(195 days)
No
The summary describes a system of dental implants, surgical tools, and a prosthetic bar for restoring chewing function. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on surgical accuracy, framework adaptation, and fatigue strength, not on any AI/ML model performance.
Yes
The device is used to restore chewing function, which is a therapeutic purpose.
No.
The TREFOIL System is a dental implant system designed to restore chewing function and esthetics, not to diagnose medical conditions. Its use involves surgical placement of implants and prosthetic components.
No
The device description explicitly details physical components such as dental implants, surgical components, and prosthetic components made of titanium, stainless steel, and titanium vanadium alloy. It also describes laboratory testing involving placement of implants into bone models and fatigue testing, indicating a hardware-based system.
Based on the provided information, the TREFOIL System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The TREFOIL System is a surgical and prosthetic system used to restore chewing function by placing implants directly into the patient's mandible. It does not involve the analysis of biological samples.
- The intended use and device description clearly outline a surgical and restorative procedure. The system is used to place dental implants and a prosthetic bar in the mandible.
- The performance studies focus on surgical accuracy, mechanical fit, and fatigue strength. These are relevant to the physical performance and placement of the device within the body, not to diagnostic testing of biological samples.
Therefore, the TREFOIL System falls under the category of a medical device used for surgical and prosthetic purposes, not an in vitro diagnostic device.
N/A
Intended Use / 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 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
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA, DZI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fully edentulous mandibles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
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.
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 (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 (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 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
2
| 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (1/14)
MARCH 2016
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
K152836-S001: Al Response (11-20-2015)
Page 20 of 270
10
3
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: (714) 282-4800 x 7830 Fax: (714) 998-9348
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.
4
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
5
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 | |
| 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 | 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.
6
Implant Comparison
| Technological
| characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Implant Design Features | TREFOIL System | Branemark Novum (K000018) | NobelActive (K142260) | |
| Implant | ||||
| Body Design | Parallel walled | Parallel walled | Expanding Taper | |
| Implant Tip | ||||
| Design | Tapered self cutting | |||
| 3.8 mm apex w/9.5° angle | Tapered self cutting with through hole | |||
| 3.5 mm apex w/15° angle | Drilling blades on apex | |||
| 5.35 mm apex | ||||
| Implant | ||||
| Length | 16.0 mm overall (11.5 mm body w/ 4.5 mm | |||
| collar) | ||||
| 17.5 mm overall (11.5 mm body w/ 6.0 mm | ||||
| collar) | 17.5 mm overall (11.5 mm body w/ 6.0 mm | |||
| collar) | 6.5, 8, 9.5, 11, 12.5 mm | |||
| Implant | ||||
| Diameter | 4.93 mm | 5.0 mm | 5.5 | |
| Platform | ||||
| Diameter | 4.5 mm | 4.5 mm | 5.5 | |
| Thread | ||||
| angle/pitch | 60°/.8mm | 60°/.8mm | variable | |
| Connection | ||||
| Type | Internal Hex with snap feature | External hex | Internal Hex | |
| Device | ||||
| Material | CP titanium | CP titanium | CP titanium | |
| Surface | ||||
| modification | TiUnite (anodic oxidation) | Machined titanium | TiUnite (anodic oxidation) |
7
Framework Bar Comparison
| Technological
| characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Bar Design Features | TREFOIL System | Branemark Novum (K000018) | NobelProcera Overdenture Bar | |
| (K132749) | ||||
| Bar Design | Preshaped single piece design screw | |||
| retained to implant. | Preshaped two piece design. Lower bar | |||
| screw retained to implants directly. Upper | ||||
| prosthetic bar screw retained to lower bar. | ||||
| Intended | ||||
| platform | TREFOIL implant (intenal conical connection | |||
| with snap fit) | Branemark Novum implant (external hex) | |||
| Materials | Titanium vanadium alloy | CP titanium | ||
| Surface | ||||
| modification | Machined titanium | Machined titanium | ||
| Compensation | ||||
| mechanism | Round abutment and corresponding | |||
| framework and screw disks | Implant collar partially shaped by pre- | |||
| torquing technique. | ||||
| Prosthetic | ||||
| media | Acrylic | Acrylic | ||
| Fixed | ||||
| cantilever | ||||
| length | 18.8 mm | 19.7 | ||
| Technological | ||||
| characteristics | Subject Device | Predicate | ||
| TREFOIL System | Branemark Novum (K000018) | |||
| Surgical tooling type | ||||
| 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 | |||
| DIN EN 10027-2 – 1.4197 | ||||
| DLC coated | Stainless Steel | |||
| 440F Hardened to MN 500 HV2 | ||||
| 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 | ||
| 24.0 mm length marked for both 11.5 mm implant thread | ||||
| Flute design | Two flutes | Three flutes | ||
| Tip design | 90° (2mm) | |||
| 130° (3.0, 3.8, 4.0, 4.2, 4.4 mm) | 120° | |||
| Intended use | The drills are used together with corresponding Templates | |||
| for drills for the preparation of the implant sites. | The drills are used together with corresponding Templates for | |||
| 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 | |||
| DIN EN 10027-2 – 1.4197 | ||||
| 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 | |||
| prepare for the threaded implant | The screw tap is used when dense bone is present to prepare for | |||
| the threaded implant | ||||
| Stabilizing | ||||
| screw | Core diameter | 1.8 | 1.8 | |
| Length | 14.0 mm (to stop) | |||
| 19.3 mm (overall) | 13.0 mm (to stop) | |||
| 20.0 mm (overall) | ||||
| Materials | 316 Stainless Steel | 316 Stainless Steel | ||
| Intended use | The stabilizing screw is used to temporarily connect the V- | |||
| template to the alveolar ridge | Short and long screws used to stabilize the V-gage template to | |||
| the alveolar ridge |
8
Surgical Tooling Comparison
9
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.