Predicate Devices

Reference Devices

K200586, K123022, K202942, K203309, K220251, K182620

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental implant system and its components, focusing on materials, dimensions, surface treatments, and mechanical/biocompatibility testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

No
The device, a dental implant system, aims to restore chewing function and support prosthetic devices, which are restorative rather than therapeutic functions.

Diagnostic

No

Explanation: The provided text describes dental implants and their associated prosthetic components, used for restoring chewing function by providing support for artificial teeth. There is no mention of the device being used to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description and intended use clearly describe physical implants and abutments made of titanium and titanium alloy, intended for surgical placement. There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The descriptions and intended uses clearly state that these devices are surgically implanted into the jawbone to support prosthetic teeth and restore chewing function. They are physical implants and components used in vivo (within the body), not for testing samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD.

Therefore, the Neodent Implant System and its components described are medical devices, but they do not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use for Helix Short Implant:

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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 Mini Straight, Angled Abutment and screws:

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 Helix Short Attachment:

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.

Indications for Use for Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The Cover Screw takes place in the conical region of the implant interface.

Indications for Use for Temporary Abutment for Helix Short Implant

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. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

Product codes

DZE, NHA

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 1x10-9;
. The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
. The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
. 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.
The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxilla or mandible bones, upper or lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. Torsion Test was performed to evaluate Helix Short Implant under static torsional loading. The results met the acceptance criteria. Insertion test was performed to evaluate the insertion torque of the Helix Short System when it is inserted in bones type I, II, IIII and IV. The Implant Surface Area simulation and Pull Out Test were also made to evaluate and represent the clinical use of the subject implants. Results demonstrated that the subject devices, despite having a slightly smaller surface area than the reference devices, presented a higher BIC rate and pull out resistance upon placement. Thus, the subject devices exhibit a level of benchtop performance equivalent to that reviewed for the reference device.

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 reference 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 reference devices.

Surface treatment: The surface treatments applied to subject devices are identical to these applied and previously evaluated for primary predicate devices. Although some reference devices have a surface with different nomenclature, the chemical processes applied to the surface are similar to create the roughness surface. Acqua implants are submitted to an additional step in order to increase their hydrophilicity, as already cleared for primary predicate device.

Sterilization validation: Sterilization of the subject implants via gamma irradiation according to ISO 11137-1 Sterilization of health care products -Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -Radiation -Part 2: Establishing the sterilization dose. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.
Sterilization of the subject 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 10-6 has been validated.

Endotoxin testing (LAL): The LAL Endotoxin Analysis is the method used to determine that the device meets pyrogen limit specifications, based in the referred FDA guidance (510(k) Submission for Devices Labeled as Sterile, issued on 21 January 2016). Routine endotoxin testing is performed with representative devices as an assessment of environmentally derived pyrogenicity. Subject devices meet the acceptance criteria for endotoxin levels as well as the primary predicate and reference devices. The subject devices are not represented to be "pyrogen free".

Shelf Life validation: The expiration date of the products was determined considering the integrity of the product and the packaging tests after shelf life testing. The packaging of the subject Helix Short Implant System is identical to the packaging of the primary predicate and reference devices. The shelf life for devices provided sterile is 5 years, except Helix Short Acqua Implants that have a shelf life of 4 years.

Biocompatibility: Representative samples of each of the subject devices was subjected to the following: Cytotoxicity testing was performed per ISO 10993-5. Chemical characterization was performed per ISO 10993-18. Biocompatibility sample preparation was performed per ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1. EO Residuals evaluation was performed in accordance with 10993-7. No new issues of biocompatibility are raised for the subject devices when compared to primary predicate and reference devices. Therefore, no additional biocompatibility testing was required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K163194

Reference Device(s)

K200586, K123022, K202942, K203309, K220251, K182620

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K223638

Trade/Device Name: Neodent Implant System - Helix Short Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 17, 2023 Received: May 25, 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.

1

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

2

Indications for Use

510(k) Number (if known) K223638

Device Name

Neodent Implant System - Helix Short Implant System

Indications for Use (Describe)

Indications for Use for Helix Short Implant:

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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 Mini Straight, Angled Abutment and screws:

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 Helix Short Attachment:

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.

Indications for Use for Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The Cover Screw takes place in the conical region of the implant interface.

Indications for Use for Temporary Abutment for Helix Short Implant

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. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

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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, 3291
Curitiba, Paraná, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MS
Director of Regulatory Affairs,
Straumann USA
E-mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509
Date Prepared	22/June/2023
Preparer / Alternate Contact	Bárbara Uzae
Regulatory Affairs Analyst
E-mail: barbara.uzae@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name
Common Name	Neodent Implant System – Helix Short Implant System
Endosseous dental implant
Classification Name	Endosseous dental implant
Classification Regulations
Product Code	21 CFR 872.3640, Class II / 21 CFR 872.3630, Class II
DZE/NHA
Classification Panel
Reviewing Branch	Dental Products Panel
Dental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K163194, Neodent Implant System - GM Line, JJGC
Indústria e Comércio de Materiais Dentários S.A
Reference Devices	K200586 - Straumann TLX Implant System, Institut
Straumann AG
K123022 - Neodent Implant System, JJGC Indústria e
Comércio de Materiais Dentários S.A

510(k) Summary

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K202942 - Straumann® 4 mm Short Implants, Straumann USA, LLC

K203309 – NUVO CF Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

K220251 - Neodent Implant System - Narrow Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

INDICATIONS FOR USE

Indications for Use for Helix Short Implant:

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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 Mini Straight, Angled Abutment and screws:

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 Helix Short Attachment:

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 Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

6

Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The seating of the Cover Screw takes place in the conical region of the implant interface.

Indications for Use for Temporary Abutment for Helix Short Implant

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. Temporary Abutments are indicated to be installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium Base is a titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cementretained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

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 1x10-9;
. The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
. The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
. 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.
The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.

7

The various materials that can be used to create top halves for titanium bases and cements were already evaluated and cleared by FDA. Please find below a table with all clearance information for these materials:

Material	Raw material	510(k) of the material
Ticon	Titanium	Exempt according to CFR
872.3710 (subpart E): Dental Base
Metal Alloys.
Coron	CoCr alloy
Zerion LT	Zirconia	K061804
IPS e.max	Lithium Dissilicate	K132209
Polycon ae	PMMA	K071548
Panavia-Kuraray cement	Chemically-active resin	K183537
Ivoclar Multilink cement	Lithium Dissilicate	K130436

