QZA and RS Dental Implant Systems

• K Number: K163640
• Device Name: QZA and RS Dental Implant Systems
• Manufacturer: TRINON Titanium GmbH
• Date Cleared: 2017-05-03 ( 131 days)
• Product Code: DZE NHA
• Regulation Number: 872.3640

Intended Use

TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function. TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors. TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

Device Description

TRINON Titanium QZA Dental Implants are made of titanium grade 5. These are two-stage implants. They have a hexagonal internal cone connection and a spiralock internal thread design. Furthermore, QZA Dental Implants have micro threads in cortical part. TRINON Titanium QZA Dental Abutments are also called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct QZA Dental Implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedures in the IFU. The RS Implants are made of titanium Grade 5. The RS Dental Implants are two-stage implants and are available in 4 diameters for ideal implant selection and four easily identifiable platforms for efficient prosthetic restoration (color-coding). All diameters are available in lengths of 8.5 mm, 10 mm, 11.5 mm, 14.5 mm and 16 mm. The RS Dental Implants have a conical hexagonal interlock. The RS Dental Implants are selftapping high torque arrow-shaped implants with counterclockwise self-tapping function. RS Dental implants have micro threads in cortical part of the implant feature. The RS Abutments are made of titanium Grade 5. These are usually called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct RS dental implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedure descripted in the IFU.

Predicate Devices

K142260, K160221

Reference Devices

K073486, K160828, K120954

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical dental implant and abutment system made of titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
The device is described as an endosseous implant intended to anchor or support tooth replacement, which is a restorative rather than a therapeutic function.

Diagnostic

No
Explanation: The device, TRINON Titanium QZA and RS Dental Implants, are explicitly described as endosseous implants intended for surgical placement to support tooth replacement and restore esthetics and chewing function. There is no mention of the device being used for diagnosis or for detecting a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states that the devices are made of titanium and are surgically placed implants and abutments, which are physical hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states that the device is for surgical placement in the jaw bone to support tooth replacement and restore esthetics and chewing function. This is a therapeutic and restorative purpose, not a diagnostic one.
• Device Description: The description details the physical characteristics and materials of dental implants and abutments, which are physical devices used in surgery and prosthetics.
• Performance Studies: The performance studies focus on biocompatibility, surface treatment, sterilization, shelf-life, and mechanical testing (fatigue). These are all relevant to the safety and function of a surgically implanted device, not an in vitro diagnostic test.
• Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease or condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function.

TRINON Titanium OZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral incisors.

TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients.

QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

Product codes

DZE, NHA

Device Description

TRINON Titanium QZA Dental Implants are made of titanium grade 5. These are two-stage implants. They have a hexagonal internal cone connection and a spiralock internal thread design. Furthermore, QZA Dental Implants have micro threads in cortical part. QZA Dental Implants come in diameters of 3.3, 3.5, 3.8, 4.2, 4.5, 4.8, 5.4, 5.7 mm and lengths of 8.0, 10.0, 12.0, 14.0 mm.

TRINON Titanium QZA Dental Abutments are also called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct QZA Dental Implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedures in the IFU. A variety of QZA abutments are available including standard, angled, ball, healing, overdenture multi-unit, Q-Cone, Q-Lock, and temporary abutments, with varying angles, diameters, lengths, and gingival heights.

The RS Implants are made of titanium Grade 5. The RS Dental Implants are two-stage implants and are available in 4 diameters for ideal implant selection and four easily identifiable platforms for efficient prosthetic restoration (color-coding). All diameters are available in lengths of 8.5 mm, 10 mm, 11.5 mm, 14.5 mm and 16 mm. The RS Dental Implants have a conical hexagonal interlock. The RS Dental Implants are selftapping high torque arrow-shaped implants with counterclockwise self-tapping function. RS Dental implants have micro threads in cortical part of the implant feature.

The RS Abutments are made of titanium Grade 5. These are usually called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct RS dental implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedure descripted in the IFU. RS abutments are available in diameters of 4.7, 5.2, 6.2, 7.2 mm, with various margin heights and abutment heights.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw bone

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)

Performance testing of the QZA Dental Implant System and RS Dental Implant System followed the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

Biocompatibility:
-. EN ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

• EN ISO 10993-5 (Cytotoxicity): Results indicate that the test material does not release substances in cytotoxic concentrations during a permanent 24±2 h contact of 4.4 cm² surface area to 1 ml physiological fluid.
• EN ISO 10993-12 / EN ISO 10993-18 (Chemical Analysis – Characterization of Organic Extractable): Test material extracted with isopropanol for 24±2 h at 37±1°C. No changes in color or shape after extraction, and extract did not differ optically from reagent control. No detectable organic substances found.
• USP 85 (LAL Endotoxin):

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2017

TRINON Titanium GmbH Katja Lvova Chief Operating Officer (COO) Augartenstr. 1 Karlsruhe, 76137 GERMANY

Re: K163640

Trade/Device Name: QZA and RS Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 17, 2017 Received: April 3, 2017

Dear Katia Lvova:

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163640

Device Name QZA and RS Dental Implant System

Indications for Use (Describe)

TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function.

TRINON Titanium OZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral incisors.

TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients.

QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

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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TRINON Titanium QZA and RS Dental Implant System 510(k) Premarket Notification

Image /page/3/Picture/1 description: The image contains the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below that, in smaller, gray letters, is the word "TITANIUM."

K163640

510(k) Summary

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Image /page/4/Picture/1 description: The image shows the logo for TRINON TITANIUM. The word "TRINON" is in large, bold, blue letters. Below it, the word "TITANIUM" is in smaller, black letters. The font is sans-serif and appears to be a corporate logo.

Issue Date: 2017-05-03

APPLICANT: TRINON Titanium GmbH Augartenstr. 1 76137 Karlsruhe, Germany Tel.: [phone] Fax: [phone] E-Mail: [e-mail] Internet: http://www.trinon.com/

CONTACT PERSON: Katja Lvova Chief Executive Officer (CEO) Tel.: [phone] E-Mail: [e-mail]

1. Device Name

Trade Name:	QZA and RS Dental Implant System
Common Name:	Implant, Endosseous, Root-form
Classification Name:	Endosseous dental implant

1.1. Classification Product Code

1.1.1. Primary Product Code

QZA and RS Dental Implant System can be classified according to following Device Name and Product Code

| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation
Number |
|--------------------------------------|----------------------|--------------|--------------|--------------|----------------------|
| implant,
endosseous,
root-form | Dental | Dental | DZE | 2 | 872.3640 |

1.1.2. Subsequent Code

Trade Name:	QZA and RS Dental Abutments
Common Name:	Abutment, Suprastructure
Classification Name:	Abutment, Implant, Dental, Endosseous

| Device | Medical
Specialty | Review Panel | Product Code | Device Class |
|-----------------------------|----------------------|--------------|--------------|--------------|
| abutment,
suprastructure | Dental | Dental | NHA | 2 |

The device has been classified as an "Endosseous Dental Implant" under the 21 CFR 872.3640 because this presents the higher risk. However, the product code of "DZE" and "NHA" is still both used in the classification of the device, with "DZE" being designated as the primary product code.

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Image /page/5/Picture/1 description: The image shows the logo for TRINON TITANIUM. The word "TRINON" is in a large, bold, blue font. Below it, the word "TITANIUM" is in a smaller, thinner, black font. The logo is simple and modern.

2. Indication for Use

TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function.

TRINON Titanium QZA and RS Dental Implants are indicated for sinqle or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors.

TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients.

QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

6

Image /page/6/Picture/1 description: The image contains the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below that, in smaller, thinner, blue letters, is the word "TITANIUM."

3. QZA Dental Implant System Description

3.1. QZA Dental Implants

TRINON Titanium QZA Dental Implants are made of titanium grade 5. These are two-stage implants. They have a hexagonal internal cone connection and a spiralock internal thread design. Furthermore, QZA Dental Implants have micro threads in cortical part.

Below are summarised the technical characteristics of the QZA dental implants:

Picture	Diameter [mm]	Length [mm]	Implant Connection
Image: dental implants	3.3	8.0
10.0
12.0
14.0	Hex 2.5
	3.5	8.0
10.0
12.0
14.0	Hex 2.5
	3.8	8.0
10.0
12.0
14.0	Hex 2.5
	4.2	8.0
10.0
12.0
14.0	Hex 2.5
	4.5	8.0
10.0
12.0
14.0	Hex 2.5
	4.8	8.0
10.0
12.0
14.0	Hex 2.5
	5.4	8.0
10.0
12.0
14.0	Hex 2.5
	5.7	8.0
10.0
12.0
14.0	Hex 2.5

3.2. QZA Dental Abutments

TRINON Titanium QZA Dental Abutments are also called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct QZA Dental Implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedures in the IFU.

Below are summarised the technical characteristics of the QZA dental abutments:

7

TRINON Titanium

QZA and RS Dental Implant System 510(k) Premarket Notification

Image /page/7/Picture/2 description: The image shows the word "TRINON" in large, bold, blue letters. Below that, in smaller, thinner, black letters, is the word "TITANIUM". The words appear to be a logo or brand name.

| Name | Picture | Angle [°] | Diameter
[mm] | Total Length
[mm] | Gingiva High
[mm] |
|-------------------------------|-----------------------------------|----------------|--------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|
| QZA Abutment | Image: QZA Abutment | 0 | 3.3
3.5
4.5
4.8
5.4
5.5
5.7
6.5 | 7.65
8.9
9.9
10.9 | 0.75
2.0
3.0
4.0 |
| QZA Angled
Abutment | Image: QZA Angled Abutment | 10
15
20 | 3.3
3.5
4.2
4.5
4.8
5.4
5.5
5.7
6.5 | 7.65
8.9
9.9
10.9 | 0.75
2.0
3.0
4.0 |
| QZA Ball
Abutment | Image: QZA Ball Abutment | 0 | 3.5
4.5
5.7 | 7.9
8.9
9.9
10.9
11.9 | 2.0
3.0
4.0
5.0
6.0 |
| QZA Healing
Abutment | Image: QZA Healing Abutment | 0 | 3.3
3.5
3.8
4.2
4.5
4.8
5.0
5.4
5.7
6.5 | 12.9
14.9
16.9 | 3.0
5.0
7.0 |
| QZA Overdenture
Multi Unit | Image: QZA Overdenture Multi Unit | 0
15
30 | 3.5
4.5
5.7 | 5.65
6.9
7.9
8.9
9.9
10.9 | 0.75
2.0
3.0
4.0
5.0
6.0 |
| QZA Q-Cone
Abutment | Image: QZA Q-Cone Abutment | 0 | 3.3
3.5
4.5
5.5
6.5 | 7.65
8.9
9.9
10.9 | 0.75
2.0
3.0
4.0 |
| QZA Q-Lock
Abutment | Image: QZA Q-Lock Abutment | 0 | 3.5
4.5
5.7 | 4.9
5.4
6.4
7.4
8.4
9.4
10.4
11.4 | 0.5
1.0
2.0
3.0
4.0
5.0
6.0
7.0 |
| QZA Temporary
Abutment | Image: Abutment | 0 | 3.3
3.5
4.5
5.5
6.5 | 11.65 | 0.75 |

8

TRINON Titanium

QZA and RS Dental Implant System 510(k) Premarket Notification

Image /page/8/Picture/2 description: The image shows the logo for TRINON TITANIUM. The word "TRINON" is in large, bold, blue letters. Below it, the word "TITANIUM" is in smaller, thinner, blue letters. The logo is simple and modern.

3.2.1. Proposed Conditions of Use / Special Considerations

Name	Picture	Condition of Use	Special Considerations
QZA Abutment	Image: QZA Abutment	For permanent single tooth restoration as well
as bridge restauration where an angular
correction is not required.	May be manually fabricated
down to a minimum height of
4mm from collar.
QZA Angled
Abutment	Image: QZA Angled Abutment	For permanent single tooth restoration as well
as bridge restauration. Different abutments
variations are available for 10°, 15° or 20°
angular correction.	May be manually fabricated
down to a minimum height of
4mm from collar.
QZA Temporary
Abutment	Image: QZA Temporary Abutment	For temporary single tooth restoration as well
as bridge restauration where an angular
correction is not required.	May be manually fabricated
down to a minimum height of
4mm from collar.
QZA Ball
Abutment	Image: QZA Ball Abutment	For overdenture only	No additional angular
correction.
QZA Q-Lock
Abutment	Image: QZA Q-Lock Abutment	For overdenture only	No additional angular
correction.
QZA Healing
Abutment	Image: QZA Healing Abutment	To form soft tissue before end restoration	-
QZA Overdenture
Multi Unit	Image: QZA Overdenture Multi Unit	For multi-unit only	No additional angular
correction.
QZA Q-Cone
Abutment	Image: QZA Q-Cone Abutment	For bridge only	No additional angular
correction.

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Image /page/9/Picture/1 description: The image shows the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below it, in smaller, black letters, is the word "TITANIUM."

