(73 days)
No
The document describes a mechanical dental attachment system and does not mention any AI or ML components, image processing, or data-driven performance metrics.
No.
The device is designed to support dental restorations, not to directly treat or cure a disease or condition for therapeutic purposes.
No
The device is designed to support fixed, partial, or full arch restorations on dental implants to restore function, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it consists of physical components like abutments, attachment housings, inserts, and tools, and is made of titanium alloy.
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 endosseous dental implants in the mandible or maxilla for the purpose of restory function." This describes a device used in vivo (within the body) for structural support and functional restoration, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a system of physical components (abutments, housings, inserts, tools) made of materials like titanium alloy, designed for mechanical connection to dental implants. This aligns with a surgical or prosthetic device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on mechanical properties (fatigue testing), sterilization, biocompatibility, and MR safety, which are relevant to implantable or surgically placed devices, not IVDs.
In summary, the High Retention Attachment System is a dental prosthetic attachment system, not a device used for in vitro diagnostic testing.
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 restory 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, Nobel Speedy | 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 |
| Zest Dental Solutions | Locator Overdenture Implant System | 2.4, 2.9, 3.5, 3.9, 4.4, 4.9 |
| 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 consists of abutments, attachment housings, inserts and seating and removal tools. The abutments are provided in various cuff heights with the implant and abutment connection specific to the Zest Anchors, LLC or 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) Alloy for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.
The High Retention Attachment System is as provided with an abutment (LOCATOR Attachment) and the surgical instrumentation necessary to place the implant.
The High Retention Attachment System is designed to accommodate a path of insertion diverqence of up to 20° per implant and no more than 40° of divergence between implants.
The abutments are identical to the High Retention Attachment System devices cleared in the predicate. K213391, with the main difference being an additional implant system compatibility. The additional compatible implant system, Zest Anchors, LLC's Locator Overdenture Implant (LODI) implants, were previously cleared in K120198 and K203701 and are included as reference devices, in the K220252 submission.
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)
No new testing was performed as a part of this submission for the determination of substantial equivalence. Fatigue testing according to ISO 14801: 2016 was performed for Zest Anchors, LLC's Locator Overdenture Implant (LODI) implants (K120198/K203701) and leveraged to support modifications to the K213391 compatibility table. Fatigue testing, sterilization, and biocompatibility testing are all leveraged from previous submissions. MR safety for the subject device system was based on the "worst-case" of the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. The "worst-case" assessment includes an evaluation of the High Retention Attachment System devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). In addition, the "worst-case" MR Safety rationale addressed parameters per the FDA guidance, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zest Anchors, LLC Richard Hines Regulatory Affairs Manager 2875 Loker East Carlsbad, California 92026
Re: K220252
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: March 24, 2022 Received: March 28, 2022
Dear Richard Hines:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K220252
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 restory 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, Nobel Speedy | 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 |
| Zest Dental Solutions | Locator Overdenture Implant System | 2.4, 2.9, 3.5, 3.9, 4.4, 4.9 |
| 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)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a bold, teal font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a bold, dark teal font, with the word "SOLUTIONS" written in a lighter teal font below it. The logo is simple and modern, and the colors are clean and professional.
510(K) Summary – K220252 High Retention Attachment System
i. General Information on Submitter
| Applicant: | Zest Anchors, LLC |
|---|---|
| Address: | 2875 Loker Avenue, East |
| Carlsbad, CA 92010 USA | |
| Telephone: | 442-244-4835, ext. 480 |
| Cellphone: | 949-395-8795 |
| Contact Person: | Richard Hines |
| Contact Title: | Regulatory Affairs Manager |
| Email: | richard.hines@zestdent.com |
| Date Prepared: | April 13, 2022 |
| Establishment Registration: | 3006796211 |
ii. General Information on Device
| Proprietary Name: | High Retention Attachment System |
|---|---|
| Common Name: | Dental Implant Abutment |
| Classification Name: | Endosseous dental implant abutment |
| (21 CFR 872.3630) | |
| Regulatory Class: | II |
| Product Code: | NHA (Abutment, Implant, Dental, Endosseous) |
- iii. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| High Retention Attachment System: Zest Anchors, LLC | K213391 |
| Reference Devices | 510(k) Number |
| Locator Overdenture Implant System, Zest Anchors, LLC | K120198 |
| Locator Overdenture Implant System, Zest Anchors, LLC | K203701 |
5
Image /page/5/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" on the left side in a blue gradient color. To the right of the letters is the text "ZEST DENTAL" in a bold, sans-serif font, with the word "SOLUTIONS" underneath in a smaller font.
iv. Description of Device
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 consists of abutments, attachment housings, inserts and seating and removal tools. The abutments are provided in various cuff heights with the implant and abutment connection specific to the Zest Anchors, LLC or 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) Alloy for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.
The High Retention Attachment System is as provided with an abutment (LOCATOR Attachment) and the surgical instrumentation necessary to place the implant.
The High Retention Attachment System is designed to accommodate a path of insertion diverqence of up to 20° per implant and no more than 40° of divergence between implants.
The abutments are identical to the High Retention Attachment System devices cleared in the predicate. K213391, with the main difference being an additional implant system compatibility. The additional compatible implant system, Zest Anchors, LLC's Locator Overdenture Implant (LODI) implants, were previously cleared in K120198 and K203701 and are included as reference devices, in the K220252 submission.
6
Image /page/6/Picture/0 description: The image is a logo for Zest Dental Solutions. The logo features the letters "ZD" in a bold, blue font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a dark blue, sans-serif font. Below "ZEST DENTAL", the word "SOLUTIONS" is written in a smaller, light blue font.
Indication for Use V.
The High Retention 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 |
| Zest Dental Solutions | Locator Overdenture Implant System | 2.4, 2.9, 3.5, 3.9, 4.4, 4.9 |
| 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 |
7
Image /page/7/Picture/0 description: The image contains the logo for Zest Dental Solutions. The logo features the letters "ZD" in a bold, blue font on the left side. To the right of the letters, the words "ZEST DENTAL" are stacked on top of the word "SOLUTIONS" in a smaller, blue font. The logo is simple and professional, and it is likely used to represent the company's brand.
vi. Predicate Device Comparison
The following table compares the Indications for Use and key technological
characteristics of the subject and predicate device:
| Characteristic
/ Feature | High Retention
Attachment System
(Subject Device) | High Retention
Attachment
System
(Predicate Device
- K213391) | Locator
Overdenture
Implant System
(Reference
Device #1 -
K120198) | The Locator
Overdenture
Implant System
(Reference
Device #2 -
K203701) | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reason for
predicate or
reference | n/a | Indications, function,
material of insert,
mechanical (retention)
performance | Design of implant added to compatibility table | | Predicate is unchanged and
reference device is added to
cleared compatibility table |
| Indication
for use | Locator 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. | 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. | Locator
Overdenture
Implant System is
designed to retain
overdentures or
partial dentures in
the mandible or
maxilla. | The Locator
Overdenture
Implant System is
designed to retain
overdentures or
partial dentures in
the mandible or
maxilla.
Immediate loading is
indicated when good
primary stability has
been achieved and with
appropriate occlusal
loading. | Similar:
The subject and the primary
predicate K223391 have identical
indications for use, with the
exception of an additional implant
system compatibility for the subject
devices.
The additional compatible implant
system, Zest Anchors, LLC's
Locator Overdenture Implant
(LODI) implants, were previously
cleared in K120198 and K203701,
and are included as reference
devices. |
| FDA
Product
Code | NHA (Abutment, Implant,
Dental, Endosseous) 21 CFR
872.3630 | NHA (Abutment,
Implant, Dental,
Endosseous) 21
CFR 872.3630 | DZE (Implant,
Endossesous,
Root-Form) 21
CFR 872.3640 | DZE (Implant,
Endossesous, Root-
Form) 21 CFR
872.3640 | Substantially Equivalent:
The subject device have
demonstrated substantial
equivalence to the primary
predicate device, K213391, in that
they utilize identical materials,
fundamental designs, intended
use and principles of operation.