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

Table 1 - Technological Characteristic Comparison Table – Helix Short Implants

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix
Short Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K163194
Neodent Implant System - GM
Line
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K200586
Straumann TLX Implant System
Institut Straumann AG	K123022
Neodent Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K202942
Straumann® 4 mm Short
Implants
Straumann USA, LLC	Equivalence
Discussion
Indications for
Use	The Neodent Implant
System is recommended
for surgical procedures on
maxilla or mandible bones.
It provides support for
prosthetic components
such as artificial teeth, thus
restoring the chewing
function. It may be used
with single-stage or two-
stage procedures, for
single or multiple unit
restorations, and may be
loaded immediately when
good primary stability is
achieved and with
appropriate occlusal
loading.	The Neodent Implant System
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.	Straumann TLX Implants are
suitable for endosteal
implantation in the upper and
lower jaws and for the
functional and esthetic oral
rehabilitation of edentulous
and partially edentulous
patients. TLX Implants can be
placed with immediate
function on single-tooth and
multiunit restorations when
good primary stability is
achieved and with appropriate
occlusal loading to restore
chewing function. The
prosthetic restorations are
connected to the implants
through the corresponding
abutment components.			Equivalent
Although the
language is slightly
different, the
indications for use
of the subject
devices is the same
as the primary
predicate device
(K163194) and
equivalent to the
indications for use
of reference
predicate device
(K200586). The
subject and
predicate devices
are 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.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix
Short Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K163194
Neodent Implant System – GM
Line
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K200586
Straumann TLX Implant System
Institut Straumann AG	K123022
Neodent Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K202942
Straumann® 4 mm Short
Implants
Straumann USA, LLC	Equivalence
Discussion
Implant-
Abutment
interface	Internal Hex	Morse taper	TorcFit (with conical fitting)	Morse taper	Internal octagon	Equivalent
The subject and
predicate devices
have internal
implant to
abutment
connection.
Design	Cylindrical body
Tissue level	Conical body (Helix)
Bone level	Tapered body
Tissue level	Cylindrical body
Bone level	Cylindrical body
Tissue level	Identical
Cylindrical shape and
tissue level as the
reference devices.
Reusable	No	No	No	No	No	Identical
The subject
devices and the
predicate devices
are indicated for
single use.
Length (mm)	4.0 / 5.5 / 7.0 / 8.5	8 / 10 / 11.5 / 13 / 16 / 18
(GM Helix)	6.0 / 8.0 / 10 / 12 / 14 / 16 / 18	- 5.0 / 6.0 (WS)	4.0	Equivalent
Subject implant
lengths are within
the range of the
predicate devices.
Collar length
(mm)	1.8	N/A	1.8	N/A	1.8	Identical
Subject implant and
reference devices with
tissue level have a
collar neck of 1.8mm.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix
Short Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K163194
Neodent Implant System – GM
Line
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K200586
Straumann TLX Implant System
Institut Straumann AG	K123022
Neodent Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K202942
Straumann® 4 mm Short
Implants
Straumann USA, LLC	Equivalence
Discussion
Diameter (Ø)
(mm)	3.75 / 4.0 / 5.0 / 6.0 / 7.0	3.5 / 3.75 / 4.0 / 4.3 / 5.0
(GM Helix)	3.75 / 4.0 / 4.5 / 5.0 / 5.5 / 6.5	4.0 / 5.0 / 6.0 (WS)	4.1 / 4.8	Equivalent
Subject device
diameters are
within the range of
diameters of the
predicates devices
or larger (Ø 7.0).
Larger diameters
do not represent a
worst case in
terms of
performance.
Material	Commercially pure
Titanium grade 4 (ASTM
F67)	Commercially pure Titanium
grade 4 (ASTM F67)	Titanium-13 Zirconium alloy	Commercially pure titanium
grade 4 (ASTM F67)	Titanium-13 Zirconium
alloy	Identical
Identical to the
primary predicate
device and the
Neodent reference
devices (K123022)
Sterilization
Method	Gamma irradiation to an
SAL of 1x10-6	Gamma irradiation to an SAL of
1x10-6	Gamma irradiation to an SAL of
1×10-6	Gamma irradiation to an SAL of
1×10-6	Gamma irradiation to an SAL
of 1x10-6	Identical
Subject
devices
and
predicate
devices
are
provided sterile by
the
same
sterilization
method.
Surface
treatment	NeoPoros
Acqua	Neoporos
Acqua	SLActive®	NeoPoros	SLActive®	Identical
Identical
to the
primary
predicate
device.

9

10

11

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix Short
Implants System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A	K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	Equivalence
Discussion
Indications for Use	Mini Straight and Angled Abutment:
The Neodent Implant System is
recommended for surgical procedures
on maxilla or mandible bones. It
provides support for
prosthetic
components such as artificial teeth,
thus restoring the chewing function. It
may be used in one- or two-stage
procedures, multiple restorations, as
well as immediate loading when there
is good primary stability and adequate
occlusal load. Multiple rehabilitations
may be splinted rigidly.	GM Mini Conical and GM Exact Mini
Conical 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.	Multi-Unit Screw Retained Abutment
CF (Straight/Angled):
The Implant System is intended to be
surgically placed in the maxilla or
mandible to provide support for
prosthetic devices such as artificial
teeth in order 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.
Multiple tooth applications may be
rigidly splinted.	Equivalent
Although the
language is slightly
different, the indications for use of the
subject devices is included into the
indications of the predicate devices. The
subject and predicate device 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.
Abutment Design	Surface:
Machined
with
pink
electrolysis
Mini Straight Abutment:
Gingival height: 0.2, 1.5, 2.5, 3.5, 4.5
Mini angled abutment:
Gingival height: 0.6, 1.5, 2.5, 3.5
Angulation: 17°	Surface: Machined
GM Mini Conical Abutments:
Gingival height: 0.8; 1.5, 2.5, 3.5, 4.5,
5.5
GM Exact Mini Conical Abutments:
Gingival height: 1.5, 2.5, 3.5
Angulation: 17° and 30°	Surface: Machined and electrolysis
Straight Abutment:
Gingival height: 1.0, 2.0, 3.0, 4.0 and 5.0
mm;
Angled Abutment:
Gingival height: 2.0 and 3.0 mm
Angulation: 17° and 30°	Equivalent
The subject device have the same surface of
reference predicate device and similar
geometry and range of dimensions and
angulation of primary predicate device.
Single Use	Yes	Yes	Yes	Identical
The subject devices and predicates
devices are indicated for single use.

