SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM

K970752 · Sulzer Calcitek, Inc. · DZE · Jun 23, 1997 · Dental

Device Facts

• Record ID: K970752
• Device Name: SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
• Applicant: Sulzer Calcitek, Inc.
• Product Code: DZE · Dental
• Decision Date: Jun 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.

Device Story

Spline Engaging Shouldered Abutment System provides anti-rotational interface for dental prosthetic restorations; used by licensed dentists in clinical settings. Device components engage spline tines at both implant/abutment and abutment/coping interfaces to prevent rotation. System supports screw-retained single or splinted prostheses (crowns, bars, bridges). Output is mechanical stability for dental implants; aids clinician in securing prosthetic restorations. Benefits patient through improved retention and stability of dental replacements.

Clinical Evidence

No clinical data provided; substantial equivalence based on design analysis and technological comparison to predicate device.

Technological Characteristics

Dental implant abutment system; features shouldered abutment with spline tines for anti-rotation at implant/abutment and abutment/coping interfaces. Materials unchanged from predicate. Supplied non-sterile.

Indications for Use

Indicated for patients requiring dental prostheses, including single crowns, bars, and bridges, in edentulous mandibles or maxillae. Used for attachment of complete dentures, fixed or removable bridgework, or free-standing single tooth replacement. Requires implants to be within 30° of parallelism for splinted prostheses.

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

• Spline Dental Implant System (K970752)

Submission Summary (Full Text)

{0}

JUN 23 1997
K970752

# 510(K) SUMMARY
## RELEASABLE THROUGH FREEDOM OF INFORMATION

Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.

| Company Name: | Sulzer Calcitek, Inc. |
| --- | --- |
| Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 |
| Telephone Number: | [phone] |
| Registration Number: | 2023141 |
| Contact Person: | Joseph S. Shan |
| Date Summary Prepared: | February 27, 1997 |
| Classification Name: | Implant, Endosseous (76DZE) |
| --- | --- |
| Common/Usual Name: | Dental Implant Abutment |
| Device Trade Name: | Spline Engaging Shouldered Abutment System |

The primary device used for comparison purposes in this summary is Sulzer Calcitek's existing Spline Dental Implant System. All implant systems are manufactured in the same facility located in Carlsbad, California.

1. **Intended Use:**
For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.

2. **Description:**
The Spline Engaging Shouldered Abutment System provides an anti-rotational option for single or multiple tooth prosthetic restorations. The components of this system are supplied non-sterile, for use by licensed dentists.

3. **Technological Characteristics:**
There has been a modification to the shouldered abutment and associated components. Both the implant/abutment and abutment/coping interface engage the spline tines, providing anti-rotation. There has been no change to the materials of this device.

4. **Comparison Analysis:**
The overall design of the prosthetic components are similar or identical to the predicate devices.

SUMMARY INFORMATION - RELEASABLE THROUGH FOI

{1}

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

JUN 23 1997

Mr. Joseph S. Shan
*Regulatory Affairs Associate
Sulzer Calcitek Incorporate
2320 Faraday Avenue
Carlsbad, California 92008

Re: K970752
Trade Name: Spline Engaging Shouldered Abutment System
Regulatory Class: II
Product Code: DZE
Dated: February 28, 1997
Received: March 3, 1997

Dear Mr. Shan:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}

Page 2 - Mr. Shan

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 at [phone].

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

{3}

Spline Engaging Shouldered Abutment System

# INDICATIONS FOR USE

## Spline Engaging Shouldered Abutment System

For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.

## Sulzer Calcitek Dental Implant Systems

Sulzer Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.


CONFIDENTIAL