3.2.2. RS Dental Implant System Description

3.2.2.1. RS Dental Implants

The RS Implants are made of titanium Grade 5. The RS Dental Implants are two-stage implants and are available in 4 diameters for ideal implant selection and four easily identifiable platforms for efficient prosthetic restoration (color-coding). All diameters are available in lengths of 8.5 mm, 10 mm, 11.5 mm, 14.5 mm and 16 mm.

The RS Dental Implants have a conical hexagonal interlock. The RS Dental Implants are selftapping high torque arrow-shaped implants with counterclockwise self-tapping function. RS Dental implants have micro threads in cortical part of the implant feature.

Picture	Diameter [mm]	Length [mm]	Implant Connection
Image: Implant	3.5	8.5
10.0
11.5
13.0
14.5
16.0	Hex 2.5
	4.3	8.5
10.0
11.5
13.0
14.5
16.0	Hex 2.5
	5.0	8.5
10.0
11.5
13.0
14.5
16.0	Hex 2.5
	6.0	8.5
10.0
11.5
13.0
14.5
16.0	Hex 2.5

Below are summarised the technical characteristics of the RS dental implants:

3.2.2.2. RS Dental Abutment

The RS Abutments are made of titanium Grade 5. These are usually called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct RS dental implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedure descripted in the IFU.

Below are summarised the technical characteristics of the RS dental abutment:

10

TRINON Titanium
QZA and RS Dental Implant System 510(k) Premarket Notification

Image /page/10/Picture/2 description: The image shows the words "TRINON" in blue, stacked on top of the word "TITANIUM" in black. The font is sans-serif and the words are aligned to the left. The word "TRINON" is larger than the word "TITANIUM".

| Standard
Abutment
O 4.7 mm | Heights
margim [mm]: | 1.5 | 3.0 | 4.5 | 6.0 | 1.5 | 3.0 | 4.5 | 6.0 |
|----------------------------------|-------------------------|-----|-----|-----|-----|-----|-----|-----|-----|
| | Abut Heights
(mm): | 4.0 | 4.0 | 4.0 | 4.0 | 6.0 | 6.0 | 6.0 | 6.0 |
| Standard
Abutment
O 5.2 mm | Heights
margim [mm]: | 1.5 | 3.0 | 4.5 | 6.0 | 1.5 | 3.0 | 4.5 | 6.0 |
| | Abut Heights
(mm): | 4.0 | 4.0 | 4.0 | 4.0 | 6.0 | 6.0 | 6.0 | 6.0 |
| Standard
Abutment
O 62 mm | Heights
margim [mm]: | 1.5 | 3.0 | 4.5 | 6.0 | 1.5 | 3.0 | 4.5 | 6.0 |
| | Abut Heights
(mm): | 4.0 | 4.0 | 4.0 | 4.0 | 6.0 | 6.0 | 6.0 | 6.0 |
| Standard
Abutment
O 7.2 mm | Heights
margim [mm]: | 1.5 | 3.0 | 4.5 | 6.0 | 1.5 | 3.0 | 4.5 | 6.0 |
| | Abut Heights
(mm): | 4.0 | 4.0 | 4.0 | 4.0 | 6.0 | 6.0 | 6.0 | 6.0 |

11

Image /page/11/Picture/1 description: The image shows the logo for "TRINON TITANIUM". The word "TRINON" is in a large, bold, sans-serif font and is colored blue. Below "TRINON" is the word "TITANIUM" in a smaller, sans-serif font and is colored black.

4. Predicate Devices

4.1. Summary of Used Predicate / Reference Devices

In the following table are listed the predicate(s) and reference device(s) deemed comparable to TRINON Titanium RS/QZA Dental Implants:

| Candidate
Devices | Predicate Device
(Manufacturer/Proprietary
Name) | Predicate
Device
510(k) N° | Reference Device 1
(Manufacturer/Proprietary
Name) | Reference
Device
510(k) N° |
|-----------------------------------------------|--------------------------------------------------------|----------------------------------|----------------------------------------------------------|----------------------------------|
| Trinon
Titanium
RS
Dental
Implant | | | Dentis Co. Ltd./Dentis Dental
Implant Systems | K073486 |
| QZA
Dental
Implant | Nobel Biocare AB/NobelActive | K142260 | | |

In the following table are listed the predicate(s) and reference device(s) deemed comparable to TRINON Titanium RS/QZA Dental Abutments:

| Candidate
Devices
Trinon
Titanium | Primary
Predicate Device
(Manufacturer/Proprietary
Name) | Primary
Predicate
Device
510(k) N° | Reference Device 1
(Manufacturer/Proprietary
Name) | Reference
Device
510(k) N° |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------|----------------------------------|
| RS
Abutment | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System (Solid
Abutments) | | Dentium Co., Ltd./Dentium
Implantium & SuperLine
Prostehtics | K160828 |
| RS
Cover Screw | | | | |
| QZA
Abutment | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System (Solid
Abutments) | | | |
| QZA
Angled
Abutment | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System (Angled
Abutments) | K160221 | | |
| QZA
Ball Abutment | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System
(O-Ring Abutments) | | - | - |
| QZA
Healing
Abutment | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System
(Healing Abutments) | | Dentium Co., Ltd./Dentium
Implantium & SuperLine
Prostehtics | K160828 |

12

TRINON Titanium

QZA and RS Dental Implant System 510(k) Premarket Notification

Image /page/12/Picture/2 description: The image contains the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below that, the word "TITANIUM" is in smaller, gray letters.

| Candidate
Devices
Trinon
Titanium | Primary
Predicate Device
(Manufacturer/Proprietary
Name) | Primary
Predicate
Device
510(k) N° | Reference Device 1
(Manufacturer/Proprietary
Name) | Reference
Device
510(k) N° |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| QZA
Overdenture
Multi Unit | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System
(Couple/Multi Abutments) | | AGS Medikal Urunleri Ith. Ihr. Tic.
Ltd. Sti./Implance Dental Implant
System, Implance Dental
Abutment System (Angled
Abutments) | K160221 |
| QZA
Q-Cone | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System (Solid
Abutments) | | Dentium Co., Ltd./Dentium
Implantium & SuperLine
Prostehtics | K160828 |
| QZA
Q-Lock | | | | |
| QZA
Temporary
Abutment | AGS Medikal Urunleri Ith. Ihr.
Tic. Ltd. Sti./Implance Dental
Implant System, Implance
Dental Abutment System
(Healing Abutments) | | Nobel Biocare USA
LLC/NobelProvera PEEK
Abutments | K120954 |

13

Image /page/13/Picture/1 description: The image shows the logo for "TRINON TITANIUM". The word "TRINON" is in a bold, sans-serif font and is colored blue. Below "TRINON" is the word "TITANIUM" in a smaller, sans-serif font and is colored black.

