The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single- or multiple-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.

Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installa or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Device Description

All the subject devices are intended for single use;
The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10 -;
The subject implants are manufactured of Commercially Pure Titanium (Grade 4) and the subject abutments are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136),
The subject implants present a Grand Morse prosthetic interface with internal indexer; cylindrical shape with double threads; cervical diameter equal to the implant body diameter (2.9 mm)
The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for a "Neodent Implant System - GM Narrow Implant System," which is a dental implant system, not an AI/ML device.

The information provided pertains to demonstrating substantial equivalence of a new dental implant system to legally marketed predicate devices, focusing on:

Indications for Use: Comparing the intended purposes of the new implant system and its components (implants, conventional abutments, temporary abutments, titanium bases) to existing predicate devices.
Technological Characteristics: Comparing material, design (e.g., interface, shape, threads, gingival height), sterilization methods, and reusability.
Performance Data: Mentioning biocompatibility testing (ISO 10993 standards), mechanical testing (Dynamic fatigue per ISO 14801), and sterilization validation (ISO 11137 for gamma irradiation, ISO 11135 for Ethylene Oxide).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The text is relevant for a traditional medical device (dental implant system) and its substantial equivalence determination.

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: K220251

Trade/Device Name: Neodent Implant System - GM Narrow Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 4, 2022 Received: August 9, 2022

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 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) K220251

Device Name

Neodent Implant System - GM Narrow Implant System

Indications for Use (Describe)

IIndications for Use for Helix NGM Implants:

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

Indications for Use for NGM Exact Temporary Abutments:

Indications for NGM Exact Titanium 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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K220251 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, MSSr. Director of Regulatory Affairs and Quality,Straumann USAE-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509
Date Prepared	06/Sep/2022
Preparer / Alternate Contact	Mariana 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 – GM Narrow Implant System
Common Name	Endosseous dental implantEndosseous dental implant abutment
Classification Name	Implant, Endosseous, Root-FormEndosseous dental implant abutment
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	K123022, Neodent Implant System, JJGC Indústria eComércio de Materiais Dentários S.A
--------------------------	------------------------------------------------------------------------------------------

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Reference Predicate Devices
	K162890 - Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC Healing Abutments, SCTemporary Abutments, SC Variobase Abutments, SCCARES Abutments - Straumann USA, LLC
	K203309 – NUVO CF Implant Line, JJGC Indústria eComércio de Materiais Dentários S.A
	K182620 - MRI Compatibility For Existing NeodentImplant System, JJGC Indústria e Comércio de MateriaisDentários S.A

INDICATIONS FOR USE

Indications for Use for Helix NGM Implants:

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 Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.

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

Indications for Use for NGM Exact Temporary Abutments:

Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installed in the maxilla or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.

Indications for NGM Exact Titanium Bases:

SUBJECT DEVICE DESCRIPTIONS

All the subject devices are intended for single use;
The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10 -;
The subject implants are manufactured of Commercially Pure Titanium (Grade 4) and the subject abutments are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136),
The subject implants present a Grand Morse prosthetic interface with internal indexer; cylindrical shape with double threads; cervical diameter equal to the implant body diameter (2.9 mm)

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The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.

SUBSTANTIAL EQUIVALENCE COMPARISON TABLES

The Substantial Equivalence Comparison tables are provided on the pages that follow below.

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Table 1: Substantial Equivalence Comparison – Indix NGM Implants and Conventional and Temporary Abutments

	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE DEVICE
COMPARISON	Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K123022Neodent Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K162890Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC HealingAbutments, SC Temporary Abutments, SCVariobase Abutments, SC CARES AbutmentsStraumann USA, LLC
Indicationsfor UseStatement	Indications for Use for Helix NGM Implants:The Neodent Implant System is intended to be surgicallyplaced in the bone of the upper or lower jaw to providesupport for prosthetic devices, such as artificial teeth, torestore chewing function. It may be used with single stage ortwo-stage procedures, for single- or multiple-unitrestorations, and may be loaded immediately when goodprimary stability is achieved and with appropriate occlusalloading. The Implant Narrow GM is indicated to replace upperlateral incisors, lower incisors or for retaining overdentureprostheses.Indications for Use for Conventional Abutments:The Neodent Implant System is intended to be surgicallyplaced in the bone of the upper or lower jaw to providesupport for prosthetic devices, such as artificial teeth, torestore chewing function. It may be used with single-stage ortwo-stage procedures, for single or multiple unit restorations,and may be loaded immediately when good primary stabilityis achieved and with appropriate occlusal loading.Indications for Use for NGM Exact Temporary Abutments:Prosthetic component to be installed in the Narrow GMImplant, providing support for prosthetic structures. Indicatedfor temporary restorations with unitary structures, screwed,on implants installed in the maxilla or mandible. TemporaryAbutments Narrow GM have a maximum duration of usage of180 days.Indications for Use for NGM Exact Titanium Bases:Titanium Base Abutment is a titanium base placed ontoNeodent dental implants to provide support for customizedprosthetic restorations as copings and crowns. It is indicated	The Neodent Implant System is intended to be surgicallyplaced in the bone of the upper or lower jaw to providesupport for prosthetic devices, such as artificial teeth, torestore chewing function. It may be used with singlestage or two-stage procedures, for single- or multiple-unit restorations, and may be loaded immediately whengood primary stability is achieved and with appropriateocclusal loading.Titamax WS implant is indicated for a delayed loadingprotocol.The Facility implant is indicated to replace upper lateralincisors, lower incisors or for retaining overdentureprostheses.	Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated fororal endosteal implantation in the upper and lower jaw and for thefunctional and aesthetic oral rehabilitation of patients with missingteeth. Straumann® Bone Level Tapered Implants Ø2.9 mm can alsobe used for immediate or early implantation following extraction orloss of natural teeth. Implants can be placed with immediatefunction on single-tooth or multiple-tooth applications when goodprimary stability is achieved and with appropriate occlusal loadingto restore chewing function. The prosthetic restorations areconnected to the implants through the corresponding components(abutments). The Straumann® Bone Level Tapered Implants Ø2.9mm are indicated for reconstruction of missing incisors in the lowerjaw and lateral incisors in the upper jaw.Straumann® Closure Caps and Healing Abutments are indicated tobe placed in the dental implant after placement in the patient's jawto protect the inner configuration of the implant and to form,maintain and stabilize the soft tissue during the healing process.Closure Caps and Healing Abutments should be used only with thecorresponding implant connection.Straumann® SC Temporary Abutments are indicated for use as anaid in prosthetic rehabilitations. Temporary components can beused prior to the insertion of the final components to maintain,stabilize and shape the soft tissue during the healing phase.Straumann® SC Temporary Abutments have a maximum duration ofusage of 180 days.Straumann® SC Variobase® abutments are indicated for use as an aidin prosthetic rehabilitations. The prosthetic restoration can becemented on the Straumann® SC Variobase® prosthetic
	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE DEVICE
COMPARISON	Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K123022Neodent Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K162890Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC HealingAbutments, SC Temporary Abutments, SCVariobase Abutments, SC CARES AbutmentsStraumann USA, LLC
	for cemented or screw mounted single-cemented applicationson implants installed on the maxilla or mandible. All digitallydesigned copings and/or crowns to be used with the TitaniumBase Abutment System are intended to be sent to Straumannfor manufacture at a validated milling center.		components. A temporary restoration can be used prior to theinsertion of the final components to maintain, stabilize and form thesoft tissue during the healing phase. Final abutments andrestorations may be placed into occlusion when the implant is fullyosseointegrated. All digitally designed copings and/or crowns for usewith the Straumann® Variobase® Abutment system are intended tobe sent to Straumann for manufacture at a validated milling center.Straumann® SC CARES® abutments are indicated for single-toothreplacements and multiple tooth restorations. The prostheticrestoration can be cemented or directly veneered/screw-retained.

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Neodent Implant System – GM Narrow Implant System

Table 2: Substantial Equivalence Comparison – Indication for Use Statements - Titanium Bases

COMPARISON	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE PREDICATE DEVICE
		K203309	K162890
	Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	NUVO CF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC HealingAbutments, SC Temporary Abutments, SCVariobase Abutments, SC CARES AbutmentsStraumann USA, LLC
Indicationsfor UseStatement	Indications for Use for NGM Exact Titanium Bases:Titanium Base Abutment is a titanium base placed ontoNeodent dental implants to provide support for customizedprosthetic restorations as copings and crowns. It is indicatedfor cemented or screw mounted single-cemented applicationson implants installed on the maxilla or mandible. All digitallydesigned copings and/or crowns to be used with the TitaniumBase Abutment System are intended to be sent to Straumannfor manufacture at a validated milling center.	CF Titanium Base for Crown is a titanium abutment placedonto dental implants to provide support for customizedprosthetic restorations, as copings or crowns. It is indicatedfor single-unit restorations, cement-retained or screw-retained in aesthetic areas on implants installed in themaxilla or mandible. All digitally designed copings and/orcrowns to be used with the Titanium Base Abutment Systemare intended to be sent to Straumann for manufacture at avalidated milling center.	Straumann® SC Variobase® abutments are indicated for use as an aid inprosthetic rehabilitations. The prosthetic restoration can be cementedon the Straumann® SC Variobase® prosthetic components. A temporaryrestoration can be used prior to the insertion of the final components tomaintain, stabilize and form the soft tissue during the healing phase.Final abutments and restorations may be placed into occlusion when theimplant is fully osseointegrated. All digitally designed copings and/orcrowns for use with the Straumann® Variobase® Abutment system areintended to be sent to Straumann for manufacture at a validated millingcenter.

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Equivalence Discussion about Indications for Use

Implants

The scope of the Indications for Use Statement for the subject Implants (K220251) are identical to the corresponding section of the Indications for Use Statement of the Facility Implant of primary predicate devices (K123022) and similar to the reference predicate devices (K162890).

	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
SUBJECT DEVICE	K123022	K162890
The Neodent Implant System isintended to be surgically placed inthe bone of the upper or lowerjaw to provide support forprosthetic devices, such asartificial teeth, to restore chewingfunction. It may be used withsingle stage or two-stageprocedures, for single- ormultiple-unit restorations, andmay be loaded immediately whengood primary stability is achievedand with appropriate occlusalloading. The Implant Narrow GMis indicated to replace upperlateral incisors, lower incisors orfor retainingoverdentureprostheses.	The Neodent Implant System isintended to be surgically placed inthe bone of the upper or lower jawto provide support for prostheticdevices, such as artificial teeth, torestore chewing function. It maybe used with single stage or two-stage procedures, for single- ormultiple-unit restorations, andmay be loaded immediately whengood primary stability is achievedand with appropriate occlusalloading.Titamax WS implant is indicatedfor a delayed loading protocol.The Facility implant is indicated toreplace upper lateral incisors,lower incisors or for retainingoverdenture prostheses.	Straumann® Bone Level Tapered Implants Ø2.9 mmare indicated for oral endosteal implantation in theupper and lower jaw and for the functional andaesthetic oral rehabilitation of patients with missingteeth. Straumann® Bone Level Tapered ImplantsØ2.9 mm can also be used for immediate or earlyimplantation following extraction or loss of naturalteeth. Implants can be placed with immediatefunction on single-tooth or multiple-toothapplications when good primary stability is achievedand with appropriate occlusal loading to restorechewing function. The prosthetic restorations areconnected to the implants through thecorresponding components (abutments). TheStraumann® Bone Level Tapered Implants Ø2.9 mmare indicated for reconstruction of missing incisorsin the lower jaw and lateral incisors in the upper jaw.

Conventional and Temporary Abutments

The indications for use of the Conventional Abutments is the same for the subject devices and primary predicate device (K123022). Regarding the Temporary Abutments, although the wording is slightly different, the indications for use are the same (K162890).

SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	K123022	K162890
Conventional Abutments:	Conventional Abutments:	Temporary Abutments:
The Neodent Implant System is intended to besurgically placed in the bone of the upper orlower jaw to provide support for prostheticdevices, such as artificial teeth, to restorechewing function. It may be used with single-stage or two-stage procedures, for single ormultiple unit restorations, and may be loadedimmediately when good primary stability isachieved and with appropriate occlusal loading.Temporary 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 loadedimmediatelywhen good primarystability is achieved and withappropriate occlusal loading.	Straumann® SC TemporaryAbutments are indicated for use asan aid in prosthetic rehabilitations.Temporary components can beused prior to the insertion of thefinal components to maintain,stabilize and shape the soft tissueduring the healing phase.Straumann® SC TemporaryAbutments have a maximumduration of usage of 180 days.
Prosthetic component to be installed in theNarrow GM Implant, providing support forprosthetic structures. Indicated for temporaryrestorations with unitary structures, screwed,on implants installed in the maxilla or mandible.Temporary Abutments Narrow GM have amaximum duration of usage of 180 days.

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Titanium Bases Abutments

The Indications for Use Statement for the subject device are equivalent to the corresponding section of the Indications for Use Statement of K203309 and K162890. Although the wording is slightly different, the Indications for the subject devices are included within the scope on Indications for the predicate devices.

SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	K203309	K162890
Titanium Base Abutment is atitanium base placed onto Neodentdental implants to provide supportfor customized prostheticrestorations as copings and crowns.It is indicated for cemented or screwmounted single-cementedapplications on implants installed onthe maxilla or mandible.All digitally designed copings and/orcrowns to be used with the TitaniumBase Abutment System are intendedto be sent to Straumann formanufacture at a validated millingcenter.	CF Titanium Base for Crown is a titaniumabutment placed onto dental implants toprovide support for customized prostheticrestorations, as copings or crowns. It isindicated for single-unit restorations,cement-retained or screw-retained inaesthetic areas on implants installed in themaxilla or mandible. All digitally designedcopings and/or crowns to be used with theTitanium Base Abutment System areintended to be sent to Straumann formanufacture at a validated millingcenter.	Straumann® SC Variobase®abutments are indicated for use as anaid in prosthetic rehabilitations. Theprosthetic restoration can becemented on the Straumann® SCVariobase® prosthetic components. Atemporary restoration can be usedprior to the insertion of the finalcomponents to maintain, stabilize andform the soft tissue during the healingphase. Final abutments andrestorations may be placed intoocclusion when the implant is fullyosseointegrated. All digitally designedcopings and/or crowns for use with theStraumann® Variobase® Abutmentsystem are intended to be sent toStraumann for manufacture at avalidated milling center.

A comparison of the technological characteristics of the subject device and the predicate and reference devices is provided in the following table.

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE	Equivalence Discussion
Implant-Abutmentinterface	K220251Neodent Implant System - Narrow ImplantSystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K123022Neodent Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K162890Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC HealingAbutments, SC Temporary Abutments, SCVariobase Abutments, SC CARES AbutmentsStraumann USA, LLC	SimilarAll the devices have Internal implant toabutment connection. The differencebetween the primary predicate and thesubject devices has been proven toincrease the system resistance (benchtestings).
Design	Grand Morse Internal Connection	Cone Morse Internal Connection	Straight implant with apical taper.	IdenticalSubject devices and Primary Predicatedevices present the same design andsurface treatment.
Reusable	Cylindrical format with double threads;cervical diameter equal to diameter ofimplant body;Surface: Neoporos and Acqua.	Cylindrical format with double threads;cervical diameter equal to diameter ofimplant body;Surface: Neoporos and Acqua.	No	IdenticalThe subject devices and the predicate devicesare indicated for single use.
Length (mm)	No	No	10; 12; 14	EquivalentRange of lengths for subject devices iscontained within the range of lengths forthe primary predicate devices and is thesame as of the reference predicate devices.
Diameter (Ø)(mm)	10; 12; 14	8; 10; 12; 14; 16	2.9	IdenticalAll the devices present the same diameter.
	2.9	2.9

Table 3. Technological Characteristic Comparison Table – Helix NGM Implants

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Neodent Implant System – GM Narrow Implant System

