Predicate Devices

Reference Devices

K150367, K132881, K153624, K180477, K182620, K192893

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant system and its components, focusing on materials, mechanical properties, and sterilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No

The device is intended to provide support for prosthetic devices to restore chewing function, which is a structural and functional restoration, not a therapeutic treatment.

Diagnostic

No
The device is described as an implant system for supporting prosthetic devices to restore chewing function, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of materials like Y-TZP and titanium alloy, and mentions sterilization and mechanical testing, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is surgically placed in the bone to support prosthetic devices for restoring chewing function. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description details the materials, design, and sterilization of a physical implant and its components. It does not describe any reagents, instruments, or systems intended for use in vitro.
Performance Studies: The performance studies focus on biocompatibility, mechanical testing, sterilization validation, MRI testing, and shelf life – all relevant to a surgical implant, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for Zirconia Bases:

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

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the 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)

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.
The wear assessment of the Titanium/Ceramic contacting pieces was done before and after the fatigue test. The data produced concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection.
Torsion Test was performed to evaluate the Zirconia Implant System under static torsional loading. Insertion test was performed to evaluate the insertion torque of the Zirconia Implant System when inserted into sawbones material representing bone type I, II, III and IV.

Sterilization validation

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

MRI Testing

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

Shelf Life

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

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K101945

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K150367, K132881, K153624, K180477, K182620, K192893

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K201491

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

Dear Jennifer Jackson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201491

Device Name

Neodent Implant System - Zirconia Implant System

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

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Indications for Use

510(k) Number (if known) K201491

Device Name

Neodent Implant System - Zirconia Implant System

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

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
X

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

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

4

510(k) Summary

ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA
(dba Neodent)
Av. Juscelino Kubitschek de Oliveira, 3291
Curitiba, Parana, 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 | 21/December/2020 |
| Preparer / Alternate Contact | Mariana Soares Hartmann
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: mariana.hartmann@neodent.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | Neodent Implant System – Zirconia Implant System |
| Common Name | Endosseous dental implant
Endosseous dental implant abutment |
| Classification Name | Endosseous dental implant |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE / NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K101945 - Neodent Implant System - CM Line, JJGC Indústria e
Comércio de Materiais Dentários S.A |
| Reference Devices | K150367 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários S.A |
| | K132881 - Z5c, Z-Systems AG |
| | K153624 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários S.A |
| | K180477 – Straumann PURE Ceramic Implant System, Institut
Straumann AG |
| | K182620 - MRI Compatibility For Existing Neodent Implant
System, JJGC Indústria e Comércio de Materiais Dentários S.A |
| | K192893 - Straumann® Ceramic Healing Abutments, Institut
Straumann AG |

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INDICATIONS FOR USE

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

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for Zirconia Bases:

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

SUBJECT DEVICE DESCRIPTIONS

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

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

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

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Equivalence Discussion
Indications
for Use	K201491
Neodent Implant System - Zirconia Implant
System - Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K101945
Neodent Implant System
Alvim Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K180477
Straumann PURE Ceramic Implant System
Implants
Institut Straumann AG	Identical
The Indications for Use of the subject
devices are the same as for the primary
predicate devices.
	The Neodent Implant System is intended
to be surgically placed in the bone of the
upper or lower jaw to provide support
for prosthetic devices, such as artificial
teeth, to restore chewing function. It
may be used with single-stage or two-
stage surgical procedures, for single or
multiple unit restorations, and may be
loaded immediately when good primary
stability is achieved and with
appropriate occlusal loading. Multiple
teeth applications can be rigidly
splinted.	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. Multiple
teeth applications can be rigidly splinted	Straumann PURE Ceramic Implant:
The Straumann PURE Ceramic Implant
is indicated for the restoration of single-
tooth gaps and in edentulous or
partially edentulous jaws. The
prosthetic restorations used are single
crowns, fixed partial or full dentures,
which are connected to the implants
through the corresponding
components.

Closure and healing caps:
Closure and Healing caps are intended
for use with the Straumann Dental
Implant System (SDIS) to protect the
inner configuration of the implant and
maintain, stabilize and form the soft
tissue during the healing process.
Closure and Healing caps should be
used only with suitable implant
connections. Do not use healing
components for longer than 6 months.

