(158 days)
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical testing of dental implants and abutments. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No.
The "Intended Use" states that the device is for the "rehabilitation of edentulous and partially edentulous patients," indicating it's a restorative device rather than a therapeutic one designed to treat or cure a disease.
No
Explanation: The device description clearly states that the TRI® Dental Implant System is intended for placement in the bone for rehabilitation and involves surgical procedures, not for diagnostic purposes.
No
The device description clearly details physical dental implants and associated hardware components (abutments, screws). There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a system of dental implants and their associated components (abutments, screws). These are physical devices intended to be surgically placed in the bone.
- Intended Use: The intended use is for the "rehabilitation of edentulous and partially edentulous patients" by placing the implants in the jawbone. This is a surgical and restorative procedure, not a diagnostic test performed on a sample.
The description clearly indicates a device used in vivo (within the body) for structural support and restoration, not a device used in vitro (outside the body) for diagnostic testing.
N/A
Intended Use / Indications for Use
The TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows for one and two-stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
TRI Dental Implant System 6.5 mm implants are intended for delayed loading only.
Product codes
DZE, NHA
Device Description
The TRI-Narrow and TRI-Vent implants are root form endosseous dental implants. They are available with two collar options, blasted or machined. TRI-Narrow is available in one implant diameter (3.3 mm) and three lengths (11.5, 13, and 16 mm). TRI-Narrow abutments include all abutment options with the exception of the Gingiva Former and the angled Screw Retained Abutment.
TRI-Vent is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Vent implant diameters have the same platform diameter (3.5 mm). TRI-Vent abutments include Healing Collar, Straight Temporary PEEK Abutment, Straight and 20° Angled Abutments, Straight and 30° Angled Screw Retained Abutment, PEEK Gingiva Former, Straight and 15° Angled Contoured Abutment, Gold-castable Abutment, Screw-retained Abutment, Ball Abutment, and applicable abutment fixation screws.
The TRI-Octa implants are root form endosseous dental implants. They have a pink, transgingival collar. TRI-Octa is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Octa implant diameters have the same platform diameter (4.8 mm). TRI-Octa abutments include Healing Collar, Straight PEEK Temporary Abutment, Straight and 20° Angled Abutments, Straight Screw Retained Abutment, Ball Abutment, and applicable abutment fixation screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
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
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1 Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, ISO 11137-2 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose, ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1; biocompatibility evaluation and testing according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cvtotoxicity; engineering dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants.
The fatigue testing provided under ISO 14801 demonstrates that the increased abutment angulation is substantially equivalent to the identified predicates with respect to performance. The surface area analysis demonstrates that the smallest diameter/shortest length combinations of the submission device are substantially equivalent to the identified reference predicate K092035 with respect to surface area available for osseointegration. Slight differences in material composition, surface treatment, or manufacturing exposures are demonstrated substantially equivalent by biocompatibility testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K101545, K113779, K072570, K092035
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Tri Dental Implants Int. AG c/o Ms. Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K151916
Trade/Device Name: TRI® Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 13, 2015 Received: November 16, 2015
Dear Ms. Schulz:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -
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
Indications for Use
510(k) Number
Device Name
TRI® Dental Implant System
Indications for Use (Describe)
The TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows for one and twostage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
TRI Dental Implant System 6.5 mm implants are intended for delayed loading only.
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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3
510(k) Summary
TRI Dental Implants Int. AG
TRI® Dental Implant System
December 18, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | TRI Dental Implants Int. AG |
|---|---|
| Lindenstrasse 14 | |
| Baar CH-6340 Switzerland | |
| Telephone: +41 32 510 1606 | |
| Fax: +41 32 510 1601 | |
| Official Contact | Sandro Venanzoni, Chief Technology Officer |
| Representative/Consultant | Linda K Schulz, BSDH, RDH |
| Floyd G. Larson, MS, MBA PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone: +1 (858) 792-1235 | |
| Fax: +1 (858) 792-1236 | |
| Email: lschulz@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Reviewing Branch
| Trade/Proprietary Name | TRI® Dental Implant System |
|---|---|
| Common Name | Endosseous dental implant |
| Classification Name | Endosseous Dental Implant |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
The primary predicate for the TRI®-Narrow and TRI®-Vent implants is: K101880, Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant, Zimmer Dental, Inc.
The primary predicate for the TRI®-Octa implants is: K012757, ITT® Dental Implant System, Straumann USA.
The primary predicate for TRI®-Dental Implant System abutments is: K083496, CAMLOG Implant System Modified Implants and Abutments, Altatec GmbH.
Dental Devices Branch
4
Reference Predicates:
K101545, Genesis Implant System, Keystone Dental; K113779, CONELOG Implant System, Altatec GmbH; K072570, NobelActive Multi-Unit Abutment, Nobel Biocare AB; and K092035, Bicon Implants with a 2.5 mm Internal Connection, Bicon, LLC.
INTENDED USE
The TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows for one and two-stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
TRI Dental Implant System 6.5 mm implants are intended for delayed loading only.
DEVICE DESCRIPTION
The TRI-Narrow and TRI-Vent implants are root form endosseous dental implants. They are available with two collar options, blasted or machined. TRI-Narrow is available in one implant diameter (3.3 mm) and three lengths (11.5, 13, and 16 mm). TRI-Narrow abutments include all abutment options with the exception of the Gingiva Former and the angled Screw Retained Abutment.
TRI-Vent is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Vent implant diameters have the same platform diameter (3.5 mm). TRI-Vent abutments include Healing Collar, Straight Temporary PEEK Abutment, Straight and 20° Angled Abutments, Straight and 30° Angled Screw Retained Abutment, PEEK Gingiva Former, Straight and 15° Angled Contoured Abutment, Gold-castable Abutment, Screw- retained Abutment, Ball Abutment, and applicable abutment fixation screws.
The TRI-Octa implants are root form endosseous dental implants. They have a pink, transgingival collar. TRI-Octa is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Octa implant diameters have the same platform diameter (4.8 mm). TRI-Octa abutments include Healing Collar, Straight PEEK Temporary Abutment, Straight and 20° Angled Abutments, Straight Screw Retained Abutment, Ball Abutment, and applicable abutment fixation screws..
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1 Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, ISO 11137-2 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose, ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1; biocompatibility evaluation and testing according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cvtotoxicity; engineering dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants.
5
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles predicate devices shown above. Below are summary tables showing technical comparison between the subject device and the primary predicate devices.
| Comparison | Subject Device | Primary Predicate Devices | |
|---|---|---|---|
| TRI Dental Int. AG | |||
| TRI® Dental Implant | |||
| System | |||
| K151916 | Zimmer Dental Inc. | ||
| Tapered Screw-Vent® T | |||
| Implant and Tapered | |||
| Screw-Vent® P Implant | |||
| K101880 | Straumann USA | ||
| ITI® Dental Implant | |||
| System | |||
| K012757 | |||
| Indications for Use | The TRI® Dental Implant System | ||
| is intended for placement in the | |||
| bone of the maxillary or | |||
| mandibular arch for the | |||
| rehabilitation of edentulous and | |||
| partially edentulous patients. | |||
| TRI® Dental Implant System | |||
| allows for one and two-stage | |||
| surgical procedures. When a one- | |||
| stage surgical procedure is | |||
| applied, the implant may be | |||
| immediately loaded when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. | |||
| TRI Dental Implant System | |||
| 6.5 mm implants are intended for | |||
| delayed loading only. | The Tapered Screw-Vent® T Implants | ||
| are designed for use in the maxilla or | |||
| mandible for immediate loading or | |||
| for loading after a conventional | |||
| healing period. Implants may be used | |||
| to replace one or more missing teeth. | |||
| Immediate loading is indicated when | |||
| there is good primary stability and an | |||
| appropriate occlusal load. | |||
| The Tapered Screw-Vent® P Implants | |||
| are designed for use in the maxilla or | |||
| mandible for loading after a | |||
| conventional healing period. Implants | |||
| may be used to replace one or more | |||
| missing teeth. | ITI® tapered implants are | ||
| intended for immediate, | |||
| delayed, or conventional | |||
| placement in the maxillary | |||
| and/or mandibular arches to | |||
| support crowns, bridges, or | |||
| overdentures in edentulous or | |||
| partially edentulous patients. | |||
| Implant Design | |||
| TRI-Narrow | |||
| Implant Diameter (mm) | 3.3 | 3.3, 3.7, 4.1, 4.7, 6.0 | |
| Platform Diameter (mm) | 3.2 | 3.5, 4.5, 5.7 | |
| Length (mm) | 11.5, 13, 16 | 8, 10, 11.5, 13, 16 | |
| Connection | Internal | Internal | |
| TRI-Vent | |||
| Implant Diameter (mm) | 3.75, 4.1, 4.7 | 3.3, 3.7, 4.1, 4.7, 6.0 | |
| Platform Diameter (mm) | 3.5 | 3.5, 4.5, 5.7 | |
| Length (mm) | 6.5, 8, 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16 | |
| Connection | Internal | Internal | |
| TRI-Octa | |||
| Implant Diameter (mm) | 3.75, 4.1, 4.7 | 3.3, 4.1, 4.8 | |