Table 2 - Technological Characteristic Comparison Table – Mini Abutments

JJGC Indústria e Comércio de Materiais Dentários S.A.

12

K223638 - Neodent Implant System – Helix Short Implant System

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix Short
Implants System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A	K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	Equivalence
Discussion
Raw material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Identical
The subject devices and predicates
devices are manufactured of the same
raw material.
Sterilization
Method	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 Ethylene Oxide to an
SAL of 10-6	Identical
The subject devices and the primary
predicate devices are provided in sterile
condition to an SAL of 1 x 10-6 by the same
sterilization method.

Table 3 - Technological Characteristic Comparison Table – Attachments

	SUBJECT DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix Short Implants
System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K220251
Neodent Implant System - Narrow Implant System
JJGC Indústria e Comércio de Materiais Dentários
S.A	Equivalence
Discussion
Indications for Use	Helix Short Attachment:
The Neodent Implant System is
recommended for surgical procedures on
maxilla or mandible bones. It provides
support for prosthetic components such as
artificial teeth, thus restoring the chewing
function. It may be used in one- or two-stage
procedures, multiple unit restorations, as
well as immediate loading when there is
primary stability and adequate occlusal load.	NGM Attachments
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.	Equivalent
Although the language is slightly different, the indications
for use of the subject devices is the same of the indications
of the predicate devices. The subject and predicate device
are 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.

JJGC Indústria e Comércio de Materiais Dentários S.A.

13

	SUBJECT DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix Short Implants
System
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K220251
Neodent Implant System - Narrow Implant System
JJGC Indústria e Comércio de Materiais Dentários
S.A	Equivalence
Discussion
Abutment Design	HS Attachments:
Gingival height: 0.2, 1.5, 2.5, 3.5
Surface Treatment: TiN Coating	NGM Attachments:
Gingival height: 0.8; 1.5, 2.5, 3.5 and 4.5
Surface Treatment: TiN Coating	Equivalent
The subject devices and predicates devices have the same
surface treatment and similar geometry and range of
dimensions.
Single Use	Yes	Yes	Identical
The subject devices and predicates devices are indicated for
single use.
Raw material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Identical
The subject devices and predicates devices are
manufactured of the same raw material.
Sterilization Method	Provided sterile via Ethylene Oxide to an
SAL of 10-6.	Provided sterile via Ethylene Oxide to an SAL of
10-6	Identical
The subject devices and the primary predicate devices are
provided in sterile condition to an SAL of 1 x 10 -6 by the
same sterilization method.

14

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix
Short Implants System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A	K203309
NUVO CF Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	Equivalence
Discussion
Indications for Use	Helix Short Healing Abutment
and Cover Screw:
This product is used for the
maintenance of soft tissue,
during the bone integration stage
of Neodent implants to be
rehabilitated with the late
loading technique.

The Healing Abutment may be
used in the implant installation
surgery or the reopening surgery
(second surgical stage).

The Cover Screw must remain
intragingival, preventing the
growth of tissue over the implant
platform. The seating of the
Cover Screw takes place in the
conical region of the implant
interface. | GM Healing abutment and Cover
Screw:
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. | NUVO CF Healing Abutments and
Cover Screws:
The Implant System is intended to
be surgically placed in the maxilla
or mandible to provide support
for prosthetic devices such as
artificial teeth in order 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.
Multiple tooth applications may
be rigidly splinted. | Equivalent
Although the language is
different, the indications for use
of the subject devices are the
same of predicate devices. The
subject and the predicate devices
are used to the maintenance of
soft tissue, during the bone
integration stage of implants to
be rehabilitated with the late
loading technique. The
indications for use are written
differently because those for the
predicate devices are talking
about the implant system as a
whole and not the healing
abutment and cover screws
specifically. |

Table 4 - Technological Characteristic Comparison Table – Healing Abutment and Cover Screw

