(156 days)
The LOCATOR R-Tx® Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The LOCATOR R-Tx Attachment System is compatible with the following implant systems: (list of compatible implant systems and diameters follows).
LOCATOR R-Tx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR as a resilient attachment for endosseous implants. All LOCATOR R-Tx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR R-Tx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR R-Tx abutments are provided with either TiCN or TiN coating and available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). The abutments are provided in diameters 3.0 - 6.5 mm as shown below in the compatibility table.
This document describes the regulatory submission for the LOCATOR R-Tx® Attachment System and its substantial equivalence to a predicate device (K150295). It's important to note that this is a dental implant attachment system, not an AI/ML powered medical device. Therefore, the questions regarding AI/ML specific acceptance criteria, test sets, ground truth, and human reader studies are not applicable to this document.
The "study that proves the device meets acceptance criteria" in this context refers to the engineering analysis and demonstration of compatibility, rather than clinical trials or AI/ML performance metrics.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance (for a physical dental device):
The acceptance criteria for the LOCATOR R-Tx® Attachment System revolve around its compatibility with various implant systems and ensuring that its performance is equivalent to the predicate device (K150295) without introducing new risks.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (How the device meets the criteria) |
|---|---|---|
| Compatibility | Compatibility with specified dental implant systems regarding dimensions, interface, and function. | Verified through: - OEM signed abutment drawings - OEM implant drawings - Established compatibility with LOCATOR abutments through mutual contractual agreements with OEM. - Engineering analysis and documentation for Line Extensions. |
| Material | Abutment material: Ti-6Al-4V ELI. Prosthetic Retention Component: Nylon or PEEK. | Matches predicate device: Abutment is Ti-6Al-4V ELI, Prosthetic Retention Component is Nylon or PEEK. |
| Design Features | Female Abutment, Nylon Male, Denture Cap. Allows for 30° divergence. Abutment diameter range 2.75 - 6.0 mm. | Matches predicate device: Female Abutment, Nylon Male, Denture Cap. Allows 30° divergence. Abutment diameter range specified (note: subject device range (2.75-6.0mm) falls within predicate range (3.0-7.0mm)). |
| Mode of Operation | Functions as an abutment connecting to a housing embedded in a denture ridge, using nylon inserts for denture connection/disconnection. | Matches predicate device's mode of operation. |
| Risk Profile | No new or increased risks compared to predicate. Remains tissue-supported. | Engineering analysis confirmed no new worst-case scenarios, no new risks, and no impact on the risk profile of the predicate device (K150295). |
| Biocompatibility | Biocompatibility remains applicable. | Compatibility confirms all testing (including biocompatibility) from predicate K150295 remains applicable. |
| Sterilization | Sterilization remains applicable. | Compatibility confirms all testing (including sterilization) from predicate K150295 remains applicable. |
| Surface Characterization | Surface characterization remains applicable. | Compatibility confirms all testing (including surface characterization) from predicate K150295 remains applicable. |
| Manufacturability, Cleaning/Disinfection, Packaging, Shipping | Identical to predicate device. | Stated as identical to the predicate device. |
Regarding the AI/ML specific questions:
- Sample size used for the test set and the data provenance: Not applicable - this is a physical dental device, not an AI/ML device. The "test set" here refers to the parameters and specifications of various dental implants.
- 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 is established by manufacturers' specifications and engineering standards for mechanical compatibility.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Ground truth is based on engineering specifications and direct compatibility checks.
- 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 physical dental device, not an AI/ML device assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable - no algorithm involved.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device is based on engineering specifications, dimensional compatibility, and established industry standards for dental implant systems. This includes signed drawings from Original Equipment Manufacturers (OEMs) and contractual agreements related to compatibility.
- The sample size for the training set: Not applicable - no AI/ML training set.
- How the ground truth for the training set was established: Not applicable - no AI/ML training set.
Summary for this specific device:
The "study" proving the device meets acceptance criteria is primarily an engineering analysis and verification of the physical compatibility of the LOCATOR R-Tx® Abutment with various dental implant systems. This involves comparing the design and dimensions of the subject device's abutment-implant interface against the specifications of the vast array of listed implant systems (OEM data, drawings, and established compatibility). The core argument for substantial equivalence is that the modifications are minor and do not introduce new risks or alter the fundamental performance demonstrated by the predicate device (K150295).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 2, 2020
Ivory Super Holdco, Inc. Zest Anchors, LLC Marysa Loustalot Sr. Regulatory Affairs Specialist 2875 Locker Ave East Carlsbad, California 92010
Re: K200827
Trade/Device Name: LOCATOR R-Tx Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 28, 2020 Received: August 31, 2020
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.
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
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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 (OS) 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 mediation-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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200827
Device Name LOCATOR R-Tx®
Indications for Use (Describe)
The LOCATOR R-Tx® Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the maxilla. LOCATOR R-Tx Attachment System is compatible with the following implant systems:
| Implant Manufacturer: | Implant System: | Implant Diameters (Ø mm): |
|---|---|---|
| Ace Surgical | Infinity OCTAGON | (3.3, 4.1, 4.8) |
| Infinity TRI-CAM | (3.5, 4.3, 5.0) | |
| Infinity External Hex | (3.3, 3.75, 4.0, 4.75) | |
| Infinity Internal Hex | (3.7, 4.1, 4.7, 5.1) | |
| Avinent | Biomimetic Ocean | (3.3, 3.5, 4.0, 4.5, 5.0) |
| Biomimetic Coral | (3.3, 3.8, 4.0, 4.2, 4.8) | |
| Biohorizons | Tapered Internal | (3.0) |
| Tapered Plus | (3.8) | |
| Laser-Lok | (3.0) | |
| Biomet 3i | 3iT3, NanoTite, OSSEOTITE | (3.25, 3.75, 4.0) |
| Blue Sky Bio | Quattro | (3.3, 4.1, 4.8) |
| One Stage | (3.3, 4.1, 4.8) | |
| Camlog | SCREW-LINE ROOT-LINE 2 | (3.3, 3.8, 4.3, 5.0) |
| SCREW-LINE | (3.3, 3.8, 4.3, 5.0) | |
| Dentsply | Astra Tech OsseoSpeed EV | (3.6, 4.2, 4.8) |
| Xive Frialit-2 | (3.4, 3.8, 4.5, 5.5) | |
| Ankylos C/X | (3.5) | |
| Astra Tech OsseoSpeed TX | (3.5, 4.0, 4.5, 5.0) | |
| Hiossen, Inc. | SS | (3.5, 4.0, 4.5) |
| ET, TS | (3.5, 4.0, 4.5, 5.0, 6.0, 7.0) | |
| US | (3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0) | |
| Implant Direct | Swish Plus | (4.1, 4.8) |
| SwishTapered | (4.1, 4.8) | |
| InterActive | (3.2, 3.7, 4.3, 5.0) | |
| ReActive | (3.7, 4.2, 4.7, 5.7) | |
| Replant | (3.5, 4.3, 5.0) | |
| Legacy 1, 2, 3, 4 | (3.7, 4.2) | |
| Legacy 2, 3, 4 | (3.2, 4.7, 5.2) | |
| Legacy 1, 3 | (5.7) | |
| Legacy 2, 4 | (5.7, 7.0) | |
| Legacy 1 | (4.7) | |
| IDS | MegaGen Any Ridge | (3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0) |
| Keystone | PrimaConnex | (3.5, 4.1, 5.0) |
| Genesis | (3.5) | |
| TILOBEMAXX | (7.0, 8.0, 9.0) | |
| MIS | C1 | (3.3, 3.75, 4.2) |
| V3 | (3.3, 3.9, 4.3, 5.0) | |
| SEVEN | (3.3) | |
| M4 | (3.3) | |
| Nobel | Replace, Replace Select, NobelSpeedy | (3.5, 4.3, 5.0) |
| NobelActive, NobelParallel CC, NobelReplace CC | (3.5, 4.3, 5.5) | |
| Branemark, Nobel Speedy, Groovy | (3.3, 3.75, 4.0, 5.0) | |
| OCO Biomedical | Engage | (3.25, 4.0, 5.0) |
| Southern Implants | Tri-Nex | (3.5, 4.3, 5.0) |
| Tri-MAX7 | (7.0) | |
| External Hex | (3.75, 4.0, 5.0, 5.1, 6.0, 7.0, 8.0) | |
| Straumann | Roxolid SLActive, Roxolid SLA | (3.3, 4.1, 4.8) |
| Zimmer | Trabecular Metal, Tapered Screw-Vent, Screw-Vent, Advent | (3.7, 4.1, 4.7, 6.0) |
| Spline Reliance Cylinder | (3.25, 4.0, 5.0) | |
| Spline Twist | (3.75) |
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Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a large, bold, blue font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a bold, dark blue font, with the word "SOLUTIONS" written below in a lighter blue font. The logo is simple and professional, and the use of blue gives it a sense of trust and reliability.