| Platform Diameter (mm) | 4.8 | 3.5, 4.8, 6.5 | |
| Length (mm) | 6.5, 8, 10, 11.5, 13, 16 | 6, 8, 10, 12, 14 | |
| Connection | Internal | Internal | |
| Material | |||
| Implant | Titanium Alloy | Titanium Alloy | CPTi |
| Comparison | Subject Device | Primary Predicate Device | |
| TRI Dental Int. AG | |||
| TRI® Dental Implant System | Altatec GmbH | ||
| CAMLOG Implant System Modified | |||
| Implants and Abutments | |||
| K151916 | K083496 | ||
| Indications for Use | The TRI® Dental Implant System is intended | ||
| for placement in the bone of the maxillary or | |||
| mandibular arch for the rehabilitation of | |||
| edentulous and partially edentulous patients. | |||
| TRI® Dental Implant System allows for one | |||
| and two-stage surgical procedures. When a | |||
| one-stage surgical procedure is applied, the | |||
| implant may be immediately loaded when | |||
| good primary stability is achieved and with | |||
| appropriate occlusal loading. | |||
| TRI Dental Implant System 6.5 mm implants | |||
| are intended for delayed loading only. | Camlog Implant System implants are intended for | ||
| immediate or delayed placement in the bone of the | |||
| maxillary or mandibular arch. Camlog Implant | |||
| System Abutments are intended for use as support | |||
| for crowns, bridges or overdentures. When a one- | |||
| stage surgical approach is applied, the implant may | |||
| be immediately loaded when good primary stabilit | |||
| is achieved and the functional load is appropriate. | |||
| Designs | |||
| Prosthesis Attachment | Screw-retained | ||
| Cement-retained | Screw-retained | ||
| Cement-retained | |||
| Restoration | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | |||
| Implant/Abutment | |||
| Connection | Internal | Internal | |
| Abutment Diameter, mm | 3.3, 3.5, 4.8 | 3.3, 3.8, 4.3, 5.0, 6.0 | |
| Abutment Angle | Straight, up to 30° | Straight, up to 20° | |
| Materials | |||
| Temporary Abutment | Titanium Alloy, PEEK | PEEK | |
| Gold Abutment | Gold alloy | Gold alloy | |
| Abutment | Titanium Alloy | Titanium Alloy, Zirconia | |
| Healing Cap | Titanium Alloy | NA | |
| Abutment Screw | Titanium Alloy | Titanium Alloy |
Device Comparison – Implants
6
Device Comparison - Abutments
In addition to the identified primary predicates, the reference predicates all have a similar intended use as they are for placement in the maxilla or mandible for restoration of chewing function by support of a prosthetic component such as crowns and bridges.
TRI-Narrow and TRI-Vent implants have a similar bone level design, tapered internal connection, and range of sizes as K101880. TRI-Octa implants have a similar trans-gingival design, tapered internal connection and range of sizes as K012757 and K101545. Smaller length of the TRI-Vent as compared to primary predicate K101880 (6.5mm length) is supported by the reference predicate K092035 which contained a 4.0x5.0 implant body. The 16mm length is supported by the primary predicates and, for TRI-Octa by the reference predicates K101545 and K113779. All three implant designs have the same materials used for implant body in the primary predicate K101880 and for the abutments in primary predicates K083496 and reference predicate K072570. Subject device abutment designs are equivalent to the primary predicate K083496. The differences are supported by the reference predicates K113779 and K072570. The primary predicate K083496 does not include pink anodization for optimal esthetics. The pink anodization of the transmucosal collar of the submission device is included in the reference predicate K101545. The primary predicate K083496 does not include a multi-unit abutment, this is included in the
7
510(k) Summary Page 5 of 5
reference predicate K072570.
The performance data included in this submission demonstrate substantial equivalence to the predicate devices with respect to any differences identified. The fatigue testing provided under ISO 14801 demonstrates that the increased abutment angulation is substantially equivalent to the identified predicates with respect to performance. The surface area analysis demonstrates that the smallest diameter/shortest length combinations of the submission device are substantially equivalent to the identified reference predicate K092035 with respect to surface area available for osseointegration. Slight differences in material composition, surface treatment, or manufacturing exposures are demonstrated substantially equivalent by biocompatibility testing.
CONCLUSION
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Overall, the subject device has the following similarities to the predicate devices:
- . has the same intended use,
- . uses the same operating principle,
- . incorporates the same basic design,
- incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes.