TREFOIL System

K152836 · Nobel Biocare AB · DZE · Apr 11, 2016 · Dental

Device Facts

• Record ID: K152836
• Device Name: TREFOIL System
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: Apr 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: - Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm). - Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. - Implant-supported prosthetics seated directly on dedicated implants

Device Story

TREFOIL System restores chewing function in fully edentulous mandibles; utilizes three threaded CP4 titanium endosseous implants placed between mental foramina. System includes surgical tooling and pre-designed titanium-vanadium alloy prosthetic bar. Implants feature internal conical abutment connection and TiUnite surface treatment. Surgical procedure involves 1-stage technique with immediate function loading protocol; early/delayed loading used if primary stability insufficient. Clinician uses guided surgery instruments to place implants; framework bar provides compensation mechanism for passive fit. System benefits patients by providing fixed prosthetic restoration. Bench testing confirms angular/translational accuracy and fatigue strength per ISO 14801.

Clinical Evidence

Bench testing only. Accuracy of surgical protocol evaluated via cone beam CT on bone models. Passive fit of framework confirmed via 3D modeling. Fatigue testing conducted per ISO 14801, demonstrating higher fatigue strength than predicate. Biocompatibility, sterilization (ANSI/AAMI/ISO 11137/17665-1), and shelf-life validated via predicate data and real-time aging.

Technological Characteristics

Implants: CP4 titanium, parallel-walled, internal conical connection, TiUnite surface (anodic oxidation). Bar: Titanium-vanadium alloy. Surgical tools: Stainless steel (DIN EN 10027-2 1.4197), DLC coated. Sterilization: Gamma radiation (sterile) or moist heat (non-sterile). Connectivity: None (mechanical system).

Indications for Use

Indicated for fully edentulous patients requiring restoration of chewing function in the mandible. Requires adequate bone (min 13mm height, 6-7mm width) and mouth opening (min 40mm). Contraindicated if insufficient primary stability is achieved for immediate loading, though early/delayed loading protocols may be used.

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

• Branemark Novum (K000018)

Reference Devices

• NobelActive (K142260)
• NobelProcera Overdenture Bar (K132749)

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

April 11, 2016

Nobel Biocare AB c/o Ms. Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K152836

Trade/Device Name: TREFOIL System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA, DZI Dated: March 2, 2016 Received: March 3, 2016

Dear Ms. Chua:

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 (reporting of medical devicerelated 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 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 yours, Tina Kiang -S

for Erin I. Keith, M.S. 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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| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| 510(k) Number (if known) | K152836 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TREFOIL System |
| Indications for Use (Describe) | The TREFOIL System is used to restore chewing function in fully edentulous mandibles. |
| | The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. |
| | The following prerequisites must be fulfilled: |
| | - Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm). |
| | - Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. |
| | - Implant-supported prosthetics seated directly on dedicated implants |

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b>Prescription Use</b></span> (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## I. SUBMITTER

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: [phone] x 7830 Fax: [phone]

Date Prepared: April 7, 2016

II. DEVICE

Name of Device: TREFOIL System Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Primary Product Code: DZE Other Product Code(s): NHA. DZI

## III. PREDICATE DEVICE

Primary predicate: Nobel Biocare - Branemark Novum (K000018) This predicate has not been subject to a design-related recall.

Reference predicates: Nobel Biocare - NobelActive (K142260) This predicate has not been subject to a design-related recall

Nobel Biocare - NobelProcera Overdenture Bar (K132749) This predicate has not been subject to a design-related recall

## IV. DEVICE DESCRIPTION

The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.

The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.

A.4.

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The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal conical abutment connection. The implant is available in 11.5 mm length with two available collar lengths (4.5, 6.0 mm). The apex of the implants have cutting chamber allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium allov. The TREFOIL System surgical tooling is made of stainless steel.

## V. INDICATIONS FOR USE

The TREFOIL System is used to restore chewing function in fully edentulous mandibles.

The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol.