4.2. Dental Implants

4.2.1. QZA Dental Implants

Technological characteristics of the QZA Dental Implant are compared with the predicate devices in the following table.

| Topic | QZA Dental Implant | Primary Predicate
Nobel Biocare AB/NobelActive |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K142260 |
| Indication for Use | TRINON Titanium QZA Dental Implants are
endosseous implants intended to be
surgically placed in the upper or lower jaw
bone for anchoring or supporting tooth
replacement to restore patient esthetics
and chewing function.
TRINON Titanium QZA Dental Implants are
indicated for single or multiple unit
restorations in non-splinted applications.
This can be achieved by a 2-stage surgical
technique in combination with delayed
loading protocols, recognizing sufficient
primary stability and appropriate occlusal
loading for the selected technique.
TRINON Titanium QZA Dental Implants
with a diameter of 3.3 mm may only be
used in the upper jaw as a single tooth
replacement of the lateral incisors and in
the lower jaw as a single tooth
replacement of the lateral and central
incisors. | NobelActive® implants are endosseous implants
intended to be surgically placed in the upper or
lower jaw bone for anchoring or supporting tooth
replacements to restore patient esthetics and
chewing function.
NobelActive® implants are indicated for single or
multiple unit restorations in splinted or non-
splinted applications. This can be achieved by a
2-stage or 1-stage surgical technique in
combination with immediate, early or delayed
loading protocols, recognizing sufficient primary
stability and appropriate occlusal loading for the
selected technique.
NobelActive® 3.0 implants are intended to
replace a lateral incisor in the maxilla and/or a
central or lateral incisor in the mandible.
NobelActive® 3.0 implants are indicated for
single unit restorations only. |
| Code | DZE | DZE |
| Implant Diameter
[mm] | 3.3
3.5
3.8
4.2
4.5
4.8
5.4
5.7 | 3.0
to
5.5 |
| Implant Length
[mm] | 8.0
10.0
12.0
14.0 | From
7.0
to
18.0 |
| Implant
Connection
(Geometry) | Hex 2.5 | Intern Hex |
| Design Stage | 2-phases | 1-phase
2-phases |
| Design Thread | Body: Single thread
Apex: Micro thread | Body: Double thread
Apex: Micro thread |
| Material | Titanium Grade 5 ELI | CP Titanium |
| Surface treat-
ment | Blasted with aluminium oxide | TiUnite |
| Delivery status | Sterile (Irradiation) | Sterile (Irradiation) |

The subject device QZA Dental Implant has a fundamentally similar design as the predicate Nobel Biocare AB / NobelActive Implants (K142260). The two implant designs share the same materials, manufacturing methods, tapered tip design, and surface treatment. The

14

Image /page/14/Picture/1 description: The image shows the logo for TRINON TITANIUM. The word "TRINON" is in large, bold, blue letters. Below it, in smaller, gray letters, is the word "TITANIUM."

QZA Dental Implant compared to the primary predicate device of Nobel Biocare AB (Nobel Active) is substantial equivalence in the technological characteristics.

All the differences between QZA Dental Implant and the chosen predicate devices do not raise any further risk concerning device safety. These differences are covered by other medical devices already FDA approved and selected as reference devices (e.g. Implant Diameter 5.7 mm is covered by Dentis Co. Ltd./Dentis Dental Implant Systems (K073486). All design differences have been addressed. Bench tests have been performed according ISO 14801 in order to prove TRINON Titanium devices effectiveness. Furthermore, 1-stage surgical technique is used when a healing abutment is placed at the time of surgery. Following a 3 to 6 month healing period in which the implant fuses to the bone, a crown is then placed on the implant restoring the immediate appearance of a healthy, normal tooth. One-stage implant systems are generally used when the bone quality is good, quaranteeing good initial implant stability. They are also used when cosmetics is not a concern, such as the back areas of the mouth. A 2-stage surgical technique is typically used for replacing teeth where there is no immediate need for a cosmetic solution and when more of a marqin of safety is required. With this approach, the implant(s) are placed into the jawbone and the qum tissues cover them. They are not exposed to the mouth, but stay buried and left to heal. Once healed, a second surgery is performed to attach an abutment for securing the crown in place. This approach is used when there is poorer bone quality or quantity. Therefore, differences concerning the Indication for use are related to the patient conditions. These, do not lead to any unforeseeable risk.

4.2.2. RS Dental Implant

| Topic | RS Dental Implant | Primary Predicate
Nobel Biocare AB/NobelActive |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K142260 |
| Indication for Use | TRINON Titanium RS Dental Implants
are endosseous implants intended to
be surgically placed in the upper or
lower jaw bone for anchoring or
supporting tooth replacement to
restore patient esthetics and chewing
function.
TRINON Titanium RS Dental Implants
are indicated for single or multiple
unit restorations in non-splinted
applications. This can be achieved by
a 2-stage surgical technique in
combination with delayed loading
protocols, recognizing sufficient
primary stability and appropriate
occlusal loading for the selected
technique. | NobelActive® implants are endosseous implants
intended to be surgically placed in the upper or lower
jaw bone for anchoring or supporting tooth
replacements to restore patient esthetics and chewing
function.
NobelActive® implants are indicated for single or
multiple unit restorations in splinted or non-splinted
applications. This can be achieved by a 2-stage or 1-
stage surgical technique in combination with
immediate, early or delayed loading protocols,
recognizing sufficient primary stability and
appropriate occlusal loading for the selected
technique.
NobelActive® 3.0 implants are intended to replace a
lateral incisor in the maxilla and/or a central or lateral
incisor in the mandible.
NobelActive® 3.0 implants are indicated for single
unit restorations only. |
| Code | DZE | DZE |
| Implant Diameter
[mm] | 3.5
4.3
5.0
6.0 | 3.0
to
5.5 |
| Implant Length
[mm] | 8.5
10.0
11.5
13.0 | From
7.0
to
18.0 |

Technological characteristics of the RS Dental Implant are compared with the predicate devices in the following table.

15

Image /page/15/Picture/1 description: The image shows the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below it, in smaller, gray letters, is the word "TITANIUM."

| Topic | RS Dental Implant | Primary Predicate
Nobel Biocare AB/NobelActive |
|-------------------------------------|-------------------------------------------|---------------------------------------------------|
| | 14.5 | |
| | 16.0 | |
| Implant
Connection
(Geometry) | Hex 2.5 | Intern Hex |
| Design Stage | 2-phases | 1-phase
2-phases |
| Design Thread | Body: Single thread
Apex: Micro thread | Body: Double thread
Apex: Micro thread |
| Material | Titanium Grade 5 ELI | CP Titanium |
| Surface treatment | Blasted with aluminium oxide | TiUnite |
| Delivery status | Sterile (Irradiation) | Sterile (Irradiation) |

The subject device RS Dental Implant has a fundamentally similar design as the predicate Nobel Biocare AB / NobelActive Implants (K142260). The two implant designs share the same materials, manufacturing methods, tapered tip design, and surface treatment. The QZA Dental Implant compared to the primary predicate device of Nobel Biocare AB (Nobel Active) is substantial equivalence in the technological characteristics.

The RS Dental Implant compared to the primary predicate device of Nobel Biocare AB (Nobel Active) is substantial equivalence in the technological characteristics. All the differences between RS Dental Implant and the chosen predicate devices do not raise any further risk concerning device safety. These differences are covered by other medical devices already FDA approved and selected as reference devices (e.g. Implant Diameter 6.0 mm is covered by Dentis Co. Ltd./Dentis Dental Implant Systems (K073486). All design differences have been addressed. Bench tests have been performed according ISO 14801 in order to prove TRINON Titanium devices effectiveness. Furthermore, 1-stage surgical technique is used when a healing abutment is placed at the time of surgery. Following a 3 to 6 month healing period in which the implant fuses to the bone, a crown is then placed on the implant restoring the immediate appearance of a healthy, normal tooth. One-stage implant systems are generally used when the bone quality is good, guaranteeing good initial implant stability. They are also used when cosmetics is not a concern, such as the back areas of the mouth. A 2-stage surgical technique is typically used for replacing teeth where there is no immediate need for a cosmetic solution and when more of a margin of safety is required. With this approach, the implant(s) are placed into the jawbone and the qum tissues cover them. They are not exposed to the mouth, but stay buried and left to heal. Once healed, a second surgery is performed to attach an abutment for securing the crown in place. This approach is used when there is poorer bone quality or quantity. Therefore, differences concerning the Indication for use are related to the patient conditions. These, do not lead to any unforeseeable risk.

4.3. Dental Abutments

4.3.1. QZA Dental Abutments

Technological characteristics of the QZA Dental Abutment are compared with the predicate devices in the following table.

Topic	QZA Dental Abutments	Primary Predicate
		AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments

16

Image /page/16/Picture/1 description: The image contains the text "TRINON" in a large, bold, blue font. Below "TRINON" is the word "TITANIUM" in a smaller, black font. The text appears to be a logo or brand name. The overall design is simple and clean, with a focus on the text.

| Topic | QZA Dental Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K160221 |
| Indication for Use | TRINON QZA abutments are used with
a dental implant to provide support to
prosthetic restorations such as crown,
bridge and overdentures in partially or
fully edentulous patients. QZA
abutment models with an angulation
of 30° are indicated for multi-unit
loading, such as bridges or
overdentures. | Implance Dental Abutment System is used
with a dental implant to provide support to
prosthetic restoration such as crown, bridge
and overdentures in partially or fully
edentulous patients. Octa Abutments models
that contain an abutments post height less
than 4 mm are indicated only for multi-unit
loading, such as bridge or overdenture. |
| Code | NHA | NHA |
| Angle [°] | 0 | 0 |
| Diameter
[mm] | 3.3
3.5
4.5
4.8
5.4
5.5
5.7
6.5 | 3.5
3.7
4.3
4.5
5.5
6.5 |
| Length
[mm] | 7.65
8.9
9.9
10.9 | 9.0
10.5
11.5
12.0
12.4
12.5
13.4
13.5
14.4
14.5
15.4
15.5
16.4 |
| Gingival Height [mm] | 0.75
2.0
3.0
4.0 | 1.0
2.0
3.0
4.0
5.0 |
| Connection (Geometry) | Hex 2.5 | Conical |
| Material | Titanium Grade 5 ELI | Titanium Grade 4
Titanium Grade 5 |
| Delivery status | Non-Sterile | Non-Sterile |

The subject device QZA Dental Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The QZA Dental Abutment compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics (e.g. Diameters of 3.3 mm, length of 7.65 and 8.9, GH 0.75). All the differences between QZA Dental Abutment and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

17

Image /page/17/Picture/1 description: The image contains the logo for TRINON TITANIUM. The word "TRINON" is in large, bold, blue letters. Below that, the word "TITANIUM" is in smaller, gray letters.

Nobel Biocare USA LLC/NobelProvera PEEK Abutments (K120954) was used as reference device because of the material used.

Dentium Co., Ltd./Dentium Implantium & SuperLine Prostehtics (K160828) was used as reference device due to dimensional and connection features.

4.3.2. QZA Angled Abutments

Technological characteristics of the QZA Dental Abutment are compared with the predicate devices in the following table.

		Primary Predicate
Topic	QZA Angled Abutments	AGS Medikal Urunleri Ith. Ihr. Tic.
Ltd. Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON QZA abutments are used with a
dental implant to provide support to
prosthetic restorations such as crown,
bridge and overdentures in partially or
fully edentulous patients. QZA abutment
models with an angulation of 30° are
indicated for multi-unit loading, such as
bridges or overdentures.	Implance Dental Abutment System is
used with a dental implant to provide
support to prosthetic restoration such as
crown, bridge and overdentures in
partially or fully edentulous patients.
Octa Abutments models that contain an
abutments post height less than 4 mm
are indicated only for multi-unit loading,
such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	10
15
20	15
25
Diameter
[mm]	3.3
3.5
4.2
4.5
4.8
5.4
5.5
5.7
6.5	3.7
4.5
5.5
6.5
Length
[mm]	7.65
8.9
9.9
10.9	From
8.5
To
13.13
Gingival Height [mm]	0.75
2.0
3.0
4.0	1.0
2.0
4.0
5.0
Connection (Geometry)	Hex 2.5	Conical Hex
Material	Titanium Grade 5 ELI	Titanium Grade 4
Titanium Grade 5
Delivery status	Non-Sterile	Non-Sterile

The subject device QZA Angled Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because mechanical tests have been performed under worst case scenario to demonstrate their

18

Image /page/18/Picture/1 description: The image shows the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below it, in smaller, black letters, is the word "TITANIUM". The logo is simple and modern.

substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The QZA Angled Abutment compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics (e.g. Angle of 10 °, Diameters of 3.3 and 3.5 mm, Length of 7.65 mm, GH 0.75). All the differences between QZA Angled Abutment and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

4.3.3. QZA Ball Abutments

Technological characteristics of the QZA Ball Abutment are compared with the predicate devices in the following table.

| Topic | QZA Ball Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K160221 |
| Indication for Use | TRINON QZA abutments are used
with a dental implant to provide
support to prosthetic restorations
such as crown, bridge and
overdentures in partially or fully
edentulous patients. QZA abutment
models with an angulation of 30° are
indicated for multi-unit loading, such
as bridges or overdentures. | Implance Dental Abutment System is used
with a dental implant to provide support to
prosthetic restoration such as crown, bridge
and overdentures in partially or fully
edentulous patients. Octa Abutments models
that contain an abutments post height less
than 4 mm are indicated only for multi-unit
loading, such as bridge or overdenture. |
| Code | NHA | NHA |
| Angle [°] | 0 | 0 |
| Diameter
[mm] | 3.5
4.5
5.7 | 2.9
3.42
3.7
4.5 |
| Length
[mm] | 7.9
8.9
9.9
10.9
11.9 | From
9.1
to
13.6 |
| Gingival Height [mm] | 2.0
3.0
4.0
5.0
6.0 | 0.5
2.0
4.0 |
| Connection (Geometry) | Screw connection | Screw connection |
| Material | Titanium Grade 5 ELI | Titanium Grade 4
Titanium Grade 5 |
| Delivery status | Non-Sterile | Non-Sterile |

The subject device QZA Ball Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because

19

Image /page/19/Picture/1 description: The image shows the logo for "TRINION TITANIUM". The word "TRINION" is in a bold, sans-serif font and is colored blue. Below "TRINION" is the word "TITANIUM" in a smaller, sans-serif font, also in blue. The overall design is clean and modern.

mechanical tests have been performed under worst case scenario to demonstrate their substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The QZA Ball Abutment compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics (e.g. Diameters of 5.7 mm, length 7.9 and 8.9 mm, GH 5 and 6 mm). All the differences between QZA Ball Abutment and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

20

Image /page/20/Picture/1 description: The image shows the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below that, the word "TITANIUM" is in smaller, black letters. The logo is simple and modern.

4.3.4. QZA Healing Abutments

Technological characteristics of the QZA Healing Abutment are compared with the predicate devices in the following table.

		Primary Predicate
Topic	QZA Healing Abutment	AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON QZA abutments are used
with a dental implant to provide
support to prosthetic restorations
such as crown, bridge and
overdentures in partially or fully
edentulous patients. QZA abutment
models with an angulation of 30° are
indicated for multi-unit loading, such
as bridges or overdentures.	Implance Dental Abutment System is used
with a dental implant to provide support to
prosthetic restoration such as crown, bridge
and overdentures in partially or fully
edentulous patients. Octa Abutments models
that contain an abutments post height less
than 4 mm are indicated only for multi-unit
loading, such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	0	0
Diameter
[mm]	3.3
3.5
3.8
4.2
4.5
4.8
5.0
5.4
5.5
5.7
6.5	3.7
4.5
5.2
5.5
6.4
6.5
Length
[mm]	12.9
14.9
16.9	7.0
7.4
8.0
8.4
9.5
9.0
10.5
11.5
12.5
13.4
13.5
Gingival Height [mm]	3.0
5.0
7.0	1.0
2.0
2.5
3.0
3.5
4.0
5.0
5.5
7.0
Connection (Geometry)	Hex 2.5	Conical
Material	Titanium Grade 5 ELI	Titanium Grade 4
Titanium Grade 5
Delivery status	Non-Sterile	Non-Sterile

The subject device QZA Healing Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

001_510(K)_Summary_Rev4.doc

21

Image /page/21/Picture/1 description: The image shows the logo for TRINON Titanium. The word "TRINON" is in large, bold, blue letters. Below it, in smaller, gray letters, is the word "TITANIUM". The logo is simple and modern.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because mechanical tests have been performed under worst case scenario to demonstrate their substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The QZA Healing Abutment compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics (e.g. Diameters of 3.3 and 3.5 mm, Length of 14.9 and 16.9). All the differences between QZA Healing Abutment and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

4.3.5. QZA Overdenture Multi-Units Abutments

Technological characteristics of the QZA Overdenture Multi-Units Abutments are compared with the predicate devices in the following table.

| Topic | QZA Overdenture Multi-Units
Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K160221 |
| Indication for Use | TRINON QZA abutments are used
with a dental implant to provide
support to prosthetic restorations
such as crown, bridge and
overdentures in partially or fully
edentulous patients. QZA abutment
models with an angulation of 30° are
indicated for multi-unit loading, such
as bridges or overdentures. | Implance Dental Abutment System is used
with a dental implant to provide support to
prosthetic restoration such as crown, bridge
and overdentures in partially or fully
edentulous patients. Octa Abutments models
that contain an abutments post height less
than 4 mm are indicated only for multi-unit
loading, such as bridge or overdenture. |
| Code | NHA | NHA |
| Angle [°] | 0
15
30 | 0 |
| Diameter
[mm] | 3.5
4.5
5.7 | 3.7
4.5
5.2
5.5
6.4
6.5 |
| Length
[mm] | 5.65
6.9
7.9
8.9
9.9
10.9 | From
8.5
to
15.63 |
| Gingival Height [mm] | 0.75
2.0
3.0
4.0
5.0
6.0 | 1.0
2.0
3.0
4.0
5.0 |
| Connection (Geometry) | Hex 2.5 | Conical
Conical Hex |
| Material | Titanium Grade 5 ELI | Titanium Grade 4 |

001 510(K) Summary Rev4.doc

22

QZA and RS Dental Implant System 510(k) Premarket Notification

Image /page/22/Picture/2 description: The image contains the logo for "TRINON TITANIUM". The word "TRINON" is in a larger, bold, blue font, while the word "TITANIUM" is in a smaller, non-bold, gray font. The two words are stacked on top of each other, with "TITANIUM" centered below "TRINON".

		Titanium Grade 5
Delivery status	Non-Sterile	Non-Sterile

The subject device QZA Overdenture Multi-Units Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because mechanical tests have been performed under worst case scenario to demonstrate their substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The QZA Overdenture Multi-Unit Abutments compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics (e.g. Angle of 15 and 30°, Diameter of 3,5, Length of 5,65 and 6,9 and 7,7, GH 0.75 and 6.0). All the differences between QZA Overdenture Multi-Unit Abutments and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

23

Image /page/23/Picture/1 description: The image shows the logo for "TRINON TITANIUM". The word "TRINON" is in a bold, sans-serif font and is colored blue. Below "TRINON" is the word "TITANIUM" in a smaller, sans-serif font and is colored black.

4.3.6. QZA Q-Cone Abutments

Technological characteristics of the QZA Q-Cone Abutments are compared with the predicate devices in the following table.

| Topic | QZA Q-Cone Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K160221 |
| Indication for Use | TRINON Titanium QZA Dental
Implants are endosseous implants
intended to be surgically placed in
the upper or lower jaw bone for
anchoring or supporting tooth
replacement to restore patient
esthetics and chewing function.
TRINON Titanium QZA Dental
Implants are indicated for single or
multiple unit restorations in non-
splinted applications. This can be
achieved by a 2-stage surgical
technique in combination with
delayed loading protocols,
recognizing sufficient primary
stability and appropriate occlusal
loading for the selected technique.
TRINON Titanium QZA Dental
Implants with a diameter of 3.3 mm
may only be used in the upper jaw
as a single tooth replacement of the
lateral incisors and in the lower jaw
as a single tooth replacement of the
lateral and central incisors. | NobelActive® implants are endosseous
implants intended to be surgically placed in
the upper or lower jaw bone for anchoring or
supporting tooth replacements to restore
patient esthetics and chewing function.
NobelActive® implants are indicated for
single or multiple unit restorations in splinted
or non-splinted applications. This can be
achieved by a 2-stage or 1-stage surgical
technique in combination with immediate,
early or delayed loading protocols,
recognizing sufficient primary stability and
appropriate occlusal loading for the selected
technique.
NobelActive® 3.0 implants are intended to
replace a lateral incisor in the maxilla and/or
a central or lateral incisor in the mandible.
NobelActive® 3.0 implants are indicated for
single unit restorations only. |
| Code | NHA | NHA |
| Angle [°] | 0 | 0 |
| Diameter
[mm] | 3.3
3.5
4.5
5.5
7.5 | 3.5
3.7
4.3
4.5
5.5
6.5 |
| Length
[mm] | 7.65
8.9
9.9
10.9 | 9.0
10.5
11.5
12.0
12.4
12.5
13.4
13.5
14.4
14.5
15.4
15.5
16.4 |
| Gingival Height [mm] | 0.75
2.0
3.0
4.0 | 1.0
2.0
3.0
4.0
5.0 |
| Connection (Geometry) | Hex 2.5 | Conical |
| Material | Titanium Grade 5 ELI | Titanium Grade 4 |
| Topic | QZA Q-Cone Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
| | | Titanium Grade 5 |
| Delivery status | Non-Sterile | Non-Sterile |

001_510(K)_Summary_Rev4.doc

24

Image /page/24/Picture/1 description: The image contains the logo for "TRINON TITANIUM". The word "TRINON" is in a bold, sans-serif font and is colored blue. Below "TRINON" is the word "TITANIUM" in a smaller, sans-serif font, also in blue. The logo is simple and modern.

The subject device QZA Q-Cone Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because mechanical tests have been performed under worst case scenario to demonstrate their substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The QZA Q-Cone Abutments compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics (e.g. Diameters of 3.3 and 7,5 mm, Length of 7,65 and 8.9, GH 0.75). All the differences between QZA Q-Cone Abutments and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

4.3.7. QZA Q-Lock Abutments

Technological characteristics of the QZA Q-Lock Abutments are compared with the predicate devices in the following table.

| Topic | QZA Q-Lock Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K160221 |
| Indication for Use | TRINON Titanium QZA Dental Implants are
endosseous implants intended to be
surgically placed in the upper or lower jaw
bone for anchoring or supporting tooth
replacement to restore patient esthetics and
chewing function.
TRINON Titanium QZA Dental Implants are
indicated for single or multiple unit
restorations in non-splinted applications.
This can be achieved by a 2-stage surgical
technique in combination with delayed
loading protocols, recognizing sufficient
primary stability and appropriate occlusal
loading for the selected technique.
TRINON Titanium QZA Dental Implants with
a diameter of 3.3 mm may only be used in
the upper jaw as a single tooth replacement
of the lateral incisors and in the lower jaw
as a single tooth replacement of the lateral
and central incisors. | NobelActive® implants are endosseous
implants intended to be surgically placed in
the upper or lower jaw bone for anchoring or
supporting tooth replacements to restore
patient esthetics and chewing function.
NobelActive® implants are indicated for
single or multiple unit restorations in splinted
or non-splinted applications. This can be
achieved by a 2-stage or 1-stage surgical
technique in combination with immediate,
early or delayed loading protocols,
recognizing sufficient primary stability and
appropriate occlusal loading for the selected
technique.
NobelActive® 3.0 implants are intended to
replace a lateral incisor in the maxilla and/or
a central or lateral incisor in the mandible.
NobelActive® 3.0 implants are indicated for
single unit restorations only. |
| Code | NHA | NHA |
| Angle [°] | 0 | 0 |

25

Image /page/25/Picture/1 description: The image contains the logo for Trinnon Titanium. The word "TRINON" is in large, bold, blue letters. Below that, in smaller, thinner, gray letters, is the word "TITANIUM."

| Topic | QZA Q-Lock Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter
[mm] | 3.5
4.5
5.7 | 3.5
3.7
4.3
4.5
5.5
6.5 |
| Length
[mm] | 4.9
5.4
6.4
7.4
8.4
9.4
10.4
11.4 | 9.0
10.5
11.5
12.0
12.4
12.5
13.4
13.5
14.4
14.5
15.4
15.5
16.4 |
| Gingival Height
[mm] | 0.5
1.0
2.0
3.0
4.0
5.0
6.0
7.0 | 1.0
2.0
3.0
4.0
5.0 |
| Connection
(Geometry) | Hex 2.5 | Conical |
| Material | Titanium Grade 5 ELI | Titanium Grade 4
Titanium Grade 5 |
| Delivery status | Non-Sterile | Non-Sterile |
| | | Primary Predicate |
| Topic | QZA Temporary Abutments | AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
| 510k# | K163640 | K160221 |
| Indication for
Use | TRINON Titanium QZA Dental Implants are
endosseous implants intended to be surgically
placed in the upper or lower jaw bone for
anchoring or supporting tooth replacement to
restore patient esthetics and chewing function.
TRINON Titanium QZA Dental Implants are
indicated for single or multiple unit restorations
in non-splinted applications. This can be
achieved by a 2-stage surgical technique in
combination with delayed loading protocols,
recognizing sufficient primary stability and
appropriate occlusal loading for the selected
technique.
TRINON Titanium QZA Dental Implants with a
diameter of 3.3 mm may only be used in the
upper jaw as a single tooth replacement of the
lateral incisors and in the lower jaw as a single
tooth replacement of the lateral and central | NobelActive® implants are endosseous
implants intended to be surgically placed in
the upper or lower jaw bone for anchoring or
supporting tooth replacements to restore
patient esthetics and chewing function.
NobelActive® implants are indicated for
single or multiple unit restorations in splinted
or non-splinted applications. This can be
achieved by a 2-stage or 1-stage surgical
technique in combination with immediate,
early or delayed loading protocols,
recognizing sufficient primary stability and
appropriate occlusal loading for the selected
technique.
NobelActive® 3.0 implants are intended to
replace a lateral incisor in the maxilla and/or
a central or lateral incisor in the mandible.
NobelActive® 3.0 implants are indicated for |
| | incisors. | single unit restorations only. |
| Code | NHA | NHA |
| Angle [°] | 0 | 0 |
| Diameter
[mm] | 3.3
3.5
4.5
5.5
6.5 | 3.7
4.5
5.2
5.5
6.4
6.5 |
| Length
[mm] | 11.65 | 7.0
7.4
8.0
8.4
9.5
9.0
10.5
11.5
12.5
13.4
13.5 |
| Gingival Height
[mm] | 0.75 | 1.0
2.0
2.5
3.0
3.5
4.0
5.0
5.5
7.0 |
| Connection
(Geometry) | Hex 2.5 | Conical |
| Material | Titanium Grade 5 ELI | Titanium Grade 4 |
| | PEEK | Titanium Grade 5 |
| Delivery status | Non-Sterile | Non-Sterile |

