(220 days)
The T.B.R.® Zirconnect endosseous dental implant is a device 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, and to restore the patient's chewing function.
The T.B.R.® Zirconnect dental implant system consists of root form, screw-type implants (made from Ti-6Al-4V ) and restorative components with many options such as Ti-6Al-4V abutments, conical abutments. castable abutments and ball abutments. The system also includes surgical and laboratory accessories. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
This 510(k) summary does not contain information typically found in a study proving a device meets acceptance criteria. Instead, it describes a dental implant system and asserts its substantial equivalence to previously marketed predicate devices. Therefore, I cannot provide a detailed answer to your request in the format you specified.
Here's why and what information is available:
What is available from the provided text:
- Device Name: T.B.R.® Zirconnect
- Intended Use: Surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices (artificial teeth) and restore chewing function.
- Predicate Devices: 3i Osseotite Certain NT (K031475) and T.B.R.® ide@ conic (K050956)
- Performance Statement: "Test conclusions demonstrate the safety and effectiveness of T.B.R.® Zirconnect implant system." and "The overall design and characteristics of the T.B.R.® Zirconnect implants are similar to the predicated devices and as safe, as effective and as performs as well or better than the legally predicate devices."
Why a full answer in your requested format isn't possible:
The provided text is a 510(k) summary, which is a document submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. For this type of device (endosseous dental implant), the primary demonstration of safety and effectiveness often relies on:
- Bench Testing: Mechanical, chemical, and biocompatibility testing to ensure the device meets established standards for dental implants.
- Comparison to Predicate Devices: Showing that the new device has similar technological characteristics (materials, design, dimensions, surface treatment, sterility) and performs similarly to devices already cleared by the FDA.
- Clinical Data (Less Common for 510(k)s for this type of device): While some 510(k)s may include summary clinical data, especially for novel features or higher-risk devices, root-form dental implants often do not require new clinical studies if they are substantially equivalent to existing devices. The focus is usually on engineering and material equivalence.
Therefore, the document does not contain the following information that you requested:
- A table of acceptance criteria and reported device performance: While the document states the device performs as well or better than predicates and test conclusions demonstrate safety and effectiveness, it doesn't provide specific quantitative acceptance criteria or detailed performance metrics. These would typically be found in detailed test reports, not a 510(k) summary.
- Sample size and data provenance for a test set: This implies a clinical study evaluating the device's performance in patients, which is not detailed here. The "test conclusions" likely refer to bench testing.
- Number of experts and qualifications for ground truth: Not applicable as there's no mention of a human-read clinical study requiring a ground truth panel.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned. The comparison is between the new device's characteristics and those of predicate devices, not human reader performance.
- Standalone (algorithm only) performance: Not applicable; this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable as there's no clinical study described that would establish such a ground truth. The "ground truth" for a device like this would be established through engineering specifications, material standards, and successful long-term clinical use of similar predicate devices.
- Sample size for the training set & how ground truth for training set was established: Not applicable, as this refers to AI/machine learning models, which is not the subject of this 510(k) submission.
In summary, the provided 510(k) is a regulatory document focused on demonstrating substantial equivalence, not a detailed study report with specific performance metrics and clinical trial data in the way you've outlined for AI/diagnostic devices.
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510(k) Summary
NOV () 9 2007
Sudimplant, SA Submitter: Parc de la Plaine 24, impasse René Couzinet 31500 Toulouse, FRANCE Tel: +33 5 62 16 71 00 Fax: +33 5 61 80 84 02
Contact: Mr. Didier Sailhan Regulatory Affairs Manager E-mail: sailhan@tbr-group.com
Date: March 28, 2007
Device Name: T.B.R.® Zirconnect
Classification Name: Endosseous dental implant (21 CFR 872.3640) and Endosseous dental implant abutment (21 CFR 872.3630)
Class II Device classification:
Legally marketed device (predicate devices):
Description of the device:
The T.B.R.® Zirconnect dental implant system consists of root form, screw-type implants (made from Ti-6Al-4V ) and restorative components with many options such as Ti-6Al-4V abutments, conical abutments. castable abutments and ball abutments. The system also includes surgical and laboratory accessories. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
Intended use:
The T.B.R.® Zirconnect endosseous dental implant is a device 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, and to restore the patient's chewing function.
Performance:
This premarket notification was written in accordance with the FDA guidance "Class II Special controls guidance document:Root-form endosseous dental implants and endosseous dental abutments" issued on May 12, 2004. Test conclusions demonstrate the safety and effectiveness of T.B.R.® Zirconnect implant system.
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Technological characteristics:
The overall design and characteristics of the T.B.R.® Zirconnect implants are similar to the predicated devices and as safe, as effective and as performs as well or better than the legally predicate devices.
| T.B.R.Zirconnect | T.B.R.Ide@ Conic | 3iOsseotite CertainNT | |
|---|---|---|---|
| 510(k) number | K050956 | K031475 | |
| Type | Self-TappingThreaded Screw | Self-TappingThreaded Screw | Self-TappingThreaded Screw |
| Lengths (mm) | 8-10.5-13-15,5 | 8-10.5-13-15,5 | 8,5-15 |
| Diameters (mm) | 3.5-4-5 | 3.5-4-5 | 3,25-6 |
| Connection | Internal Octagon | Internal Octagon | Internal Hexagon |
| Shape | Tapered | Tapered | Tapered |
| Materials | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Surface | Sandblasted/ Acid-etched | Sandblasted/ Acid-etched | Acid-etched |
| Sterility | Gamma | Gamma | Gamma |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Mr. Didier Sailhan Regulatory Affairs Manager Sudimplant, SA Parc De La Plaine 24 Impasse Rene Couzinet 31500 Toulouse, FRANCE
Re: K070935
Trade/Device Name: T.B.R. @ Zirconnect Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 19, 2007 Received: October 22, 2007
Dear Mr. Sailhan;
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Sailhan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R. Gyl
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: T.B.R.® Zirconnect
Indications For Use:
The T.B.R.® Zirconnect endosseous dental implant is a device 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, and to restore the patient's chewing function.
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
Sue Curry
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K070935
§ 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.