The reference devices, K120198
and K203701, are only included
as reference devices for additional
implant system compatibilities. |
| | | | DESIGN | | |
| Abutment
platform
diameter | 2.3 mm to 7.0 mm,
multiple systems | 2.3 mm to 7.0
mm, multiple
systems | N/A | N/A | Substantially Equivalent.
Predicate and subject
abutment platform
diameters are identical. |
| Abutment
angle | Straight | Straight | N/A | N/A | Substantially Equivalent.
Predicate and subject abutment
angles are identical |
| Abutment /
implant
interface | Conical, External Hex,
Internal Hex, Internal
Multi Lobe | Conical,
External Hex,
Internal Hex,
Internal Multi
Lobe | External Hex | External Hex | Substantially Equivalent.
Predicate and subject device
abutment/implant interfaces are
identical. |
| | | | | | |
| Divergence
Allowance | 20°/40° (except when
not allowed by the
implant manufacturer) | 20°/40° (except
when not allowed
by the implant
manufacturer) | N/A | N/A | Substantially Equivalent.
Divergence allowance is
unchanged from the predicate
device. |
| Prosthesis
attachment
type | PEEK insert retained
in denture attachment
housing | PEEK insert
retained in
denture
attachment
housing | N/A | N/A | Substantially Equivalent.
Predicate and subject device
prosthesis attachment type are
identical. |
| Materials | | | | | |
| Abutment
or Implant
Material | Abutment: Ti-6AI-4V
ELI | Abutment: Ti-
6AI-4V ELI | Implant: Ti
6AI-4V ELI | Implant: Ti
6AI-4V ELI | Substantially Equivalent.
both the abutment and the
implants in the subject,
predicate, and reference
devices are made from the
same titanium alloy (Ti-6Al-
4V ELI). |
| Device
Material
Surface
Treatment | Abutment: TiN | Abutment: TiN | Implant:
Resorbable
Blast Media
(RBM) using
MCD Apatatic
Abrasive | Implant:
Resorbable
Blast Media
(RBM) using
MCD Apatatic
Abrasive | Substantially Equivalent.
Predicate and subject device use
identical surface treatment
process. |
| Prosthetic
retention
component | PEEK | PEEK | N/A | N/A | Substantially Equivalent.
Predicate and subject device
retention components are
identical. |
| Reference
Implant
Size | N/A | N/A | 2.4mm, 2.9mm | 3.5mm, 3.9mm,
4.4mm, 4.9mm | Reference Devices are cleared
for implants of 2.4mm to 4.9mm
in diameter |
| Sterilization | | | | | |
| Sterile | No | No | Yes | Yes | Substantially Equivalent.
Predicate and subject device are
both supplied non-sterile. |
8
Image /page/8/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a bold, blue font on the left side. To the right of the letters are the words "ZEST DENTAL" in a smaller, blue font, with the word "SOLUTIONS" underneath in a lighter blue. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.
As noted in the table above, the subject and predicate devices are identical. Fatigue testing according to ISO 14801: 2016 was performed for Zest Anchors, LLC's Locator Overdenture Implant (LODI) implants (K120198/K203701) and leveraged to support modifications to the K213391 compatibility table.
Summary of Non-Clinical Performance Testing vii.
No new testing was performed as a part of this submission for the determination of substantial equivalence.
Fatigue testing, sterilization, and biocompatibility testing are all leveraged from previous submissions
9
Image /page/9/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo features the letters "ZD" in a bold, blue font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a similar bold, blue font. Below "ZEST DENTAL", the word "SOLUTIONS" is written in a lighter blue color.
MR safety for the subject device system was based on the "worst-case" of the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. The "worst-case" assessment includes an evaluation of the High Retention Attachment System devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795).
In addition, the "worst-case" MR Safety rationale addressed parameters per the FDA guidance, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
viii. Substantial Equivalence
The risk management activities and results of the other activities described above provide reasonable assurance that the subject devices have demonstrated substantial equivalence to the predicate devices in the that they utilize the same materials and fundamental designs and also have the same intended use and principles of operation.