SPLINE DENTAL IMPLANT SYSTEMS

K962106 · Calcitek, Inc. · DZE · Aug 29, 1996 · Dental

Device Facts

• Record ID: K962106
• Device Name: SPLINE DENTAL IMPLANT SYSTEMS
• Applicant: Calcitek, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Spline Dental Implant System; endosseous dental implant; used in edentulous mandibles or maxillae; placed by licensed dentist; provides attachment for complete dentures, fixed/removable bridgework, or single tooth replacement; modified apical portion enables self-tapping; supplied sterile; prosthetic components unchanged; interface unchanged; available in textured and untextured surfaces.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant; modified apical geometry for self-tapping; available in textured and untextured surfaces; supplied sterile; materials unchanged from predicate.

Indications for Use

Indicated for patients with edentulous mandibles or maxillae requiring complete denture prostheses, fixed or removable bridgework, or single tooth replacement.

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 (K962106)

Submission Summary (Full Text)

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AUG 29 1996
K962106

# 510(K) SUMMARY

## RELEASABLE THROUGH FREEDOM OF INFORMATION

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

| Company Name: | Calcitek, Inc. |
| --- | --- |
| Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 |
| Telephone Number: | [phone] |
| Registration Number: | 2023141 |
| Contact Person: | Donna K. Howard |
| Date Summary Prepared: | May 20, 1996 |
| Classification Name: | Implant, Endosseous (76DZE) |
| --- | --- |
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | Spline Dental Implant System |

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

1. **Intended Use:** The statements of intended use are identical.
"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."

2. **Description:** These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.

3. **Technological Characteristics:**
There has been a modification to the apical portion of the implant body to provide the implant with self tapping capabilities. There has been no change to the materials of this device. The implant bodies are offered in both the untextured and textured surfaces. The interface remains unchanged.

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

SUMMARY INFORMATION - RELEASABLE THROUGH FOI