(77 days)
Not Found
Not Found
No
The summary describes a dental implant system and does not mention any AI or ML components or functionalities.
No
The device, an endosseous implant, is used to replace missing teeth, acting as an artificial root structure. While it restores function, it does not treat or cure a disease or medical condition.
No
The device is described as an "endosseous implant" that serves as "artificial root structures" for teeth or bridgework. Its intended use is to replace missing teeth, which is a therapeutic rather than a diagnostic function. Diagnostic devices are used to identify the presence of a disease or condition.
No
The device description explicitly states "Saber Tech Implants System (GIS) endosseous implant," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an artificial root structure for dental implants. This is a surgical implant placed directly into the body.
- Device Description: The device is described as an "endosseous implant," which further confirms it is a device implanted within bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Saber Tech Implants System (GIS) is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To serve as artificial root structures for single teeth or bridge abutments for bridgework in edentulous sites with adequate bone of sufficient quality to support the implant and function.
Product codes
DZE
Device Description
Saber Tech Implants System (GIS) endosseous implant
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a row, with the first profile being the most defined and the subsequent profiles fading slightly. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2003
Mr. J. Brad Vance Director, Regulatory Affairs & New Projects Manager IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401
Re: K024044
Trade/Device Name: Saber Tech Implants System (GIS) Endosseous Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 4, 2002 Received: December 6, 2002
Dear Mr. Vance:
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.
1
Page 2 – Mr. Vance
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Dunross
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
December 3, 2002
K 024044
SUBJECT: 510 (K) NOTIFICATION Endosseous Implant
ATTENTION: Document Mail Clerk
INDICATIONS FOR USE STATEMENT
Device Name:
Saber Tech Implants System (GIS) endosseous implant
Indications for Use:
To serve as artificial root structures for single teeth or bridge abutments for bridgework in edentulous sites with adequate bone of sufficient quality to support the implant and function.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ==============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Nuley Son MSSR
510(k) Number:
Prescription Use レー Use (Per 21 CFR 801.109) OR
Over the Counter
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices