5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS

K955619 · Calcitek, Inc. · DZE · Mar 8, 1996 · Dental

Device Facts

• Record ID: K955619
• Device Name: 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
• Applicant: Calcitek, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 8, 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

5.0mm Spline Endosseous Dental Implant System; endosseous dental implant for tooth replacement or prosthetic support. Device placed by licensed dentist in clinical setting. System provides structural foundation for dental restorations. Scaling of existing Spline system to 5.0mm diameter; utilizes identical materials and design principles as predicate. Increased cross-sectional area provides enhanced mechanical strength compared to smaller predicate versions.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence based on design, material identity, and mechanical strength analysis.

Technological Characteristics

Endosseous dental implant; 5.0mm diameter. Materials identical to predicate Spline system. Sterile, single-use. Mechanical strength derived from cross-sectional geometry and established material properties.

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 (K955619)

Submission Summary (Full Text)

{0}

-8 K955619

# 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: | December 4, 1995 |
| Classification Name: | Implant, Endosseous (76DZE) |
| --- | --- |
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | 5.0mm Spline Endosseous 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**

**Design:** There has been no significant change to the design of these parts.

**Materials:** The materials used for the are the same as previously mentioned out in the premarket notifications. The material specifications remain unchanged.

SUMMARY INFORMATION - RELEASABLE THROUGH FOI

{1}

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

### 4. Comparison Analysis:

The overall design of the implants and prostheses is identical to the predicate devices. The subject implants and components have been scaled up to the 5.0mm size. Given that mechanical strength is generally a function of cross-section and material properties, and that identical materials are used to manufacture the 5.0mm implants and prostheses, it is expected that the 5.0mm components will be stronger than the predicate devices.

SUMMARY INFORMATION - RELEASABLE THROUGH FOI