The LOCATOR® Overdenture Implant System is designed to retain overdentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

The LOCATOR Overdenture Implant (LODI) was originally cleared under K120198. This submission is to add additional implant sizes to the LODI family that for distinction purposes, will hereinafter be called the Standard Ridge LOCATOR Overdenture Implant (LODI) System. The added implant sizes are listed in Table 1.0 below:

	LENGTH
DIAMETER	8mm	10mm	12mm	14mm
3.5mm	x	x	x	x
3.9mm	x	x	x	x
4.4mm	x	x	x	x
4.9mm	x	x	x	x

Table 1.0 Subiect Device Sizes

Identical to K120198, the subject LODI Standard Ridge System is designed to retain overdentures of partial dentures in the mandible or maxilla. The System includes a threaded and tapered endosseous dental implant that is made from the identical material, 6Al-4V ELI Titanium, and maintains its conformance to ASTM F136. The implant surface is roughened by Resorbable Blast Media (RBM) up to the abutment seating platform by the same manufacturing processes with the same manufacturing equipment as the existing LODI implant.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "LOCATOR® Overdenture Implant System," specifically to add additional implant sizes to the existing system. The document focuses on demonstrating substantial equivalence to a predicate device (K120198) and a reference device (K192221) rather than presenting a study to prove acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

Therefore, many of the requested fields are not directly applicable to this type of submission which primarily relies on engineering and material testing to confirm equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Attribute	Reported Device Performance / Conclusion
Mechanical Properties:
- Body Type	Identical Threaded and Tapered Body Type as Predicate.
- Thread Type	Dual Lead (Predicate was variable single lead). A dual lead thread does not create a new worst case regarding implant performance or strength.
- Tip Type	Blunted (Predicate was sharp). The blunted tip of the subject stops the implant from advancing past the drilled depth.
Corrosion Testing	N/A - Implant and implant attachment are made from the same type of material (titanium alloy); therefore, the implant will see no effects from galvanic corrosion. Titanium alloy is inherently corrosion resistant; therefore, the implant will see no effects of corrosion of the base metal.
Biocompatibility	The category, contact, and contact duration per ISO 10993-1 Table A.1 are the same for the Subject and Predicate device. The increased surface area of the device does not alter the ISO 10993-1 medical device categorization and therefore does not impact the biocompatibility profile of the LODI implant cleared under K120198. The biocompatibility of Ti-6AL-4V ELI remains unchanged from that of the Predicate.
Sterilization (SAL 10-6)	Validation testing per ISO 11137-2:2015 was conducted to ensure that the Standard Ridge LODI Implant can also be sterilized in the same manner as the predicate implant by 25 kGy to achieve a sterility assurance level (SAL) of 10-6.
Cleanability	The Total Organic Carbon and cytotoxicity test result demonstrated that the new worst-case implant, the Standard Ridge LODI 4.9mm implant, meets the acceptance criteria for HFE cleaning, HNO3 cleaning, and IPA cleaning.
Fatigue Strength	Due to the larger cross-sectional area of the subject device, the identical finishing, material, and manufacturing processes, it can be concluded that the subject device does not introduce a new worst case in respect to fatigue strength. Therefore, the fatigue testing reported in 510(k) K120198 remains applicable to the subject device.
Shelf-Life	The Subject device is supplied sterile in standard plastic tray with Tyvek™ lid using the same validated processes and materials as the Predicate. Accelerated aging conducted on the Predicate device as the worst case (2.9mm X 10mm with 4mm Cuff Height LOCATOR Abutment) validated for a period of up to 5 years. The Subject device does not introduce a new worst case and therefore falls within the scope of the Predicate Shelf-Life testing.
Surface Treatment (RBM)	The Resorbable Blast Media used for the implant surface treatment is the identical process and material used on the predicate implant cleared under K120198.
Endotoxin Testing (limit 20 EU/Device)	The method of detection for bacterial endotoxin uses the kinetic turbidimetric and chromogenic techniques per USP <85>, USP <161>, and AAMI ST72, with a limit of 20 EU/Device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. This submission relies on engineering design principles, material science, and performance testing for mechanical, biological (biocompatibility, sterilization, cleanability, endotoxin), and shelf-life attributes, rather than a "test set" of clinical data. The acceptance criteria for manufacturing processes (e.g., sterilization, cleanability) are evaluated on representative devices or materials.
Data Provenance: Not applicable in the context of clinical test data. The data provenance relates to internal manufacturing and testing records (e.g., ISO and USP standards for testing methods).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a clinical study involving expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

5. 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 a medical device (dental implant) and not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (dental implant) and not an AI-driven algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the sense of clinical ground truth for a diagnostic device. The "ground truth" for this submission are the established engineering standards (e.g., ASTM F136 for material, ISO 11137-2 for sterilization, ISO 10993-1 for biocompatibility, USP for endotoxin) and the performance characteristics of the predicate device.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established:

Not applicable. This is not a machine learning or AI-driven device.

