QZA and RS Dental Implant Systems

K163640 · Trinon Titanium GmbH · DZE · May 3, 2017 · Dental

Device Facts

• Record ID: K163640
• Device Name: QZA and RS Dental Implant Systems
• Applicant: Trinon Titanium GmbH
• Product Code: DZE · Dental
• Decision Date: May 3, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

System consists of endosseous root-form dental implants and prosthetic abutments; used for anchoring/supporting tooth replacements (crowns, bridges, overdentures). Implants surgically placed in upper/lower jaw bone; 2-stage surgical technique with delayed loading. Implants feature titanium grade 5 construction, hexagonal internal cone connection, spiralock thread, and micro-threads in cortical region. Abutments provide prosthetic support; various models (angled, ball, healing, multi-unit, Q-Cone, Q-Lock) available. Used in dental clinics by trained clinicians. Output is a stable foundation for prosthetic restoration, restoring patient esthetics and chewing function. Benefits include improved oral function and appearance for edentulous patients.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1, -5, -12, -18 and USP 85. Fatigue testing performed per ISO 14801. Sterilization and packaging validated per ISO 11137, ISO 11607, and ASTM standards.

Technological Characteristics

Materials: Titanium Grade 5 ELI. Design: Two-stage, root-form endosseous implants with hexagonal internal cone connection and spiralock thread. Surface: Blasted with aluminium oxide. Sterilization: Irradiation (implants), steam (abutments). Connectivity: Mechanical connection to prosthetic components.

Indications for Use

Indicated for single or multiple unit restorations in non-splinted applications in partially or fully edentulous patients requiring tooth replacement. 3.3 mm QZA implants restricted to lateral incisors (upper jaw) and lateral/central incisors (lower jaw).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nobel Biocare AB/NobelActive (K142260)
• AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implance Dental Implant System, Implance Dental Abutment System (Solid Abutments) (K160221)

Reference Devices

• Dentis Co. Ltd./Dentis Dental Implant Systems (K073486)
• Dentium Co., Ltd./Dentium Implantium & SuperLine Prostehtics (K160828)
• Nobel Biocare USA LLC/NobelProvera PEEK Abutments (K120954)

Submission Summary (Full Text)

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical 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<br>Specialty | Review Panel | Product Code | Device Class | Regulation<br>Number |
|--------------------------------------|----------------------|--------------|--------------|--------------|----------------------|
| implant,<br>endosseous,<br>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<br>Specialty | Review Panel | Product Code | Device Class |
|-----------------------------|----------------------|--------------|--------------|--------------|
| abutment,<br>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.

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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<br>10.0<br>12.0<br>14.0 | Hex 2.5 |
| | 3.5 | 8.0<br>10.0<br>12.0<br>14.0 | Hex 2.5 |
| | 3.8 | 8.0<br>10.0<br>12.0<br>14.0 | Hex 2.5 |
| | 4.2 | 8.0<br>10.0<br>12.0<br>14.0 | Hex 2.5 |
| | 4.5 | 8.0<br>10.0<br>12.0<br>14.0 | Hex 2.5 |
| | 4.8 | 8.0<br>10.0<br>12.0<br>14.0 | Hex 2.5 |
| | 5.4 | 8.0<br>10.0<br>12.0<br>14.0 | Hex 2.5 |
| | 5.7 | 8.0<br>10.0<br>12.0<br>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:

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

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### 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<br>as bridge restauration where an angular<br>correction is not required. | May be manually fabricated<br>down to a minimum height of<br>4mm from collar. |
| QZA Angled<br>Abutment | Image: QZA Angled Abutment | For permanent single tooth restoration as well<br>as bridge restauration. Different abutments<br>variations are available for 10°, 15° or 20°<br>angular correction. | May be manually fabricated<br>down to a minimum height of<br>4mm from collar. |
| QZA Temporary<br>Abutment | Image: QZA Temporary Abutment | For temporary single tooth restoration as well<br>as bridge restauration where an angular<br>correction is not required. | May be manually fabricated<br>down to a minimum height of<br>4mm from collar. |
| QZA Ball<br>Abutment | Image: QZA Ball Abutment | For overdenture only | No additional angular<br>correction. |
| QZA Q-Lock<br>Abutment | Image: QZA Q-Lock Abutment | For overdenture only | No additional angular<br>correction. |
| QZA Healing<br>Abutment | Image: QZA Healing Abutment | To form soft tissue before end restoration | - |
| QZA Overdenture<br>Multi Unit | Image: QZA Overdenture Multi Unit | For multi-unit only | No additional angular<br>correction. |
| QZA Q-Cone<br>Abutment | Image: QZA Q-Cone Abutment | For bridge only | No additional angular<br>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<br>10.0<br>11.5<br>13.0<br>14.5<br>16.0 | Hex 2.5 |
| | 4.3 | 8.5<br>10.0<br>11.5<br>13.0<br>14.5<br>16.0 | Hex 2.5 |
| | 5.0 | 8.5<br>10.0<br>11.5<br>13.0<br>14.5<br>16.0 | Hex 2.5 |
| | 6.0 | 8.5<br>10.0<br>11.5<br>13.0<br>14.5<br>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:

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

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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<br>Devices | Predicate Device<br>(Manufacturer/Proprietary<br>Name) | Predicate<br>Device<br>510(k) N° | Reference Device 1<br>(Manufacturer/Proprietary<br>Name) | Reference<br>Device<br>510(k) N° |
|-----------------------------------------------|--------------------------------------------------------|----------------------------------|----------------------------------------------------------|----------------------------------|
| Trinon<br>Titanium<br>RS<br>Dental<br>Implant | | | Dentis Co. Ltd./Dentis Dental<br>Implant Systems | K073486 |
| QZA<br>Dental<br>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<br>Devices<br>Trinon<br>Titanium | Primary<br>Predicate Device<br>(Manufacturer/Proprietary<br>Name) | Primary<br>Predicate<br>Device<br>510(k) N° | Reference Device 1<br>(Manufacturer/Proprietary<br>Name) | Reference<br>Device<br>510(k) N° |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------|----------------------------------|
| RS<br>Abutment | AGS Medikal Urunleri Ith. Ihr.<br>Tic. Ltd. Sti./Implance Dental<br>Implant System, Implance<br>Dental Abutment System (Solid<br>Abutments) | | Dentium Co., Ltd./Dentium<br>Implantium & SuperLine<br>Prostehtics | K160828 |
| RS<br>Cover Screw | | | | |
| QZA<br>Abutment | AGS Medikal Urunleri Ith. Ihr.<br>Tic. Ltd. Sti./Implance Dental<br>Implant System, Implance<br>Dental Abutment System (Solid<br>Abutments) | | | |
| QZA<br>Angled<br>Abutment | AGS Medikal Urunleri Ith. Ihr.<br>Tic. Ltd. Sti./Implance Dental<br>Implant System, Implance<br>Dental Abutment System (Angled<br>Abutments) | K160221 | | |
| QZA<br>Ball Abutment | AGS Medikal Urunleri Ith. Ihr.<br>Tic. Ltd. Sti./Implance Dental<br>Implant System, Implance<br>Dental Abutment System<br>(O-Ring Abutments) | | - | - |
| QZA<br>Healing<br>Abutment | AGS Medikal Urunleri Ith. Ihr.<br>Tic. Ltd. Sti./Implance Dental<br>Implant System, Implance<br>Dental Abutment System<br>(Healing Abutments) | | Dentium Co., Ltd./Dentium<br>Implantium & SuperLine<br>Prostehtics | K160828 |

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

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

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

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

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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<br>Nobel Biocare AB/NobelActive |
|-------------------------------------|-------------------------------------------|---------------------------------------------------|
| | 14.5 | |
| | 16.0 | |
| Implant<br>Connection<br>(Geometry) | Hex 2.5 | Intern Hex |
| Design Stage | 2-phases | 1-phase<br>2-phases |
| Design Thread | Body: Single thread<br>Apex: Micro thread | Body: Double thread<br>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.<br>Sti/Abutments |

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

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Image /page/17/Picture/1 description: The image contains the logo for TRINON TITANIU…