15

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix
Short Implants System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de
Materiais Dentários S.A	K203309
NUVO CF Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	Equivalence
Discussion
Abutment Design	Surface: Machined with pink
electrolysis.
HS Healing Abutment:
Gingival height: 1.5, 2.5, 3.5, 4.5,
5.5
Cover Screw:
0.35 mm height above the implant
platform level	Surface: Machined
GM Healing abutment:
Gingival height: 0.8, 1.5, 2.5, 3.5, 4.5,
5.5
Cover Screw:
Gingival height: at the bone level,
or with a height of 2 mm	Surface: Machined with pink
electrolysis.
NUVO CF Healing Abutments and
Cover Screws:
Gingival height: 1.0, 2.0, 3.0, 4.0 and
5.0
Cover Screw: 0.3, 2. 0 mm	Equivalent
The subject devices and the
reference predicate devices have
the same surface treatment. The
subject and predicate devices have
similar geometry and dimensions.
Single Use	Yes	Yes	Yes	Identical
The
subject
devices
and
predicates devices are indicated
for single use.
Raw material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Identical
The subject devices and predicate
devices are manufactured of the
same raw material.
Sterilization
Method	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 Ethylene
Oxide to an SAL of 10-6.	Identical
The subject devices and the
predicate devices are provided in
sterile condition to an SAL of 1 x 10-6
by the same sterilization
method.

16

| | SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | Equivalence
Discussion |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Helix Short Implants System
JJGC Indústria e Comércio de Materiais Dentários S.A. | K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários
S.A. | K220251
Neodent Implant System - Narrow Implant System
JJGC Indústria e Comércio de Materiais Dentários
S.A | |
| Indications for
Use | Temporary Abutment:
The Implant System is indicated for surgical
procedures on maxilla or mandible bones, providing
support for dental prostheses with the purpose of
restoring the chewing function as well as aesthetics.
It may be used in one- or two-stage procedures, single
or multiple restorations, and immediate loading
when there is good primary stability and adequate
occlusal load. Temporary Abutments are indicated to
be installed over Helix Short Implants and to provide
support for prosthetic structures for up to 6 months. | Temporary Abutments:
The Implant System is intended to be surgically
placed in the maxilla or mandible to provide
support for prosthetic devices such as artificial
teeth in order 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. Multiple
tooth applications may be rigidly splinted. | 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. | Equivalent
Although the language is
slightly different, the
indications for use of the
subject devices is included into
the indications of the
predicate devices. The subject
and predicate devices are
intended to be surgically
placed in the maxilla or
mandible to provide support
for prosthetic devices such as
artificial teeth in order to
restore chewing function. It
may be used in one- or two-
stage procedures, single or
multiple restorations, and
immediate loading when there
is good primary stability and
adequate occlusal load. All are
indicated to be used for up to
6 months. |
| Abutment
Design | Temporary Abutments:
Gingival height: 0.2; 1.5; 2.5; 3.5
Surface: Machined with pink electrolysis. | Temporary Abutments:
Gingival height: 0.5, 1.0 and 3.0 mm
Surface: Machined with pink electrolysis. | Temporary Abutments:
Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5
Surface: Machined | Equivalent
The subject devices and the
primary predicate devices have
the same surface treatment. The
subject and predicate devices
have similar geometry and
dimensions. |

Table 5 - Technological Characteristic Comparison Table – Temporary Abutments

JJGC Indústria e Comércio de Materiais Dentários S.A.

17

| | SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | Equivalence
Discussion |
|-------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System - Helix Short Implants System
JJGC Indústria e Comércio de Materiais Dentários S.A. | K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A. | K220251
Neodent Implant System - Narrow Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A | |
| Single Use | Yes | Yes | Yes | Identical
The subject devices and
predicates devices are
indicated for single use. |
| Raw material | Titanium alloy ASTM F136. | Titanium alloy ASTM F136. | Titanium alloy ASTM F136. | Identical
The subject devices and
predicates devices are
manufactured of the same raw
material. |
| Sterilization
Method | 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 Ethylene Oxide to an SAL
of 10-6 | Identical
The subject devices and the
primary predicate devices are
provided in sterile condition to
an SAL of 1 x 10 -6 by the same
sterilization method. |

