(118 days)
No
The summary describes a mechanical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as an implant system for retaining overdentures, which is a structural component of a dental prosthetic, not a device that provides therapeutic treatment itself.
No
The device is described as an "Overdenture Implant System" designed to "retain overdentures in the mandible or maxilla." Its purpose is to physically support dentures, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "threaded and tapered endosseous dental implant" made from titanium, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retain overdentures in the mandible or maxilla." This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a dental implant, a physical object implanted into bone.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, sterilization, and fatigue, which are typical for implanted medical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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 Predicate. 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.
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 , USP , and AAMI ST72, with a limit of 20 EU/Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
2
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------- |
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
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
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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 Overdenture | ||
| Implant (LODI) System | LOCATOR Overdenture | ||
| Implant (LODI) System | Legacy2, Legacy3, | ||
| Legacy4, simplyLegacy2, | |||
| simplyLegacy3 | |||
| Manufacturer | Zest Anchors, LLC | Zest Anchors, LLC | Implant Direct Sybron |
| Manufacturing, LLC | |||
| Indications | |||
| for Use | 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. | The LOCATOR® | ||
| Overdenture Implant | |||
| System is designed to | |||
| retain overdentures or | |||
| partial dentures in the | |||
| mandible or maxilla | These implants are | ||
| intended for use in partially | |||
| and fully edentulous upper | |||
| and lower jaws in support | |||
| of single or multiple-unit | |||
| restorations and terminal or | |||
| intermediate abutment | |||
| support for fixed | |||
| bridgework. | |||
| Implants can be indicated | |||
| for immediate loading | |||
| when good primary | |||
| stability has been achieved | |||
| and with appropriate | |||
| occlusal 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 |
|---|---|---|---|
| Material | |||
| Surface | |||
| Treatment | 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 regarding |
| implant 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 , USP , 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.