LOCATOR RTx

K150295 · Zest Anchors, Inc. · NHA · Jul 24, 2015 · Dental

Device Facts

• Record ID: K150295
• Device Name: LOCATOR RTx
• Applicant: Zest Anchors, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The LOCATOR® RTx 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.

Device Story

LOCATOR RTx is a dental implant attachment system consisting of titanium alloy abutments, nylon or PEEK liners, and denture caps. It functions as a resilient attachment for endosseous implants. The abutment connects to the implant via a threaded apical end; the coronal end features a double-ridge design for retention. It accommodates implant path divergence up to 30°. Used in dental clinics by dentists to secure overdentures or partial dentures. The device provides a mechanical connection between the implant and the prosthesis, improving denture stability and patient comfort. Abutments are available in various cuff heights and diameters to match specific implant systems.

Clinical Evidence

Bench testing only. Testing included sterilization validation (ISO 17665-1/2), biocompatibility (ISO 10993-1, -5, -10), and characterization of the TiCN coating.

Technological Characteristics

Materials: Ti-6Al-4V ELI titanium alloy abutments with TiCN or TiN coating; nylon or PEEK retention liners. Design: Coronal double-ridge retention; threaded apical connection. Dimensions: 3.0-7.0 mm diameter; 1-6 mm cuff heights. Sterilization: Moist heat. Connectivity: None (mechanical).

Indications for Use

Indicated for patients requiring overdentures or partial dentures retained by endosseous implants in the mandible or maxilla.

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 Implant Anchor (K072878)

Reference Devices

• OsseoSpeed Plus (K120414)
• Biomet 3i Osseotite® Certain® (K063341)
• Biomet 3i Osseotite® (K063286)
• Zimmer Tapered Screw-vent® (K061410)
• Zimmer Spline (K010073)
• Zimmer SwissPlus (K082639)
• MIS (K103089)
• Straumann Bone Level (K062129)
• Straumann Standard (K130222)
• Nobel Biocare Replace™ Select (K020646)
• Nobel Biocare NobelActive™ (K071370)
• Nobel Biocare NobelActive™ (K102436)
• Nobel Biocare Brånemark (K022562)
• Dentsply Friadent® Ankylos® (K041509)
• Dentsply Friadent® Frialit/XiVE® (K073075)
• Camlog Rootform Implant System (K000100)
• Camlog Implant System (K083496)
• Conelog Implant System (K113779)
• Camlog iSy Implant System (K133991)
• Camlog iSy Implant System (K071638)
• BioHorizons Internal (K093321)
• BioHorizons Internal (K143022)
• BioHorizons External Hex (K030463)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, one behind the other, with flowing lines representing hair or fabric.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24,2015

Zest Anchors, LLC % Linda Schulz Regulatory Affairs Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K150295

Trade/Device Name: LOCATOR RTx Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 17, 2015 Received: June 18, 2015

Dear Linda Schulz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K150295

Device Name

LOCATOR® RTx

#### Indications for Use (Describe)

The LOCATOR® RTx 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.

LOCATOR® RTx Attachment System is compatible with the following implant systems.

| Implant Manufacturer: | System: |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm)<br>External Hex (3.5, 4.0, 5.0 mm) |
| Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm)<br>External Hex (3.4, 4.1, 5.0, 6.0 mm) |
| Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm)<br>iSy (3.8, 4.4, 5.0 mm) |
| Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm)<br>XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm)<br>Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) |
| MIS Implants | Internal Hex (3.75, 4.5 mm) |
| Nobel Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm),<br>NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm),<br>Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) |
| Straumann | Tissue Level (3.5, 4.8, 6.5 mm)<br>Bone Level (3.3, 4.1, 4.8 mm) |
| Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm)<br>Spline (3.25, 4.0, 5.0 mm)<br>Swiss Plus: Internal Octagon (3.8, 4.8 mm) |

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 Zest Anchors, LLC LOCATOR® RTx K150295

July 23, 2015

# ADMINISTRATIVE INFORMATION

| Manufacturer Name | Zest Anchors, LLC<br>2061 Wineridge Place<br>Escondido, CA 92029 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] ext. 140 |
| Fax: | [phone] |
| Official Contact | Annie Wright<br>Regulatory Affairs Manager |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail]<br>[e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | LOCATOR® RTx |
|---------------------------|------------------------------------|
| Common Name | Dental implant abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulation | Class II, 21 CFR 872.3630 |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |

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## 510(k) Summary LOCATOR® RTx

## INTENDED USE

The LOCATOR® RTx 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.

LOCATOR® RTx Attachment System is compatible with the following implant systems.

| Implant<br>Manufacturer | Connection |
|-------------------------|-------------------------------------------------------|
| BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm) |
| | External Hex (3.5, 4.0, 5.0 mm) |
| Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm) |
| | External Hex (3.4, 4.1, 5.0, 6.0 mm) |
| Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm) |
| | iSy (3.8, 4.4, 5.0 mm) |
| Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm) |
| | XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm) |
| | Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) |
| MIS Implants | Internal Hex (3.75, 4.5 mm) |
| Nobel | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm) |
| Biocare | NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm) |
| | Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) |
| Straumann | Tissue Level (3.5, 4.8, 6.5 mm) |
| | Bone Level (3.3, 4.1, 4.8 mm) |
| Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm) |
| | Spline (3.25, 4.0, 5.0 mm) |
| | Swiss Plus: Internal Octagon (3.8, 4.8 mm) |

# DEVICE DESCRIPTION

LOCATOR® RTx 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 RTx 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 RTx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR RTx abutments are provided with either TiCN or TiN coating and are available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). They are provided in diameters 3.0 - 7.0 mm as shown in the compatibility table above.

# PERFORMANCE DATA

Performance testing to demonstrate substantial equivalence included methods described in the following standards: ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; ISO 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1; ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity; and

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ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization testing, biocompatibility testing of the TiCN coating, and characterization testing of the TiCN coating. The performance data included in this submission demonstrate substantial equivalence to the predicate devices listed below.

# EQUIVALENCE TO MARKETED DEVICE

LOCATOR RTx is substantially equivalent to LOCATOR in that it uses the identical interface for compatible implant systems and it is a nylon or PEEK liner overdenture system with varying cuff heights.

Primary predicate: Zest Anchors, Inc., Modification to Locator Implant Anchor cleared under K072878.

Reference Device: Astra Tech AB, OsseoSpeed Plus cleared under K120414.

| 510(k) Number | Implant System Compatibility |
|---------------|----------------------------------|
| K063341 | Biomet 3i Osseotite® Certain® |
| K063286 | Biomet 3i Osseotite® |
| K061410 | Zimmer Tapered Screw-vent® |
| K010073 | Zimmer Spline |
| K082639 | Zimmer SwissPlus |
| K103089 | MIS |
| K062129 | Straumann Bone Level |
| K130222 | Straumann Standard |
| K020646 | Nobel Biocare Replace™ Select |
| K071370 | Nobel Biocare NobelActive™ |
| K102436 | Nobel Biocare NobelActive™ |
| K022562 | Nobel Biocare Brånemark |
| K041509 | Dentsply Friadent® Ankylos® |
| K073075 | Dentsply Friadent® Frialit/XiVE® |
| K120414 | Astra Tech OsseoSpeed Plus (EV) |
| K000100 | Camlog Rootform Implant System |
| K083496 | Camlog Implant System |
| K113779 | Conelog Implant System |
| K133991 | Camlog iSy Implant System |
| K071638 | Camlog iSy Implant System |
| K093321 | BioHorizons Internal |
| K143022 | BioHorizons Internal |
| K030463 | BioHorizons External Hex |

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| | Subject Device | Primary Predicate Device | Additional Predicate Device |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Zest Anchors, Inc. | Astra Tech AB |
| | Zest Anchors, LLC<br>LOCATOR® RTx | LOCATOR Implant Anchor<br>Abutment for Endosseous<br>Dental Implant<br>K072878 | OsseoSpeed Plus<br>K120414 |
| Indications for Use | The LOCATOR® RTx Implant<br>Attachment System is designed<br>for use with overdentures or<br>partial dentures, retained in<br>whole or in part, by endosseous<br>implants in the mandible or<br>maxilla. | The LOCATOR Implant Anchor<br>Abutment for Endosseous Dental<br>Implants is appropriate for use<br>with overdentures or partial<br>dentures retained in whole or in<br>part by endosseous implants in<br>the mandible or maxilla. | Astra Tech Implant System Plus<br>abutments are intended to be<br>used in conjunction with Astra<br>Tech Implant System Plus in<br>fully edentulous or partially<br>edentulous maxillary and/or<br>mandibular arches to provide<br>support for crowns, bridges or<br>overdentures. |
| Design | | | |
| Abutment<br>Diameter, mm | 3.0 to 7.0 | 3.25 to 6.5 | 3.0 to 5.4 |
| Abutment Angle | Straight | Straight | Straight |
| Abutment/Implant<br>Interface | Conical, External Hex, Internal<br>Hex, Internal Multi Lobe | Conical, External Hex, Internal<br>Hex, Internal Multi Lobe | Internal Taper |
| Divergence<br>Allowance | 30°/60°<br>(except when prohibited<br>by implant manufacturer) | 20°/40° | 33°/66° |
| Prosthesis<br>Attachment Type | Nylon or PEEK male<br>retention cap | Nylon male retention cap | Screw-retained |
| Material | | | |
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Prosthetic<br>Retention<br>Component | Nylon or PEEK | Nylon | NA |

The subject device is the same in all features as the primary predicate with the exception of the compatible implant/abutment interface. The subject device has the same divergence allowance as the reference device. The subject device has a resilient overdenture prosthesis attachment and the reference device is for a screw-retained prosthesis.

# CONCLUSION

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Overall, the subject device has the following similarities to the predicate devices:

- has the same intended use, ●
- uses the same operating principle,
- incorporates the same basic design,
- incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same processes.