18

	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE DEVICE
COMPARISON	Subject
Neodent Implant System - Titanium Bases for
Helix Short Implant Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais Dentários
S.A.	K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários
S.A.	EQUIVALENCE DISCUSSION
Indications for Use	The Helix Short Implant Titanium Base is a
titanium base that is placed over Neodent
dental implants to provide support for
customized prosthetic restorations, such as
copings and crowns. It is indicated for
single- and multiple-structure restorations,
screw- or cement-retained on implants
installed in the maxilla or mandible. All
digitally-designed copings and/or crowns to
be used with the Neodent Titanium Base
System must be sent to Straumann for
manufacture at a validated milling center.	Titanium Base Abutment is a titanium base
placed onto Neodent dental implants to
provide support for customized prosthetic
restorations. It is used with a coping and
crown, or crown alone, and is indicated for
cement- or screw-retained single or multi-unit
restorations single. All digitally designed
copings and/or crowns to be used with the
Neodent Titanium Base Abutment System are
intended to be sent to Straumann for
manufacture at a validated milling center. The
GM Titanium Base for Bridge is indicated for
cement or screw-retained
multi-unit
restorations.	Titanium Base for Bridge:
CF Titanium Base for Bridge is a titanium
abutment placed onto dental implants to
provide support for customized prosthetic
restorations. The CF Titanium Base for Bridge
is indicated for cement or screw-retained
multi-unit restorations. 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.
Titanium Base for Crown:
CF Titanium Base for Crown is a titanium
abutment placed onto dental implants to
provide support for customized prosthetic
restorations, as copings or crowns. It is
indicated for single-unit restorations, cement-
retained or screw-retained in aesthetic areas
on implants installed in 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.	Equivalent
Although the language is
slightly different, the
indications for use of the
subject and predicate devices
are the same. The subject and
predicate devices are
intended to place onto dental
implants to provide support
for customized prosthetic
restorations, such as copings
and crowns.

Table 6 - Technological Characteristic Comparison Table – Helix Short Titanium Bases

19

		SUBJECT DEVICES		PRIMARY PREDICATE			REFERENCE DEVICE
COMPARISON	Subject
Neodent Implant System – Titanium Bases for
Helix Short Implant Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.			K163194
Neodent Implant System - GM Line
JJGC Indústria e Comércio de Materiais Dentários
S.A.		K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários
S.A.			EQUIVALENCE DISCUSSION
Abutment Design	Cylindrical format provided in different
gingival heights.
Angulation: 0°
Gingival Heights: 0.2; 1.5, 2.5 and 3.5 mm
Surface: Machined and Electrolysis
Cementable portion height: 6.0 and 4.5
mm			Cylindrical format provided in different
gingival heights.
Angulation: 0°
Gingival Heights: 0.8; 1.5; 2.5; 3.5; 4.5 mm
Surface: Machined
Cementable portion height: 6.0 and 4.0		Conical format provided in different gingival
heights.
Angulation: 0°
Gingival Heights: 0.5; 1.0; 3 mm
Surface: Machined and Electrolysis
Cementable portion height: 6.0 and 4.5 mm			Equivalent
The subject devices and the
reference predicate devices
share the same surface finish,
similar geometry and range
of dimensions.
Single Use	Yes			Yes		Yes			Identical
Subject and predicate devices
are not reusable.
Raw material	Titanium Alloy (Ti-6Al-4V) – according to
ASTM F136.			Titanium Alloy (Ti-6Al-4V) – according to
ASTM F136.		Titanium Alloy (Ti-6Al-4V) – according to ASTM
F136.			Identical
The subject and predicate
devices are manufactured of
the same raw material.
Top Half Materials	Material	Minimum
thickness	Maximum
allowable
angulation	Material	Minimum
thickness	Maximum
allowable
angulation	Material	Minimum
thickness	Maximum
allowable
angulation	Equivalent
The top half materials of the
subject devices are contained
within the scope of the top
half materials of the
predicate device. The
maximum allowable
angulation of subject device
is smaller than the maximum
angulation of the predicate
devices, therefore it is less
critical.
	Coron
(CoCr)	0.3		Coron (CoCr)	0.3		Coron (CoCr)	0.3
	Ticon
(Titanium)	0.4	16°	Ticon (Titanium)	0.4
	IPS e.max	0.9		Zerion LT	0.5	30°	Zerion LT	0.5
	Zerion LT	0.5		IPS e.max CAD	0.9		IPS e.max CAD	0.9	30°
	Polycon
ae*(PMMA)	1.0		3M ESPE Lava
Plus Zirconia	0.7		Polycon
ae*(PMMA)	1.0
	* Polycon ae material is only recommended
for temporary/provisional prosthetic
restorations.			Polycon
ae*(PMMA)	1.0			*Polycon ae is indicated to remain in the mouth
only for up to 180 days.

