TRINON Q & Q3 IMPLANT SYSTEM

K103577 · Trinon Titanium GmbH · DZE · Jul 3, 2012 · Dental

Device Facts

• Record ID: K103577
• Device Name: TRINON Q & Q3 IMPLANT SYSTEM
• Applicant: Trinon Titanium GmbH
• Product Code: DZE · Dental
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Trinon Q & Q3 Implant System is indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Trinon Q & Q3 Implant System might be loaded in the anterior mandibular arch if four are splinted together with a bar.

Device Story

One-piece endosseous dental implant system; titanium construction; self-cutting thread design. Used in dental practices by qualified implantologists, oral surgeons, or maxilla surgeons. Input: surgical site in partially edentulous jaw. Operation: implant placed into bone; transgingival healing; supports telescopic/conical crowns, crowns, bridges, and ball attachment restorations. Output: fixed dental restoration support. Benefits: immediate placement of temporary crown; eliminates need for second surgery. Healthcare providers use clinical judgment and radiographic assessment to determine bone adequacy before placement.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included risk analysis, cleanliness, biocompatibility (ISO 10993), sterilization, cytotoxicity, and packaging. All acceptance criteria met; performance equivalent to predicate devices.

Technological Characteristics

One-piece endosseous dental implant; titanium material; self-cutting thread; integral pre-contoured abutment. Available in 8, 10, 12, 14mm lengths and 3.5, 4.5mm diameters. Q-system features 7° cone; Q3-system features ballpoint-head. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for support and retention of fixed single tooth and fixed partial denture restorations in premolar, cuspid, and incisor regions of partially edentulous jaws. May be loaded in anterior mandibular arch if four are splinted with a bar. Requires adequate bone quality, width, and height. Contraindicated in patients with systemic conditions (e.g., diabetes, smokers) or allergies to implant components.

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

• Zimmer Dental Inc. (K062281)
• Zimmer Dental Inc. (K061717)
• Zimmer Dental Inc. (K052997)

Submission Summary (Full Text)

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| 510(k) Summary as required by section 807.92(c) | Date: 6/27/12 |
|-------------------------------------------------|---------------|
|-------------------------------------------------|---------------|

| K-number: | K103577 |
|-------------------------------------------|-----------------------------------------------------------------------------|
| Submission Applicant: | Trinon Titanium GmbH<br>Augartenstr. 1<br>76137 Karlsruhe |
| | JUL 3 2012 |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Establishment Registration Number: | 3007636114 |
| Application correspondent/Contact person: | think!<br>Markus Denk<br>Schwarzwaldstraße 5<br>78532 Tuttlingen<br>Germany |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Trade name: | Trinon Q an Q³ implant system |
| Common name: | One-piece implant system |

### Classfication name:

Endosseous dental implant, Dental (21 CFR 872.3640- DZE)

# Predicate Devices: K062281, K061717, K052997– Zimmer Dental Inc. , 1900 Aston Ave., Carlsbad, CA 92008

KU022261, KU061717, KU052997 - Zimmer Dental Inc., 1900 Aston Ave., Carlsbad, CA 92008

### Description of the Device:

This low-cost implant system was developed to cover many indications in implant dentistry. Designed to provide simplicity and clarity, TRINON TITANIUM GmbH has created a system that removes many of the disadvantages of earlier implant systems. This single-phase enossal implant is made of titanium and there are no complex components. Its self-cutting thread allows the immediate placement of a temporary crown. The transgingival healing makes a second operation unnecessary.

The application areas are telescopic and conical crowns, crowns and bridges, and ball attachment restorations.

Our one-piece implant system line is divided into the Q-implant system and the Q3 implant-system. The top of the Q-implant system was designed with a 7° cone, whereas the Q3-implant sytem is a one-phase implant with a ballpoint-head. The TRINON Q- and Q³ Implants and its components are available in the lengths 8, 10, 12 and 14mm and diameters 3.5 and 4.5mm.

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# Indication range:

For single and multiple tooth replacement in the upper and lower jaw. Adequate bone quality, width and height must be available. It has to be proven carefully, if the systemic state of the patient is adequate for an implantation, and especially if there are any allergic reactions on the implant components as well as any prohibitive diseases (e.q. diabetes, smoker).

# Indications for Use:

Trinon Q & Q3 Implant System is indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Trinon Q & Q3 Implant System might be loaded in the anterior mandibular arch if four are splinted together with a bar.

