LOCATOR F-Tx Attachment System

K151789 · Zest Anchors, LLC · NHA · Mar 4, 2016 · Dental

Device Facts

• Record ID: K151789
• Device Name: LOCATOR F-Tx Attachment System
• Applicant: Zest Anchors, LLC
• Product Code: NHA · Dental
• Decision Date: Mar 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The LOCATOR® F-Tx 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 LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform Astra Tech OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm BioHorizons Internal Hex: 3.0, 3.5, 4.5, 5.7 mm Biomet 3i Osseotite® Certain®: 3.4, 4.1, 5.0, 6.0 mm Camlog Camlog, 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 MIS Implants Internal Hex: 3.75, 4.5 mm Nobel Biocare NobelActive™: 3.0, 3.5, 3.9 mm Replace™ Select: 3.5, 4.3, 5.0, 6.0 mm Straumann Brånemark: 3.5, 4.1, 5.1 mm Bone Level: 3.3, 4.1, 4.8 mm Standard: 4.8, 6.5 mm Zimmer Tapered Screw-Vent®: 3.5, 4.5, 5.7 mm

Device Story

LOCATOR F-Tx Attachment System provides rigid connection for fixed, partial, or full arch dental restorations; utilizes snap-in attachment mechanism. System components include titanium alloy abutments (various gingival cuff heights) and PEEK healing caps. Abutments interface with specific endosseous dental implants; optional TiN or TiCN coatings applied to abutments. Clinician installs abutments onto implants; hybrid restoration snaps onto abutment. Unlike predicate devices removable by patients, F-Tx restorations are fixed and require clinician-only removal using specialized tool. System benefits include secure retention for hybrid restorations, facilitating masticatory function restoration.

Clinical Evidence

No clinical data. Bench testing included sterilization validation (ISO 17665-1/2), biocompatibility (ISO 10993-1/5/12), and mechanical denture retention testing. Retention strength of F-Tx system with High Retention Balls was statistically greater than tensile force of masticating worst-case sticky food (p<0.05).

Technological Characteristics

Abutments: Ti-6Al-4V ELI (ASTM F136); optional TiN or TiCN coating. Healing caps: PEEK. Interface: Conical, External Hex, Internal Hex, Internal Multi Lobe. Divergence allowance: 20°. Sterilization: Moist heat.

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 Implant Anchor Abutment for Endosseous Dental Implant (K072878)
• LOCATOR RTx (K150295)

Reference Devices

• OsseoSpeed™ Plus (K120414)
• BioHorizons Tapered Internal Implant System (K071638)
• BioHorizons Laser-Lok 3.0 Implant System (K093321)
• BioHorizons Tapered Internal Implants (K143022)
• 3i OSSEOTITE® Certain® Dental Implants (K063341)
• CAMLOG Rootform Implant System (K000100)
• CAMLOG Implant System Modified Implants and Abutments (K083496)
• CONELOG® Implant System (K113779)
• iSy® Implant System (K133991)
• ANKYLOS® Dental Implant System (K041509)
• MIS Dental Implant System (K040807)
• NobelActive Internal Connection Implant (K071370)
• NobelActive 3.0 (K102436)
• Replace™ HA Coated Implant (K020646)
• Various Brånemark System Implants (K022562)
• P.004 Implants (K062129)
• Straumann® Dental Implant System (K130222)
• Zimmer Dental Implant System (K061410)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.

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

March 4, 2016

Zest Anchors, LLC c/o Kevin A. Thomas, Ph.D. Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K151789

Trade/Device Name: LOCATOR® F-Tx Attachment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 2, 2016 Received: February, 03, 2106

Dear Dr. Thomas:

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.

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Page 2 - Kevin A. Thomas, Ph.D.

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 801and Part 809); medical device reporting (reporting of medical device-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 and Part 809), 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, Tina Kiang

for Erin I. 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

S

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K151789

#### Device Name

LOCATOR® F-Tx Attachment System

#### Indications for Use (Describe)

The LOCATOR® F-Tx 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 restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform

| Astra Tech | OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm |
|---------------|---------------------------------------------------------------------|
| BioHorizons | Internal Hex: 3.0, 3.5, 4.5, 5.7 mm |
| Biomet 3i | Osseotite ^® Certain ^® : 3.4, 4.1, 5.0, 6.0 mm |
| Camlog | Camlog, 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 |
| MIS Implants | Internal Hex: 3.75, 4.5 mm |
| Nobel Biocare | NobelActive ^™ : 3.0, 3.5, 3.9 mm |
| | Replace ^™ Select: 3.5, 4.3, 5.0, 6.0 mm |
| | Brånemark: 3.5, 4.1, 5.1 mm |
| Straumann | Bone Level: 3.3, 4.1, 4.8 mm |
| | Standard: 4.8, 6.5 mm |
| Zimmer | Tapered Screw-Vent ^® : 3.5, 4.5, 5.7 mm |

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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# 510(k) Summary ZEST Anchors, LLC LOCATOR® F-Tx Attachment System

March 1, 2016

### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Zest Anchors, LLC<br>2061 Wineridge Place<br>Escondido, CA 92029 |
|---------------------------|------------------------------------------------------------------|
| | Telephone: [phone] ext. 140<br>Fax: [phone] |
| Official Contact | Annie Wright<br>Regulatory Affairs Manager |
| Representative/Consultant | Kevin A. Thomas, PhD<br>Linda K. Schulz, RSDH, RDH |

| ntative/Consultant | Kevin A. Thomas, PhD<br>Linda K. Schulz, BSDH, RDH |
|---------------------------------|----------------------------------------------------|
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail]<br>[e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | LOCATOR® F-Tx Attachment System |
|---------------------------|------------------------------------|
| 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 |

# PREDICATE DEVICE INFORMATION

The primary predicate is K072878. The reference predicate device for the TiCN coating is K150295. The reference predicate devices for the abutment-implant interface compatibilities are K120414, K071638, K093321, K143022, K063341, K000100, K083496, K113779, K133991, K041509, K040807, K071370, K102436, K020646, K022562, K062129, K130222, and K061410.

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# INTENDED USE

The LOCATOR® F-Tx 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 LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform

| Astra Tech | OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm |
|---------------|--------------------------------------------------------------------------------------|
| BioHorizons | Internal Hex: 3.0, 3.5, 4.5, 5.7 mm |
| Biomet 3i | Osseotite® Certain®: 3.4, 4.1, 5.0, 6.0 mm |
| Camlog | Camlog, 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 |
| MIS Implants | Internal Hex: 3.75, 4.5 mm |
| Nobel Biocare | NobelActive™: 3.0, 3.5, 3.9 mm<br>Replace™ Select: 3.5, 4.3, 5.0, 6.0 mm |
| Straumann | Brånemark: 3.5, 4.1, 5.1 mm<br>Bone Level: 3.3, 4.1, 4.8 mm<br>Standard: 4.8, 6.5 mm |
| Zimmer | Tapered Screw-Vent®: 3.5, 4.5, 5.7 mm |

# DEVICE DESCRIPTION

The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.

# 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 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials. Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization testing, characterization and biocompatibility testing of the TiCN coating, biocompatibility testing of the PEEK Healing Caps, and mechanical denture retention testing. The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p<0.05). No clinical data were included in this submission.

# EQUIVALENCE TO MARKETED DEVICES

LOCATOR F-Tx Attachment System is substantially equivalent in indications and design principles to the legally marketed predicate devices shown in the following table.

| K072878 | Locator Implant Anchor Abutment for Endosseous Dental Implant | Zest Anchors, Inc. |
|-------------------------------------------|---------------------------------------------------------------|-----------------------------------|
| K150295 | LOCATOR RTx | Zest Anchors, LLC |
| Predicates for Compatible Implant Systems | | |
| K120414 | OsseoSpeed™ Plus | Astra Tech AB |
| K071638 | BioHorizons Tapered Internal Implant System | BioHorizons Implant Systems, Inc. |
| K093321 | BioHorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. |
| K143022 | BioHorizons Tapered Internal Implants | BioHorizons Implant Systems, Inc. |
| K063341 | 3i OSSEOTITE® Certain® Dental Implants | Implant Innovations, Inc. |
| K000100 | CAMLOG Rootform Implant System | Altatec Biotechnologies |
| K083496 | CAMLOG Implant System Modified Implants and Abutments | Altatec GmbH |
| K113779 | CONELOG® Implant System | Altatec GmbH |
| K133991 | iSy® Implant System | Altatec GmbH |
| K041509 | ANKYLOS® Dental Implant System | Friadent GmbH |
| K040807 | MIS Dental Implant System | MIS - Implant Technologies Ltd. |
| K071370 | NobelActive Internal Connection Implant | Nobel Biocare AB |
| K102436 | NobelActive 3.0 | Nobel Biocare AB |
| K020646 | Replace™ HA Coated Implant | Nobel Biocare USA Inc. |
| K022562 | Various Brånemark System Implants | Nobel Biocare AB |
| K062129 | P.004 Implants | Institut Straumann AG |
| K130222 | Straumann® Dental Implant System | Straumann USA, LLC |
| K061410 | Zimmer Dental Implant System | Zimmer Dental Inc. |

# Table of Predicate Devices

The primary predicate is K072878.

The reference predicate device for the TiCN coating is K150295.

The reference predicate devices for the abutment-implant interface compatibilities are: K120414, K071638, K093321, K143022, K063341, K000100, K083496, K113779, K133991, K041509, K040807, K071370, K102436, K020646, K022562, K062129, K130222, and K061410.

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| Comparison | Subject Device | Primary Predicate Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Zest Anchors, LLC<br>LOCATOR® F-Tx Attachment System<br>K151789 | Zest Anchors, Inc.<br>Locator Implant Anchor Abutment<br>for Endosseous Dental Implant<br>K072878 |
| Indications for Use | The LOCATOR® F-Tx Attachment System is<br>designed to support fixed, partial or full arch<br>restorations on endosseous dental implants in<br>the mandible or maxilla for the purpose of<br>restoring masticatory function. It is used in<br>fixed hybrid restorations that can be attached<br>with a snap-in system.<br>See page 2 for complete list of compatible<br>dental implants. | The LOCATOR Implant Anchor Abutment<br>for Endosseous Dental Implants is appropriate<br>for use with overdentures or partial dentures<br>retained in whole or in part by endosseous<br>implants in the mandible or maxilla. |
| Design | | |
| Abutment Platform Diameter | 3.0 mm to 7.0 mm; Multiple Systems | 2.5 mm to 6.5 mm, Multiple Systems |
| Abutment Angle | Straight | Straight |
| Abutment/Implant Interface | Conical, External Hex, Internal Hex,<br>Internal Multi Lobe | Conical, External Hex, Internal Hex,<br>Internal Multi Lobe |
| Divergence Allowance | 20° | 20° |
| Prosthesis Attachment Type | PEEK Retention Ball attached to Denture<br>Attachment Housing | Nylon Insert engaged to Denture Attachment<br>Housing |
| Material | | |
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Abutment Coating | TiN, TiCN | TiN |
| Prosthetic Retention Component | PEEK | Nylon |

### Comparison of Subject Device and Primary Predicate Device

LOCATOR F-Tx is substantially equivalent to Locator (K072878) and the reference predicate LOCATOR RTx (K150295) in that it uses the identical interface for compatible implant systems. The previous interfaces have been demonstrated through contractual agreements with the OEM implant manufacturers. The compatible dental implants with the corresponding interfaces are listed above in the Table of Predicate Devices. LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments.

The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments. The subject device and primary predicate device abutments are intended to be used in conjunction with dental implants for the purpose of supporting partial or full arch restorations. The subject device is for use with fixed hybrid restorations removed only by the clinician, whereas the primary predicate device is for use with restorations that may be removed by the patient.

The subject device is indicated for fixed hybrid implant restorations using a snap-in connection. The LOCATOR F-Tx snap-in connection is similar to the Locator (K072878), but has a PEEK retention ball attached to the center of the denture attachment housing instead of a nylon insert

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on the abutment. Removal of the hybrid denture restoration by the clinician requires the use of the LOCATOR F-Tx denture removal tool.

The TiN coating for the subject device is the same as that used on the predicate Locator device (K072728). The TiCN coating for the subject device is the same as that used on the reference predicate LOCATOR RTx (K150295).

# CONCLUSION

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