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	K220251Neodent Implant System - Narrow ImplantSystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K123022Neodent Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K162890Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC HealingAbutments, SC Temporary Abutments, SCVariobase Abutments, SC CARES AbutmentsStraumann USA, LLC	EquivalenceDiscussion
Material	Commercially Pure Titanium (Grade 4)	Commercially Pure Titanium (Grade 4)	Titanium-13 Zirconium alloy (Roxolid®)	IdenticalSubject devices and Primary Predicatedevices are manufactured of the same rawmaterial.
SterilizationMethod	Provided sterile via gamma irradiation toan SAL of 10-6.	Provided sterile via gamma irradiation to anSAL of 10-6.		IdenticalSubject devices and primary predicate devicesare provided sterile by the same sterilizationmethod.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE		Equivalence Discussion
	Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A..	K123022Neodent Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K162890Straumann Ø2.9 mm Bone LevelTapered Implants, SC Closure Cap, SCHealing Abutments, SC TemporaryAbutments, SC Variobase Abutments,SC CARES AbutmentsStraumann USA, LLC
NGM Exact ClickUniversalabutmentsdesign	Gingival height: 0,8; 1.5, 2.5, and 3.5	Gingival height: 1.5, 2.5, 3.5; 4.5 and 5.5		EquivalentRange of lengths for subjectdevices is very similar to theprimary predicate devices and isthe same as of the referencepredicate devices.
NGM Microabutmentsdesign	Gingival height: 0,8; 1.5, 2.5, and 3.5	Gingival height: 1.5, 2.5, 3.5 and 4.5		EquivalentRange of lengths for subjectdevices is very similar to theprimary predicate devices and isthe same as of the referencepredicate devices.
Healingabutmentsdesign	Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5	Gingival height: 1.5, 2.5, 3.5 and 4.5		EquivalentRange of lengths for subjectdevices is very similar to theprimary predicate devices and isthe same as of the referencepredicate devices.
Temporaryabutmentsdesign	Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5		Gingival height: 1.0, 2.0, and 3.0mm	EquivalentRange of lengths for subjectdevices is very similar to theprimary predicate devices and isthe same as of the referencepredicate devices. The differencebetween the reference predicateand the subject devices has beenmitigated during performance
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE		EquivalenceDiscussion
	Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A..	K123022Neodent Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K162890Straumann Ø2.9 mm Bone LevelTapered Implants, SC Closure Cap, SCHealing Abutments, SC TemporaryAbutments, SC Variobase Abutments,SC CARES AbutmentsStraumann USA, LLC
				bench tests.
AttachmentsNarrow GMdesign	Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5Surface Treatment: NiT Coating	Gingival height: 1.5, 2.5, 3.5 and 4.5Surface Treatment: NiT Coating		EquivalentRange of lengths for subjectdevices is very similar to theprimary predicate devices and isthe same as of the referencepredicate devices.Both subject and predicatedevices present the same surfacetreatment.
Reusable	No	No	No	IdenticalThe subject devices and predicatesdevices are indicated for single use.
Material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Ti-6Al-7Nb	IdenticalThe subject devices andpredicates devices aremanufactured of the same rawmaterial.
SterilizationMethod	Provided sterile via Ethylene Oxide to an SAL of$10^{-6}$ .	Provided sterile via Ethylene Oxide to an SAL of $10^{-6}$ .	Provided sterile via EthyleneOxide to an SAL of $10^{-6}$ .	IdenticalThe subject devices and the primarypredicate devices are provided insterile condition to an SAL of 1 x $10^{-6}$by the same sterilization method.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE	EQUIVALENCE DISCUSSION
	Neodent Implant System - Narrow ImplantSystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K203309NUVO CF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K162890Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC HealingAbutments, SC Temporary Abutments, SCVariobase Abutments, SC CARES AbutmentsStraumann USA, LLC
Implant-Abutmentinterface	Grand Morse Internal Connection	Internal Hex	Small CrossFit® (SC)	EquivalentSubject devices and Primary Predicate devicespresent internal connection implant-abutmentinterface.
Design	Angulation: 0Gingival Height: 0.8; 1.5; 2.5; 3.5 and 4.5Cementable portion height: 4.0 and 6.0	Angulation: 0Gingival Height: 0.5, 1.0 and 3.0 mmCementable portion height: 6.0	Angulation: 0Gingival Height: 1.0, 2.0 and 3.0 mm	EquivalentAll the devices are straight, the gingivalheight of the subject devices is similar to therange of gingival height of the predicatedevices and bench tests were performed toverify the strength of the system.
Reusable	No	No	No	IdenticalThe subject devices and the predicate devicesare intended for single use.
Material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Ti-6Al-7Nb	IdenticalThe subject devices have the same material ofconstruction as the primary predicate devices.