Summary of the Study/Approach:

The submission K203701 for the LOCATOR® Overdenture Implant System demonstrates substantial equivalence by showing that the new implant sizes are

Made from the identical material (6Al-4V ELI Titanium conforming to ASTM F136).
Have the same surface roughening process (Resorbable Blast Media, RBM).
Maintain the same manufacturing processes and equipment.
The Indications for Use remain within the scope of the predicate device (K120198).
Performance testing (mechanical properties, corrosion, biocompatibility, sterilization, cleanability, fatigue, shelf-life, surface treatment, endotoxin) confirmed that adding new implant sizes either did not alter the existing safety and performance profile of the predicate device or, in cases of slight design changes (e.g., dual lead thread, blunted tip), did not create a new worst-case scenario. For instance, the larger cross-sectional area of the new implants was deemed to not introduce a new worst case for fatigue strength, and previous fatigue testing from K120198 was considered applicable. Similarly, the "new worst-case implant" (Standard Ridge LODI 4.9mm) was specifically tested for cleanability to meet acceptance criteria.

Note: "No clinical studies are provided as part of this 510(k) submission" is explicitly stated, reinforcing that this clearance relies on non-clinical (bench and material) testing and established equivalency principles.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

Zest Anchors LLC Marysa Loustalot Sr. Regulatory Affairs Specialist 2875 Loker Avenue East Carlsbad, California 92010

Re: K203701

Trade/Device Name: Locator® Overdenture Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: March 19, 2021 Received: March 22, 2021

Dear Marysa Loustalot:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203701

Device Name

The LOCATOR® Overdenture Implant System

Indications for Use (Describe)

The LOCATOR® Overdenture Implant Ssystem is designed to retain overdentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image is a logo for Zest Dental Solutions. The logo has the letters "ZD" in a bold, blue font on the left side. To the right of the letters is the text "ZEST DENTAL" in a bold, blue font, with the word "SOLUTIONS" underneath in a lighter blue font.

April 08. 2021

SUBMITTER I.

Zest Anchors, LLC 2875 Loker Ave. East. Carlsbad. CA 92010 Phone: +1 (760) 743-7744 Contact: Marysa Loustalot ext. 596 Date Prepared: April 8, 2021

II. DEVICE INFORMATION

Device / Trade Name: LOCATOR® Overdenture Implant System Common Name: Dental Implant System Classification Name: Endosseous dental implant Regulatory Classification: Class II, 21 CFR 872.3640 Product Code: DZE

III. PREDICATE DEVICE(s)

Primary Predicate: LOCATOR® Overdenture Implant System (K120198)

Reference Device(s): Legacy2, Legacy3, Legacy4, SimplyLegacy2, SimplyLegacy3 Dental Implants (K192221)

IV. DEVICE DESCRIPTION

	LENGTH
DIAMETER	8mm	10mm	12mm	14mm
3.5mm	x	x	x	x
3.9mm	x	x	x	x
4.4mm	x	x	x	x
4.9mm	x	x	x	x

Table 1.0 Subiect Device Sizes

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Image /page/4/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a dark blue color on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a dark blue color, and the word "SOLUTIONS" is written in a lighter blue color.

the identical material, 6Al-4V ELI Titanium, and maintains its conformance to ASTM F136. The implant surface is roughened by Resorbable Blast Media (RBM) up to the abutment seating platform by the same manufacturing processes with the same manufacturing equipment as the existing LODI implant.

Additional wording was added to the Indications for Use statement for clarification purposes only. The Subject device's Indications for Use statement remains within scope of that cleared in K120198.

INDICATIONS FOR USE V.

The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.

FEATURES	SUBJECT	PREDICATE	REFERENCE DEVICE
510(k)Number	K203701	K120198	K192221
Device Name	LOCATOR OverdentureImplant (LODI) System	LOCATOR OverdentureImplant (LODI) System	Legacy2, Legacy3,Legacy4, simplyLegacy2,simplyLegacy3
Manufacturer	Zest Anchors, LLC	Zest Anchors, LLC	Implant Direct SybronManufacturing, LLC
Indicationsfor Use	The LOCATOR®Overdenture ImplantSystem is designed toretain overdentures orpartial dentures in themandible or maxilla.Immediate loading isindicated when goodprimary stability has beenachieved and withappropriate occlusalloading.	The LOCATOR®Overdenture ImplantSystem is designed toretain overdentures orpartial dentures in themandible or maxilla	These implants areintended for use in partiallyand fully edentulous upperand lower jaws in supportof single or multiple-unitrestorations and terminal orintermediate abutmentsupport for fixedbridgework.Implants can be indicatedfor immediate loadingwhen good primarystability has been achievedand with appropriateocclusal loading.
Product Code	DZE	DZE	DZE
Classification	Class II	Class II	Class II
Regulation	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640
RX / OTC	RX	RX	RX
Material	Ti 6Al-4V ELI	Ti 6Al-4V ELI	Ti 6Al-4V ELI

SUBSTANTIAL EQUIVALENCY COMPARISON VI.

