(90 days)
The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.
The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.
This document (K243272) is a 510(k) premarket notification for a dental device, the LOCATOR Angled Abutment. It is important to note that this document does not describe the performance of software or an AI device. Instead, it describes a mechanical dental implant component and its substantial equivalence to previously cleared predicates.
Therefore, many of the requested categories related to AI/software performance criteria, expert adjudication, MRMC studies, ground truth establishment for AI/ML, and training set information are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding the acceptance criteria (in terms of performance testing for a mechanical device) and how the device meets them:
1. Table of Acceptance Criteria (for a mechanical device) and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Verification (Fit and Performance with OEM Implants) | Critical features of OEM implant bodies, abutments, and abutment fixation screws were identified and measured using calibrated equipment. Specifications for the design were created based on this data. All critical tolerances were verified functionally in OEM implants, demonstrating that the abutments fit and perform as intended. |
| Fatigue Resistance (ISO 14801:2016) | Fatigue testing was performed for the tallest abutment cuff height LOCATOR Angled Abutment with the smallest diameter OEM implant. While no specific numerical acceptance threshold for fatigue cycles is explicitly stated, the implication is that the device met the performance requirements for substantial equivalence to the predicate, which would include passing this test. |
| TiN Coating Performance (ASTM F1044, ASTM F1147) | The Titanium Nitride (TiN) coating performance was tested per ASTM F1044 and ASTM F1147. This indicates that the coating, identical to the predicate device, meets the specified standards for performance. |
| Packaging and Shipping Validation | Packaging and shipping validation testing was completed. The LOCATOR Angled Abutment (worst-case device and packaging) was undamaged after the test, meeting the desired outcome. |
| Cleaning and Sterilization Efficacy | The cleaning and sterilization methods are identical to the predicate device (K233587), implying they meet established efficacy standards. |
| MR Compatibility (ASTM F2052-21, F2213-17, F2182-19, F2119-07 and FDA Guidance) | MR compatibility testing (Force, Torque, Heating (RF & Gradient field), Image Quality, Vibration) was previously conducted on similar Ti-6Al-4V components. An engineering analysis established that the LOCATOR Angled Abutment does not create a new worst-case scenario for MR compatibility, thus meeting the criteria based on existing data. |
| Biocompatibility (ISO 10993-1, ISO 10993-5) | Biocompatibility assessment was conducted using testing from K072878 and additional cytotoxicity testing per ISO 10993-5 (cleared under K233587). This indicates the device materials and design are biocompatible and safe for use in the human body. |
Study Details (for a mechanical device):
-
Sample sizes used for the test set and the data provenance:
- Specific quantitative sample sizes for each mechanical test (e.g., number of abutments fatigued, number of coatings tested) are not detailed in this summary.
- The data provenance is from non-clinical performance testing conducted by the manufacturer, Zest Anchors, LLC. This is typically internal laboratory testing.
- The nature of the tests (fatigue, coating, packaging, functional fit) indicates this is prospective testing performed specifically to support this regulatory submission. Country of origin for data is not specified but is implicitly from the manufacturer's testing facilities (likely USA, given the submission location).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a mechanical device is established through objective engineering measurements and standardized performance tests (e.g., ISO, ASTM standards), not by human expert consensus on interpretations. The "experts" involved would be qualified engineers and technicians performing the tests.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers/experts in AI/medical image analysis. For mechanical device testing, the results are objectively measured and compared against predefined performance specifications.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical dental abutment, not an AI or software product. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical abutment, not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established engineering principles, material science specifications, and adherence to international standards (e.g., ISO 14801, ASTM F1044, ASTM F1147, ISO 10993). Functional fit was verified against OEM implant specifications through direct testing.
-
The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning model. There is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set exists for this type of device.
In summary, the provided document explicitly states that the submission aims to demonstrate substantial equivalence of the new LOCATOR Angled Abutment variations to existing predicate devices. This is achieved by showing that the new abutments share the same intended use, principles of operation, materials, manufacturing processes, and fundamental design, and they meet the same functional and performance characteristics through non-clinical testing. The "acceptance criteria" here refer to the successful completion and passing of these engineering and material performance tests against established standards.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 14, 2025
Zest Anchors, LLC Maleata Hall Director Regulatory Affairs 2875 Loker Ave E Carlsbad, California 92010
Re: K243272
Trade/Device Name: LOCATOR Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 15, 2024 Received: October 16, 2024
Dear Maleata Hall:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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 -S
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
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Indications for Use
510(k) Number (if known) K243272
Device Name LOCATOR Angled Abutment
Indications for Use (Describe)
The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image is 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, 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 on the company's website, marketing materials, and products.
510(K) Summary – K243272 LOCATOR Angled Abutment
i. General Information on Submitter
| Applicant: | Zest Anchors, LLC |
|---|---|
| Address: | 2875 Loker Avenue EastCarlsbad, CA 92010 USA |
| Telephone: | (800) 262-2310 |
| Contact Person: | David Lin |
| Contact Title: | Sr. Regulatory Affairs Specialist |
| Email: | regulatoryaffairs@zestdent.com |
| Date Prepared: | December 16, 2024 |
ii. General Information on Device
| Proprietary Name: | LOCATOR Angled Abutment |
|---|---|
| Common Name: | Dental Implant Abutment |
| Requlation Number: | 21 CFR 872.3630 |
| Classification Name: | Endosseous dental implant abutment |
| Regulatory Class: | Class II |
| Product Code: | NHA (Abutment, Implant, Dental, Endosseous) |
iii. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| LOCATOR Angled Abutment: Zest Anchors, LLC | K233587 |
| Reference Devices | 510(k) Number |
| Hex-Lock Prepared Abutment (Straight & Angled), Zimmer Dental Inc. | K052600 |
| SBF 15 Esthetic Abutment 1mm NP, Model 33699, SFB 15 Esthetic Abutment1mm RP, Model 33701, CFB 15 Esthetic Abutment 2mm, Nobel Biocare AB | K062749 |
| Neodent® Implant System - GM Line, JJGC Industria e Comercio de MateriaisDentarios SA | K163194 |
| Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. | K013227 |
| Tapered Screw-Vent Implant, 4.1mm, Zimmer Dental, Inc. | K072589 |
| NobelActive Internal Connection Implant, Nobel Biocare AB | K071370 |
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Image /page/5/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo consists of 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 smaller, black font. Below "ZEST DENTAL", the word "SOLUTIONS" is written in a smaller, blue font.
Description of Device iv.
The purpose of this submission is to expand the LOCATOR Angled Abutment product line by adding new devices, specifically abutments compatible with various dental implant systems from different dental implant manufacturers (OEMs). The Locator Angled Abutment (K233587) has been cleared by the FDA for compatibility with the Straumann BLX implant. This 510(k) submission expands compatibility to include the Zimmer TSV 3.5/4.5(ZimVie), Nobel RP/NP, and Neodent Grand Morse (GM) implant systems. The LOCATOR Angled Abutment is designed and cleared to be used with LOCATOR FIXED (K213391) and LOCATOR Attachment Systems (K072878) for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla.
The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.
The abutment/implant interface of the LOCATOR Angled Abutment cleared in K233587 is compatible with the OEM implant system, Straumann BLX. The submission herein is to expand the abutment/implant interface compatibility of the LOCATOR Angled Abutment to include the Zimmer (ZimVie) TSV 3.5/4.5, Nobel RP/NP, and Neodent Grand Morse implant systems. LOCATOR Angled Abutment compatibility is demonstrated through reverse engineering of OEM devices and verified for functional performance via ISO14801 testing of the LOCATOR Angled Abutment with the smallest diameter OEM implant to ensure that the abutments fit and perform as intended.
Indication for Use
The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient.
| Zest Model | Implant Mfg | Implant Diameters(Ø) mm | Implant SystemName | ImplantPlatform Name | PlatformDiameter(Ø) mm | ConnectionType |
|---|---|---|---|---|---|---|
| LAA 15°,Straumann, BLX | Straumann | 3.5, 3.75, 4.0, 4.5 | BLX | Regular Base | 2.9 | Bone Level |
| Straumann | 5.0, 5.5, 6.5 | BLX | Wide Base | 2.9 | Bone Level |
IMPLANT COMPATIBILITY
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Image /page/6/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 bold, dark blue font, with the word "SOLUTIONS" written in a lighter blue font below. The logo is simple and professional, and it effectively communicates the company's name and focus.
| Zest Model | Implant Mfg | Implant Diameters(Ø) mm | Implant SystemName | ImplantPlatform Name | PlatformDiameter(Ø) mm | ConnectionType |
|---|---|---|---|---|---|---|
| LAA 15°, Nobel(NP) | Nobel | 3.5 | NobelActive,NobelParallel CC,NobelReplace CC | Narrow Platform | 3.0 | Conical |
| LAA 15°, Nobel(RP) | 4.3 | NobelActive,NobelParallel CC,NobelReplace CC | Regular Platform | 3.5 | Conical | |
| LAA 15°,Neodent (GM) | Neodent | 3.5, 3.75, 4.0, 5.0,6.0 | Helix GM | N/A | Conical /Grand Morse | |
| 3.5, 4.3, 5.0 | Drive GM | N/A | 3.0 | Conical /Grand Morse | ||
| 3.5, 3.75, 4.0, 5.0 | Titamax GM | N/A | Conical /Grand Morse | |||
| LAA 15°, TSV | ZimVie | 3.7 & 4.1 Green | Trabecular Metal,Tapered Screw-Vent,Screw-Vent,Advent | N/A | 3.5 | Internal Hex |
| 4.7 Purple | Trabecular Metal,Tapered Screw-Vent, Screw-Vent,Advent | N/A | 4.5 | Internal Hex |
Predicate Device Comparison V.
The following table compares the Indications for Use and key technological characteristics of the subject and predicate device:
| Characteristic/ Feature | Zest Anchors,Inc.LOCATORAngled Abutment(Subject Device -K24xxxx) | Zest Anchors,Inc.LOCATORAngled Abutment(Predicate Device- K233587) | ZIMMER DENTALHEX-LOCKPREPAREDABUTMENT(STRAIGHT &ANGLED) (ReferenceDevice #1 - K052600) | NOBEL BIOCARE ABSBF 15 ESTHETICABUTMENT 1MM NP,MODEL 33699, SFB 15ESTHETIC ABUTMENT1MM RP, MODEL33701, CFB 15ESTHETIC ABUTMENT2MM (ReferenceDevice #2 - K062749) | JJGC Industria eComercio deMateriais DentariosSANeodent® ImplantSystem - GM Line(Conventionalabutments)(Reference Device #3-K163194) | Comparison |
|---|---|---|---|---|---|---|
| Reason forpredicate orreference | n/a | Design of LocatorAngled Abutment | Zimmer TSVconnection | Nobel NP/RPconnection | GM implant/abutmentconnection | Predicate isunchanged andreference deviceis added forexpandingcompatibility. |
| Indicationfor use | The LOCATORAngled Abutmentis indicated for theattachment of fullor partial, fixedand removable,restorationsretained byendosseousimplants to restoremasticatoryfunction for thepatient.A completeImplantManufacturer'scompatibility tableis provided in theInstructions ForUse. | The LOCATORAngled Abutmentis indicated for theattachment of fullor partial, fixedand removable,restorationsretained byendosseousimplants to restoremasticatoryfunction for thepatient.The completeIndications for UseStatement withOEM implantcompatibilities isprovided in the510(k) Summaryfor K233587. | The Zimmer DentalHex-Lock PreparedStraight Abutment isused as a terminal orintermediate abutmentfor a cementedprosthesis. TheZimmer DentalHexLock PreparedAngled Abutment isused as a terminal orintermediate abutmentfor a cementedprosthesis where theangle needs to beoffset by 17°. Eitherabutment can be usedfor a single ormultiple-unitrestoration. | Nobel Biocare's SFBand CFB AngledAbutments arepremanufacturedprosthetic componentsdirectly connected tothe SFB & CFBendosseous dentalimplants and areintended for use as anaid in prostheticrehabilitation. | Indications for Use forGM conventionalabutments: TheNeodent ImplantSystem is intended tobe surgically placed inthe bone of the upperor lower jaw to providesupport for prostheticdevices such asartificial teeth, torestore chewingfunction. It may beused with single-stageor two-stageprocedures, for singleor multiple unitrestorations, and maybe loaded immediatelywhen good primarystability is achievedand with appropriateocclusal loading. | Same: Thesubject andpredicate deviceshave the sameindication for use. |
| Restoration Type | Full or partial,fixed andremovable,restorations | Full or partial, fixedand removable,restorations | Full arch or partialrestorations | Full arch or partialrestorations | Full arch or partialrestorations | Same: Thesubject andpredicate deviceshave the samerestoration type. |
| FDAProductCode | NHA (Abutment,Implant, Dental,Endosseous) 21 CFR872.3630 | NHA(Abutment,Implant,Dental,Endosseous)21 CFR872.3630 | NHA (Abutment,Implant, Dental,Endosseous) 21CFR 872.3630 | NHA (Abutment,Implant, Dental,Endosseous) 21CFR 872.3630 | NHA (Abutment,Implant, Dental,Endosseous) 21CFR 872.3630 | Same: Thesubject andpredicatedevices havethe sameFDA productcode |
| DESIGN | ||||||
| AbutmentHeight | 2.5 mm to 7.5 mm | 2.5 mm to 7.5mm | 1.5 - 6.5 mm | 1.75mm, 3mm | 0.8- 5.5mm | Same.Predicate,reference,and subjectabutmentheight are thesame. |
| AbutmentType | Angled | Angled | Straight andAngled | Straight and Angled | Straight | Same.Predicate,and subjectabutmentangles arethe same. |
| AbutmentAngled | 15° | 15° | 0 and 17° | 0°, 15° | 0°, 17°, 30° | Same.Predicate,and subjectabutmentangles aresame. |
| AbutmentScrew | M1.6 x 0.35Thread type(Nobel NP,Neodent GM)M2.0 X 0.4-6g | M1.6 x 0.35 Threadtype | #1-72 UNF 2AZimmer (ZimVie)Thread type | M1.6 x 0.35 Threadtype (Nobel NP)M2.0 X 0.4-6gThread type(Nobel RP) | M1.6 X 0.35-6g(Neodent GM)Thread type | Similar.Criticalabutmentscrewfeatures aresimilar to |
| Thread type(Nobel RP)#1-72 UNF 2AZimmer(ZimVie)Thread type | Materials | eachreferencedevice. | ||||
| AbutmentAndAbutmentScrewMaterial | Ti-6Al-4V ELI | Ti-6Al-4V ELI | TAV (Ti-6Al-4V) | Ti-6Al-4V ELI | Titanium Alloy, Ti-6Al-4V ELI | Same:subject, andpredicate aremade fromthe samematerial -titanium (Ti-6Al-4V) |
| DeviceMaterialSurfaceTreatment | TiN | TiN | Partially anodized /TiN coated | NA | NA | Same.Predicateand subjectdevice useidenticalsurfacetreatmentprocess |