#### Comparison with Predicate Devices:

The Trinon product is similiar to the Predicate Devices in terms of technical characteristics, design, Indications for Use, target population, where it is used, performance, biocompatibility characteristics as well as sizes and configurations. Similar as the Zimmer predicate devices the Trinon implants are onepiece constructions, have an integral, pre-contoured abutment, a tapered implant body, a titanium alloy construction, self-cutting thread, and an implant head with symmetrical, axially directed grooves.

| Relevant Areas | TRINON Q- and Q3-implant system | | Result Zimmer One-Piece Implant (straight &<br>angled) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Indications for use | Trinon Q & Q3 Implant System is indicated for<br>the support and retention of fixed single tooth<br>and fixed partial denture restorations in the<br>premolar, cuspid, and incisor regions of<br>partially edentulous jaws. Trinon Q & Q3<br>Implant System might be loaded in the anterior<br>mandibular arch if four are splinted together<br>with a bar | s.e. | Zimmer® One-Piece 4.7mm, Straight implants<br>are indicated for the support and retention of<br>fixed single tooth and fixed partial denture<br>restorations in the premolar, cuspid, and incisor<br>regions of partially edentulous jaws. Zimmer(@<br>One-Piece 4.7mm, Straight implants may be<br>loaded immediately in the anterior mandibular<br>arch if four are splinted together with a bar. The<br>Zimmer® One-Piece 4.7mm, Straight implant may be immediately restored with a temporary<br>prosthesis that is not in functional occlusion. |
| Material | TRINON Q-Implants are made of Titanium | s.e.: | Identical |
| Target population | Professional use only - qualified dental<br>implantologists, oral surgeons or maxilla<br>surgeons only. Strictly reserved to specialise<br>and trained users. | Is.e. | Identical |
| Where used | Dental practises | s.e. | Dental practises |
| Design | All implants are delivered in a double blister<br>packaging for sterile handling. They come in a<br>polypropylene sleeve, supported by a | s.e.: | Identical |
| | polypropylene plug. The sleeve with the<br>implant is sealed in a double transparent<br>blister, the outer blister of which is supplied | | |
| | with a sandwich tag for transference to the<br>patient file (LOT No.) | | |
| Performance./<br>Biocompatibility | Testing according ISO 10993 Biological<br>Evaluation of Medical Devices applying all<br>relevant provisions for the devices.<br>All relevant testing regarding biocompatibility | s.e. | The same material is used for the predicate<br>devices manufactured and distributed by Zimmer<br>Dental Inc., Carlsbad, CA 92008, |
| | was carried out by TRINON TITANIUM GmbH<br>with a total compliance with the provisions of<br>ISO 10993 | | USA, which received market clearance and are in<br>commercial distribution. |
| Sterilisation | Implants, drills and other invasive components<br>are sold and used sterile. All other components<br>and accessories are sold non-sterile. | s.e. | Identical |
| Design, Sizes,<br>Shades | TRINON Q- and Q3 Implants and its<br>components are available in the following | s.e. | Zimmer One-Piece implants (straight & angled)<br>and its components are available in the following |

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K103577

# >Summarv

lengths and diameters: Diameter: 0.3.5 and 4.5mm Length: 8, 10, 12 and 14mm

lengths and diameters:

Diameter:
Ø3.0, 3.7 and 4.7mm
Length:
10, 11.5, 13 and 16mm

Conclusion: The Trinon product can be deemed substantially equivalent for its indicated use.

# Summary of the non-clinical Tetsing Data

Results of risk analysis, case studies, cleanliness testing, biocompatibility, sterilization, cytotoxicity and packaging testing have demonstrated that TRINON Q- and Q³ Implants are equivalent to the predicate device implants tested. When compared with predicate devices, results of bench performance testing indicated all acceptance criteria were met, and demonstrated the subject implants are equivalent. A series of safety and performance testing were performed to demonstrate that the TRINON Q- and Q3 Implants do not raise any new issues of safety and efficacy.

## Summary

The presented data that was conducted on the Trinon products shows in its results and in comparison to the predicate devices substantially equivalent to predicate devices for their intended use. All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures. The used materials are well researched.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side.

#### Public Health Service

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

Trinon Titanium GmbH C/O Mr. Markus Denk Regulatory Affairs Manager think! Schwarzwald Strasse 5 Tuttlingen Germany 78576

3 2012 JUL

Re: K103577

Trade/Device Name: Trinon Q & Q Implant System (One-Piece Implant System) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 28, 2012 Received: July 2, 2012

Dear Mr. Denk:

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 Eederal Register.

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# Page 2 - Mr. Denk

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

# Enclosure

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# Indication for Use

510(k) Number: K103577

Device Name: Trinon Q & Q3 Implant System (One-Piece Implant System)

Indications for use:

Indications for use.
Trinon Q & Qª Implant System is indicated for the support and retention of fixed single tooth and fixed Thilion & & Timplant Oyoton to marcator , cuspid, and incisor regions of partially edentulous jaws. partial centre resorations in the promotal, each if the anterior mandibular arch if four are splinted together with a bar.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of DCRH, Office of Device Evaluation (ODE)

Page 01 of 01

Sheenabain for MSR

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control. Dental Devices

510(k) Number: K163577