LODI Standard Ridge

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Image /page/5/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo features the letters "ZD" in a bold, teal font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a dark teal font, with the word "SOLUTIONS" written below in a lighter teal font.

FEATURES	SUBJECT	PREDICATE	REFERENCE DEVICE
MaterialSurfaceTreatment	Resorbable Blast Media	Resorbable Blast Media	Soluble Blast Media
Diameter (Ø)	3.5mm, 3.9mm, 4.4mm,4.9mm	2.4mm and 2.9mm	3.2mm, 3.7mm, 4.2mm,4.7mm, 5.2mm, 5.7mm,7.0mm
Length	8mm, 10mm, 12mm,14mm	10mm, 12mm, 14mm,16mm	6mm, 8mm, 10mm,11.5mm, 13mm 16mm

VII. PERFORMANCE TESTING

ATTRIBUTE TEST	DISCUSSION / RESULTS
Mechanical Properties
- Body Type	Identical Threaded and Tapered Body Type as Predicate
- Thread Type	Thread type is a Dual Lead compared to the variable single lead of the
- Tip Type	Predicate. A dual lead thread does not create a new worst case regardingimplant performance or strength.
	Blunted (Predicate was sharp): The blunted tip of the Subject stops the
	implant from advancing past the drilled depth.
Corrosion Testing	N/A - Implant and implant attachment are made from the same type of material
	(titanium alloy); therefore, the implant will see no effects from galvanic corrosion.
	Titanium alloy is inherently corrosion resistant; therefore, the implant will see no
	effects of corrosion of the base metal.
Clinical Studies	No clinical studies are provided as part of this 510(k) submission.
Biocompatibility	The category, contact, and contact duration per ISO 10993-1 Table A.1 are the same
	for the Subject and Predicate device. The increased surface are of the device does not
	alter the ISO 10993-1 medical device categorization and therefore does not impact the
	biocompatibility profile of the LODI implant cleared under K120198. The
	biocompatibility of Ti-6AL-4V ELI remains unchanged from that of the Predicate.
Sterilization	Validation testing per ISO 11137-2:2015 was conducted to ensure that the Standard
	Ridge LODI Implant can also be sterilized in the same manner as the predicate implant
	by 25 kGy to achieve a sterility assurance level (SAL) of 10-6.
Cleanability	The Total Organic Carbon and cytotoxicity test result demonstrated that the new
	worst-case implant, the Standard Ridge LODI 4.9mm implant, meets the acceptance
	criteria for HFE cleaning, HNO3 cleaning, and IPA cleaning.
Fatigue Testing	Due to the larger cross-sectional area of the subject device, the identical finishing,
	material and manufacturing processes, it can be concluded that the subject device does
	not introduce a new worst case in respect to fatigue strength. Therefore, the fatigue
	testing reported in 510(k) K120198 remains applicable to the subject device.
Shelf-Life	The Subject device is supplied sterile in standard plastic tray with Tyvek™ lid using
	the same validated processes and materials as the Predicate. Accelerated aging
	conducted on the Predicate device as the worst case (2.9mm X 10mm with 4mm Cuff
	Height LOCATOR Abutment) validated for a period to to 5 years. The Subject device
	does not introduce a new worst case and therefore falls within the scope of the
	Predicate Shelf-Life testing.
Surface Treatment	The Resorbable Blast Media used for the implant surface treatment is the identical
	process and material used on the predicate implant cleared under K120198.
Endotoxin Testing	The method of detection for bacterial endotoxin uses the kinetic turbidimetric and
	chromogenic techniques per USP <85>, USP <161>, and AAMI ST72, with a limit of
	20 EU/Device.

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Image /page/6/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a dark blue color on the left side. To the right of the letters, the words "ZEST DENTAL" are written in dark blue, with the word "SOLUTIONS" written below in a lighter blue color.

VII. CONCLUSION

The Standard Ridge LODI System is identical to the LODI System cleared under K120198 in terms of intended use, system components, materials, and packaging. The equivalency of the Standard Ridge LODI System to the original LODI System has been demonstrated through verification and validation activities.

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.