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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TRINON Titanium QZA and RS Dental Implant Systems. This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than proving its effectiveness through clinical trials with specific performance metrics.

Therefore, the acceptance criteria and study information, as commonly sought for AI/ML device performance, are not explicitly present in the provided text. The document focuses on demonstrating substantial equivalence through comparisons with predicate devices and performance bench testing rather than clinical study outcomes.

However, I can extract information related to the performance data presented (bench tests and biocompatibility).

Here's an interpretation based on the provided text, addressing the points where information is available or noting its absence:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates) for a study proving effectiveness. Instead, it relies on demonstrating substantial equivalence to predicate devices and acceptable results from specific bench tests and biocompatibility studies.

Acceptance Criterion (Implicit)	Reported Device Performance (Bench Testing/Standards)
Biocompatibility: No cytotoxicity	Test material does not release substances in cytotoxic concentrations during permanent 24±2 hr contact of 4.4 cm² surface area to 1 ml physiological fluid (EN ISO 10993-5).
Biocompatibility: Chemical composition	Isopropanol extract did not contain detectable organic substances (EN ISO 10993-12, EN ISO 10993-18).
Biocompatibility: Endotoxin levels	< 0.30 EU / Sample (USP 85 LAL Endotoxin).
Sterilization: Sterility Assurance Level (SAL)	Validated to ensure a SAL of 10⁻⁶ (for sterilized implants) and 10⁻⁶ (for end-user sterilized abutments) (ISO 11137-1, ISO 11137-2).
Packaging: Integrity	Passed tests for detecting gross leaks, determining integrity of seals, seal strength, and dye penetration (ASTM F2096, ASTM F1886/F1886M, ASTM F88/F88M, EN 868-5, ASTM F1929).
Transport: Validation	Validated in accordance with ISO 11607-1.
Mechanical Testing: Fatigue Strength	Worst-case QZA and RS implant/abutment combinations found consistent with FDA Class II Special Controls guidance and ISO 14801.
Substantial Equivalence: Design, Materials, Intended Use	Device has "same or similar intended use, material composition, basic design, dimensions and surface treatment" as predicate devices (Conclusion statement).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Testing: The document does not specify a "test set" in the context of clinical data. For the reported bench tests (biocompatibility, mechanical, sterilization, packaging), the sample sizes are not explicitly stated. The tests refer to "test material," "worst case product," or "worst case QZA and RS Dental Implant System with the worst case Abutments," implying a limited number of samples selected specifically for these engineering tests.
Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based. The device manufacturer, TRINON Titanium GmbH, is based in Karlsruhe, Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document does not describe a clinical study involving human expert review for establishing ground truth or diagnostic performance. The context is product design validation against standards and comparison to predicate devices, not AI/ML diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no clinical test set or subjective expert evaluation for adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or described. This document pertains to a dental implant system, not a diagnostic AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (dental implant and abutment) and not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground truth, in the context of this 510(k) submission, is established through adherence to recognized international and national standards (e.g., ISO 10993 for biocompatibility, ISO 14801 for mechanical fatigue, ISO 11137 for sterilization) and comparison of technological characteristics to existing FDA-cleared predicate devices. There is no clinical "ground truth" (like pathology or outcomes data) presented.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human profiles facing right, with flowing lines beneath them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a "-S" below the name. The signature is a complex, looping design to the left of the name.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163640

Device Name QZA and RS Dental Implant System

Indications for Use (Describe)

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 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)

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."

{3}------------------------------------------------

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

{4}------------------------------------------------

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.: +49 721 932700 Fax: +49-(0)721-24991 E-Mail: trinon@trinon.com Internet: http://www.trinon.com/

CONTACT PERSON: Katja Lvova Chief Executive Officer (CEO) Tel.: +49 721 932700 E-Mail: katja.lvova@trinon.com

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	MedicalSpecialty	Review Panel	Product Code	Device Class	RegulationNumber
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	MedicalSpecialty	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.

{5}------------------------------------------------

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 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 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

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

Picture	Diameter [mm]	Length [mm]	Implant Connection
Image: dental implants	3.3	8.010.012.014.0	Hex 2.5
	3.5	8.010.012.014.0	Hex 2.5
	3.8	8.010.012.014.0	Hex 2.5
	4.2	8.010.012.014.0	Hex 2.5
	4.5	8.010.012.014.0	Hex 2.5
	4.8	8.010.012.014.0	Hex 2.5
	5.4	8.010.012.014.0	Hex 2.5
	5.7	8.010.012.014.0	Hex 2.5

3.2. QZA Dental Abutments

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	3.33.54.54.85.45.55.76.5	7.658.99.910.9	0.752.03.04.0
QZA AngledAbutment	Image: QZA Angled Abutment	101520	3.33.54.24.54.85.45.55.76.5	7.658.99.910.9	0.752.03.04.0
QZA BallAbutment	Image: QZA Ball Abutment	0	3.54.55.7	7.98.99.910.911.9	2.03.04.05.06.0
QZA HealingAbutment	Image: QZA Healing Abutment	0	3.33.53.84.24.54.85.05.45.76.5	12.914.916.9	3.05.07.0
QZA OverdentureMulti Unit	Image: QZA Overdenture Multi Unit	01530	3.54.55.7	5.656.97.98.99.910.9	0.752.03.04.05.06.0
QZA Q-ConeAbutment	Image: QZA Q-Cone Abutment	0	3.33.54.55.56.5	7.658.99.910.9	0.752.03.04.0
QZA Q-LockAbutment	Image: QZA Q-Lock Abutment	0	3.54.55.7	4.95.46.47.48.49.410.411.4	0.51.02.03.04.05.06.07.0
QZA TemporaryAbutment	Image: Abutment	0	3.33.54.55.56.5	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 wellas bridge restauration where an angularcorrection is not required.	May be manually fabricateddown to a minimum height of4mm from collar.
QZA AngledAbutment	Image: QZA Angled Abutment	For permanent single tooth restoration as wellas bridge restauration. Different abutmentsvariations are available for 10°, 15° or 20°angular correction.	May be manually fabricateddown to a minimum height of4mm from collar.
QZA TemporaryAbutment	Image: QZA Temporary Abutment	For temporary single tooth restoration as wellas bridge restauration where an angularcorrection is not required.	May be manually fabricateddown to a minimum height of4mm from collar.
QZA BallAbutment	Image: QZA Ball Abutment	For overdenture only	No additional angularcorrection.
QZA Q-LockAbutment	Image: QZA Q-Lock Abutment	For overdenture only	No additional angularcorrection.
QZA HealingAbutment	Image: QZA Healing Abutment	To form soft tissue before end restoration	-
QZA OverdentureMulti Unit	Image: QZA Overdenture Multi Unit	For multi-unit only	No additional angularcorrection.
QZA Q-ConeAbutment	Image: QZA Q-Cone Abutment	For bridge only	No additional angularcorrection.

{9}------------------------------------------------

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

Picture	Diameter [mm]	Length [mm]	Implant Connection
Image: Implant	3.5	8.510.011.513.014.516.0	Hex 2.5
	4.3	8.510.011.513.014.516.0	Hex 2.5
	5.0	8.510.011.513.014.516.0	Hex 2.5
	6.0	8.510.011.513.014.516.0	Hex 2.5

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

3.2.2.2. RS Dental Abutment

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".

StandardAbutmentO 4.7 mm	Heightsmargim [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
StandardAbutmentO 5.2 mm	Heightsmargim [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
StandardAbutmentO 62 mm	Heightsmargim [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
StandardAbutmentO 7.2 mm	Heightsmargim [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:

CandidateDevices	Predicate Device(Manufacturer/ProprietaryName)	PredicateDevice510(k) N°	Reference Device 1(Manufacturer/ProprietaryName)	ReferenceDevice510(k) N°
TrinonTitaniumRSDentalImplant			Dentis Co. Ltd./Dentis DentalImplant Systems	K073486
QZADentalImplant	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:

CandidateDevicesTrinonTitanium	PrimaryPredicate Device(Manufacturer/ProprietaryName)	PrimaryPredicateDevice510(k) N°	Reference Device 1(Manufacturer/ProprietaryName)	ReferenceDevice510(k) N°
RSAbutment	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System (SolidAbutments)		Dentium Co., Ltd./DentiumImplantium & SuperLineProstehtics	K160828
RSCover Screw
QZAAbutment	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System (SolidAbutments)
QZAAngledAbutment	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System (AngledAbutments)	K160221
QZABall Abutment	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System(O-Ring Abutments)		-	-
QZAHealingAbutment	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System(Healing Abutments)		Dentium Co., Ltd./DentiumImplantium & SuperLineProstehtics	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.

CandidateDevicesTrinonTitanium	PrimaryPredicate Device(Manufacturer/ProprietaryName)	Reference Device 1(Manufacturer/ProprietaryName)	ReferenceDevice510(k) N°
QZAOverdentureMulti Unit	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System(Couple/Multi Abutments)	AGS Medikal Urunleri Ith. Ihr. Tic.Ltd. Sti./Implance Dental ImplantSystem, Implance DentalAbutment System (AngledAbutments)	K160221
QZAQ-Cone	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System (SolidAbutments)	Dentium Co., Ltd./DentiumImplantium & SuperLineProstehtics	K160828
QZAQ-Lock
QZATemporaryAbutment	AGS Medikal Urunleri Ith. Ihr.Tic. Ltd. Sti./Implance DentalImplant System, ImplanceDental Abutment System(Healing Abutments)	Nobel Biocare USALLC/NobelProvera PEEKAbutments	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 PredicateNobel Biocare AB/NobelActive
510k#	K163640	K142260
Indication for Use	TRINON Titanium QZA Dental Implants areendosseous implants intended to besurgically placed in the upper or lower jawbone for anchoring or supporting toothreplacement to restore patient estheticsand chewing function.TRINON Titanium QZA Dental Implants areindicated for single or multiple unitrestorations in non-splinted applications.This can be achieved by a 2-stage surgicaltechnique in combination with delayedloading protocols, recognizing sufficientprimary stability and appropriate occlusalloading for the selected technique.TRINON Titanium QZA Dental Implantswith a diameter of 3.3 mm may only beused in the upper jaw as a single toothreplacement of the lateral incisors and inthe lower jaw as a single toothreplacement of the lateral and centralincisors.	NobelActive® implants are endosseous implantsintended to be surgically placed in the upper orlower jaw bone for anchoring or supporting toothreplacements to restore patient esthetics andchewing function.NobelActive® implants are indicated for single ormultiple unit restorations in splinted or non-splinted applications. This can be achieved by a2-stage or 1-stage surgical technique incombination with immediate, early or delayedloading protocols, recognizing sufficient primarystability and appropriate occlusal loading for theselected technique.NobelActive® 3.0 implants are intended toreplace a lateral incisor in the maxilla and/or acentral or lateral incisor in the mandible.NobelActive® 3.0 implants are indicated forsingle unit restorations only.
Code	DZE	DZE
Implant Diameter[mm]	3.33.53.84.24.54.85.45.7	3.0to5.5
Implant Length[mm]	8.010.012.014.0	From7.0to18.0
ImplantConnection(Geometry)	Hex 2.5	Intern Hex
Design Stage	2-phases	1-phase2-phases
Design Thread	Body: Single threadApex: Micro thread	Body: Double threadApex: 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 PredicateNobel Biocare AB/NobelActive
510k#	K163640	K142260
Indication for Use	TRINON Titanium RS Dental Implantsare endosseous implants intended tobe surgically placed in the upper orlower jaw bone for anchoring orsupporting tooth replacement torestore patient esthetics and chewingfunction.TRINON Titanium RS Dental Implantsare indicated for single or multipleunit restorations in non-splintedapplications. This can be achieved bya 2-stage surgical technique incombination with delayed loadingprotocols, recognizing sufficientprimary stability and appropriateocclusal loading for the selectedtechnique.	NobelActive® implants are endosseous implantsintended to be surgically placed in the upper or lowerjaw bone for anchoring or supporting toothreplacements to restore patient esthetics and chewingfunction.NobelActive® implants are indicated for single ormultiple unit restorations in splinted or non-splintedapplications. This can be achieved by a 2-stage or 1-stage surgical technique in combination withimmediate, early or delayed loading protocols,recognizing sufficient primary stability andappropriate occlusal loading for the selectedtechnique.NobelActive® 3.0 implants are intended to replace alateral incisor in the maxilla and/or a central or lateralincisor in the mandible.NobelActive® 3.0 implants are indicated for singleunit restorations only.
Code	DZE	DZE
Implant Diameter[mm]	3.54.35.06.0	3.0to5.5
Implant Length[mm]	8.510.011.513.0	From7.0to18.0

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 PredicateNobel Biocare AB/NobelActive
	14.5
	16.0
ImplantConnection(Geometry)	Hex 2.5	Intern Hex
Design Stage	2-phases	1-phase2-phases
Design Thread	Body: Single threadApex: Micro thread	Body: Double threadApex: 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 PredicateAGS Medikal Urunleri Ith. Ihr. Tic. Ltd.Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON QZA abutments are used witha dental implant to provide support toprosthetic restorations such as crown,bridge and overdentures in partially orfully edentulous patients. QZAabutment models with an angulationof 30° are indicated for multi-unitloading, such as bridges oroverdentures.	Implance Dental Abutment System is usedwith a dental implant to provide support toprosthetic restoration such as crown, bridgeand overdentures in partially or fullyedentulous patients. Octa Abutments modelsthat contain an abutments post height lessthan 4 mm are indicated only for multi-unitloading, such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	0	0
Diameter[mm]	3.33.54.54.85.45.55.76.5	3.53.74.34.55.56.5
Length[mm]	7.658.99.910.9	9.010.511.512.012.412.513.413.514.414.515.415.516.4
Gingival Height [mm]	0.752.03.04.0	1.02.03.04.05.0
Connection (Geometry)	Hex 2.5	Conical
Material	Titanium Grade 5 ELI	Titanium Grade 4Titanium 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 adental implant to provide support toprosthetic restorations such as crown,bridge and overdentures in partially orfully edentulous patients. QZA abutmentmodels with an angulation of 30° areindicated for multi-unit loading, such asbridges or overdentures.	Implance Dental Abutment System isused with a dental implant to providesupport to prosthetic restoration such ascrown, bridge and overdentures inpartially or fully edentulous patients.Octa Abutments models that contain anabutments post height less than 4 mmare indicated only for multi-unit loading,such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	101520	1525
Diameter[mm]	3.33.54.24.54.85.45.55.76.5	3.74.55.56.5
Length[mm]	7.658.99.910.9	From8.5To13.13
Gingival Height [mm]	0.752.03.04.0	1.02.04.05.0
Connection (Geometry)	Hex 2.5	Conical Hex
Material	Titanium Grade 5 ELI	Titanium Grade 4Titanium 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 PredicateAGS Medikal Urunleri Ith. Ihr. Tic. Ltd.Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON QZA abutments are usedwith a dental implant to providesupport to prosthetic restorationssuch as crown, bridge andoverdentures in partially or fullyedentulous patients. QZA abutmentmodels with an angulation of 30° areindicated for multi-unit loading, suchas bridges or overdentures.	Implance Dental Abutment System is usedwith a dental implant to provide support toprosthetic restoration such as crown, bridgeand overdentures in partially or fullyedentulous patients. Octa Abutments modelsthat contain an abutments post height lessthan 4 mm are indicated only for multi-unitloading, such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	0	0
Diameter[mm]	3.54.55.7	2.93.423.74.5
Length[mm]	7.98.99.910.911.9	From9.1to13.6
Gingival Height [mm]	2.03.04.05.06.0	0.52.04.0
Connection (Geometry)	Screw connection	Screw connection
Material	Titanium Grade 5 ELI	Titanium Grade 4Titanium 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.

