ROOTFORM DENTAL IMPLANT SYSTEM

K954758 · Swiss Dental Center · DZE · Aug 18, 1997 · Dental

Device Facts

• Record ID: K954758
• Device Name: ROOTFORM DENTAL IMPLANT SYSTEM
• Applicant: Swiss Dental Center
• Product Code: DZE · Dental
• Decision Date: Aug 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rootform Dental Implant is an endosseous dental implant intended to provide support for prosthetic attachments. The Rootform Dental Implant is surgically placed in the bone of the upper or lower jaw arches to provide attachment and support for an abutment and prosthetic devices including artificial teeth, bridges, and dentures.

Device Story

Rootform Dental Implant System consists of two-stage, cylindrical, endosseous implants; available in non-hex top (3.3mm, 3.8mm) and universal hex-lock top (3.3mm, 4.0mm) configurations. System includes implants, cover screws, healing abutments, and various prosthetic attachments. Surgically placed in jaw bone by dental professionals to provide stable foundation for artificial teeth, bridges, or dentures. Device functions as mechanical anchor for prosthetic restoration; no electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence determination based on design and material similarity to predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti6AL4V). Design: Two-stage, rootform, cylindrical, press-fit endosseous implant. Configurations: Non-hex top (3.3mm, 3.8mm) and hex-lock top (3.3mm, 4.0mm). Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants to support prosthetic attachments, artificial teeth, bridges, or dentures in the upper or lower jaw arches.

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

• Mini and Universal Implants (K912262)
• HA and TPS Coated Cylindrical Implants (K921966)
• Opti-Max Dental Implant (K926101)

Submission Summary (Full Text)

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Swiss Dental Center
510(k) Premarket Notification
Rootform Dental Implant System

# 510(k) SUMMARY

$$k954758$$

AUG 19 1997

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR § 807), and in particular § 807.92, the following summary of safety and effectiveness information is provided:

## Submitted By

Swiss Dental Center
567 Marsh Street
San Luis Obispo, California 93401
Telephone: [phone]
Telefacsimile: [phone]
Contact: Carol L. Phillips, D.D.S.
Date Prepared: October 13, 1995

## Device Name

Trade or Proprietary Name: Rootform Dental Implant System
Common or Usual Name: Dental Implant
Classification Name: Endosseous Implant (per 21 CFR § 872.3640)

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Swiss Dental Center
510(k) Premarket Notification
Rootform Dental Implant System

## Predicate Devices

| 510(k) | Sponsor | Device Name |
| --- | --- | --- |
| K912262 | Imtec Corp. | Mini and Universal Implants |
| K921966 | Steri-Oss | HA and TPS Coated Cylindrical Implants |
| K926101 | Phoenix Dental, Inc. | Opti-Max Dental Implant |
| K926102 | | |

## Device Description

The Rootform Dental Implant System has two “families” -- one without a hex top with 3.3 mm and 3.8 mm diameter cylinders and a second with a hex lock top with 3.3 mm and 4.0 mm diameters.

The components of each system are as follows:

### Rootform 3.3 mm and 3.8 mm Non-Hex Top Implant System

- Implants with internal thread
- Cover screws
- Healing abutments
- Prepable abutments
- Bar or tissue abutments
- Abutment screws
- Tissue abutment with cap
- Prosthetic attachment screws

### Rootform 3.3 mm and 4.0 mm Universal Hex Top Implant System

- Implants with internal thread
- Cover screws
- Fixation screws
- Healing abutments
- Straight abutments
- Angled abutments

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Les Phillips
Swiss Dental Center
567 Marsh Street
San Luis Obispo, California 93401

AUG 19 1997

Re: K954758
Trade Name: Rootform Dental Implant System
Regulatory Class: III
Product Code: DZE
Dated: June 6, 1997
Received: June 12, 1997

Dear Mr. Phillips

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

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Page 2 - Mr. Phillips

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

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Swiss Dental Center
510(k) Premarket Notification
Rootform Dental Implant System

# Intended Use

The Rootform Dental Implant is an endosseous dental implant intended to provide support for prosthetic attachments. The Rootform Dental Implant is surgically placed in the bone of the upper or lower jaw arches to provide attachment and support for an abutment and prosthetic devices including artificial teeth, bridges, and dentures.

# Comparison to Predicate Devices

The technological characteristics of the current device closely parallel those of the predicate devices. For example, the current device and each of the predicate device implants as well as their associated prosthetic components are manufactured from the same material, titanium alloy (Ti6AL4V). The designs are also similar in that each implant is a two-stage, rootform, cylindrical, press-fit - type implant. As such they share many common features in addition to design principles including surgical implantation and loading procedures and restorative methods and techniques.

# Summary of Nonclinical Tests

Not Applicable. The determination of substantial equivalence was not based on an assessment of performance data.

# Summary of Clinical Tests

Not Applicable. The determination of substantial equivalence was not based on an assessment of performance data.

# Conclusions of Nonclinical and Clinical Tests

Not Applicable

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number _______________

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