(256 days)
Not Found
No
The provided text describes a standard dental implant and does not mention any AI or ML components or functionalities.
No
The device is a dental implant used to restore missing teeth, which is a restorative rather than a therapeutic function.
No
The device is a dental implant used to restore missing teeth, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a physical dental implant made of titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant used to restore missing teeth and fix overdentures. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The description confirms it's a physical implant made of titanium, designed to be surgically placed.
- 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 biological samples. This device is implanted inside the body.
N/A
Intended Use / Indications for Use
BTI Dental implants 5.5 - 6.5 mm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure.
These implants are not indicated for immediate loading.
These implants are not indicated to support removable resilient retained restorations or angled abutments.
Product codes
DZE
Device Description
The BTI Dental Implant 5.5-6.5 is a self tapping, threaded dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameters: 4.5, 5.0, 5.5, 6.0 and lengths: 5.5, 6.5
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
KO91387
510(k) Summary As Required By 21 CFR 807.92
Biotechnology Institute, SL. Submitter: Parque Tecnológico de Alava C/Leonardo Da Vinci 14B, 1B. 01510 Miñano (Alava) Spain
JAN 22 2010
Alfredo Gómez Contact Person: Regulatory Affairs Department Biotechnology Institute, SL. Parque Tecnológico de Alava C/Leonardo Da Vinci 14B, 1B. 01510 Miñano (Alava) Spain .
Date Prepared: May 08, 2009
BTI Dental implant 5.5-6.5 Device Trade Name:
IMPLANT, ENDOSSEOUS, ROOT-FORM Common Name:
Substantial Equivalence: K022258 BTI Dental Implant System K053355 BTI Interna Dental Implant System K063779 OsseoSpeedTM 4.0S - 6mm
The BTI Dental Implant 5.5-6.5 is a self tapping, threaded Device Description: dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameters: 4.5, 5.0, 5.5, 6.0 and lengths: 5.5, 6.5
BTI Dental implants 5.5 - 6.5 mm are intended to be used to Intended Use: restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure.
These implants are not indicated for immediate loading.
These implants are not indicated to support removable resilient retained restorations or angled abutments.
Technological Aspects:
A comparison of the device features, intended use and other information demonstrate that the BTI Dental implants 5.5 -6.5mm substantially equivalent to the predicate devices.
1
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
Mr. Alfredo Gómez Regulatory Affairs Specialist B.T. I. Biotechnology Institute, S.L. Parque Tecnológico de Alava Leonardo Da Vinci, 14B 01510 Miñano (Alava) SPAIN
JAN 22 2010
Re: K091387
Trade/Device Name: BTI Dental Implant 5.5 - 6.5 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 17, 2009 Received: January 11, 2010
Dear Mr. Gómez:
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 régistration, 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 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.
2
Page 2- Mr. Gómez
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/Reporta Problem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ah 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
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Indications for Use
510(k) Number (if known): __K091387
Device Name: BTI Dental Implant 5.5 - 6.5
Indications For Use:
BTI Dental implants 5.5 - 6.5 mm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure.
These implants are not indicated for immediate loading.
These implants are not indicated to support removable resilient retained restorations or angled abutments.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) |
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| Division of Anesthesiology, General Hospital |
Infection Control, Dental Devices
510(k) Number: K091387
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