(539 days)
The NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant patients. The implants are to be used in single or multiple units in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported partial denture, implant supported bar/overdenture, implant 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.
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.
The provided text is a 510(k) summary for a medical device (endosseous implant system), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed studies with acceptance criteria and performance data as would be found in a clinical trial or performance study report for a novel device.
The document primarily focuses on demonstrating substantial equivalence to existing devices based on design, materials, manufacturing processes, gamma sterilization, geometry, and materials. There are no specific acceptance criteria or details of a study explicitly proving the device meets performance criteria in the way a diagnostic AI device or a novel therapeutic device would.
Therefore, many of the requested elements for the acceptance criteria and study section cannot be extracted directly from this 510(k) summary.
Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The substantial equivalence is based on the device being "similar to the predicate devices currently on the market" in its characteristics and intended use.
2. Sample size used for the test set and the data provenance
No test set or data provenance is mentioned. This is a premarket notification for a device based on similarity to predicate devices, not a study reporting performance data on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set or ground truth establishment process is described.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, and no MRMC study content is present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is mentioned. The device's safety and effectiveness are established through substantial equivalence to predicate devices, implying that past clinical experience and regulatory approvals of similar devices form the basis.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for a training set is described.
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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.
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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
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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
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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
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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,
§ 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.