I. SUBMITTER
Zest Anchors, LLC 2875 Loker Ave. East. Carlsbad, CA 92010 Phone: +1 (760) 743-7744 Contact: Marysa Loustalot ext. 596 Date Prepared: September 1, 2020
DEVICE INFORMATION II.
Device / Trade Name: LOCATOR R-Tx® Common Name: Dental Implant Abutment Classification Name: Endosseous dental implant abutment Regulatory Classification: Class II, 21 CFR 872.3630 Product Code: NHA
PREDICATE DEVICE III.
The subject device is identical to the predicate device in terms of manufacturability, cleaning/disinfection/sterilization, biocompatibility, packaging, and shipping. The subject device is similar in design to the predicate device and identical to the predicate in regards to the abutment-implant interface as described in K150295.
IV. DEVICE DESCRIPTION
LOCATOR R-Tx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR as a resilient attachment for endosseous implants. All LOCATOR R-Tx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR R-Tx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR R-Tx abutments are provided with either TiCN or TiN coating and available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). The abutments are provided in diameters 3.0 - 6.5 mm as shown below in the compatibility table.
V. INDICATIONS FOR USE
The LOCATOR R-Tx® Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The LOCATOR R-Tx Attachment System is compatible with the following implant systems:
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Image /page/5/Picture/0 description: The image is a logo for Zest Dental Solutions. The logo has the letters "ZD" in a dark teal color on the left side of the image. To the right of the letters is the text "ZEST DENTAL" in a dark teal color, with the word "SOLUTIONS" underneath in a lighter teal color.
| Implant Manufacturer: | Implant System: | Implant Diameters (Ø mm): |
|---|---|---|
| Ace Surgical | Infinity OCTAGON | (3.3, 4.1, 4.8) |
| Infinity TRI-CAM | (3.5, 4.3, 5.0) | |
| Infinity External Hex | (3.3, 3.75, 4.0, 4.75) | |
| Infinity Internal Hex | (3.7, 4.1, 4.7, 5.1) | |
| Avinent | Biomimetic Ocean | (3.3, 3.5, 4.0, 4.5, 5.0) |
| Biomimetic Coral | (3.3, 3.8, 4.0, 4.2, 4.8) | |
| Biohorizons | Tapered Internal | (3.0) |
| Tapered Plus | (3.8) | |
| Laser-Lok | (3.0) | |
| Biomet 3i | 3iT3, NanoTite, OSSEOTITE | (3.25, 3.75, 4.0) |
| Blue Sky Bio | Quattro | (3.3, 4.1, 4.8) |
| One Stage | (3.3, 4.1, 4.8) | |
| Camlog | SCREW-LINE ROOT-LINE 2 | (3.3, 3.8, 4.3, 5.0) |
| SCREW-LINE | (3.3, 3.8, 4.3, 5.0) | |
| Dentsply | Astra Tech OsseoSpeed EV | (3.6, 4.2, 4.8) |
| Xive Frialit-2 | (3.4, 3.8, 4.5, 5.5) | |
| Ankylos C/X | (3.5) | |
| Astra Tech OsseoSpeed TX | (3.5, 4.0, 4.5, 5.0) | |
| Hiossen, Inc. | SS | (3.5, 4.0, 4.5) |
| ET, TS | (3.5, 4.0, 4.5, 5.0, 6.0, 7.0) | |
| US | (3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0) | |
| Implant Direct | Swish Plus | (4.1, 4.8) |
| SwishTapered | (4.1, 4.8) | |
| InterActive | (3.2, 3.7, 4.3, 5.0) | |
| ReActive | (3.7, 4.2, 4.7, 5.7) | |
| Replant | (3.5, 4.3, 5.0) | |
| Legacy 1, 2, 3, 4 | (3.7, 4.2) | |
| Legacy 2, 3, 4 | (3.2, 4.7, 5.2) | |
| Legacy 1, 3 | (5.7) | |
| Legacy 2, 4 | (5.7, 7.0) | |
| Legacy 1 | (4.7) | |
| IDS | MegaGen Any Ridge | (3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0) |
| Keystone | PrimaConnex | (3.5, 4.1, 5.0) |
| Genesis | (3.5) | |
| TILOBEMAXX | (7.0, 8.0, 9.0) | |
| MIS | C1 | (3.3, 3.75, 4.2) |
| V3 | (3.3, 3.9, 4.3, 5.0) | |
| SEVEN | (3.3) | |
| M4 | (3.3) | |
| Nobel | Replace, Replace Select, NobelSpeedy | (3.5, 4.3, 5.0) |
| NobelActive, NobelParallel CC, NobelReplace CC | (3.5, 4.3, 5.5) | |
| Branemark, Nobel Speedy, Groovy | (3.3, 3.75, 4.0, 5.0) | |
| OCO Biomedical | Engage | (3.25, 4.0, 5.0) |
| Southern Implants | Tri-Nex | (3.5, 4.3, 5.0) |
| Tri-MAX7 | (7.0) | |
| External Hex | (3.75, 4.0, 5.0, 5.1, 6.0, 7.0, 8.0) | |
| Straumann | Roxolid SLActive, Ro | (3.3, 4.1, 4.8) |
| Zimmer | Trabecular Metal, Tapered Screw-Vent, Screw-Vent, Advent (3.7, 4.1, 4.7, 6.0) | |
| Spline Reliance Cylinder | (3.25, 4.0, 5.0) | |
| Spline Twist | (3.75) |
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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 teal color on the left side of the image. To the right of the letters is the text "ZEST DENTAL" in a dark teal color, with the word "SOLUTIONS" underneath in a lighter teal color.