Temporary Abutments:
The provisional components are
intended to serve as a base for
temporary crown or bridge restoration
out of occlusion for the Straumann®
PURE Ceramic Implant System. The
Straumann® Temporary Abutment VITA
CAD-Temp® for the Straumann® PURE
Ceramic Implant is indicated for
temporary usage of up to 180 days.
CI RD Straumann PUREbase Abutments: | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Equivalence
Discussion |
| | K201491
Neodent Implant System - Zirconia Implant
System - Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K101945
Neodent Implant System
Alvim Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K180477
Straumann PURE Ceramic Implant System
Implants
Institut Straumann AG | |
| | | | CI RD Straumann PUREbase abutment is
a titanium base placed onto Straumann
ceramic dental implants to provide
support for customized prosthetic
restorations and is indicated for screw-
retained single tooth or cement-
retained single tooth and bridge
restorations. All digitally designed
copings and/or crowns for use with the
Straumann® Variobase Abutment
system are intended to be sent to
Straumann for manufacture at a
validated milling center. | |
| Implant-
Abutment
interface | Straight internal connection
indexing features (Zilock) | CM Morse Taper | Straight internal connection
indexing features (RD) | Equivalent
Subject devices and reference devices
present internal connection and are
equipped with a rotational lock and an
inner thread for fixation of the
temporary components and final
abutments. |
| Design | Apically Tapered format
Trapezoidal threads profile
Bone compression capacity during
installation | Apically Tapered format
Trapezoidal threads profile | Straight cylindrical implant body | Equivalent
The subject devices have the same
apically-tapered shape and trapezoidal
thread form as the primary predicate
device. |
| Reusable | No | No | No | Identical
The subject devices and the primary
predicate devices are indicated for single
use. |
| Length (mm) | 8; 10; 11.5; 13 | 8; 10; 11.5; 13; 16 | 8; 10; 12; 14 | Equivalent
Range of lengths for subject devices is
within the range of lengths for the
primary predicate devices. |
| Diameter (Ø) | 4.3 mm | 3.5; 4.3; 5.0 mm | Endosteal 4.1 mm | Equivalent |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
| | K201491
Neodent Implant System - Zirconia Implant
System - Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K101945
Neodent Implant System
Alvim Implants
JJGC Indústria e Comércio de Materiais
Dentários S.A. | K180477
Straumann PURE Ceramic Implant System
Implants
Institut Straumann AG | Equivalence
Discussion |
| (mm) | | | Platform 4.8 mm | Diameter of subject devices is within
the range of diameters for the primary
predicate devices. |
| Material | Yttrium-stabilized zirconium dioxide
(Y-TZP). | Commercially pure titanium (Grade 4) | Yttrium-stabilized zirconium dioxide
(Y-TZP). | Equivalent
The subject devices have the same
material of construction as the
identified reference devices. |
| Sterilization
Method | Provided sterile via Ethylene Oxide to
an SAL of 10-6 | Provided sterile via Gamma irradiation to
an SAL of 1x10-6 | Provided sterile via Ethylene Oxide to an
SAL of 10-6 | Equivalent
The subject devices and the primary
predicate devices are provided in sterile
condition to an SAL of 1 x 10-6. The subject
devices use the same sterilization method
as for the reference devices. |

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8

9

| SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | Equivalence
Discussion | | SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K201491
Neodent Implant System - Zirconia
Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K180477
Straumann PURE Ceramic Implant System
PUREbase Abutments
Institut Straumann AG | K150367
Neodent Implant System
Titanium Base Abutments
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K132881
Z5c
Z-Systems AG | | | K201491
Neodent Implant System - Zirconia
Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K180477
Straumann PURE Ceramic Implant System
PUREbase Abutments
Institut Straumann AG | K150367
Neodent Implant System
Titanium Base Abutments
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K132881
Z5c
Z-Systems AG | Equivalence
Discussion | |
| Indications
for Use | The Zirconia Base is an
abutment placed over Neodent
Zirconia Implants in order to
provide support for patient-
specific prosthetic restorations,
such as copings or crowns. It
may be used for cement- or
screw retained single unit
restorations. All digitally
designed copings and/or
crowns to be used with the
Neodent Zirconia Base
Abutment System are intended
to be sent to Straumann for
manufacture at a validated
milling center. | Straumann PURE Ceramic Implant:
The Straumann PURE Ceramic Implant is
indicated for the restoration of single-tooth gaps
and in edentulous or partially edentulous jaws.
The prosthetic restorations used are single
crowns, fixed partial or full dentures, which are
connected to the implants through the
corresponding components.
Closure and healing caps:
Closure and Healing caps are intended for use
with the Straumann Dental Implant System
(SDIS) to protect the inner configuration of the
implant and maintain, stabilize and form the soft
tissue during the healing process. Closure and
Healing caps should be used only with suitable
implant connections. Do not use healing
components for longer than 6 months.
Temporary Abutments:
The provisional components are intended to
serve as a base for temporary crown or bridge
restoration out of occlusion for the Straumann®
PURE Ceramic Implant System. The Straumann®
Temporary Abutment
VITA CAD-Temp® for the Straumann® PURE
Ceramic Implant is indicated for temporary
usage of up to 180 days.
CI RD Straumann PUREbase Abutments:
CI RD Straumann PUREbase abutment is a
titanium base placed onto Straumann ceramic
dental implants to provide support for
customized prosthetic restorations and is
indicated for screw-retained single tooth or
cement-retained single tooth and bridge
restorations. All digitally designed copings and/or
crowns for use with the Straumann® Variobase
Abutment system are intended to 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 | Z5c implants are designed for
surgical implantation into
the upper and lower jaw for
the attachment of
prosthodontic appliances to
replace missing teeth. Z5c
implant system is also
suitable for patients with
metal allergies and the
chronic diseases resulting
from them. Z5c implants are
intended for delayed
loading. | Equivalent
The Indications for the
subject devices are
equivalent to
reference devices
(K150367). Although
the words are
different, the content
of the indications for
use are similar. The
primary predicate
covers the indications
for use of the
reference devices. The
indications for use of
the subject devices
are contained within
the indications for use
of the primary
predicate devices. | Abutment
Material | Zirconia Base: Yttrium-
stabilized zirconium dioxide
(Y-TZP).
Screw: Titanium alloy Screw
according to ASTM F136
standard. | Ti-6Al-7Nb | Titanium alloy according to
ASTM F136 standard. | Yttrium-stabilized zirconium
dioxide
(Y-TZP). | Equivalent
The subject devices
and the reference
devices (K132881)
have the same
material of
construction. |
| | SUBJECT DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | Restoration
Material | zerion LT
zerion UTML
3M LavaPlus Zirconia | polycon ae (temporary)
zerion LT/HT (permanent)
zerion ML/UTML (permanent)
IPS e.max CAD (permanent)
n!ce (permanent) | Zirconia | -- | Equivalent
The subject devices
and the reference
devices have
equivalent materials
of construction. |
| | K201491
Neodent Implant System - Zirconia
Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K180477
Straumann PURE Ceramic Implant System
PUREbase Abutments
Institut Straumann AG | K150367
Neodent Implant System
Titanium Base Abutments
JJGC Indústria e Comércio de
Materiais Dentários S.A. | K132881
Z5c
Z-Systems AG | Equivalence
Discussion | Design
workflow | Zirconia Base library on Dental
Wings and 3Shape systems or
software | CAD with CARES Visual v.11 | CARES Visual, Dental Wings
and 3shape software | -- | Equivalent
The subject and
reference devices are
indicated for use
within a digital
restorative workflow.
The same CAD
software can be used
to design the
prosthetic portion of
the devices. |
| Implant-
Abutment
interface | Straight internal connection
indexing features (Zilock) | Straight internal connection
indexing features (RD) | CM Morse Taper | -- | Equivalent
Subject devices and
reference devices
(K180477) present
internal connection
and are equipped
with a rotational lock
and an inner thread
for fixation of the
temporary
components and final
abutments. | | | | | | |
| Maximum
Angulation of
Prosthetic
Structure | 30° | 30° | 30° | 15° | Identical
The maximum
restorative angulation
for the subject and
reference devices
(K180477 and
K150367) is the same. | | | | | | |
| Gingival
height (mm) | 1.5 – 2.5 mm | -- | 0.8 - 4.5 mm | -- | Equivalent
The range of gingival
heights for the
subject devices is
within the range of
gingival heights of the
reference devices
| | | | | | |
| Reusable | No | No | No | No | Identical
The subject devices and
reference devices are
indicated for single use. | | | | | | |

Table 2. Technological Characteristic Comparison Table - Zirconia Bases

10

11

12

	SUBJECT DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	K201491
Neodent Implant System - Zirconia
Implant System
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K180477
Straumann PURE Ceramic Implant System
PUREbase Abutments
Institut Straumann AG	K150367
Neodent Implant System
Titanium Base Abutments
JJGC Indústria e Comércio de
Materiais Dentários S.A.	K132881
Z5c
Z-Systems AG	Equivalence
Discussion
Manufacturing
workflow	Straumann Milling Center	Straumann Milling Center	Straumann Milling Center	--	Identical
The prosthetic
portion of the
assembly for the
subject devices and
reference devices
(K180477 and
K150367) are
indicated for
fabrication in a
registered medical
device manufacturing
facility.
Sterilization
Method	Provided sterile via Ethylene
Oxide to an SAL of 10-6
End user sterilized via moist
heat following cementation of
coping and before use	Non-sterile
End user sterilized via moist heat following
cementation of coping and before use	Provided sterile via Ethylene Oxide
to an SAL of 10-6	--	Identical
The subject devices and
the reference devices
(K150367) are provided
sterile condition to an SAL
of 1 x 10-6. The subject
devices use the same
sterilization method as
for the reference devices.

13

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	EQUIVALENCE DISCUSSION
	Neodent Implant System - Zirconia Implant System
Cover Screws
JJGC Indústria e Comércio de Materiais Dentários S.A.	K101945
Neodent Implant System
Cover Screws
JJGC Indústria e Comércio de Materiais Dentários S.A.
Indications for Use	The Neodent Implant System is intended to be
surgically placed in the bone of the upper or lower
jaw to provide support for prosthetic devices, such
as artificial teeth, to restore chewing function. It
may be used with single-stage or two-stage
surgical procedures, for single or multiple unit
restorations, and may be loaded immediately
when good primary stability is achieved and with
appropriate occlusal loading. Multiple teeth
applications can be rigidly splinted.	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
The Indications for the subject devices are included
within the scope on Indications for the primary
predicate devices.
Reusable	No	No	Identical
The subject devices and the primary predicate devices
are both intended for single use.
Material	Titanium alloy according to ASTM F136 standard.	Titanium alloy according to ASTM F136 standard.	Identical
The subject devices have the same material of
construction as the primary predicate devices.
Sterilization Method	Provided sterile via Ethylene Oxide to an SAL of 10-6	Provided sterile via Ethylene Oxide to an SAL of 10-6	Identical
The subject devices have the same sterilization
method and same SAL as the primary predicate
devices.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Equivalence Discussion
	Neodent Implant System - Zirconia Implant
System
Healing Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K101945
Neodent Implant System
Healing Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K192893
Straumann Ceramic Healing Abutments
Healing Abutments
Institut Straumann AG.
Indications
for Use	The Neodent Implant System is intended
to be surgically placed in the bone of the
upper or lower jaw to provide support
for prosthetic devices, such as artificial
teeth, to restore chewing function. It
may be used with single-stage or two-
stage surgical procedures, for single or
multiple unit restorations, and may be
loaded immediately when good primary
stability is achieved and with
appropriate occlusal loading. Multiple
teeth applications can be rigidly
splinted.	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. Multiple
teeth applications can be rigidly splinted	Straumann® Ceramic Healing abutments
are indicated to be placed in the patient's
mouth at the end of the implant placement
to protect the inner configuration of the
implant and maintain, stabilize and form
the soft tissue during the healing process.
Healing abutments should be used only
with suitable implant connections. The
healing components are intended to be
used up to 6 months.	Equivalent
The Indications for the subject devices
are included within the scope on
Indications for the primary predicate
devices.
Implant-
Abutment
interface	Straight internal connection
indexing features (Zilock)	CM	Straight internal connection
indexing features (RD)	Equivalent
Subject devices and reference devices
(K192893) present internal connection
and are equipped with a rotational lock
and an inner thread for fixation of the
temporary components and final
abutments.
Reusable	No	No	No	Identical
The subject and primary predicate
devices are indicated for single use.
Material	Healing Abutment: Yttrium-stabilized
zirconium dioxide (Y-TZP)
Screw: Titanium alloy Screw according
to ASTM F136 standard.	Healing Abutment and Screw: Titanium
alloy according to ASTM F136 standard.	Healing Abutment: Yttrium-stabilized
zirconium dioxide (Y-TZP)
Screw: Titanium alloy (Ti-6Al-7Nb or
TAN)	Equivalent
The materials of construction for the
subject devices are equivalent to those
of the reference devices.
Diameter (Ø)
(mm)	3.75 and 4.5	3.3 and 4.5 mm	NC: 3.6 and 4.8 mm
RC: 4.5, 5.0, 6.0, and 6.5 mm	Equivalent
The range of diameters of the subject
devices are within the range of diameters
for the primary predicate devices.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Equivalence Discussion
	Neodent Implant System - Zirconia Implant
System
Healing Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K101945
Neodent Implant System
Healing Abutments
JJGC Indústria e Comércio de Materiais
Dentários S.A.	K192893
Straumann Ceramic Healing Abutments
Healing Abutments
Institut Straumann AG.
Gingival height
(mm)	1.5 – 2.5 mm	0.8, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5	NC: 2.0, 3.5, and 5.0 mm
RC: 2.0, 4.0, and 6.0 mm	Equivalent
The range of gingival heights of the
subject devices are within the range of
gingival heights for the primary
predicate devices.
Sterilization	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 have the same
sterilization method and same SAL as
the primary predicate devices.

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

14

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

15

16

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

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

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

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

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

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

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

PERFORMANCE DATA

Biocompatibility

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

. Biocompatibility sample preparation was made according to ISO 10993-12.
Biological Safety Assessment guided by ISO 10993-1,
Cytotoxicity testing was performed per ISO 10993-5 and
. Chemical characterization was performed per ISO 10993-18.

Mechanical testing

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the dental implant system, according to FDA Guidance. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.

17

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

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

Sterilization validation

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

MRI Testing

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

Shelf Life

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

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

CONCLUSION

The subject devices and the primary predicate and reference devices have equivalent intended use, design and technological characteristics. Equivalent range of overall dimensions and sterilization method. The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.