The following prerequisites must be fulfilled:

- Adequate quantity of bone (minimum height of 13mm and minimum width of 6-7mm).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants

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#### VI. Comparison of Technological Characteristics

## Comparison of indication for use statement

| | Subject Device | Primary Predicate |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TREFOIL System | Branemark Novum (K000018) |
| Indication for use statement | The TREFOIL System is used to restore chewing function<br>in fully edentulous mandibles.<br><br>The three implants of the TREFOIL System are placed<br>between the mental foramina in fully edentulous mandibles<br>in a 1-stage surgical technique combined with an<br>immediate function loading protocol, provided sufficient<br>primary stability for the selected technique is achieved.<br>In cases where sufficient primary stability for two implants or<br>more is not reached, the implants along with the Framework<br>may also be used with an early or delayed loading protocol.<br><br>The following prerequisites must be fulfilled:<br>- Adequate quantity of bone (minimum height of<br>13mm and minimum width of 6-<br>7mm).<br>- Adequate mouth opening (minimum 40 mm) to<br>accommodate the guided surgery instruments.<br>- Implant-supported prosthetics seated directly<br>on dedicated implants | Totally edentulous mandibles with a minimum height of 13 mm and a minimum width of 6mm. Patient must be subject to dental treatment with endosseous implants. For use in a single stage procedure where the implants are immediately loaded. |

Comparison of Indications for Use: The intended use of the TREFOL System is substantially equivalent to the Branemark Novum (K000018) predicate. The prerequisites for minimum bone with remain the same, while the TREFOL System provides additional safety prerequisites for mouth opening minimum size and implant supporting of seated prosiderations from the labeling of the Branemark Novum (K00018) predicate have been added to the indications for use of the TREFOL System regarding number of implants for placement, functional loading, and primary stability, which do not affect the intended use.

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## Implant Comparison

| Technological<br>characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|----------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------|
| Implant Design Features | TREFOIL System | Branemark Novum (K000018) | NobelActive (K142260) | |
| | Implant<br>Body Design | Parallel walled | Parallel walled | Expanding Taper |
| | Implant Tip<br>Design | Tapered self cutting<br>3.8 mm apex w/9.5° angle | Tapered self cutting with through hole<br>3.5 mm apex w/15° angle | Drilling blades on apex<br>5.35 mm apex |
| | Implant<br>Length | 16.0 mm overall (11.5 mm body w/ 4.5 mm<br>collar)<br>17.5 mm overall (11.5 mm body w/ 6.0 mm<br>collar) | 17.5 mm overall (11.5 mm body w/ 6.0 mm<br>collar) | 6.5, 8, 9.5, 11, 12.5 mm |
| | Implant<br>Diameter | 4.93 mm | 5.0 mm | 5.5 |
| | Platform<br>Diameter | 4.5 mm | 4.5 mm | 5.5 |
| | Thread<br>angle/pitch | 60°/.8mm | 60°/.8mm | variable |
| | Connection<br>Type | Internal Hex with snap feature | External hex | Internal Hex |
| | Device<br>Material | CP titanium | CP titanium | CP titanium |
| | Surface<br>modification | TiUnite (anodic oxidation) | Machined titanium | TiUnite (anodic oxidation) |

