LOCATOR IMPLANT ANCHOR

K994257 · Zest Anchors, Inc. · DZE · Mar 17, 2000 · Dental

Device Facts

• Record ID: K994257
• Device Name: LOCATOR IMPLANT ANCHOR
• Applicant: Zest Anchors, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

Device Story

Locator Implant Anchor is an abutment for endosseous dental implants; used to retain overdentures or partial dentures in mandible or maxilla. Device features an Angle Correction Base for mal-aligned implants. Operates by providing mechanical retention for dental prostheses. Used in clinical dental settings by practitioners. Performance measured by removal retention force (mean 4.7 lbs) and fatigue strength under occlusal loading (175 lbs after 5 million cycles). Benefits include secure prosthetic attachment and accommodation of divergent implant placement.

Clinical Evidence

Bench testing only. Comparative analysis of removal retention force (n=not specified) showed mean values of 4.7 lbs (SD=0.207) for subject device vs 4.2 lbs (SD=0.483) for predicate. Fatigue testing of the Angle Correction Base component performed over 5 million cycles of compression at 25-degree angulation with 4mm gingival cuff height, demonstrating fatigue strength of at least 175 lbs.

Technological Characteristics

Endosseous dental implant abutment; includes Angle Correction Base for mal-aligned implants. Mechanical retention mechanism. Fatigue strength tested to 175 lbs after 5 million cycles. No software or electronic components.

Indications for Use

Indicated for patients requiring overdentures or partial dentures retained by endosseous implants in the mandible or maxilla.

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

• ZAAG Implant Anchor (K934668)

Submission Summary (Full Text)

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## ZEST ANCHORS. INC.

K994257

MAR 1 7 2000

## Attachment 6

## 510 (k) Summary of Safety and Effectiveness Information

Preparation Date: December 15, 1999 Zest Anchors, Inc. 2061 Wineridge Place #100 Escondido, CA 92029

Phone # [phone] Fax # [phone] Contact Person: Paul Zuest, President

Trade Name: Locator Implant Anchor Common Name: Abutment for Endosseous Implant Classification Name: Endosseous Dental Implant (accessory) 76DZE

The legally marketed device to which our firm is claiming equivalence is identified as the ZAAG Implant Anchor manufactured by Zest Anchors, Inc., and cleared for market under K934668. The predicate device is an abutment for endosseous implants which is intended for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The 510 (k) notification is based upon the fact that there are no significant differences between the Locator Implant Anchor (subject of this submittal) and the ZAAG Implant Anchor (predicate device) in terms of indications for use, design, and materials.

The most significant functional requirement of the devices is the value of the retentive force. Experience has shown that it should fall between 3.0 pounds and 5.0 pounds. Removal retention force was measured for both the Locator Implant Anchor and the ZAAG Implant Anchor. Mean values were 4.7 pounds (SD = .207) for the Locator Implant Anchor, and 4.2 pounds (SD = .483) for the ZAAG Implant Anchor.

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Safety of the devices can be influenced by their ability to withstand occlusal forces in a divergently placed implant fixture. The Locator Implant Anchor and ZAAG Implant Anchor share the exact same Angle Correction Base which threads into a mal-aligned endosseous implant. Results of fatigue testing of the Angle Correction Base show that, under the most severe conditions (25 degree angled component with a 4mm gingival cuff height), after 5 million cycles of compression testing, the fatigue strength of the attachment components is still at least 175 pounds.

In conclusion, this 510 (k) Summary is based upon the facts drawn from the results of testing which indicate the determination of substantial equivalence between the Locator Implant Anchor (subject of this submittal) and the ZAAG Implant Anchor (predicate device).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2000

Mr. Paul Zuest President Zest Anchors, Inc. 2061 Wineridge Place, Suite 100 Escondido, California 92029

Re : K994257 Locator Implant Anchor Trade Name: Requlatory Class: III Product Code: DZE Dated: December 15, 1999 Received: December 17, 1999

Dear Mr. Zuest:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ 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 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 obliqation you might have under sections 531 through 542 of

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Page 2 - Mr. Zuest

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 leqally 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 [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

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

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K994257

Page 1 of of l

510(k) Number (if known): K99-4257

Device Name: Locator Implant Anchor

Indications For Use: The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rump

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)