g., sensitivity, specificity, AUC). Instead, it presents a comparison of technological characteristics and states that the "tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices" in mechanical testing.

Here's a summary of the performance data presented, which implies meeting an "equivalent" performance to predicates rather than specific numerical acceptance criteria for a new software.

Performance Area	Reported Device Performance
Biocompatibility	Representative samples of each device subjected to tests per ISO 10993-1, ISO 10993-5, ISO 10993-12, and ISO 10993-18. (Implied acceptance is successful completion according to these standards).
Mechanical Testing	Dynamic Fatigue Test (per ISO 14801): "exhibit a level of performance equivalent to that reviewed for the predicate devices."
	Wear Assessment (Titanium/Ceramic contacting pieces): "concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection."
	Torsion Test: Performed to evaluate static torsional loading. (Implied acceptance is meeting design specifications and being comparable to predicates).
	Insertion Test: Performed to evaluate insertion torque in sawbones materials (bone type I, II, III, IV). (Implied acceptance is meeting design specifications and being comparable to predicates).
Sterilization	Achieved a "Sterility Assurance Level of 1x10⁻⁶" via Ethylene Oxide per ISO 11135-1. Residuals according to ISO 10993-7. Not represented as "pyrogen free."
MRI Testing	Done according to documents presented in K182620 (a previously cleared device for MRI compatibility). (Implied acceptance is being MRI compatible as per the reference device).
Shelf Life	5 years. Packaging assessment per ISO 11607-1, with maintenance of sterile barrier and sealing integrity confirmed by Dye Penetration, Sealing Strength, and Bubble Test after Accelerated Aging.

No information is available regarding points 2-9 as they are specific to AI/software device studies to establish performance against a ground truth. This document is a 510(k) summary for a physical dental implant system and components, establishing substantial equivalence to existing devices.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "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: K201491

Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 20, 2020 Received: November 23, 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 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 (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.

Andrew Steen Assistant 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) K201491

Device Name

Neodent Implant System - Zirconia Implant System

Indications for Use (Describe) Indications for Use for Zirconia Implants, Cover Screw and Healing Abutment:

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 singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

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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Indications for Use

510(k) Number (if known) K201491

Device Name

Neodent Implant System - Zirconia Implant System

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

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.

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)
X

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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	21/December/2020
Preparer / Alternate Contact	Mariana Soares HartmannRegulatory Affairs AnalystJJGC Indústria e Comércio de Materiais Dentários SAE-mail: mariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary Name	Neodent Implant System – Zirconia Implant System
Common Name	Endosseous dental implantEndosseous dental implant abutment
Classification Name	Endosseous dental implant
Classification Regulations	21 CFR 872.3640, Class II
Product Code	DZE / NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K101945 - Neodent Implant System - CM Line, JJGC Indústria eComércio de Materiais Dentários S.A
Reference Devices	K150367 - Neodent Implant System, JJGC Indústria e Comércio deMateriais Dentários S.A
	K132881 - Z5c, Z-Systems AG
	K153624 - Neodent Implant System, JJGC Indústria e Comércio deMateriais Dentários S.A
	K180477 – Straumann PURE Ceramic Implant System, InstitutStraumann AG
	K182620 - MRI Compatibility For Existing Neodent ImplantSystem, JJGC Indústria e Comércio de Materiais Dentários S.A
	K192893 - Straumann® Ceramic Healing Abutments, InstitutStraumann AG

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INDICATIONS FOR USE

Indications for Use for Zirconia Implants, Cover Screw, and Healing Abutments:

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 surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for Zirconia Bases:

SUBJECT DEVICE DESCRIPTIONS

Intended for single use;
Zirconia implants provided sterile via Ethylene Oxide; Zirconia Base abutments are provided sterile but require end user sterilization via moist heat following cementation of the restoration and before use
All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide), except for the Zirconia Implant Cover Screw and the Basal Screw, which is manufactured of titanium alloy according to ASTM F136 standard;
ZiLock prosthetic interface with internal indexer;
Apically tapered implant with trapezoidal thread profile;
Implant provided with sand-blasted, acid etched surface finish to facilitate osseointegration.
The final finished Zirconia Base abutments are two-piece abutments composed of a zirconia base bottom-half bonded to a CAD-CAM zirconia top-half.

