LOCATOR OVERDENTURE IMPLANT SYSTEM

K120198 · Zest Anchors, LLC · DZE · Jun 6, 2012 · Dental

Device Facts

• Record ID: K120198
• Device Name: LOCATOR OVERDENTURE IMPLANT SYSTEM
• Applicant: Zest Anchors, LLC
• Product Code: DZE · Dental
• Decision Date: Jun 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla.

Device Story

The LOCATOR® Overdenture Implant (LODI) System is a narrow-diameter endosseous dental implant system used to retain overdentures or partial dentures. The system consists of a narrow-diameter dental implant (2.4mm or 2.9mm diameter; 10-16mm length) and a screw-retained abutment. The implant features a flared collar to accommodate the abutment. The device is surgically placed in the mandible or maxilla by a dental professional. It functions as a mechanical anchor for prosthetic dentures, providing stability for the patient. No electronic or software components are involved.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ISO 14801, including static compression and dynamic compression (fatigue) tests, demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Materials: Ti 6Al-4V ELI (ASTM F136 for implants, ASTM B348 for abutments). Surface: Resorbable Blast Media. Dimensions: 2.4mm or 2.9mm diameter implants; 10, 12, 14, or 16 mm lengths; 2.9mm platform abutments with 2mm or 4mm cuff heights. Mechanical fixation principle. No software, electronics, or connectivity.

Indications for Use

Indicated for patients requiring retention of overdentures or partial dentures 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

• Ace Surgical Secure-Mini™ LOCATOR® Implant System (K092594)

Submission Summary (Full Text)

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# K-120198

JUN - 6 2012

### 510(k) SUMMARY

#### SAFETY AND EFFECTIVENESS

Submitted By:

Zest Anchors, LLC 2061 Wineridge Place Escondido, CA 92029

A) Device Trade Name: Common Name: Classification Name: Device Class: Product Code:

Contact: Annie Wright Tel: [phone] ext 140 Fax: [phone]

LOCATOR® Overdenture Implant System Endosseous Implant Screw Implant, Endosseous, Root-form 21CFR 872.3640, Class II DZE

- B) Date prepared:
April 30, 2012

- C) Predicate Device:
- Ace Surgical Supply Co., Inc., Ace Surgical Secure-Mini™ LOCATOR® Implant . System (K092594)
- D) Intended Use:

The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla.

- E) Device Description:
The LOCATOR® Overdenture Implant (LODI) System comprises a narrow diameter endosseous dental implant (2.4mm or 2.9mm in diameter and 10, 12, 14, or 16 mm in length) and a screw-retained abutment (2.9mm platform with cuff heights of 2 or 4mm). The collar of the 2.4mm diameter implant is flared to a 2.9mm platform to accommodate the 2.9mm abutment. The implant is made of Ti 6Al-4V ELI conforming to ASTM F136 and the abutment is made of Ti 6AI-4V ELI conforming to ASTM B348.

- F) Technological Comparison:
The LOCATOR® Overdenture Implant (LODI) System comprises a narrow diameter endosseous dental implant and a screw-retained abutment. Similar to its predicate, it is designed to retain overdentures or partial dentures in the mandible or maxilla. The implant diameters and lengths are similar to those cleared in K092594 (Ace Surgical Secure-Mini™ LOCATOR® Implant System) and the material (Ti 6Al-4V ELI) as well as surface texturing (Resorbable Blast Media) is identical. The screw-retained abutment is identical in material, cuff height and platform diameter to that cleared in K092594.

- G) Nonclinical Testing:
The following mechanical testing in accordance to ISO 14801 was performed on the LOCATOR® Overdenture Implant (LODI) System and its predicate. The subject device was found to be substantially equivalent to the predicate device when tested side-by-side.

- Static Compression Test .
- Dynamic Compression (Fatigue) Test .

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#### H. Conclusion:

The LOCATOR® Overdenture Implant System is substantially equivalent to the predicate device cleared in K092594 (Ace Surgical Secure-Mini™ LOCATOR® implant System) based on similar or identical indications for use, technological comparison and overall device functionality.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Annie Wright Regulatory Affairs Manger Zest Anchors, LLC 2061 Wineridge Place Escondido, California 92029

JUN 6 2012

Re: K120198

Trade/Device Name: LOCATOR Overdenture Implant System Regulation Number: Endosseous Dental Implant Regulation Name: 21 CFR 872.3640 Regulatory Class: II Product Code: DZE Dated: April 30, 2012 Received: May 1, 2012.

Dear Ms. Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2- Ms. Wright

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## Indications for Use

## 510(k) Number (if known): K120198

Device Name: LOCATOR® Overdenture Implant System

Indications for Use:

The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla.

Prescription Use (Part 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Runore

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: