(102 days)
Not Found
No
The summary describes a standard dental implant system with no mention of AI or ML capabilities.
Yes
The device is described as a dental implant system used for the restoration of missing teeth and fixation of overdentures to restore or enhance chewing capacity, which are therapeutic interventions.
No
This device is a dental implant system used for restoring missing teeth and supporting prosthetic devices. Its function is to provide structural support, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "Dental implant system comprising endosseous titanium implants and prosthetic elements," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this is a dental implant system used for the restoration of missing teeth and fixation of overdentures. This is a surgical and prosthetic device that is implanted into the body, not used to test samples taken from the body.
The information provided aligns with a Class II or Class III medical device used for surgical and restorative purposes, not an IVD.
N/A
Intended Use / Indications for Use
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The BTI Interna Dental Implant System is designed to server as support for prosthetic devices to restore chewing function. The implants have a surgical diameter range of from 3.3 to 4.0 mm for the universal platform implant. 4.0 for Universal Plus Platform and 4.5 to 5.0 mm for wide platform. Lengths range from 7,0 to 18,0 mm.
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): 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
MAR 1 4 2006
510 (K) SUBMISSION BT Interna Dental Implant System
Kos 3355
Attachment 5
510 (K) SUMMARY
SAFETY AND EFFECTIVENESS INFORMATION
BTI INTERNA DENTAL IMPLANT SYSTEM
SUBMITTER'S NAME. ADDRESS AND TELEPHONE NUMBER:
B.T.J. Biotechnology Institute, S.L. Parque Tecnológico de Álava Leonardo da Vinci, 14 B Miñano (Álava) 01510 Spain PH: +34 945 297030 FAX: +34 945 297031
CONTACT PERSON
Alfredo Gómez Mengod Quality Assurance Manager
SUMARY PREPARATION DATE:
November 2005
3004417597
ESTABLISHMENT REGISTRATION No:
PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION NAME:
BTI INTERNA DENTAL IMPLANT SYSTEM
Dental implant
IMPLANT, ENDOSSEOUS, ROOT-FORM
PRODUCT CODE: DZE
1
DEVICE CLASSIFICATION: Class II
PREDICATE DEVICE
The BTI Interna Dental Implant System is claimed to be substantially equivalent in material, design, and function to the BTI Dental Implant System cleared by FDA under 510 (k) K022258 on Sep 11, 2003
DEVICE DESCRIPTION
The BTI Interna Dental Implant System is designed to server as support for prosthetic devices to restore chewing function. The implants have a surgical diameter range of from 3.3 to 4.0 mm for the universal platform implant. 4.0 for Universal Plus Platform and 4.5 to 5.0 mm for wide platform. Lengths range from 7,0 to 18,0 mm.
INTENDED USE
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
SUBSTANTIAL EQUIVALENCE
The BTI Interna Dental Implant System is considered to be substantially equivalent to BTI Dental Implant System
CONCLUSION
The BTI Interna Dental Implant System is considered to be substantially equivalent in design, material and function to the BTI Dental Implant System.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
MAR 1 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alfredo Gómez Mengod Quality Assurance Manager B.T.I. Biotechnology Institute, S.L. Parque Tecnológico de Álava Leonardo da Vinci, 14 B Miñano (Alava), 01510 Spain
Re: K053355
Trade/Device Name: BTI Interna Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 16, 2006 Received: February 21, 2006
Dear Mr. Mengod:
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.
3
Page 2 - Mr. Mengod
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be ad rised that that your device complies with other requirements mean that I Drima and regulations and regulations administered by other Federal agencies. or the ret of with all the Act's requirements, including, but not limited to: registration r od intiles compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF ref Lav 807), eguality 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) I rus reter wrification. The FDA finding of substantial equivalence of your device to a premaired 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), n free 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 maj Vetant Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ours
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
4
510 (K) SUBMISSION BTI Interna Dental Implant System
Attachment 2
Indications for Use
510(k) Number (if known): K053355
Device Name: BTI Interna Dental Implant System
Indications For Use:
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
Prescription Use X (Part 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kunne
! lony, General Hospi
Lumal DOVICES
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