The subject device QZA Q-Lock Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because mechanical tests have been performed under worst case scenario to demonstrate their substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The QZA Q-Lock Abutments compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics(e.g. length less the 9, GH 0.5, 6 and 7). All the differences between QZA Q-Lock Abutments and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

26

Image /page/26/Picture/1 description: The image contains the logo for Trinon Titanium. The word "TRINON" is in large, bold, blue letters. Below that, in smaller, gray letters, is the word "TITANIUM."

4.3.8. QZA Temporary Abutments

Technological characteristics of the QZA Temporary Abutments are compared with the predicate devices in the following table.

001_510(K)_Summary_Rev4.doc

27

Image /page/27/Picture/1 description: The image shows the logo for TRINON TITANIUM. The word "TRINON" is in a large, bold, blue font. Below it, the word "TITANIUM" is in a smaller, thinner, black font. The logo is simple and modern.

The subject device QZA Temporary Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because mechanical tests have been performed under worst case scenario to demonstrate their substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The QZA Temporary Abutments compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments is substantial equivalence in the technological characteristics(e.g. Diameters of 3.3 and 3.5 mm, GH 0.75). All the differences between QZA Temporary Abutments and the chosen predicate devices do not raise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

28

Image /page/28/Picture/1 description: The image shows the logo for TRINION TITANIUM. The word "TRINION" is in large, bold, blue letters. Below that, in smaller black letters, is the word "TITANIUM."

4.4. RS Abutments

Technological characteristics of the RS Abutments are compared with the predicate devices in the following table.

| Topic | RS Abutments | Primary Predicate
AGS Medikal Urunleri Ith. Ihr. Tic. Ltd.
Sti/Abutments |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k# | K163640 | K160221 |
| Indication for Use | TRINON RS abutments are used with a
dental implant to provide support to
prosthetic restorations such as crown,
bridge and overdentures in partially or
fully edentulous patients. | Implance Dental Abutment System is used
with a dental implant to provide support to
prosthetic restoration such as crown, bridge
and overdentures in partially or fully
edentulous patients. Octa Abutments models
that contain an abutments post height less
than 4 mm are indicated only for multi-unit
loading, such as bridge or overdenture. |
| Code | NHA | NHA |
| Angle [°] | 0 | 0 |
| Diameter
[mm] | 4.7
5.2
6.2
7.2 | 3.5
3.7
4.3
4.5
5.5
6.5 |
| Length
[mm] | 8.0
9.5
10.0
11.0
11.5
12.5
13.0
14.5 | 9.0
10.5
11.5
12.0
12.4
12.5
13.4
13.5
14.4
14.5
15.4
15.5
16.4 |
| Gingival Height
[mm] | 1.5
3.0
4.5
6.0 | 1.0
2.0
3.0
4.0
5.0 |
| Connection
(Geometry) | Hex 2.5 | Conical |
| Material | Titanium Grade 5 ELI | Titanium Grade 4
Titanium Grade 5 |
| Delivery status | Non-Sterile | Non-Sterile |

The subject device RS Abutment has a fundamentally similar design as the predicate AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Angled Abutments) (K160221). The two abutment designs share the same dimensions, materials, and manufacturing methods.

The described devices have a fundamentally similar design as the aforementioned predicate. The abutments share the same materials, manufacturing methods, and technical characteristics. The discovered differences are not expected to lead to any hazard situation because mechanical tests have been performed under worst case scenario to demonstrate their

001_510(K)_Summary_Rev4.doc

29

Image /page/29/Picture/1 description: The image shows the logo for "TRINION TITANIUM". The word "TRINION" is in large, bold, blue letters. Below it, "TITANIUM" is written in smaller, gray letters.

substantial equivalence. Furthermore, Dental Implants and Abutments FDA guideline has been fulfilled in accordance with requested info.

The RS Abutments compared to the primary predicate device of AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti/Abutments are substantial equivalence in the technological characteristics (e.q. Diameters of 7.2 mm, length of 8, GH 6). All the differences between RS Abutments and the chosen predicate devices do not rise any further risk concerning device safety. All design differences have been addressed. Bench tests have been performed according ISO 14801 on worst case product considering connection between implant and abutment.

30

Image /page/30/Picture/1 description: The image contains the logo for "TRINION TITANIUM". The word "TRINION" is in a larger, bold, blue font. Below it, "TITANIUM" is written in a smaller, non-bold, blue font. The logo is simple and clean, with a focus on the company name.

5. Performance Data

Performance testing of the QZA Dental Implant System and RS Dental Implant System followed the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

5.1. Biocompatibility

Following standard has been implemented in order to assess the biological safety of our devices:

• . EN ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Standard	Test	Result
EN ISO
10993-5	Cytotoxicity	The results indicate that the test material does not release substances in
cytotoxic concentrations during a permanent 24±2 h contact of 4.4 cm²
surface area to 1 ml physiological fluid.
EN ISO
10993-12	Chemical Analysis
– Characterization
of
Organic Extractable	In the present investigation the test material was extracted with
isopropanol for 24±2 h at a physiological temperature of 37±1°C. The test
material showed no changes in color or shape after isopropanol
extraction. The extract did not differ optically from the reagent control.
The isopropanol extract did not contain detectable organic substances.
Peaks with a signal-to-noise ratio between 3 were disregarded.
EN ISO
10993-18
USP 85	LAL Endotoxin