(88 days)
No
The device description and performance studies focus on mechanical properties and material compatibility, with no mention of AI or ML.
Yes
This device is designed to restore masticatory function by supporting dental restorations on implants, which directly addresses a health-related condition.
No
The device is a system designed to support fixed dental restorations on endosseous dental implants, restoring masticatory function. It does not provide any diagnostic information or assessment of a medical condition.
No
The device description explicitly lists physical components such as abutment housings, inserts, laboratory processing tools, and seating and removal tools, made of materials like titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, 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 for restoring masticatory function. This is a mechanical function within the body.
- Device Description: The device is a system of mechanical components (abutments, housings, inserts, tools) designed to connect dental restorations to implants.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the human body.
- Performance Studies: The performance studies focus on mechanical properties (retention force) and biocompatibility, not on diagnostic accuracy or analysis of biological samples.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device is a mechanical prosthetic component used for structural support and function within the mouth.
N/A
Intended Use / Indications for 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.
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 |
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
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)
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).
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/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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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 |
3
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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FORM FDA 3881 (6/20)
Page 1 of I
PSC Publishing Services (301) 443-6740 EF
4
510(k) Summary
K213391
High Retention Attachment System
Zest Anchors, LLC
January 10, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Zest Anchors, LLC
2875 Loker Ave. East
Carlsbad, CA 92010 |
|-------------------|-----------------------------------------------------------------|
| Telephone: | +1 (442) 244-4835 |
| Official Contact | Mark Stavro, Regulatory Affairs Director |
|---|---|
| Representative/Consultant | Melissa Burbage |
| Kevin A. Thomas, PhD; 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: mburbage@paxmed.com | |
| kthomas@paxmed.com; flarson@paxmed.com |
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 |
| (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
5
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 |
6
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).
7
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| | Zest Anchors, Inc.
High Retention
Attachment System
K213391 | Zest Anchors, LLC
LOCATOR® F-Tx
Attachment System
K151789 | Zest Anchors, Inc.
LOCATOR® Implant
Anchor Abutment
K072878 | Zest Anchors, Inc.
LOCATOR R-Tx®
Attachment System
K200827 | |
| Indications
for 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. | 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 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. | The LOCATOR R-Tx®
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. | Same as
Predicate and
Reference |
| Design | | | | | |
| Abutment
Platform
Diameter | 2.3 mm to 7.0 mm,
Multiple Systems | 3.0 mm to 7.0 mm;
Multiple Systems | 2.3 mm to 7.0 mm,
Multiple Systems | 3.0 mm to 7.0 mm;
Multiple Systems | Same as
Reference |
| Abutment
Angle | Straight | Straight | Straight | Straight | Same |
| Abutment/
Implant
Interface | Conical, External Hex,
Internal Hex, Internal
Multi Lobe | Conical, External Hex,
Internal Hex, Internal
Multi Lobe | Conical, External Hex,
Internal Hex, Internal
Multi Lobe | Conical, External Hex,
Internal Hex, Internal
Multi Lobe | Same |
| Divergence
Allowance | 20°/40°
(except when not allowed
by the implant
manufacturer) | 20° | 20° | 30°/60° | Same |
| Prosthesis
Attachment
Type | PEEK Insert retained in
Denture Attachment
Housing | PEEK Retention Ball
attached to Denture
Attachment Housing | Nylon Insert retained in
Denture Attachment
Housing | Nylon Male
Retention Cap | Same as
Predicate |
| Materials | | | | | |
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Same |
| Abutment
Coating | TiN | TiN, TiCN | TiN | TiN, TiCN | Same |
| Prosthetic
Retention | PEEK | PEEK | Nylon | Nylon | Same as
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.