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.

Device Description

These Class III dental implants are supplied sterile, ready for placement by a licensed dontist.

AI/ML Overview

The provided text is a 510(k) summary for Calcitek HA-Coated Endosseous Dental Implants from 1997. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device. However, this document does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.

Specifically, the document focuses on:

Company and contact information.
Classification and trade names.
Intended Use statement.
Description of the device.
Technological characteristics (noting no change in design, and same materials except for an enhanced HA coating composition).
Comparison Analysis emphasizing the identical overall design to predicate devices and the change in HA coating composition.
FDA correspondence affirming substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details about comparative effectiveness studies, as this information is not present in the provided text. The document's purpose is to establish substantial equivalence for regulatory approval, not to present a detailed clinical or performance study report.

Summary

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K970127

JUN 23 1997

Calcitek HA-Coated Endosseous Dental Implants January 1997

510(k) SUMMARY INFORMATION - RELEASABLE THROUGH ! OI

Summary of Information Concerning Safety and Effectiveness for Purposes of establishing Substantial to a Predicate Device 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:	(619) 431-9515
Registration Number:	2023141
Contact Person:	Donna K. Howard
Date Summary Prepared:	December 1996

Classification Name:	Implant, Endosseous (76DZE)
Common/Usual Name:	Dental Implant System
Device Trade Name:	Calcitek HA-Coated Endosseous Dental Implant Systems

The primary devices used for comparison purposes in this summary rire Calcitek's existing HA-coated endosseous dental implant systems. All implant systems are manufactured in the same facility located in Carlsbad, California.

The statements of intended use are identical. I . 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."

Description: These Class III dental implants are supplied sterile, ready for 2. placement by a licensed dontist.
ੜ . Technological Characteristics

Design: There has been no change to the design of these implants.

Materials: The materials used for the dental implants are the same as previously mentioned in the premarket notifications.

510(K) SUMMARY INKUKMATION - Releasable through FOI

092-1 ED.9 328-T

ESTE ! EPOGL

Chargar Carol Tex US: UI US 13350

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Calcitek HA-Coated Endosseous Dental Implants January 1997

4. Comparison Analysis:

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The overall design of the implants is identical to the predicato devices. The composition of the HA coating has been changed. the crystalline HA content has been enhanced and the content of all non-HA components have been decreased.

510(K) SUMMARY INFORMATION - Releasable through FO1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three faces in profile, overlaid with three horizontal lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1997

Ms. Donna K. Howard Supervisor, Clinical Affairs Sulzer Calcitek Incorporated 2320 Faraday Avenue Carlsbad, California 92008-7216

Re : K970127 Endosseous Dental Implant Trade Name: Regulatory Class: III Product Code: DZE Dated: January 10, 1997 Received: January 14, 1997

Dear Ms. Howard:

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 The general controls provisions of the Act 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 requlations 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) requlation (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 requlation may result in requlatory 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.

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Page 2 - Ms. Howard

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638+2041 or at (301) 443-6597.

Sincerely yours,

Timothy A. Ulatowski

Timoth 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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510(k) Number (if known): K970127

Device Name: HA coated Endosseous Dental Implant

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Susan Rapser
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K972007

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use $\mu b$

(Optional Format 1 -2-96)

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.