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Neodent Implant System – GM Narrow Implant System

Table 4. Technological Characteristic Comparison Table – Conventional and Temporary Abutments

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Neodent Implant System – GM Narrow Implant System

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Neodent Implant System – GM Narrow Implant System

Table 5. Technological Characteristic Comparison Table – CAD/CAM Abutments (Titanium Bases)

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Neodent Implant System – GM Narrow Implant System

	SUBJECT DEVICE		PRIMARY PREDICATE DEVICE		REFERENCE PREDICATE DEVICE			EQUIVALENCE DISCUSSION
	Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.		K203309NUVO CF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.		K162890Straumann Ø2.9 mm Bone Level TaperedImplants, SC Closure Cap, SC HealingAbutments, SC Temporary Abutments, SCVariobase Abutments, SC CARES AbutmentsStraumann USA, LLC
Top Half Materials	Material	Minimum thickness (mm)	Maximum allowable angulation	Material	Minimum thickness (mm)	Maximum allowable angulation	Material	Minimum thickness (mm)	Maximum allowable angulation
	Coron (CoCr)	0.3	30°	Coron (CoCr)	0.3	30°	Coron (CoCr)	0.3	30°	SameThe subject top half materials are the samethe cleared top half materials for the primarypredicate device and using the same cleareddesign parameters.
	IPS e.max CAD	0.9		IPS e.max CAD	0.9		IPS e.max CAD	0.9
	Zerion LT	0.5		Zerion LT	0.5		Zerion LT	0.4
	Polycon ae*	1.0		Polycon ae*	1.0		Polycon ae*	0.5
	The Narrow GM Titanium Base with cementable area height of 6 mm allows customization. In case of customization, it is indicated to maintain the minimum height of 4 mm of cementable area.			The CF Titanium Base for Crown with 6 mm Incementable height are supplied without angulation, but allow customization by reducing the height of cementable area to 4 mm.			*Polycon ae is indicated to remain in the mouth only for up to 180 days
	*Polycon ae is indicated to remain in the mouth only for up to 180 days.			*Polycon ae is indicated to remain in the mouth only for up to 180 days
Sterilization Method	Provided sterile via Ethylene Oxide to an SAL of 1x10-6If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 132°C (270°F) for 3 minutes exposure.			Provided sterile via Ethylene Oxide to an SAL of 1x10-6If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 132°C (270°F) for 3 minutes exposure.			Delivered not sterile. If customized on the chairside, must be sterilized before the installation via moist heat (steam), Gravity displacement or dynamic air removal in 132°C (270°F) for 4 minutes exposure.			IdenticalThe subject devices have the same sterilization methods and same SAL as the primary predicate devices.

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

Subject and predicate implants have the similar implant-to-abutment interface. Both present the same surfaces and same sterile barrier system. The subject implants are manufactured of the same materials and are sterilized using the same sterilization method as the primary predicate devices. Subject and reference predicate devices present the same range of sizes and similar overall design.

The subject conventional abutments have the same indications for use and same overall design as the primary predicate devices. They also present the same sterilization method and raw materials.

The subject Base abutments have the same indications for use, same maximum angulation and same gingival height as the primary predicate devices and primary predicate devices, present the same sterilization method. The subject bases are made of the same material as the primary predicate devices and are indicated to be used with the same restoration materials of the predicate devices. All digitally designed copings and/or crowns for use with the subject Titanium Bases are intended to be sent to Straumann for manufacture at a validated milling center.

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.

Sterilization validation

The subject implants are sterilized by Gamma Irradiation, according to ISO 11137-1 and ISO 11137-2, and the subject abutments by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. The method achieved a Sterility Assurance Level of 1x10 °.

The Subject devices are not represented to be "pyrogen free".

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CONCLUSION

The subject devices and the predicate 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.