20

	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
COMPARISON	Subject
Neodent Implant System – Titanium Bases for
Helix Short Implant Line
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K163194
Neodent Implant System – GM Line
JJGC Indústria e Comércio de Materiais Dentários
S.A.	K203309
NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários
S.A.
Sterilization Method	• Provided sterile via Ethylene Oxide
to an SAL of 1x10-6

The final prosthesis must be sterilized by the
end used before installation in the mouth
via moist heat (steam), gravity displacement
or dynamic air removal in 132°C (270°F) for
3 minute exposure. | • Provided sterile via Ethylene Oxide to
an SAL of 1x10-6

To be sterilized by user after superstructure
cementation, before placed in patient mouth
(moist steam sterilization). | • Provided sterile via Ethylene Oxide to
an SAL of 1x10-6

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 3 minute exposure. | Identical
The subject devices and
predicate devices share the
same sterilization method. |

21

The subject implants have equivalent indications for use and 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, are manufactured of the same materials and are sterilized using the same sterilization method. Subject and reference predicate devices present the same range of sizes and similar overall design.

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

The subject Base abutments have the equivalent indications for use and same sterilization method as the primary predicate devices. Both, subject and primary predicate devices, are made of the same material. The top half materials of the subject devices are contained within the scope of the top half materials of the predicate devices and 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 as the predicate devices. The subject devices and the reference predicate devices share the same surface finish, similar geometry and range of dimensions.

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

· same intended use,
· same operating principle,
· incorporate the equivalent basic design,
incorporate the same materials, and
are sterilized using the same materials and processes

PERFORMANCE DATA

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.

Torsion Test was performed to evaluate Helix Short Implant under static torsional loading. The results met the acceptance criteria. Insertion test was performed to evaluate the insertion torque of the Helix Short System when it is inserted in bones type I, II, IIII and IV.

The Implant Surface Area simulation and Pull Out Test were also made to evaluate and represent the clinical use of the subject implants. Results demonstrated that the subject devices, despite having a slightly smaller surface area than the reference devices, presented a higher BIC rate and pull out resistance upon placement. Thus, the subject devices exhibit a level of benchtop performance equivalent to that reviewed for the reference device.

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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 reference 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 reference devices.

Surface treatment

The surface treatments applied to subject devices are identical to these applied and previously evaluated for primary predicate devices. Although some reference devices have a surface with different nomenclature, the chemical processes applied to the surface are similar to create the roughness surface. Acqua implants are submitted to an additional step in order to increase their hydrophilicity, as already cleared for primary predicate device.

Sterilization validation

Sterilization of the subject implants via gamma irradiation according to ISO 11137-1 Sterilization of health care products -Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -Radiation -Part 2: Establishing the sterilization dose. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

Sterilization of the subject 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 10-6 has been validated.

Endotoxin testing (LAL)

The LAL Endotoxin Analysis is the method used to determine that the device meets pyrogen limit specifications, based in the referred FDA guidance (510(k) Submission for Devices Labeled as Sterile, issued on 21 January 2016). Routine endotoxin testing is performed with representative devices as an assessment of environmentally derived pyrogenicity. Subject devices meet the acceptance criteria for endotoxin levels as well as the primary predicate and reference devices. The subject devices are not represented to be "pyrogen free".

Shelf Life validation

The expiration date of the products was determined considering the integrity of the product and the packaging tests after shelf life testing. The packaging of the subject Helix Short Implant System is identical to the packaging of the primary predicate and reference devices. The shelf life for devices provided sterile is 5 years, except Helix Short Acqua Implants that have a shelf life of 4 years.

Biocompatibility

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

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Cytotoxicity testing was performed per ISO 10993-5. Chemical characterization was performed per ISO 10993-18.

Biocompatibility sample preparation was performed per ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1.

EO Residuals evaluation was performed in accordance with 10993-7.

No new issues of biocompatibility are raised for the subject devices when compared to primary predicate and reference devices. Therefore, no additional biocompatibility testing was required.

CONCLUSION

The data included in this submission demonstrate that the subject system is substantially equivalent to the primary predicate and reference devices in terms of intended use, design, technological characteristics, mechanical properties, shelf life, sterilization method and material.