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

Table 1. Technological Characteristic Comparison Table - Zirconia Implants, Cover Screws, and Healing Abutments

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Equivalence Discussion
Indicationsfor Use	K201491Neodent Implant System - Zirconia ImplantSystem - ImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K101945Neodent Implant SystemAlvim ImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K180477Straumann PURE Ceramic Implant SystemImplantsInstitut Straumann AG	IdenticalThe Indications for Use of the subjectdevices are the same as for the primarypredicate devices.
	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 surgical procedures, for single ormultiple unit restorations, and may beloaded immediately when good primarystability is achieved and withappropriate occlusal loading. Multipleteeth applications can be rigidlysplinted.	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 primarystability is achieved and withappropriate occlusal loading. Multipleteeth applications can be rigidly splinted	Straumann PURE Ceramic Implant:The Straumann PURE Ceramic Implantis indicated for the restoration of single-tooth gaps and in edentulous orpartially edentulous jaws. Theprosthetic restorations used are singlecrowns, fixed partial or full dentures,which are connected to the implantsthrough the correspondingcomponents.Closure and healing caps:Closure and Healing caps are intendedfor use with the Straumann DentalImplant System (SDIS) to protect theinner configuration of the implant andmaintain, stabilize and form the softtissue during the healing process.Closure and Healing caps should beused only with suitable implantconnections. Do not use healingcomponents for longer than 6 months.Temporary Abutments:The provisional components areintended to serve as a base fortemporary crown or bridge restorationout of occlusion for the Straumann®PURE Ceramic Implant System. TheStraumann® Temporary Abutment VITACAD-Temp® for the Straumann® PURECeramic Implant is indicated fortemporary usage of up to 180 days.CI RD Straumann PUREbase Abutments:
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EquivalenceDiscussion
	K201491Neodent Implant System - Zirconia ImplantSystem - ImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K101945Neodent Implant SystemAlvim ImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K180477Straumann PURE Ceramic Implant SystemImplantsInstitut Straumann AG
			CI RD Straumann PUREbase abutment isa titanium base placed onto Straumannceramic dental implants to providesupport for customized prostheticrestorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridgerestorations. All digitally designedcopings and/or crowns for use with theStraumann® Variobase Abutmentsystem are intended to be sent toStraumann for manufacture at avalidated milling center.
Implant-Abutmentinterface	Straight internal connectionindexing features (Zilock)	CM Morse Taper	Straight internal connectionindexing features (RD)	EquivalentSubject devices and reference devicespresent internal connection and areequipped with a rotational lock and aninner thread for fixation of thetemporary components and finalabutments.
Design	Apically Tapered formatTrapezoidal threads profileBone compression capacity duringinstallation	Apically Tapered formatTrapezoidal threads profile	Straight cylindrical implant body	EquivalentThe subject devices have the sameapically-tapered shape and trapezoidalthread form as the primary predicatedevice.
Reusable	No	No	No	IdenticalThe subject devices and the primarypredicate devices are indicated for singleuse.
Length (mm)	8; 10; 11.5; 13	8; 10; 11.5; 13; 16	8; 10; 12; 14	EquivalentRange of lengths for subject devices iswithin the range of lengths for theprimary predicate devices.
Diameter (Ø)	4.3 mm	3.5; 4.3; 5.0 mm	Endosteal 4.1 mm	Equivalent
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K201491Neodent Implant System - Zirconia ImplantSystem - ImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K101945Neodent Implant SystemAlvim ImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K180477Straumann PURE Ceramic Implant SystemImplantsInstitut Straumann AG	EquivalenceDiscussion
(mm)			Platform 4.8 mm	Diameter of subject devices is withinthe range of diameters for the primarypredicate devices.
Material	Yttrium-stabilized zirconium dioxide(Y-TZP).	Commercially pure titanium (Grade 4)	Yttrium-stabilized zirconium dioxide(Y-TZP).	EquivalentThe subject devices have the samematerial of construction as theidentified reference devices.
SterilizationMethod	Provided sterile via Ethylene Oxide toan SAL of 10-6	Provided sterile via Gamma irradiation toan SAL of 1x10-6	Provided sterile via Ethylene Oxide to anSAL of 10-6	EquivalentThe subject devices and the primarypredicate devices are provided in sterilecondition to an SAL of 1 x 10-6. The subjectdevices use the same sterilization methodas for the reference devices.

