(234 days)
No
The document describes a standard dental implant system made of titanium, with no mention of AI or ML technology in its design, function, or testing.
Yes
The device is a dental implant system used for oral rehabilitation, which involves treating a disease or injury to restore health and improve function, fitting the definition of a therapeutic device.
No
The device is a dental implant system used for oral rehabilitation, not for diagnosing medical conditions.
No
The device description explicitly states it is a screw type dental implant system made of Ti-6-AL-4V ELI and includes a cover screw, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental implant system used for oral rehabilitation in patients. This is a surgical device implanted into the body.
- Device Description: The description details the physical components, materials, and sterilization method of a dental implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is implanted inside the body.
N/A
Intended Use / Indications for Use
The TriMark™ TriCam™ Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.
The TriMark™ TriCam™ Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system is intended for use with all standard straight abutment prosthetics and is not intended for use with angled abutments. The system can also be used for single tooth restorations. The TriCam Dental Implant System uses a two-stage implantation process and is not intended for immediate loading.
The TriMark™ TriCam™ Dental Implant System is compatible with 0 (zero) degree, straight version of the Atlantis™ Abutment for Nobel Replace Interface.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The ACE Surgical TriMark™ TriCam™ Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Implant System (K954513) designed with technology occubilent (K023113). The ACE Surgical TriMark™ TriCam™ Dental Implant is made of Ti-6-AL-4V ELI per ASTM F136 standard and surface treated with resorbable blast media (RBM). The TriCam™ Dental Implant tapered external thread geometry is consistent with industry standard screw implant fixtures. A cover screw is included with each implant to protect the internal features of the implants are provided sterile and sterile and sterily is achieved by gamma radiation pursuant to ISO 11137.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and/or mandible
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)
The following non clinical mechanical tests were conducted to support the substantial equivalence of the ACE Surgical TriMark™ TriCam™ to the ACE Screw Dental Implant System (K954513) and the Nobel Biocare™ Replace Dental Implant (K023113): torsional insertion and shear loading and compressive bending and fatigue strength. The data generated from these tests demonstrates the ACE Surgical TriMark™ TriCam™ the ACE Screw Dental Implant System (K954513) and the Nobel Biocare™ Replace Dental Implant (K023113) to be substantially equivalent.
No clinical testing was conducted
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.
Not Found
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
K103 790
Revised June 14, 2011
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Manufacturer Name: | ACE Surgical Supply Co., Inc. |
|---|---|
| Manufacturer Address: | 1034 Pearl St., Brockton, MA 02301 |
| Telephone Number: | (508) 588-3100 |
| Fax Number: | (508) 523-3140 |
| Date Prepared: | October 1, 2010 |
| Official Contact: | Leigh Hayward, Director of Compliance |
| DEVICE NAME: | |
| Device Trade Name: | ACE Surgical TriMark™ TriCam™ Dental Implant |
| Device Common Name: | Screw Dental Implant |
Not previously marketed in the USA Reason for submission:
ESTABLISHMENT REGISTRATION NUMBER:
The Establishment License Number for ACE Surgical Supply Co. Inc. is 1287163.
DEVICE CLASSIFICATION:
Implant, Endosseous, Root-Form, product code, DZE, 21CFR 872.3640.
PREDICATE DEVICES:
ACE Surgical Screw Dental Implant System (K954513) Nobel Biocare Replace TiUnite Endosseous Implant (K023113) Atlantis TM Abutment for Nobel Replace Interface (K053654)
INTENDED USE:
The TriMark™ TriCam™ Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.
The TriMark™ TriCam™ Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system is intended for use with all standard straight abutment prosthetics and is not intended for use with angled abutments. The system can also be used for single tooth restorations. The TriCam Dental Implant System uses a two-stage implantation process and is not intended for immediate loading.
The TriMark™ TriCam™ Dental Implant System is compatible with 0 (zero) degree, straight version of the Atlantis™ Abutment for Nobel Replace Interface.
DEVICE DESCRIPTION:
The ACE Surgical TriMark™ TriCam™ Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Implant System (K954513) designed with technology occubilent (K023113). The ACE Surgical TriMark™ TriCam™ Dental
1
Implant is made of Ti-6-AL-4V ELI per ASTM F136 standard and surface treated with resorbable blast media (RBM). The TriCam™ Dental Implant tapered external thread geometry is consistent with industry standard screw implant fixtures. A cover screw is included with each implant to protect the internal features of the implants are provided sterile and sterile and sterily is achieved by gamma radiation pursuant to ISO 11137.
PERFORMANCE CHARACTERISTICS:
The following non clinical mechanical tests were conducted to support the substantial equivalence of the ACE Surgical TriMark™ TriCam™ to the ACE Screw Dental Implant System (K954513) and the Nobel Biocare™ Replace Dental Implant (K023113): torsional insertion and shear loading and compressive bending and fatigue strength. The data generated from these tests demonstrates the ACE Surgical TriMark™ TriCam™ the ACE Screw Dental Implant System (K954513) and the Nobel Biocare™ Replace Dental Implant (K023113) to be substantially equivalent.
No clinical testing was conducted
EQUIVALENCE TO MARKETED DEVICE:
The ACE Surgical TriMark™ TriCam™ Dental Implant is substantially equivalent to the ACE Screw Dental Implant System (K954513) and the Nobel Biocare™ Replace Dental Implant (K023113). The candidate device and the predicate devices have intended use and similar technological characteristics as Materials: The candidate device and predicate devices are made of titanium alloy and follows. commercially pure titanium respectively, both have similar performance characteristics. The candidate and predicate devices have comparable roughened surface treatments. Diameters: Both the predicate and the candidate device are offered in diameters of 3.5; 4.3 and 5.0mm external thread diameters. The candidate and predicate devices are offered in similar lengths 8 - 16mm and 8 - 16 mm respectively. Internal threads: Both devices have 1.8 and 2.0mm metric internal threads. The candidate and predicate devices are packaged and sterilized by identical methods. Both the ACE Surgical Screw Implant and the ACE Surgical TriMark™ TriCam™ Dental Implant use a 2 stage implantation process. The Nobel Biocare™ Replace Dental Implant utilizes either a one or two stage implantation process.
A review of the technological characteristics and the non-clinical test data demonstrates ACE Surgical TriMark™ TriCam™ to the ACE Screw Dental Implant System (K954513) and the Nobel Biocare™ Replace Dental Implant (K023113) are substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion around a symbol. The symbol consists of three stylized human figures, each represented by a curved line suggesting a head and body. The figures are stacked vertically, with the top figure slightly larger than the others, creating a sense of depth and hierarchy.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ms. Denise Williams Quality Assurance Manager ACE Surgical Supply Company Incorporated 1034 Pearl Street Brockton, Massachusetts 02401
AUG 1 8 2011
Re: K103790
Trade/Device Name: ACE Surgical TriMark™ TriCam™ Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 2, 2011 Received: August 3, 2011
Dear Ms. Williams:
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 vour 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.
3
Page 2 - Ms. Houts
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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/ReportalProblem/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-fice number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ph 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
4
Revised June 14, 2011
Indications For Use:
The TriMark™ TriCam™ Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.
The TriMark™ TriCam™ Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system is intended for use with all standard straight abutment prosthetics and is not intended for use with angled intents. The system can also be used for single tooth restorations. The TriMark™ TriCam™ Dental Implant System uses a two-stage implantation process and is not intended for immediate loading.
The TriMark™ TriCam™ Dental Implant System is compatible with 0 (zero) degree, straight version of the Atlantis™ Abutment for Nobel Replace Interface.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Pearson
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: | K103796