Who is the manufacturer of LOCATOR Angled Abutment?

Zest Anchors, LLC filed the 510(k) submission for LOCATOR Angled Abutment (K243272).

What is the FDA product code for LOCATOR Angled Abutment?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for LOCATOR Angled Abutment?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like LOCATOR Angled Abutment?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LOCATOR Angled Abutment

Q: What are the predicate devices for LOCATOR Angled Abutment?

LOCATOR Angled Abutment (K233587).

K243272 · Zest Anchors, LLC · NHA · Jan 14, 2025 · Dental

Device Facts

Record ID	K243272
Device Name	LOCATOR Angled Abutment
Applicant	Zest Anchors, LLC
Product Code	NHA · Dental
Decision Date	Jan 14, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

LOCATOR Angled Abutment is a dental implant abutment designed to provide 15-degree angle correction for prosthetic restorations. It interfaces with specific OEM endosseous dental implants (Zimmer TSV, Nobel RP/NP, Neodent Grand Morse) and connects to LOCATOR FIXED or LOCATOR Attachment System accessories (retention inserts, denture attachment housings). The device is used by dental clinicians in a clinical setting to attach fixed or removable prostheses to implants. The abutment is manufactured from Ti-6Al-4V ELI with a titanium nitride (TiN) coating. Compatibility is achieved through reverse engineering of OEM implant interfaces and verified via functional performance testing. The device is supplied non-sterile and requires moist heat sterilization by the end-user. By providing an angled interface, the device allows clinicians to compensate for implant angulation, facilitating the attachment of restorations and restoring patient masticatory function.

Clinical Evidence

Bench testing only. Fatigue testing performed per ISO 14801:2016. TiN coating performance tested per ASTM F1044 and ASTM F1147. Biocompatibility assessment per ISO 10993-1 and ISO 10993-5. MR compatibility leveraged from previous testing per ASTM F2052-21, F2213-17, F2182-19, F2119-07.

Technological Characteristics

Material: Ti-6Al-4V ELI with TiN coating. Design: 15-degree angled abutment for endosseous dental implants. Dimensions: 2.5 mm to 7.5 mm cuff heights. Connectivity: Mechanical interface with specific OEM implant systems (Zimmer, Nobel, Neodent). Sterilization: Moist heat (end-user).

Indications for Use

Indicated for patients requiring attachment of full or partial, fixed or removable, dental restorations retained by endosseous implants to restore masticatory function.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

LOCATOR Angled Abutment (K233587)

Reference Devices

Hex-Lock Prepared Abutment (Straight & Angled), Zimmer Dental Inc. (K052600)
SBF 15 Esthetic Abutment 1mm NP, Model 33699, SFB 15 Esthetic Abutment 1mm RP, Model 33701, CFB 15 Esthetic Abutment 2mm, Nobel Biocare AB (K062749)
Neodent® Implant System - GM Line, JJGC Industria e Comercio de Materiais Dentarios 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)

Related Devices

K233587 — LOCATOR Angled Abutment (Various) · Zest Anchors, LLC · Jun 3, 2024
K250721 — LOCATOR® Angled Abutment · Zest Anchors, LLC · Aug 20, 2025
K252944 — LOCATOR® Angled Abutment · Zest Anchors, LLC · Oct 15, 2025
K232560 — Angled Abutment · Arum Dentistry Co., Ltd. · Dec 19, 2023
K071838 — NEOSS VARIOUS TITANIUM ABUTMENTS · Neoss, Ltd. · Oct 19, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 East Carlsbad, 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 Abutment 1mm RP, Model 33701, CFB 15 Esthetic Abutment 2mm, Nobel Biocare AB | K062749 | | Neodent® Implant System - GM Line, JJGC Industria e Comercio de Materiais Dentarios 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 | {5}------------------------------------------------ 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 System Name | Implant Platform Name | Platform Diameter (Ø) mm | Connection Type | |----------------------------|-------------|-----------------------------|------------------------|--------------------------|--------------------------------|--------------------| | 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 {6}------------------------------------------------ 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 System Name | Implant Platform Name | Platform Diameter (Ø) mm | Connection Type | |--------------------------|-------------|-----------------------------|-----------------------------------------------------------------------|--------------------------|--------------------------------|--------------------------| | 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. LOCATOR Angled Abutment (Subject Device - K24xxxx) | Zest Anchors, Inc. LOCATOR Angled Abutment (Predicate Device - K233587) | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) (Reference Device #1 - K052600) | NOBEL BIOCARE AB SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM (Reference Device #2 - K062749) | JJGC Industria e Comercio de Materiais Dentarios SA Neodent® Implant System - GM Line (Conventional abutments) (Reference Device #3 - K163194) | Comparison | |--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Reason for predicate or reference | n/a | Design of Locator Angled Abutment | Zimmer TSV connection | Nobel NP/RP connection | GM implant/abutment connection | Predicate is unchanged and reference device is added for expanding compatibility. | | | | | | | | | | 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. A complete Implant Manufacturer's compatibility table is provided in the Instructions 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. The complete Indications for Use Statement with OEM implant compatibilities is provided in the 510(k) Summary for K233587. | The Zimmer Dental Hex-Lock Prepared Straight Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The Zimmer Dental HexLock Prepared Angled Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Either abutment can be used for a single or multiple-unit restoration. | Nobel Biocare's SFB and CFB Angled Abutments are premanufactured prosthetic components directly connected to the SFB & CFB endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. | Indications for Use for GM conventional abutments: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. | Same: The subject and predicate devices have the same indication for use. | | Restoratio n Type | Full or partial, fixed and removable, restorations | Full or partial, fixed and removable, restorations | Full arch or partial restorations | Full arch or partial restorations | Full arch or partial restorations | Same: The subject and predicate devices have the same restoration type. | | FDA Product Code | NHA (Abutment, Implant, Dental, Endosseous) 21 CFR 872.3630 | NHA (Abutment, Implant, Dental, Endosseous) 21 CFR 872.3630 | NHA (Abutment, Implant, Dental, Endosseous) 21 CFR 872.3630 | NHA (Abutment, Implant, Dental, Endosseous) 21 CFR 872.3630 | NHA (Abutment, Implant, Dental, Endosseous) 21 CFR 872.3630 | Same: The subject and predicate devices have the same FDA product code | | | | | | DESIGN | | | | Abutment Height | 2.5 mm to 7.5 mm | 2.5 mm to 7.5 mm | 1.5 - 6.5 mm | 1.75mm, 3mm | 0.8- 5.5mm | Same. Predicate, reference, and subject abutment height are the same. | | Abutment Type | Angled | Angled | Straight and Angled | Straight and Angled | Straight | Same. Predicate, and subject abutment angles are the same. | | Abutment Angled | 15° | 15° | 0 and 17° | 0°, 15° | 0°, 17°, 30° | Same. Predicate, and subject abutment angles are same. | | Abutment Screw | M1.6 x 0.35 Thread type (Nobel NP, Neodent GM) M2.0 X 0.4-6g | M1.6 x 0.35 Thread type | #1-72 UNF 2A Zimmer (ZimVie) Thread type | M1.6 x 0.35 Thread type (Nobel NP) M2.0 X 0.4-6g Thread type (Nobel RP) | M1.6 X 0.35-6g (Neodent GM) Thread type | Similar. Critical abutment screw features are similar to | | | Thread type (Nobel RP) #1-72 UNF 2A Zimmer(ZimVie) Thread type | | | Materials | | each reference device. | | Abutment And Abutment Screw Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | TAV (Ti-6Al-4V) | Ti-6Al-4V ELI | Titanium Alloy, Ti- 6Al-4V ELI | Same: subject, and predicate are made from the same material - titanium (Ti- 6Al-4V) | | Device Material Surface Treatment | TiN | TiN | Partially anodized / TiN coated | NA | NA | Same. Predicate and subject device use identical surface treatment process | | | | | Sterilization | | | | | Sterile | Moist heat end user sterilization | Moist heat end user sterilization | Delivered sterile by EO exposure | Moist heat end user sterilization | Delivered sterile by EO exposure | Same. Predicate and subject device are both supplied non-sterile. | {7}------------------------------------------------ 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. K243272 ## Page 4 of 6 {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, 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 {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, 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.