(168 days)
No
The device description and intended use clearly define a mechanical attachment system for dentures, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on sterilization, biocompatibility, and coating characterization, not algorithmic performance.
Yes.
This device is designed for use in retaining overdentures or partial dentures, which is a therapeutic function addressing tooth loss.
No
The device is an attachment system for overdentures and partial dentures, designed to retain them to implants. It does not perform any diagnostic function.
No
The device description clearly states it consists of physical components like abutments, liners, and denture caps made of titanium alloy and nylon/PEEK, which are hardware.
Based on the provided information, the LOCATOR® RTx Attachment System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is designed for use with overdentures or partial dentures, retained by endosseous implants in the mandible or maxilla. This describes a device used in vivo (within the body) for mechanical retention of dental prosthetics.
- Device Description: The description details the physical components (abutments, liners, caps) and their function in connecting to implants and overdentures. This aligns with a mechanical dental device, not a diagnostic test performed on biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on sterilization, biocompatibility, and coating characterization, which are relevant for implantable or surgically placed devices, not typically for IVDs.
In summary, the LOCATOR® RTx Attachment System is a dental prosthetic attachment system used directly in the patient's mouth, which is characteristic of a medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for 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 Manufacturer: | System: |
|---|---|
| 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 Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm), |
| 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) |
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 10993-10 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 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
1
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 (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,
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
2
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) |
| 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 Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm), |
| 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) |
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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3
510(k) Summary Zest Anchors, LLC LOCATOR® RTx K150295
July 23, 2015
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 | Linda K. Schulz, BSDH, RDH
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 |
| Telephone: | +1 (858) 792-1235 |
| Fax: | +1 (858) 792-1236 |
| Email: | lschulz@paxmed.com
flarson@paxmed.com |
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 |
4
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
| 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
5
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 |
6
| Subject Device | Primary Predicate Device | Additional Predicate Device | |
|---|---|---|---|
| Zest Anchors, Inc. | Astra Tech AB | ||
| Zest Anchors, LLC | |||
| LOCATOR® RTx | LOCATOR Implant Anchor | ||
| Abutment for Endosseous | |||
| Dental Implant | |||
| K072878 | OsseoSpeed Plus | ||
| K120414 | |||
| Indications for Use | The LOCATOR® RTx Implant | ||
| 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 Implant Anchor | ||
| Abutment for Endosseous Dental | |||
| Implants is appropriate for use | |||
| with overdentures or partial | |||
| dentures retained in whole or in | |||
| part by endosseous implants in | |||
| the mandible or maxilla. | Astra Tech Implant System Plus | ||
| abutments are intended to be | |||
| used in conjunction with Astra | |||
| Tech Implant System Plus in | |||
| fully edentulous or partially | |||
| edentulous maxillary and/or | |||
| mandibular arches to provide | |||
| support for crowns, bridges or | |||
| overdentures. | |||
| Design | |||
| Abutment | |||
| Diameter, mm | 3.0 to 7.0 | 3.25 to 6.5 | 3.0 to 5.4 |
| Abutment Angle | Straight | Straight | Straight |
| Abutment/Implant | |||
| Interface | Conical, External Hex, Internal | ||
| Hex, Internal Multi Lobe | Conical, External Hex, Internal | ||
| Hex, Internal Multi Lobe | Internal Taper | ||
| Divergence | |||
| Allowance | 30°/60° | ||
| (except when prohibited | |||
| by implant manufacturer) | 20°/40° | 33°/66° | |
| Prosthesis | |||
| Attachment Type | Nylon or PEEK male | ||
| retention cap | Nylon male retention cap | Screw-retained | |
| Material | |||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Prosthetic | |||
| Retention | |||
| 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.