{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 usedwith a dental implant to providesupport to prosthetic restorationssuch as crown, bridge andoverdentures in partially or fullyedentulous patients. QZA abutmentmodels with an angulation of 30° areindicated for multi-unit loading, suchas bridges or overdentures.	Implance Dental Abutment System is usedwith a dental implant to provide support toprosthetic restoration such as crown, bridgeand overdentures in partially or fullyedentulous patients. Octa Abutments modelsthat contain an abutments post height lessthan 4 mm are indicated only for multi-unitloading, such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	0	0
Diameter[mm]	3.33.53.84.24.54.85.05.45.55.76.5	3.74.55.25.56.46.5
Length[mm]	12.914.916.9	7.07.48.08.49.59.010.511.512.513.413.5
Gingival Height [mm]	3.05.07.0	1.02.02.53.03.54.05.05.57.0
Connection (Geometry)	Hex 2.5	Conical
Material	Titanium Grade 5 ELI	Titanium Grade 4Titanium 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 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-UnitsAbutments	Primary PredicateAGS Medikal Urunleri Ith. Ihr. Tic. Ltd.Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON QZA abutments are usedwith a dental implant to providesupport to prosthetic restorationssuch as crown, bridge andoverdentures in partially or fullyedentulous patients. QZA abutmentmodels with an angulation of 30° areindicated for multi-unit loading, suchas bridges or overdentures.	Implance Dental Abutment System is usedwith a dental implant to provide support toprosthetic restoration such as crown, bridgeand overdentures in partially or fullyedentulous patients. Octa Abutments modelsthat contain an abutments post height lessthan 4 mm are indicated only for multi-unitloading, such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	01530	0
Diameter[mm]	3.54.55.7	3.74.55.25.56.46.5
Length[mm]	5.656.97.98.99.910.9	From8.5to15.63
Gingival Height [mm]	0.752.03.04.05.06.0	1.02.03.04.05.0
Connection (Geometry)	Hex 2.5	ConicalConical 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 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 PredicateAGS Medikal Urunleri Ith. Ihr. Tic. Ltd.Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON Titanium QZA DentalImplants are endosseous implantsintended to be surgically placed inthe upper or lower jaw bone foranchoring or supporting toothreplacement to restore patientesthetics and chewing function.TRINON Titanium QZA DentalImplants are indicated for single ormultiple unit restorations in non-splinted applications. This can beachieved by a 2-stage surgicaltechnique in combination withdelayed loading protocols,recognizing sufficient primarystability and appropriate occlusalloading for the selected technique.TRINON Titanium QZA DentalImplants with a diameter of 3.3 mmmay only be used in the upper jawas a single tooth replacement of thelateral incisors and in the lower jawas a single tooth replacement of thelateral and central incisors.	NobelActive® implants are endosseousimplants intended to be surgically placed inthe upper or lower jaw bone for anchoring orsupporting tooth replacements to restorepatient esthetics and chewing function.NobelActive® implants are indicated forsingle or multiple unit restorations in splintedor non-splinted applications. This can beachieved by a 2-stage or 1-stage surgicaltechnique in combination with immediate,early or delayed loading protocols,recognizing sufficient primary stability andappropriate occlusal loading for the selectedtechnique.NobelActive® 3.0 implants are intended toreplace a lateral incisor in the maxilla and/ora central or lateral incisor in the mandible.NobelActive® 3.0 implants are indicated forsingle unit restorations only.
Code	NHA	NHA
Angle [°]	0	0
Diameter[mm]	3.33.54.55.57.5	3.53.74.34.55.56.5
Length[mm]	7.658.99.910.9	9.010.511.512.012.412.513.413.514.414.515.415.516.4
Gingival Height [mm]	0.752.03.04.0	1.02.03.04.05.0
Connection (Geometry)	Hex 2.5	Conical
Material	Titanium Grade 5 ELI	Titanium Grade 4
Topic	QZA Q-Cone Abutments	Primary PredicateAGS 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 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 PredicateAGS Medikal Urunleri Ith. Ihr. Tic. Ltd.Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON Titanium QZA Dental Implants areendosseous implants intended to besurgically placed in the upper or lower jawbone for anchoring or supporting toothreplacement to restore patient esthetics andchewing function.TRINON Titanium QZA Dental Implants areindicated for single or multiple unitrestorations in non-splinted applications.This can be achieved by a 2-stage surgicaltechnique in combination with delayedloading protocols, recognizing sufficientprimary stability and appropriate occlusalloading for the selected technique.TRINON Titanium QZA Dental Implants witha diameter of 3.3 mm may only be used inthe upper jaw as a single tooth replacementof the lateral incisors and in the lower jawas a single tooth replacement of the lateraland central incisors.	NobelActive® implants are endosseousimplants intended to be surgically placed inthe upper or lower jaw bone for anchoring orsupporting tooth replacements to restorepatient esthetics and chewing function.NobelActive® implants are indicated forsingle or multiple unit restorations in splintedor non-splinted applications. This can beachieved by a 2-stage or 1-stage surgicaltechnique in combination with immediate,early or delayed loading protocols,recognizing sufficient primary stability andappropriate occlusal loading for the selectedtechnique.NobelActive® 3.0 implants are intended toreplace a lateral incisor in the maxilla and/ora central or lateral incisor in the mandible.NobelActive® 3.0 implants are indicated forsingle 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 PredicateAGS Medikal Urunleri Ith. Ihr. Tic. Ltd.Sti/Abutments
Diameter[mm]	3.54.55.7	3.53.74.34.55.56.5
Length[mm]	4.95.46.47.48.49.410.411.4	9.010.511.512.012.412.513.413.514.414.515.415.516.4
Gingival Height[mm]	0.51.02.03.04.05.06.07.0	1.02.03.04.05.0
Connection(Geometry)	Hex 2.5	Conical
Material	Titanium Grade 5 ELI	Titanium Grade 4Titanium 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 forUse	TRINON Titanium QZA Dental Implants areendosseous implants intended to be surgicallyplaced in the upper or lower jaw bone foranchoring or supporting tooth replacement torestore patient esthetics and chewing function.TRINON Titanium QZA Dental Implants areindicated for single or multiple unit restorationsin non-splinted applications. This can beachieved by a 2-stage surgical technique incombination with delayed loading protocols,recognizing sufficient primary stability andappropriate occlusal loading for the selectedtechnique.TRINON Titanium QZA Dental Implants with adiameter of 3.3 mm may only be used in theupper jaw as a single tooth replacement of thelateral incisors and in the lower jaw as a singletooth replacement of the lateral and central	NobelActive® implants are endosseousimplants intended to be surgically placed inthe upper or lower jaw bone for anchoring orsupporting tooth replacements to restorepatient esthetics and chewing function.NobelActive® implants are indicated forsingle or multiple unit restorations in splintedor non-splinted applications. This can beachieved by a 2-stage or 1-stage surgicaltechnique in combination with immediate,early or delayed loading protocols,recognizing sufficient primary stability andappropriate occlusal loading for the selectedtechnique.NobelActive® 3.0 implants are intended toreplace a lateral incisor in the maxilla and/ora 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]	3.33.54.55.56.5	3.74.55.25.56.46.5
Length[mm]	11.65	7.07.48.08.49.59.010.511.512.513.413.5
Gingival Height[mm]	0.75	1.02.02.53.03.54.05.05.57.0
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 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 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 PredicateAGS Medikal Urunleri Ith. Ihr. Tic. Ltd.Sti/Abutments
510k#	K163640	K160221
Indication for Use	TRINON RS abutments are used with adental implant to provide support toprosthetic restorations such as crown,bridge and overdentures in partially orfully edentulous patients.	Implance Dental Abutment System is usedwith a dental implant to provide support toprosthetic restoration such as crown, bridgeand overdentures in partially or fullyedentulous patients. Octa Abutments modelsthat contain an abutments post height lessthan 4 mm are indicated only for multi-unitloading, such as bridge or overdenture.
Code	NHA	NHA
Angle [°]	0	0
Diameter[mm]	4.75.26.27.2	3.53.74.34.55.56.5
Length[mm]	8.09.510.011.011.512.513.014.5	9.010.511.512.012.412.513.413.514.414.515.415.516.4
Gingival Height[mm]	1.53.04.56.0	1.02.03.04.05.0
Connection(Geometry)	Hex 2.5	Conical
Material	Titanium Grade 5 ELI	Titanium Grade 4Titanium 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.

