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.

AI/ML Overview

The provided document describes a medical device submission, K120198, for the LOCATOR® Overdenture Implant System. However, this submission is for a traditional 510(k) premarket notification for a dental implant system, which is a physical device, and not an AI/ML-enabled medical device.

Therefore, most of the requested information (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) is not applicable to this type of device submission.

The primary method of demonstrating substantial equivalence for this physical device is through nonclinical mechanical testing and comparison to a legally marketed predicate device.

Here's a breakdown of the relevant information from the provided text:

Acceptance Criteria and Reported Device Performance (Table)

Acceptance Criteria (Test Type)	Reported Device Performance
Static Compression Test	Subject device found substantially equivalent to predicate
Dynamic Compression (Fatigue) Test	Subject device found substantially equivalent to predicate

Explanation Regarding Non-Applicable Sections:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" for this device refers to the physical samples used in mechanical testing, not a dataset of patient information.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods (ISO 14801), not expert medical interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations, not objective mechanical test results.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/ML-enabled devices.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI/ML-enabled devices.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" is adherence to established mechanical performance standards (ISO 14801) and equivalence to the predicate device under those conditions. It is not based on clinical pathology or outcomes data for this type of submission.
The sample size for the training set: Not applicable. There is no AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable. There is no AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted was a nonclinical mechanical testing based on ISO 14801. The tests performed were:

Static Compression Test
Dynamic Compression (Fatigue) Test

The purpose of these tests was to demonstrate substantial equivalence to the predicate device, the Ace Surgical Supply Co., Inc., Ace Surgical Secure-Mini™ LOCATOR® Implant System (K092594). The document explicitly states: "The subject device was found to be substantially equivalent to the predicate device when tested side-by-side." This means that the LOCATOR® Overdenture Implant System performed comparably to its predicate device under the standardized mechanical stress conditions outlined in ISO 14801.

Summary

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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: (760) 743-7744 ext 140 Fax: (760) 743-7975

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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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 (800) 638-2041 or (301) 796-7100 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:

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.