(307 days)
Not Found
No
The 510(k) summary describes a standard dental implant system and its mechanical and biocompatibility testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device, a dental implant, is intended to support prosthetic devices and restore chewing function, which addresses a functional deficit rather than treating a disease or therapeutic condition.
No
The device is an endosseous dental implant intended to provide support for prosthetic devices and restore chewing function, not to diagnose a condition.
No
The device description clearly states it is a system of physical implants and abutments made from Ti-6Al-4V, which are surgically placed. It also mentions surgical and laboratory components and mechanical testing of the physical implants. This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a surgically implanted device (a dental implant) used to support prosthetic devices and restore chewing function. It is placed directly into the bone of the jaw.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any specimens from the human body.
This device falls under the category of a surgical implant or dental device, not an IVD.
N/A
Intended Use / Indications for Use
The T.B.R.® ide@ conic endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to to be ourglean; prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Description of the donic/Conic dental implant system consists of selftapping threaded screw-type implants (made from Ti-6AI-4V ) and tapping througou overs with many options such as Ti-6Al-4V abutments, tapered abutments, castable abutments, ball abutments and ceramic/Titapered abutments. The system also include surgical and laboratory ord av abutiments. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw arches
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)
Mechanical testing was done in accordance with the FDA guidance "Class Mechaniour controls guidance document:Root-form endosseous dental implants and endosseous dental abutments" issued on May 12, 2004. Implans and ondessendent laboratory showed T.B.R.R.® ide@ conic to have sufficient mechanical static and dynamic strength. Additionnal test report include biocompatibility testing. Test conclusions demonstrate the report include blocompatistiky tooling." safety and effectiveness of T.B.R.® ide@ conic implant system.
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.
K031475, K032454, K013227, K011028
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
K050956
FEB 1 6 2006
510(k) Summary
- Sudimplant, SA Submitter: Parc de la Plaine 24, impasse René Couzinet 31500 Toulouse, FRANCE Tel: +335 62 16 71 00 Fax: +335 61 80 84 02
- Mr. Didier Sailhan Contact: Requlatory Affairs Manager E-mail: production@tbridea.com
June 22, 2005 Date:
Device Name: T.B.R.6 ide@ conic
Endosseous dental implant (21 CFR Classification Name: 872.3640) and Endosseous dental implant abutment (21 CFR 872.3630)
Legally marketed device (predicate devices):
- 3i Osseotite Certain NT (K031475) u
- Bio-Lok Silhouette & Silhouette IC (K032454) L
- Zimmer Dental (formerly Sulzer Dental) Tapered Screw-Vent 트 (K013227, K011028)
Description of the device:
Description of the donic/Conic dental implant system consists of selftapping threaded screw-type implants (made from Ti-6AI-4V ) and tapping througou overs with many options such as Ti-6Al-4V abutments, tapered abutments, castable abutments, ball abutments and ceramic/Titapered abutments. The system also include surgical and laboratory ord av abutiments. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
Intended use:
The T.B.R.® ide@ conic endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to to be ourglean; prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Summary of testing:
Mechanical testing was done in accordance with the FDA guidance "Class Mechaniour controls guidance document:Root-form endosseous dental implants and endosseous dental abutments" issued on May 12, 2004. Implans and ondessendent laboratory showed T.B.R.R.® ide@ conic to have sufficient mechanical static and dynamic strength. Additionnal test
1
report include biocompatibility testing. Test conclusions demonstrate the report include blocompatistiky tooling."
safety and effectiveness of T.B.R.® ide@ conic implant system.
Technological characteristics:
The overall design and characteristics of the T.B.R.® ide@ conic/Conic The overall design and charactoriotics of the and as safe, as effective implants are similar to the production as nowledgedly predicate devices.
| New device | Predicate Devices | |||
|---|---|---|---|---|
| Bio-Lok | ||||
| Silhouette | Zimmer | |||
| Tapered | ||||
| Screw-Vent | 3i | |||
| Osseotite | ||||
| Certain NT | ||||
| Conic | ||||
| 510(k) number | K032454 | K013227 | ||
| K011028 | K031475 | |||
| Type | Self-Tapping | |||
| Threaded | ||||
| Screw | Self-Tapping | |||
| Threaded | ||||
| Screw | Self-Tapping | |||
| Threaded | ||||
| Screw | Self-Tapping | |||
| Threaded | ||||
| Screw | ||||
| Lengths (mm) | 8-15,5 | 8-15 | 8-16 | 8,5-15 |
| Diameters (mm) | 3,5-5 | 3,45-6,5 | 3,5-5,7 | 3,25-6 |
| Connection | Internal | |||
| Octagon | Internal | |||
| Connection or | ||||
| External | ||||
| hexagon | Internal | |||
| Hexagon | Internal | |||
| Hexagon | ||||
| Shape | Tapered | Tapered | Tapered | Tapered |
| Materials | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Surface | Sandblasted/ | |||
| Acid-etched | Osseo-Lok | |||
| HA-coated | ||||
| Laser-Lok | Machined / | |||
| blasted- | ||||
| etched | ||||
| Machined/HA | Acid-etched | |||
| Sterility | Gamma | Unknown | Unknown | Gamma |
| Abutment | ||||
| containing | ||||
| ceramic | Available | Available | No | No |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
FEB 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Didier Sailhan Regulatory Affairs Manager Sudimplant SA 24 Impasse Rene Couzinet Parc De La Plaine Toulouse, France 31500
Re: K050956
Trade/Device Name: T.B.R.® ide@-conic Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: January 20, 2006 Received: January 20, 2006
Dear Ms. Sailhan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater mined the device is substantially equivalent (for the icitications 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 microlie conments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de rous that the Act (Act) that do not require approval of a premarket the Federal F ood, Drag, the Commay, therefore, market the device, subject to the general approvincianon (Printers) (The general controls provisions of the Act include controls provisions or 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 (1 MA), it may of subject to back add of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the over announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Didier 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 (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.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sengate Y. Michie Davis
Chíu 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
4
Image /page/4/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K050956". The characters are written in black ink on a white background.
Indications for Use
510(k) Number (if known):
Device Name: T.B.R.® ide@ conic
Indications For Use:
The T.B.R.® ide@ conic 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)
Susan Quares
Case Cit
s
KCB50756