(539 days)
No
The summary describes a standard dental implant system with implants, tools, and prosthetic abutments. There is no mention of AI, ML, image processing, or any data-driven components that would suggest the use of these technologies.
No
The device, an endosseous implant system, is used for the reconstruction of edentulous patients, which falls under restorative or reconstructive purposes rather than directly treating a disease or condition to restore health.
No
The provided text describes an implant system used for reconstruction of partial and totally edentulous patients. Its purpose is to replace missing teeth, not to diagnose a condition or disease.
No
The device description explicitly states it consists of implants, tools, and prosthetic abutments, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is an "Endosseous implant system" used for the "reconstruction of partial and totally edentulous implant patients." It involves implants, tools, and prosthetic abutments that are surgically placed in the maxilla and mandible.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples from the patient. The device is a physical implant system used for structural support and prosthetic attachment.
Therefore, this device falls under the category of a medical device, specifically a dental implant system, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant The implants are to be used in single or multiple units patients. in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported implant supported bar/overdenture, implant partial denture, retained overdenture, fixed-detachable implant prosthesis, and totally edentulous implant retained prosthetic designs. The diameter changes of the implant system are to correspond with the maximum available bone width in the treatment areas. Large diameter implants can be utilized to engage the greatest amount of bone volume. These implants can also be used in a submerged protocol if the tissue is thick and a short healing cover screw is utilized. The nonsubmerged protocol does not imply immediate loading, and the implants should integrate in a 3-8 month healing phase based on the bone density before prosthetic load is incorporated into the implant sites.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Endosseous implant system consists of implants, tools and prosthetic abutments. This submission includes premachine angulated abutments less than 30°, specifically included are 15 and 25° abutments. In addition, in the wide body series there are a series of one and two piece prosthetic abutments with 4, 5, and 6mm platform diameters. These diameters match with the platform diameters of the appropriate implant bodies included in this system. This system includes cylindrical and screw implants of a variety of lengths and geometrical shapes. These devices are similar in their intended use and follow the appropriate integration protocol phase and following prosthetic attachments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous regions of the maxilla and mandible
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.
K902433, K902434, K902435, K932123
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.
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
SEP - 9 1997
EMERGING TECHNOLOGIES GROUP 824 U.S. Highway 1, Suite 370 North Palm Beach, FL 33408
September 17, 1996
RE: 510 (k) Summary- K 96-1381
To Whom It May Concern.
Pursuant to your request, information regarding the above reference PMN-510 (k) summary for substantial equivalence of the above referenced document is enclosed. The above referenced devices have been reviewed by CDRH, as well as the Office of Compliance, and have received a substantial equivalence letter.
CREDITED DEVICES
- Dental Imaging Associates- K902433, also Dental Imaging Associates-K902434, Dental Imaging Associates-K902435, and Implant Innovations Inc. preangled abutments-K932123
- Predicate devices for wide body implants, Nobelpharma K925766, Iniplant Innovations K933462
DEVICE DESCRIPTION
- Endosseous implant system consists of implants, tools and prosthetic abutments. This submission includes premachine angulated abutments less than 30°, specifically included are 15 and 25° abutments. In addition, in the wide body series there are a series of one and two piece prosthetic abutments with 4, 5, and 6mm platform diameters. These diameters match with the platform diameters of the appropriate implant bodies included in this system. This system includes cylindrical and screw implants of a variety of lengths and geometrical shapes. These devices are similar in their intended use and follow the appropriate integration protocol phase and following prosthetic attachments.
INTENDED USE
- The implants and wide body implants, as well as abutments and prosthetic system are similar to those of other implant systems in their intended use, which is to facilitate the prosthetic phase and insulation of a prosthesis for the patient.
1
TECHNOLOGICAL CHARACTERISTIC SUMMARY
- Design, materials, manufacturing processes, gamma sterilization, geometry and . materials are similar to the predicate devices currently on the market.
- This PMN includes devices for prosthetic attachment, as well as angled correction, as . well as standard and wide body diameters for prosthetic reconstruction phase of the patient case. The materials are ASTM standard, B-348-93 titanium Grade 3, 4, and 5, as well as titanium alloy ELI-Grade 5. GMP guidelines are in place to track the product development and manufacturing processes. The Food and Drug Administration, Office of Compliance has inspected and deemed all stages of the GMP process are in compliance with GMP standards.
If I can be of further assistance, please do not hesitate to contact me.
Sincerely,
Jack T. Krause, DMD
JTK/lb
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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Jack T. Krauser, D.M.D. The Emerging Technologies Group 824 US Highway 1, Suite 370 N. Palm Beach, Florida 33408
K961381 Re: KIS-III Non-Submerged Implant, Screws and Trade Name: Cylinders Regulatory Class: III Product Code: DZE Dated: June 9, 1997 Received: June 11, 1997
Dear Dr. Krauser:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
3
Page 2 - Dr. Krauser
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EMERGING TECHNOLOGIES GROUP 824 U.S. Highway 1, Suite 370 North Palm Beach, FL 33408 (516)627-5560
Indication for Use Statement
The NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant The implants are to be used in single or multiple units patients. in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported implant supported bar/overdenture, implant partial denture, retained overdenture, fixed-detachable implant prosthesis, and totally edentulous implant retained prosthetic designs. The diameter changes of the implant system are to correspond with the maximum available bone width in the treatment areas. Large diameter implants can be utilized to engage the greatest amount of bone volume. These implants can also be used in a submerged protocol if the tissue is thick and a short healing cover screw is utilized. The nonsubmerged protocol does not imply immediate loading, and the implants should integrate in a 3-8 month healing phase based on the bone density before prosthetic load is incorporated into the implant sites.
Susan Runor
Division Sign-Off of Dental, Infection Control,