VI. COMPARISON TO PREDICATE DEVICE
| Attribute | Subject Device | Predicate Device | SE? |
|---|---|---|---|
| 510(k) Number | TBD | K150295 | N/A |
| Name | The LOCATOR R-Tx®Attachment System | The LOCATOR R-Tx®Attachment System | Y |
| Manufacturer | Zest Anchors, LLC | Zest Anchors, LLC | Y |
| Indicationsfor Use | The LOCATOR R-Tx®Attachment System isdesigned for use withoverdentures or partialdentures, retained in wholeor in part, by endosseousimplants in the mandible ormaxilla. | The LOCATOR® R-TxAttachment System isdesigned for use withoverdentures or partialdentures, retained in whole orin part, by endosseousimplants in the mandible ormaxilla. | Y;Clarificationonly to addadditionalcompatibleimplants |
| Product Code | NHA | NHA | Y |
| Classification | II | II | Y |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | Y |
| RX/OTC | RX | RX | Y |
| Features | Female AbutmentNylon MaleDenture Cap | Female AbutmentNylon MaleDenture Cap | Y |
| Mode of Operation | Abutment design thatconnects to a housingembedded in a denture ridge,which nylon inserts are usedto allow connection anddisconnection of the dentureto the abutment for"removable" denture solutionfor the patient | Abutment design that connectsto a housing embedded in adenture ridge, which nyloninserts are used to allowconnection and disconnectionof the denture to the abutmentfor "removable" denturesolution for the patient | Y |
| Design | |||
| Abutment Diameter(mm) | 2.75 - 6.0 | 3.0 - 7.0 | Y |
| Abutment Angle | Straight | Straight | Y |
| Divergence Allowance | 30° | 30° | Y |
| Material | |||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Y |
| Prosthetic RetentionComponent | Nylon or Peek | Nylon or Peek | Y |
K200827 LOCATOR R-Tx® Special 510(k)
©2020 ZEST Anchors LLC. All rights reserved. Zest Dental Solutions is a registered trademark of ZEST IP Holdings, LLC.
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Image /page/7/Picture/0 description: The image is a logo for Zest Dental Solutions. The logo has the letters "ZD" in a dark teal color on the left side of the image. To the right of the letters are the words "ZEST DENTAL" in a dark teal color, with the word "SOLUTIONS" underneath in a lighter teal color.
VII. PERFORMANCE TESTING
The abutment-implant interface of the R-Tx abutment is verified to be compatible through either OEM signed abutment drawings, OEM implant drawings, or established compatibility demonstrated with the use of LOCATOR abutments through mutual contractual agreements with the OEM. Once the specifications and tolerances have been identified, the R-Tx abutment-implant interface is then verified through engineering analysis and documented per Zest internal procedures for Line Extensions. No additional performance testing is required as compatibility confirms that all testing (i.e., biocompatibility, sterilization, surface characterization) provided in predicate K150295 remains applicable to the new abutment-implant connection, with no impact to the risk profile of the LOCATOR R-Tx Attachment System.
CONCLUSION VIII.
The minor modifications made for implant compatibility on the LOCATOR R-Tx abutment design does not introduce a new worst case as the abutments remain tissue supported, the changes do not identify new risks, nor do the changes impact the risk profile of the device cleared under K150295. Therefore, the new abutment-implant connections and modified abutment designs identified within this Special 510(k) are substantially equivalent to those cleared in K150295.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)