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## Framework Bar Comparison

| Technological<br>characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|----------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Bar Design Features | TREFOIL System | Branemark Novum (K000018) | NobelProcera Overdenture Bar<br>(K132749) | |
| | Bar Design | Preshaped single piece design screw<br>retained to implant. | Preshaped two piece design. Lower bar<br>screw retained to implants directly. Upper<br>prosthetic bar screw retained to lower bar. | |
| | Intended<br>platform | TREFOIL implant (intenal conical connection<br>with snap fit) | Branemark Novum implant (external hex) | |
| | Materials | Titanium vanadium alloy | CP titanium | |
| | Surface<br>modification | Machined titanium | Machined titanium | |
| | Compensation<br>mechanism | Round abutment and corresponding<br>framework and screw disks | Implant collar partially shaped by pre-<br>torquing technique. | |
| | Prosthetic<br>media | Acrylic | Acrylic | |
| | Fixed<br>cantilever<br>length | 18.8 mm | 19.7 | |
| Technological<br>characteristics | | | Subject Device | Predicate |
| | | | TREFOIL System | Branemark Novum (K000018) |
| Surgical tooling type<br>Drill | Diameter | 2.0, 3.0, 3.8, 4.0, 4.2, 4.4 mm | 2.0, 2.5, 3.0, 3.5, 3.8, 4.0, 4.2, 4.3, 4.4 mm | |
| | Flute length | 16.0 mm (including tip) | 18.0, 24.0 mm (excluding tip) | |
| | Material | Stainless Steel<br>DIN EN 10027-2 – 1.4197<br>DLC coated | Stainless Steel<br>440F Hardened to MN 500 HV2<br>No coating | |
| | Connection | ISO 1797 Type 1 | ISO 1797 Type 1 | |
| | Markings | All drills marked at 11.5 mm and 13.5 mm | 18.0 mm length single marked for 11.5 mm implant thread<br>24.0 mm length marked for both 11.5 mm implant thread | |
| | Flute design | Two flutes | Three flutes | |
| | Tip design | 90° (2mm)<br>130° (3.0, 3.8, 4.0, 4.2, 4.4 mm) | 120° | |
| | Intended use | The drills are used together with corresponding Templates<br>for drills for the preparation of the implant sites. | The drills are used together with corresponding Templates for<br>drills for the preparation of the implant sites. | |
| Screw Tap | Flute length | 17.0 mm | 15.5 mm | |
| | Diameter | 5.0 mm | 4.5 mm | |
| | Materials | Stainless Steel<br>DIN EN 10027-2 – 1.4197<br>DLC coated | Titanium vanadium alloy | |
| | Connection | ISO 1797 Type 1 | 2.4 mm square | |
| | Intended use | The screw tap is used when dense bone is present to<br>prepare for the threaded implant | The screw tap is used when dense bone is present to prepare for<br>the threaded implant | |
| Stabilizing<br>screw | Core diameter | 1.8 | 1.8 | |
| | Length | 14.0 mm (to stop)<br>19.3 mm (overall) | 13.0 mm (to stop)<br>20.0 mm (overall) | |
| | Materials | 316 Stainless Steel | 316 Stainless Steel | |
| | Intended use | The stabilizing screw is used to temporarily connect the V-<br>template to the alveolar ridge | Short and long screws used to stabilize the V-gage template to<br>the alveolar ridge | |

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# Surgical Tooling Comparison

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## VII. PERFORMANCE DATA

Laboratory testing was performed to establish the accuracy of the TREFOIL System surgical protocol. This testing included placement of the Trefoil implants into bone models following the Trefoil Instructions for Use and utilizing Trefoil surgical tooling. The results were evaluated by cone beam computed tomography. This testing established the angular and translational accuracy errors generated by the surgical procedure.

The ability of the Trefoil framework compensation mechanism to adapt to the expected angular and translational accuracy errors qenerated by the surgical procedure was established through the use of three-dimensional modeling. The modeling confirmed that the Trefoil compensation mechanism will ensure a passive fit of the framework bar on the Trefoil implants.

Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. Fatigue testing was done by using a test scenario developed for splinted implant applications. Fatigue testing was conducted and results analyzed in accordance with ISO 14801. The results demonstrate higher fatigue strength than the predicate Branemark Novum (K000018).

## Summary of Non-Clinical Testing:

Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).

- . Sterile Device Information
- The sterilization method for the subiect devices provided sterile is the same as o the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- The sterilization methods for the subject devices provided non-sterile and to be o end user sterilized are pre-vacuum and gravity moist heat sterilization and have been validated in accordance with ANSI/AAMI/ISO ISO 17665-1.
- . Device Packaging
- The packaging for the subject device is the same as the predicate. This is a o titanium cylinder placed in a plastic vial with PVC shrink-wrap and tamper resistant strip. Therefore, no additional testing was required.
- . Shelf Life
- The packaging for the subject device is the same as the predicate and is labeled o with a 5 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- . Biocompatibility
- The subject device is manufactured from the same material using the same o manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required
- . Surface Treatment
- The Trefoil implants have the same surface treatment (TiUnite) as the predicate O NobelActive implants. The TiUnite surface treatment was qualified through Auger analysis, IR spectrum analysis, and cytotoxicity testing. Therefore, no additional testing was required.

## VIII. CONCLUSIONS

The information provided in this submission demonstrates that the device is substantially equivalent to the predicate devices.