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 ISO10993-5	Cytotoxicity	The results indicate that the test material does not release substances incytotoxic concentrations during a permanent 24±2 h contact of 4.4 cm²surface area to 1 ml physiological fluid.
EN ISO10993-12	Chemical Analysis– CharacterizationofOrganic Extractable	In the present investigation the test material was extracted withisopropanol for 24±2 h at a physiological temperature of 37±1°C. The testmaterial showed no changes in color or shape after isopropanolextraction. 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 ISO10993-18
USP 85	LAL Endotoxin	< 0.30 EU / Sample

Then requirements provided in the below listed standards have been fulfilled:

Biocompatibility evaluation is able to demonstrate the biological safety of the QZA and RS Dental Implant Systems.

Bioburden is evaluated in accordance with:

. EN ISO 11737-1: Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

5.2. Surface Treatment Analysis

Trinon QZA and RS-Dental Implants are blasted with white corundum (aluminium oxide). SEM analysis of the blasted surface found that QZA and RS Dental Implant surface is homogeneous. Chemical characterization of the QZA and RS surface was performed after washing. No detectable substances were found.

Sterilization and Shelf-Life Validation 5.3.

QZA and RS Dental Implants are sterilized using irradiation sterilization process that has been validated to ensure a SAL of 105. The QZA and RS abutments are provided non-sterile. Sterilization of the dental abutment system is performed by the end-user following parameters used in a validated steam sterilization method that achieves a SAL of 10°. The QZA and RS Dental Implants are labelled sterile with a 5-year shelf life.

Following validations/tests have been performed in order to ensure the substantial equivalence of our devices:

Sterilization Validation in accordance with: .

{31}------------------------------------------------

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

Image /page/31/Picture/2 description: The image contains the logo for "TRINON TITANIUM". The word "TRINON" is in a larger, bold, blue font, stacked on top of the word "TITANIUM". The word "TITANIUM" is in a smaller, non-bold, black font. The logo is simple and clean, with a focus on the company name.

י ISO 11137-1: Sterilization of health care products- Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
I ISO 11137-2: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Packaging Validation in accordance with: ●
- י ASTM F2096: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- I ASTM F1886/F1886M: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- י ASTM F 88/F 88M: Standard Test Method for Seal Strength of Flexible Barrier Materials
- I EN 868-5: Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
- I ASTM F 1929: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Transport Validation in accordance with: .
- I ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

Mechanical Testing 5.4.

Fatigue testing on the worst case QZA and RS Dental Implant System with the worst case Abutments was conducted in accordance with the ISO 14801 Dentistry-Implants-Dynamic fatique test for Endosseous dental implants. Results of the fatique testing found that the worst case QZA and RS implant/abutment combinations were consistent with FDA Class II Special Controls guidance and ISO 14801.

6. Risk to Health

Trinon performed the risk analyses according to DIN EN ISO 14971:2013 Medical devices -Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012.

The risk management includes the following activities:

. Initial identification and assessment of risks associated with the use of the products based on risk analysis, which are part of the technical documentation;
Monitoring of emerging risks based on the evaluation of recognized complaints;
Observation of notifications from other manufactures based on the BfArM database;
Updating existing risk analysis based on the analyzed data; ●
Annual assessment of risk management activities based on the management review.

{32}------------------------------------------------

Image /page/32/Picture/1 description: The image contains the logo for "TRINION TITANIUM". The word "TRINION" is in a bold, sans-serif font and is colored in blue. Below "TRINION" is the word "TITANIUM" in a smaller, sans-serif font, also in blue. The logo is simple and modern, with a focus on the company name.

7. Conclusions

The QZA and RS Dental Implant System have the same or similar intended use, material composition, basic design, dimensions and surface treatment.

Based on an a comparative assessment with the predicate devices, and the performance test data, the QZA and RS Dental Implant Systems are determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.