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SUBJECT DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	EquivalenceDiscussion		SUBJECT DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
K201491Neodent Implant System - ZirconiaImplant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K180477Straumann PURE Ceramic Implant SystemPUREbase AbutmentsInstitut Straumann AG	K150367Neodent Implant SystemTitanium Base AbutmentsJJGC Indústria e Comércio deMateriais Dentários S.A.	K132881Z5cZ-Systems AG			K201491Neodent Implant System - ZirconiaImplant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K180477Straumann PURE Ceramic Implant SystemPUREbase AbutmentsInstitut Straumann AG	K150367Neodent Implant SystemTitanium Base AbutmentsJJGC Indústria e Comércio deMateriais Dentários S.A.	K132881Z5cZ-Systems AG	EquivalenceDiscussion
Indicationsfor Use	The Zirconia Base is anabutment placed over NeodentZirconia Implants in order toprovide support for patient-specific prosthetic restorations,such as copings or crowns. Itmay be used for cement- orscrew retained single unitrestorations. All digitallydesigned copings and/orcrowns to be used with theNeodent Zirconia BaseAbutment System are intendedto be sent to Straumann formanufacture at a validatedmilling center.	Straumann PURE Ceramic Implant:The Straumann PURE Ceramic Implant isindicated for the restoration of single-tooth gapsand in edentulous or partially edentulous jaws.The prosthetic restorations used are singlecrowns, fixed partial or full dentures, which areconnected to the implants through thecorresponding components.Closure and healing caps:Closure and Healing caps are intended for usewith the Straumann Dental Implant System(SDIS) to protect the inner configuration of theimplant and maintain, stabilize and form the softtissue during the healing process. Closure andHealing caps should be used only with suitableimplant connections. Do not use healingcomponents for longer than 6 months.Temporary Abutments:The provisional components are intended toserve as a base for temporary crown or bridgerestoration out of occlusion for the Straumann®PURE Ceramic Implant System. The Straumann®Temporary AbutmentVITA CAD-Temp® for the Straumann® PURECeramic Implant is indicated for temporaryusage of up to 180 days.CI RD Straumann PUREbase Abutments:CI RD Straumann PUREbase abutment is atitanium base placed onto Straumann ceramicdental implants to provide support forcustomized prosthetic restorations and isindicated for screw-retained single tooth orcement-retained single tooth and bridgerestorations. All digitally designed copings and/orcrowns for use with the Straumann® VariobaseAbutment system are intended to be sent toStraumann for manufacture at a validated millingcenter.	Titanium Base Abutment is atitanium base placed ontoNeodent dental implants toprovide support for customizedprosthetic restorations. It isused with a coping and crown,or crown alone, and is indicatedfor cement- or screw-retainedsingle or multi-unit restorationssingle. All digitally designedcopings and/or crowns to beused with the NeodentTitanium Base AbutmentSystem are intended to be sentto Straumann for manufactureat a validated milling center.The GM Titanium Base forBridge is indicated for cementor screw-retained multi-unitrestorations	Z5c implants are designed forsurgical implantation intothe upper and lower jaw forthe attachment ofprosthodontic appliances toreplace missing teeth. Z5cimplant system is alsosuitable for patients withmetal allergies and thechronic diseases resultingfrom them. Z5c implants areintended for delayedloading.	EquivalentThe Indications for thesubject devices areequivalent toreference devices(K150367). Althoughthe words aredifferent, the contentof the indications foruse are similar. Theprimary predicatecovers the indicationsfor use of thereference devices. Theindications for use ofthe subject devicesare contained withinthe indications for useof the primarypredicate devices.	AbutmentMaterial	Zirconia Base: Yttrium-stabilized zirconium dioxide(Y-TZP).Screw: Titanium alloy Screwaccording to ASTM F136standard.	Ti-6Al-7Nb	Titanium alloy according toASTM F136 standard.	Yttrium-stabilized zirconiumdioxide(Y-TZP).	EquivalentThe subject devicesand the referencedevices (K132881)have the samematerial ofconstruction.
	SUBJECT DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE		RestorationMaterial	zerion LTzerion UTML3M LavaPlus Zirconia	polycon ae (temporary)zerion LT/HT (permanent)zerion ML/UTML (permanent)IPS e.max CAD (permanent)n!ce (permanent)	Zirconia	--	EquivalentThe subject devicesand the referencedevices haveequivalent materialsof construction.
	K201491Neodent Implant System - ZirconiaImplant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K180477Straumann PURE Ceramic Implant SystemPUREbase AbutmentsInstitut Straumann AG	K150367Neodent Implant SystemTitanium Base AbutmentsJJGC Indústria e Comércio deMateriais Dentários S.A.	K132881Z5cZ-Systems AG	EquivalenceDiscussion	Designworkflow	Zirconia Base library on DentalWings and 3Shape systems orsoftware	CAD with CARES Visual v.11	CARES Visual, Dental Wingsand 3shape software	--	EquivalentThe subject andreference devices areindicated for usewithin a digitalrestorative workflow.The same CADsoftware can be usedto design theprosthetic portion ofthe devices.
Implant-Abutmentinterface	Straight internal connectionindexing features (Zilock)	Straight internal connectionindexing features (RD)	CM Morse Taper	--	EquivalentSubject devices andreference devices(K180477) presentinternal connectionand are equippedwith a rotational lockand an inner threadfor fixation of thetemporarycomponents and finalabutments.
MaximumAngulation ofProstheticStructure	30°	30°	30°	15°	IdenticalThe maximumrestorative angulationfor the subject andreference devices(K180477 andK150367) is the same.
Gingivalheight (mm)	1.5 – 2.5 mm	--	0.8 - 4.5 mm	--	EquivalentThe range of gingivalheights for thesubject devices iswithin the range ofgingival heights of thereference devices
Reusable	No	No	No	No	IdenticalThe subject devices andreference devices areindicated for single use.

Table 2. Technological Characteristic Comparison Table - Zirconia Bases

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	SUBJECT DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	K201491Neodent Implant System - ZirconiaImplant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K180477Straumann PURE Ceramic Implant SystemPUREbase AbutmentsInstitut Straumann AG	K150367Neodent Implant SystemTitanium Base AbutmentsJJGC Indústria e Comércio deMateriais Dentários S.A.	K132881Z5cZ-Systems AG	EquivalenceDiscussion
Manufacturingworkflow	Straumann Milling Center	Straumann Milling Center	Straumann Milling Center	--	IdenticalThe prostheticportion of theassembly for thesubject devices andreference devices(K180477 andK150367) areindicated forfabrication in aregistered medicaldevice manufacturingfacility.
SterilizationMethod	Provided sterile via EthyleneOxide to an SAL of 10-6End user sterilized via moistheat following cementation ofcoping and before use	Non-sterileEnd user sterilized via moist heat followingcementation of coping and before use	Provided sterile via Ethylene Oxideto an SAL of 10-6	--	IdenticalThe subject devices andthe reference devices(K150367) are providedsterile condition to an SALof 1 x 10-6. The subjectdevices use the samesterilization method asfor the reference devices.

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Table 3. Technological Characteristic Comparison Table – Zirconia Implant Cover Screw

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Table 4. Technological Characteristic Comparison Table - Zirconia Implant Healing Abutments

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The subject implants have identical indications for use and an equivalent range of lengths and diameter as the primary predicate devices, being within the range of lengths and diameter of the predicate devices.

Subject and predicate devices have implant-to-abutment internal indexing. Both present sand-blast and acid-etch surface finishes and same sterile barrier system. The subject implants have the identical surface modification as the reference device (K180477). The subject implants have equivalent materials and sterilization method as the reference device (K180477).

The subject Base abutment have the same indications for use and an equivalent range of gingival height as the primary predicate devices, being within the range of gingival height of the predicate devices. Both, subject devices and primary predicate devices, present the same maximum angulation and sterilization method. The subject bases are made of the same material as the reference devices (K132881).

The subject Cover screws have the same indications for use, same sterilization method, similar design and are made of the same material as the primary predicate devices (K101945).

The subject Healing Abutments have the same indications for use and an equivalent range of gingival height and diameter as the primary predicate devices, being within the range of gingival height and diameter of the predicate devices. They also present the same sterilization method. The subject devices and reference devices are made of the same material (K192893).

Overall, the subject devices are equivalent to the predicate devices as follows:

same intended use,
same operating principle,
. incorporate the same basic design,
incorporate the same materials, and
have same packaging and are sterilized using the same materials and processes

PERFORMANCE DATA

Biocompatibility

Representative samples of each of the subject devices was subjected to the following:

. 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.

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.

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The wear assessment of the Titanium/Ceramic contacting pieces was done before and after the fatigue test. The data produced concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection.

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

Sterilization validation

The subject devices are sterilized by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. The residuals from ethylene oxide sterilization are according to ISO 10993-7 The method achieved a Sterility Assurance Level of 1x10 °. The Subject devices are not represented to be "pyrogen free".

MRI Testing

The MRI Testing was done according to the documents presented on K182620

Shelf Life

The Shelf Life of the Zirconia Implant System is 5 years.

The packaging assessment is guided according to ISO 11607-1 and maintenance of the sterile barrier and the integrity of the sealing after 5 years of Accelerated Aging were confirmed by Dye Penetration, Sealing Strength and Bubble Test.

CONCLUSION

The subject devices and the primary predicate and reference devices have equivalent intended use, design and technological characteristics. Equivalent range of overall dimensions and sterilization method. 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.

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	EQUIVALENCE DISCUSSION
	Neodent Implant System - Zirconia Implant SystemCover ScrewsJJGC Indústria e Comércio de Materiais Dentários S.A.	K101945Neodent Implant SystemCover ScrewsJJGC Indústria e Comércio de Materiais Dentários S.A.
Indications for Use	The Neodent Implant System is intended to besurgically placed in the bone of the upper or lowerjaw to provide support for prosthetic devices, suchas artificial teeth, to restore chewing function. Itmay be used with single-stage or two-stagesurgical procedures, for single or multiple unitrestorations, and may be loaded immediatelywhen good primary stability is achieved and withappropriate occlusal loading. Multiple teethapplications can be rigidly splinted.	The Neodent Implant System is intended to besurgically placed in the bone of the upper or lowerjaw to provide support for prosthetic devices, suchas artificial teeth, to restore chewing function. Itmay be used with single-stage or two-stageprocedures, for single or multiple unit restorations,and may be loaded immediately when goodprimary stability is achieved and with appropriateocclusal loading.	EquivalentThe Indications for the subject devices are includedwithin the scope on Indications for the primarypredicate devices.
Reusable	No	No	IdenticalThe subject devices and the primary predicate devicesare both intended for single use.
Material	Titanium alloy according to ASTM F136 standard.	Titanium alloy according to ASTM F136 standard.	IdenticalThe subject devices have the same material ofconstruction as the primary predicate devices.
Sterilization Method	Provided sterile via Ethylene Oxide to an SAL of 10-6	Provided sterile via Ethylene Oxide to an SAL of 10-6	IdenticalThe subject devices have the same sterilizationmethod and same SAL as the primary predicatedevices.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Equivalence Discussion
	Neodent Implant System - Zirconia ImplantSystemHealing AbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	K101945Neodent Implant SystemHealing AbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	K192893Straumann Ceramic Healing AbutmentsHealing AbutmentsInstitut Straumann AG.
Indicationsfor Use	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 surgical procedures, for single ormultiple unit restorations, and may beloaded immediately when good primarystability is achieved and withappropriate occlusal loading. Multipleteeth applications can be rigidlysplinted.	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 primarystability is achieved and withappropriate occlusal loading. Multipleteeth applications can be rigidly splinted	Straumann® Ceramic Healing abutmentsare indicated to be placed in the patient'smouth at the end of the implant placementto protect the inner configuration of theimplant and maintain, stabilize and formthe soft tissue during the healing process.Healing abutments should be used onlywith suitable implant connections. Thehealing components are intended to beused up to 6 months.	EquivalentThe Indications for the subject devicesare included within the scope onIndications for the primary predicatedevices.
Implant-Abutmentinterface	Straight internal connectionindexing features (Zilock)	CM	Straight internal connectionindexing features (RD)	EquivalentSubject devices and reference devices(K192893) present internal connectionand are equipped with a rotational lockand an inner thread for fixation of thetemporary components and finalabutments.
Reusable	No	No	No	IdenticalThe subject and primary predicatedevices are indicated for single use.
Material	Healing Abutment: Yttrium-stabilizedzirconium dioxide (Y-TZP)Screw: Titanium alloy Screw accordingto ASTM F136 standard.	Healing Abutment and Screw: Titaniumalloy according to ASTM F136 standard.	Healing Abutment: Yttrium-stabilizedzirconium dioxide (Y-TZP)Screw: Titanium alloy (Ti-6Al-7Nb orTAN)	EquivalentThe materials of construction for thesubject devices are equivalent to thoseof the reference devices.
Diameter (Ø)(mm)	3.75 and 4.5	3.3 and 4.5 mm	NC: 3.6 and 4.8 mmRC: 4.5, 5.0, 6.0, and 6.5 mm	EquivalentThe range of diameters of the subjectdevices are within the range of diametersfor the primary predicate devices.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Equivalence Discussion
	Neodent Implant System - Zirconia ImplantSystemHealing AbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	K101945Neodent Implant SystemHealing AbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	K192893Straumann Ceramic Healing AbutmentsHealing AbutmentsInstitut Straumann AG.
Gingival height(mm)	1.5 – 2.5 mm	0.8, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5	NC: 2.0, 3.5, and 5.0 mmRC: 2.0, 4.0, and 6.0 mm	EquivalentThe range of gingival heights of thesubject devices are within the range ofgingival heights for the primarypredicate devices.
Sterilization	Provided sterile via Ethylene Oxide toan SAL of 10-6	Provided sterile via Ethylene Oxide toan SAL of 10-6	Provided sterile via Ethylene Oxide toan SAL of 10-6	IdenticalThe subject devices have the samesterilization method and same SAL asthe primary predicate devices.