High Retention Attachment System

K213391 · Zest Anchors, LLC · NHA · Jan 11, 2022 · Dental

Device Facts

• Record ID: K213391
• Device Name: High Retention Attachment System
• Applicant: Zest Anchors, LLC
• Product Code: NHA · Dental
• Decision Date: Jan 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

Device Story

System provides rigid connection for fixed/detachable hybrid dentures to endosseous dental implants; accommodates implant divergence up to 20° per implant and 40° between implants. Components include titanium alloy abutments (TiN coated), PEEK inserts, denture attachment housings, and processing/seating tools. Used by dental professionals in clinical settings to attach restorations via snap-in mechanism. Benefits patient by providing secure, retentive support for dental prostheses, restoring masticatory function.

Clinical Evidence

Bench testing only. Mechanical denture retention testing demonstrated retention force exceeding that of predicate K151789. Compatibility verified via OEM drawings and engineering analysis.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136) with TiN coating. Components: Abutment housings, PEEK inserts, processing/seating tools. Interface: Conical, external hex, internal hex, internal multi-lobe. Sterilization: Identical to predicates. Connectivity: None.

Indications for Use

Indicated for patients requiring fixed, partial, or full arch restorations supported by endosseous dental implants in the mandible or maxilla to restore masticatory function.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• LOCATOR F-Tx Attachment System (K151789)

Reference Devices

• LOCATOR Implant Anchor Abutment (K072878)
• LOCATOR R-Tx Attachment System (K200827)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Zest Anchors, LLC % Melissa Burbage RA Sr Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K213391

Trade/Device Name: High Retention Attachment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 15, 2021 Received: October 15, 2021

Dear Melissa Burbage:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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)

K213391

Device Name

High Retention Attachment System

#### Indications for Use (Describe)

The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory finction. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The High Retention Attachment System is compatible with the following implants:

| Implant Manufacturer | Implant System | Implant Diameter |
|----------------------|----------------------------------------------------------|--------------------------------------------------|
| Ace Surgical | Infinity OCTAGON | 3.3, 4.1, 4.8 |
| | Infinity TRI-CAM | 3.5, 4.3, 5.0 |
| | Infinity Internal Hex | 3.7, 4.1, 4.7, 5.1 |
| 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 |
| Straumann | Roxolid SLActive, Roxolid SLA | 3.3, 4.1, 4.8 |
| Zimmer Dental | 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)

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### 510(k) Summary

# K213391

# High Retention Attachment System

# Zest Anchors, LLC

January 10, 2022

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Zest Anchors, LLC<br>2875 Loker Ave. East<br>Carlsbad, CA 92010 |
|-------------------|-----------------------------------------------------------------|
| Telephone: | [phone] |

| Official Contact | Mark Stavro, Regulatory Affairs Director |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Representative/Consultant | Melissa Burbage<br>Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>[e-mail]; [e-mail] |

### DEVICE NAME AND CLASSIFICATION

| Trade/Device Name | High Retention Attachment System |
|----------------------|----------------------------------------------------------------------------------------------|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices<br>(OHT1) Dental Devices (DHT1B) |

#### PREDICATE DEVICE INFORMATION

Primary Predicate Device K151789, LOCATOR F-Tx Attachment System, Zest Anchors, LLC

Reference Devices K072878, LOCATOR Implant Anchor Abutment, Zest Anchors, LLC K200827, LOCATOR R-Tx Attachment System, Zest Anchors, LLC

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### INDICATIONS FOR USE STATEMENT

The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The High Retention Attachment System is compatible with the following implants:

| Implant Manufacturer | Implant System | Implant Diameter |
|----------------------|----------------------------------------------------------|--------------------------------------------------|
| Ace Surgical | Infinity OCTAGON | 3.3, 4.1, 4.8 |
| | Infinity TRI-CAM | 3.5, 4.3, 5.0 |
| | Infinity Internal Hex | 3.7, 4.1, 4.7, 5.1 |
| 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 |
| Straumann | Roxolid SLActive, Roxolid SLA | 3.3, 4.1, 4.8 |
| Zimmer Dental | 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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510(k) Summary Page 3 of 4

## SUBJECT DEVICE DESCRIPTION

The High Retention Attachment System is a system that provides rigid connection of fixed partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It is designed to accommodate a path of insertion on implants to accommodate a divergence of up to 20° per implant and no more than 40° of divergence between implants. The components are similar to the LOCATOR Implant Anchor Abutment, cleared in K072878; however, the retention and removal of the inserts is similar to that of the LOCATOR F-Tx Attachment System cleared in K151789.

The High Retention Attachment System consists of abutment housings, inserts, laboratory processing tools and seating and removal tools. Abutments, attachment housings and inserts are Class II subject devices (Product Code NHA) and laboratory processing tools and seating and removal tools are Class I accessories (Product Code NDP). The abutments are provided in various cuff heights with the implant/abutment connection specific to the OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.

### PERFORMANCE DATA

Non-clinical testing data referenced/relied upon to demonstrate substantial equivalence included: sterilization validation and biocompatibility testing. Both the material and Titanium Nitride (TiN) coating have the same specifications, processes, and are manufactured in the same facilities as the predicate F-Tx Attachment System (K151789) and predicate LOCATOR device (K072878).

Non-clinical testing data submitted to demonstrate substantial equivalence included: mechanical denture retention testing. The mechanical testing demonstrated that the retention force of the High Retention Attachment System was greater than retention force of the predicate device K151789.

The subject abutment-implant interface of the High Retention Attachment System 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 performance testing is required, as demonstrated for the predicate LOCATOR R-Tx Attachment System (K200827).

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| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| | Zest Anchors, Inc.<br>High Retention<br>Attachment System<br>K213391 | Zest Anchors, LLC<br>LOCATOR® F-Tx<br>Attachment System<br>K151789 | Zest Anchors, Inc.<br>LOCATOR® Implant<br>Anchor Abutment<br>K072878 | Zest Anchors, Inc.<br>LOCATOR R-Tx®<br>Attachment System<br>K200827 | |
| Indications<br>for Use | The High Retention<br>Attachment System is<br>designed to support fixed,<br>partial or full arch<br>restorations on endosseous<br>dental implants in the<br>mandible or maxilla for<br>the purpose of restoring<br>masticatory function. It is<br>used in fixed hybrid<br>restorations that can be<br>attached with a snap-in<br>system. | The LOCATOR® F-Tx<br>Attachment System is<br>designed to support fixed,<br>partial or full arch<br>restorations on endosseous<br>dental implants in the<br>mandible or maxilla for<br>the purpose of restoring<br>masticatory function. It is<br>used in fixed hybrid<br>restorations that can be<br>attached with a snap-in<br>system. | The Locator Implant<br>Anchor Abutment for<br>Endosseous Dental<br>Implants is appropriate for<br>use with overdentures or<br>partial dentures retained in<br>whole or in part by<br>endosseous implants in<br>the mandible or maxilla. | The LOCATOR R-Tx®<br>Attachment System is<br>designed for use with<br>overdentures or partial<br>dentures, retained in<br>whole or in part, by<br>endosseous implants in<br>the mandible or maxilla. | Same as<br>Predicate and<br>Reference |
| Design | | | | | |
| Abutment<br>Platform<br>Diameter | 2.3 mm to 7.0 mm,<br>Multiple Systems | 3.0 mm to 7.0 mm;<br>Multiple Systems | 2.3 mm to 7.0 mm,<br>Multiple Systems | 3.0 mm to 7.0 mm;<br>Multiple Systems | Same as<br>Reference |
| Abutment<br>Angle | Straight | Straight | Straight | Straight | Same |
| Abutment/<br>Implant<br>Interface | Conical, External Hex,<br>Internal Hex, Internal<br>Multi Lobe | Conical, External Hex,<br>Internal Hex, Internal<br>Multi Lobe | Conical, External Hex,<br>Internal Hex, Internal<br>Multi Lobe | Conical, External Hex,<br>Internal Hex, Internal<br>Multi Lobe | Same |
| Divergence<br>Allowance | 20°/40°<br>(except when not allowed<br>by the implant<br>manufacturer) | 20° | 20° | 30°/60° | Same |
| Prosthesis<br>Attachment<br>Type | PEEK Insert retained in<br>Denture Attachment<br>Housing | PEEK Retention Ball<br>attached to Denture<br>Attachment Housing | Nylon Insert retained in<br>Denture Attachment<br>Housing | Nylon Male<br>Retention Cap | Same as<br>Predicate |
| Materials | | | | | |
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Same |
| Abutment<br>Coating | TiN | TiN, TiCN | TiN | TiN, TiCN | Same |
| Prosthetic<br>Retention | PEEK | PEEK | Nylon | Nylon | Same as<br>Predicate |

# EQUIVALENCE TO MARKETED DEVICES

### CONCLUSION

The subject devices, the primary predicate device and reference devices have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions, are manufactured from the same materials, and are to be sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.