CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM

K954432 · Crystal Medical Technology · DZE · Jul 24, 1996 · Dental

Device Facts

• Record ID: K954432
• Device Name: CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM
• Applicant: Crystal Medical Technology
• Product Code: DZE · Dental
• Decision Date: Jul 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Endosseous dental implant system (post/screw-type); manufactured from titanium or titanium alloy; intended for surgical placement in jawbone to support dental prosthetics. Used by dentists/prosthodontists in clinical settings. Device provides foundation for restored oral function and aesthetics. Safety/effectiveness supported by long-term clinical literature and established Branemark implant techniques.

Clinical Evidence

Literature-based evidence; review of 639 Medline entries and NIH Consensus Development Conference proceedings. Cites Toronto 10-year study on Branemark implants demonstrating predictable, reliable outcomes for edentulous patients.

Technological Characteristics

Titanium or titanium alloy construction; post/screw-type configuration; sterilized via radiation or ethylene oxide; standard endosseous implant design.

Indications for Use

Indicated for edentulous patients requiring dental restoration to improve oral comfort, function, and appearance.

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.

Submission Summary (Full Text)

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JUL 23 1996
K954432

# XIII. SAFE MEDICAL DEVICES ACT SUMMARY OF SAFETY AND EFFECTIVENESS DATA. (Separate Page)

I. Classification Name and Number: Endosseous Implant (76DZE),
II. Common/Usual Name: Dental Implant, Endosseous, Post (or screw)-type, titanium or titanium alloy.
III. Proprietary Name: CRYSTAL and CRYSTAL-PLUS Implants System
IV. Classification: This device was classified by the Dental Devices Panel (Title 21 CFR 872.3640.

V. Brief Literature Review
Endosseous implants, and especially those of titanium or titanium alloy, in the "post" or "screw" configuration, have been proved safe and effective through the years. The possible adverse effects summarized in this 510(k) cover those listed by the United States classification panel [Federal Register, vol. 45, No. 251, pp 86025-6, Dec. 30, 1980], as well as to those revealed in a recent literature search. Matukas, "Medical Risks Associated with Dental Implants," states, "Little or no hard data could be found on the medical risks associated with [dental] implants." Because of the wide-spread usage of dental implants, Smith and Zarb made a careful review of the literature and proposed criteria for implant success.

A thorough computerized Medline literature search produced 579 entries. An update of this search produced 60 new review articles. The Journal of Dental Education published a special issue "Proceedings of the Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988], Vol. 52, No. 12, pp. 677-831, Dec. 1988. This added to the literature search above, with some especially pertinent reprints from the scientific literature, provide a comprehensive summary of available scientific data.

Zarb completed his report of the detailed Toronto 10-year study by concluding that "the tried and tested Branemark implant technique has revolutionized the treatment options open to the prosthodontist. For the edentulous patient...the prospect for a lifetime of restored oral comfort, function, and appearance have now become predictable and reliable." These results are ample evidence of the safety and effectiveness of these endosseous implants.

VI. These devices are manufactured from the titanium materials proved effective by the above summarized years of clinical usage, sterilized by the standard methods of radiation or ethylene oxide, and are constructed according to methods in the cited substantially equivalent products. Thus, they involve no new types of technology and no new technological questions.

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