LOCATOR Angled Abutment (Various)
Device Facts
| Record ID | K233587 |
|---|---|
| Device Name | LOCATOR Angled Abutment (Various) |
| Applicant | Zest Anchors, LLC |
| Product Code | NHA · Dental |
| Decision Date | Jun 3, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications 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.
Device Story
LOCATOR Angled Abutment is a dental implant abutment designed to connect endosseous implants to fixed or removable dental restorations. It features a 15-degree angle for angle correction, differing from traditional coaxial abutments. The device consists of an abutment body with an integrated screw, manufactured from Ti-6Al-4V titanium with a titanium nitride (TiN) coating. It is used by dental professionals in clinical settings. The abutment interfaces with Straumann BLX implants and utilizes standard LOCATOR attachment accessories (inserts, housings). By providing an angled interface, it allows clinicians to align restorations with the implant axis, facilitating proper masticatory function. The device is supplied non-sterile and requires end-user moist heat sterilization.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including fatigue testing (ISO 14801:2016), TiN coating performance (ASTM F1044, ASTM F1147), biocompatibility (ISO 10993-1, ISO 10993-5), and MR compatibility testing (ASTM F2052-15, F2213-17, F2182-19, F2119-07).
Technological Characteristics
Material: Ti-6Al-4V ELI titanium; Surface: Titanium Nitride (TiN) coating. Dimensions: 2.5mm to 7.5mm height. Connection: 15-degree angled interface for Straumann BLX implants. Sterilization: Moist heat (end-user). Standards: ISO 14801 (fatigue), ASTM F1044/F1147 (coating), ISO 10993 (biocompatibility), ASTM F2052/F2213/F2182/F2119 (MR compatibility).
Indications for Use
Indicated for patients requiring full or partial, fixed or removable, dental restorations retained by endosseous implants in the mandible or maxilla 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 High Retention Attachment System (LOCATOR FIXED) (K213391)
Reference Devices
- Straumann BLX Line Extension - New Abutments (K190040)
- LOCATOR Implant Anchor Abutment (K072878)
- Straumann® BLX Implant System (K173961, K191256, K181703, K210855, K212533)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zest Anchors, LLC Maleata Hall Director Regulatory Affairs 2875 Loker Ave E Carlsbad, California 92010
June 3, 2024
Re: K233587
Trade/Device Name: LOCATOR Angled Abutment (Various) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 3, 2023 Received: May 6, 2023
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.
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
INSTRUCTIONS
Submission Number (if known)
K233587
Device Name
LOCATOR Angled Abutment (Various)
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.
## IMPLANT COMPATIBILITY
| Implant Mfg | Implant Diameters (Ø) mm | Implant System<br>Name | Implant<br>Platform Name | Platform<br>Diameter (Ø)<br>mm | Connection<br>Type |
|-------------|--------------------------|------------------------|--------------------------|--------------------------------|--------------------|
| Straumann | 3.5, 3.75, 4.0, 4.5 | BLX | Regular Base | 2.9 | Bone Level |
| | 5.0, 5.5, 6.5 | BLX | Wide Base | 2.9 | Bone Level |
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 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 blue font, with the word "SOLUTIONS" appearing below in a smaller font. The logo is clean and professional, suggesting a company that provides dental solutions.
## 510(K) Summary – K233587 LOCATOR Angled Abutment
#### i. General Information on Submitter
| Applicant: | Zest Anchors, LLC |
|-----------------|---------------------------------------------------|
| Address: | 2875 Loker Avenue, East<br>Carlsbad, CA 92010 USA |
| Telephone: | 800-487-1357 |
| Contact Person: | David Lin |
| Contact Title: | Sr. Regulatory Affairs Specialist |
| Email: | regulatoryaffairs@zestdent.com |
| Date Prepared: | May 31, 2024 |
#### ii. General Information on Device
| Proprietary Name: | LOCATOR Angled Abutment (Various) |
|----------------------|---------------------------------------------------------|
| Common Name: | Dental Implant Abutment |
| Classification Name: | Endosseous dental implant abutment<br>(21 CFR 872.3630) |
| Regulatory Class: | II |
| Product Code: | NHA (Abutment, Implant, Dental, Endosseous) |
#### iii. Predicate Device
| Predicate Device | 510(k) Number |
|--------------------------------------------------------------------------------|-----------------------------------------------------|
| Locator High Retention Attachment System (LOCATOR FIXED): Zest Anchors,<br>LLC | K213391 |
| Reference Devices | 510(k) Number |
| Straumann BLX Line Extension - New Abutments: Institut Straumann AG | K190040 |
| LOCATOR Implant Anchor Abutment: Zest Anchors, LLC | K072878 |
| Straumann® BLX Implant System | K173961<br>K191256<br>K181703<br>K210855<br>K212533 |
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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, bold, blue font, with the word "SOLUTIONS" written below in a slightly smaller, lighter blue font.
#### Description of Device iv.
The purpose of this submission is to obtain marketing clearance for the LOCATOR Angled Abutment. The LOCATOR Angled Abutment is designed to be used with LOCATOR FIXED and LOCATOR Attachment Systems 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 abutment bodies with an integrated abutment screw. The attachment features are identical compared to LOCATOR Abutments of the LOCATOR High Retention Attachment System (LOCATOR FIXED), cleared in K213391. The LOCATOR Angled Abutment is compatible with Straumann BLX Implant System cleared in K173961. 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 uses identical attachment features as the LOCATOR Abutments, but instead of the attachment features being aligned coaxially, the interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the device of K190040. The LOCATOR Angled Abutments and integrated abutment screw are manufactured from titanium (Ti-6Al-4V). The LOCATOR Angled Abutment body is titanium nitride (TiN) coated, identical to LOCATOR Abutments.
## 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.
| Implant Mfg | Implant Diameters (Ø) mm | Implant System<br>Name | Implant<br>Platform Name | Platform<br>Diameter (Ø)<br>mm | Connection<br>Type |
|-------------|--------------------------|------------------------|--------------------------|--------------------------------|--------------------|
| 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 stacked on top of the word "SOLUTIONS" in a smaller, blue font. The logo is clean and modern, and the use of blue gives it a professional and trustworthy feel.
#### Predicate Device Comparison V.
The following table compares the Indications for Use and key technological characteristics of the subject and predicate device:
| Characteristic<br>/ Feature | LOCATOR<br>Angled Abutment<br>(Subject Device –<br>K233587) | Locator High<br>Retention<br>Attachment<br>System<br>(Predicate Device<br>– K213391) | Straumann BLX<br>Line Extension –<br>New abutments<br>(Reference<br>Device #1 –<br>K190040) | LOCATOR<br>Implant Anchor<br>Abutment<br>(Reference<br>Device #2 –<br>K072878) | Comparison |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reason for<br>predicate or<br>reference | n/a | Fixed arch<br>restoration indication | Abutment<br>angulation feature | Design of abutment<br>attachment features | Predicate is<br>unchanged and<br>reference device is<br>added for angulation<br>feature. |
| Indication<br>for use | The LOCATOR<br>Angled Abutment is<br>indicated for the<br>attachment of full or<br>partial, fixed and<br>removable,<br>restorations retained<br>by endosseous<br>implants to restore<br>masticatory function<br>for the patient. The<br>LOCATOR Angled<br>Abutment is<br>compatible with<br>Straumann BLX<br>Implant System<br>RB/WB Ø 3.5, 3.75,<br>4.0, 4.5, 5.0, 5.5, 6.5 | The High Retention<br>Attachment System is<br>designed to support<br>fixed, partial or full arch<br>restorations on<br>endosseous dental<br>implants in the mandible<br>or maxilla for the<br>purpose of restoring<br>masticatory function. It is<br>used in fixed hybrid<br>restorations that can be<br>attached with a snap-in<br>system. | The Straumann<br>Retentive System<br>is indicated for the<br>attachment of full<br>or partial dentures<br>on Straumann<br>dental implants. | The Locator Implant<br>Anchor Abutment for<br>Endosseous Dental<br>Implants is appropriate<br>for use with<br>overdentures or partial<br>dentures retained in<br>whole or in part by<br>endosseous implants in<br>the mandible or maxilla. | Similar: The subject<br>and predicate devices<br>have a similar<br>indication for use. |
| Restoration<br>Type | Fixed and removable | Fixed | Fixed and<br>removable | Removable | Similar: In addition to<br>a Fixed restoration<br>type as indicated for<br>the predicate device,<br>the subject device is<br>also indicated for a<br>removable restoration<br>type. |
| FDA<br>Product<br>Code | NHA (Abutment, Implant,<br>Dental, Endosseous) 21<br>CFR 872.3630 | NHA (Abutment,<br>Implant, Dental,<br>Endosseous) 21<br>CFR 872.3630 | NHA<br>(Abutment,<br>Implant, Dental,<br>Endosseous)<br>21 CFR<br>872.3630 | NHA<br>(Abutment,<br>Implant, Dental,<br>Endosseous)<br>21 CFR<br>872.3630 | Same: The<br>subject and<br>predicate devices<br>have the same<br>FDA product code |
| DESIGN | | | | | |
| Abutment<br>Height | 2.5 mm to 7.5 mm | N/A | 1.5mm to<br>6.5mm | 0 - 6.0 mm | Similar.<br>Predicate,<br>reference, and<br>subject abutment<br>height are similar. |
| Abutment<br>Type | Angled | N/A | Straight and<br>Angled | Straight | Similar.<br>Predicate,<br>reference, and<br>subject abutment<br>angles are similar. |
| Abutment<br>Angled | 15° | N/A | 0° and 15° | 0° | Similar.<br>Predicate,<br>reference, and<br>subject abutment<br>angles are<br>similar. |
| Abutment<br>Screw | M1.6 x 0.35 Thread,<br>.069" Thread Depth,<br>Ø.062" Screw Body<br>Diameter,<br>90° Screw Head Taper | N/A | M1.6 x 0.35 Thread,<br>.069" Thread Depth,<br>Ø.062" Screw Body<br>Diameter,<br>90° Screw Head<br>Taper | N/A | Same.<br>Predicate<br>reference of critical<br>abutment screw<br>features are the<br>same. |
| Materials | | | | | |
| Abutment<br>And<br>Abutment<br>Screw<br>Material | Ti-6Al-4V ELI | N/A | TAV (Ti-6Al-4V) | Ti-6Al-4V ELI | Same: subject,<br>predicate, and<br>reference devices<br>are made from the<br>same material -<br>titanium (Ti-6Al-<br>4V) |
| Device<br>Material<br>Surface<br>Treatment | TiN | N/A | TiN | TiN | Same. Predicate<br>and subject device<br>use identical<br>surface treatment<br>process |
| Sterilization | | | | | |
| Sterile | Moist heat end user<br>sterilization | Moist heat end<br>user sterilization | Moist heat end<br>user sterilization | Moist heat end<br>user sterilization | Same. Predicate<br>and subject device<br>are both supplied<br>non-sterile |
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Image /page/7/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a bold, dark blue font on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a smaller, dark blue font. Below that, the word "SOLUTIONS" is written in a light blue font with a trademark symbol next to it.
#### 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 TiN coated. TiN coating performance was tested per ASTM F1044 and ASTM F1147.
The packaging of the LOCATOR Angled Abutments is equivalent to the packaging of the predicate device. Packaging and shipping validation testing was completed where the LOCATOR Angled Abutment worst case device and packaging were undamaged after the test, as desired.
Cleaning and sterilization are leverage in K072878 and this 510(k).
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Image /page/8/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo features the letters "ZD" in a stylized, connected design on the left side. To the right of the letters, the words "ZEST DENTAL" are written in a bold, sans-serif font, with the word "SOLUTIONS" appearing in a smaller font size below "DENTAL".
MR compatibility testing was conducted per ASTM F2052-15, ASTM F2213-17, ASTM F2182-19, ASTM F2119-07, and FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment". 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.
An assessment for biocompatibility per ISO 10993-1 was conducted using testing from K072878 and additional cytotoxicity testing per ISO 10993-5 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 utilize the same materials and fundamental designs and also have the same intended use and principles of operation.
