(261 days)
No
The summary describes a physical dental implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a dental implant, which is a prosthetic device used to replace missing teeth, not a therapeutic device that treats or cures a disease or condition.
No
Explanation: The device description clearly states that Touareg CloseFit™ Dental Implants are threaded, root-form dental implants intended for surgical placement. They are prosthetic devices used to support crowns, bridges, or overdentures, and their function is mechanical support, not diagnosis.
No
The device description clearly states it is a threaded, root-form dental implant, which is a physical hardware device. The summary also describes fatigue testing, a common evaluation for physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures." This describes a surgical procedure and a physical implant, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "threaded, root-form dental implant" and its physical characteristics and design changes. This aligns with a medical device for implantation, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
The device is a dental implant, which is a type of medical device used in surgical procedures.
N/A
Intended Use / Indications for Use
Touareg CloseFit™ Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Touareg CloseFit™ Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
Touareg CloseFit™ Dental Implants are threaded, root-form dental implants intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The Touareg CloseFit™ Dental Implants are similar in design to the Touareg Dental Implant cleared under Adin Dental Implant System. K081751. The predicate internal connection was changed to internal hex (hexagonal) Morse tapered connection. In addition, dental implant name was changed from Touareg Dental Implants to the Touareg CloseFit™ Dental Implants to extend Touareg Implants family's product line, and surface treatment name was changed to OsseoFix™ due to marketing reasons only. Also, lengths and diameters were added - implants are now provided in diameter of 4.3mm, and lengths of 15.0 mm and 18.0 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/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 (study type, sample size, AUC, MRMC, standalone performance, key results)
For a determination of substantial equivalence, the following analysis and bench performance test was performed on Subject Devices ahd Predicate Devices:
- Fatigue testing according to ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants" was done with angled abutments to demonstrate the design changes did not change the fatigue properties. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use. The fatigue properties of the new design are similar to those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
KI12585
Image /page/0/Picture/1 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" inside a circle, followed by the word "ADIN" in bold, sans-serif font. Below the word "ADIN" is the text "Dental Implants Sys. LTD." in a smaller font size.
MAY 2 4 2012
Adin Dental Implant Systems Ltd. Touareg CloseFit™ Dental Implant Special 510(k)
Revised 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92
Submitter Information
Adin Dental Implants Systems Ltd Industrial Zone Alon Tavor P.O. Box 1128 Afula 18550 Israel, Tel: (+972-4-6426732, Fax: (+972) 4-6426733 Establishment Reg. Number: 3007518363 Submission contact person: Mrs. Yana Prus-Galynsky
Quality and Regulatory Director Tel: (+972-4-6426732 ext. 159, Fax: (+972) 4-6426733
Submission Date:
3rd of April, 2012
Device Classification
Touareg CloseFit™ Dental Implant Trade/Proprietary Device Name: Common name: Endosseous Dental Implant CFR 21
872.3640
Product Code: Classification Name: Classification Regulation: Classification Panel: Regulatory Class:
DZE (subsequent code NHA) Endosseous Dental Implant 21 CFR §872.3640 (subsequent 21 CFR872.3630) Dental Devices II
Identification of Legally Marketed Predicate Devices
Adin Dental Implants System -
1
Device Description
Touareg CloseFit™ Dental Implants are threaded, root-form dental implants intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The Touareg CloseFit™ Dental Implants are similar in design to the Touareg Dental Implant cleared under Adin Dental Implant System. K081751. The predicate internal connection was changed to internal hex (hexagonal) Morse tapered connection. In addition, dental implant name was changed from Touareg Dental Implants to the Touareg CloseFit™ Dental Implants to extend Touareg Implants family's product line, and surface treatment name was changed to OsseoFix™ due to marketing reasons only. Also, lengths and diameters were added - implants are now provided in diameter of 4.3mm, and lengths of 15.0 mm and 18.0 mm.
Intended Use of Device
Touareg CloseFit™ Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Touareg CloseFit™ Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
Brief Discussion and conclusions drawn from the Non-Clinical Tests Submitted
For a determination of substantial equivalence, the following analysis and bench performance test was performed on Subject Devices ahd Predicate Devices:
- Fatigue testing according to ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants" was done with angled abutments to demonstrate the design changes did not change the fatigue properties. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use. The fatigue properties of the new design are similar to those of the predicate device.
Substantial Equivalence Statement
Based on the performance testing results, and compliance to performance standards, it is Adin Dental Implant Systems Ltd opinion that the proposed Touareg CloseFit™ Dental Implant is substantially equivalent in terms of design, functional features to the unmodified Adin Dental Implants System (legally marketed predicate device)
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
Mrs. Yana Prus-Galynsky Ouality and Regulatory Director Adin Dental Implants Systems Ltd Industrial Zone Alon Tavor P.O. Box 1128 Afula ISRAEL 18550
MAY 2 4 2012
Re: K112585
Trade/Device Name: Touareg CloseFit™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 23, 2012 Received: May 23, 2012
Dear Mrs. Prus-Galynsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
3
Page 2 - Mrs. Prus-Galynsky
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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
| Adin Dental Implants Systems Ltd. Touareg CloseFit™ Implant Special 510(k) | ADIN Dental Implants Sys. LTD. |
|---|---|
| ---------------------------------------------------------------------------- | -------------------------------------------------------------- |
| 510(k) Number (if known): | K112585 |
|---|---|
| Device Name: | Touareg CloseFit™ Dental Implant System |
| Indications for Use: |
Touareg CloseFit™ Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Touareg CloseFit™ Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading
| Prescription Use (21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|
| ----------------------------------------- | -------- | --------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Center for Devices and Radiological Health / CDRH
| (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K112585 | Page 1 of 1 | |
|---|---|---|
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