(247 days)
No
The summary describes a mechanical dental attachment system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is designed to "restore function" by supporting dental restorations on implants, which directly addresses a health problem (missing teeth) and improves the body's function. This aligns with the definition of a therapeutic device.
No
The device is designed to support fixed dental restorations on implants, focusing on the mechanical connection and material properties, not on diagnosing medical conditions.
No
The device description clearly states that the system includes physical components like abutments and healing caps made of titanium alloy and PEEK, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support fixed, partial or full arch restorations on dental implants to restore function. 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 system of abutments and healing caps made of materials like titanium alloy and PEEK. These are physical components used in a surgical and restorative procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on mechanical properties, sterilization, and biocompatibility, not diagnostic accuracy.
Therefore, the LOCATOR® F-Tx Attachment System is a medical device used in dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
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
Not Found
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)
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 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
§ 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.)
0
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary ZEST Anchors, LLC LOCATOR® F-Tx Attachment System
March 1, 2016
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Zest Anchors, LLC
2061 Wineridge Place
Escondido, CA 92029 |
|---------------------------|------------------------------------------------------------------|
| | Telephone: +1 (760) 743-7744 ext. 140
Fax: +1 (760) 743-7975 |
| Official Contact | Annie Wright
Regulatory Affairs Manager |
| Representative/Consultant | Kevin A. Thomas, PhD
Linda K. Schulz, RSDH, RDH |
| ntative/Consultant | Kevin A. Thomas, PhD
Linda K. Schulz, BSDH, RDH |
|---------------------------------|----------------------------------------------------|
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone: | +1 (858) 792-1235 |
| Fax: | +1 (858) 792-1236 |
| Email: | KThomas@paxmed.com
LSchulz@paxmed.com |
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.
4
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 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
5
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