| Sterilization | ||||||
| Sterile | Moist heat end usersterilization | Moist heat endusersterilization | Delivered sterileby EO exposure | Moist heat end usersterilization | Delivered sterileby EO exposure | Same.Predicateand subjectdevice areboth suppliednon-sterile. |
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Image /page/7/Picture/0 description: The image is a logo for Zest Dental Solutions. The logo features the letters "ZD" in a bold, sans-serif font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a similar font, with "SOLUTIONS" appearing below in a smaller font. The colors used in the logo are a shade of blue.
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Image /page/8/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a bold, sans-serif font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a similar font, with the word "SOLUTIONS" written below in a smaller font. The logo is in a blue color.
vi. Summary of Non-Clinical Performance Testing
The critical features were identified on the OEM components (implant bodies, abutments, and abutment fixation screws), which are required for proper function. Using calibrated equipment with the appropriate accuracy the critical features were measured and documented. Using the data collected, including the variations, the specifications for the design were created. These specifications were reviewed for manufacturability. All critical tolerances were verified functionally in OEM implants.
Fatigue testing according to ISO 14801: 2016 was performed for the tallest abutment cuff height LOCATOR Angled Abutment along with the smallest diameter OEM implant.
The LOCATOR Angled Abutments are made of Ti-6Al-4V ELI with a TiN coating, identical to the predicate device. TiN coating performance was tested per ASTM F1044 and ASTM F1147.
The packaging of the LOCATOR Angled Abutments is similar to the packaging of the predicate device, consisting of the LOCATOR angled abutment placed in a vial and sealed in a polybag, along with a parallel post (class I device) used to visually confirm the desired abutment orientation. Additionally, some packaged configuration will include the LOCATOR Angled Abutment Screw packaged in a separate vial and sealed in the same polybag as the abutment and parallel post. Packaging and shipping validation
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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, with the word "SOLUTIONS" appearing below in a lighter blue color. The logo is clean and professional, suggesting a company that provides dental solutions.
testing was completed where the LOCATOR Angled Abutment worst case device and packaging were undamaged after the test, as desired.
The cleaning and sterilization are identical to the predicate device cleared under K233587.
MR compatibility testing was conducted previously per ASTM F2052-21, ASTM F2213-17, ASTM F2182-19, ASTM F2119-07, and FDA guidance "Testing and Labeling Medical Devices for Safety in the Maqnetic Resonance (MR) Environment" on abutment and implant components made of Ti-6AI-4V and designed with similar features as the LOCATOR Angled Abutments of this 510(K) submission. The tests that were conducted are Force: static magnetic field induced displacement force, Torque: static magnetic field induced torque, Heating: Radiofrequency field (RF) induced heating, Image Quality: susceptibility induced image artifacts, Heating: Gradient field induced heating, and Vibration: Gradient field induced vibration. The results have been leveraged for the LOCATOR Angled Abutment where engineering analysis established that the LOCATOR Angled Abutment does not create a new worst-case scenario.
An assessment for biocompatibility per ISO 10993-1 was conducted using testing from K072878 and additional cytotoxicity testing per ISO 10993-5 cleared under K233587 was provided in this submission.
No other new testing was performed as a part of this submission for the determination of substantial equivalence.
vii. Substantial Equivalence
The risk management activities and results of the testing described above provide reasonable assurance that the subject devices have demonstrated substantial equivalence to the predicate devices in the that they share intended use and principles of operation, use the same materials and manufacturing processes, and utilize the same fundamental design including identical prosthetic attachment features.
§ 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.)