KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS

K961381 · The Emerging Technologies Group · DZE · Sep 9, 1997 · Dental

Device Facts

• Record ID: K961381
• Device Name: KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS
• Applicant: The Emerging Technologies Group
• Product Code: DZE · Dental
• Decision Date: Sep 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Endosseous implant system comprising implants, tools, and prosthetic abutments. Includes cylindrical and screw-type implants; premachined angulated abutments (15° and 25°); wide body prosthetic abutments (4, 5, 6mm diameters). Used by dental clinicians for prosthetic reconstruction in edentulous patients. System facilitates prosthetic phase and insulation of prosthesis. Implants placed in maxilla or mandible; integrated over 3-8 months before loading. Benefits include restoration of dental function and aesthetics for edentulous patients.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: ASTM B-348-93 titanium Grade 3, 4, 5, and titanium alloy ELI-Grade 5. Components: Cylindrical and screw implants, angulated abutments (<30°), wide body abutments (4-6mm). Sterilization: Gamma. Manufacturing: GMP compliant.

Indications for Use

Indicated for reconstruction of partial and totally edentulous patients. Used in single or multiple units in maxilla and mandible. Applications include single tooth, partial denture, bar/overdenture, retained overdenture, and fixed-detachable prosthesis. Diameter selection based on available bone width; large diameters used for maximum bone volume. Suitable for submerged or non-submerged protocols; requires 3-8 month integration phase prior to prosthetic loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Dental Imaging Associates (K902433)
• Dental Imaging Associates (K902434)
• Dental Imaging Associates (K902435)
• Implant Innovations Inc. preangled abutments (K932123)
• Nobelpharma (K925766)
• Implant Innovations (K933462)

Submission Summary (Full Text)

{0}

P. 02
K961381
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, Implant 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}

DR. KRAUSER
10-3928320
P. 03

# 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. Krauser, DMD

JTK/lb

{2}

HUMAN SERVICES

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP - 9 1997

Jack T. Krauser, D.M.D.
The Emerging Technologies Group
824 US Highway 1, Suite 370
N. Palm Beach, Florida 33408

Re: K961381
Trade Name: KIS-III Non-Submerged Implant, Screws and 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 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 (Premarket Approval), 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 895. A 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 Drug 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 Register. Please note: this response to your premarket notification submission does not affect any obligation 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 regulations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
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
[phone]

# 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 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.