(208 days)
No
The device description and performance studies focus on mechanical properties, materials, and compatibility with existing systems, with no mention of AI or ML.
Yes
The device is designed to restore masticatory function, which directly addresses a physiological function of the body, indicating a therapeutic purpose.
No
The device is an angled abutment for dental implants designed to restore masticatory function, not to diagnose a condition.
No
The device description clearly states the device is a physical abutment made of titanium and titanium nitride, designed for attachment to implants. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient." This describes a device used in vivo (within the body) for a therapeutic purpose (restoring function).
- Device Description: The description details a physical implant component made of titanium, designed to be placed in the mandible or maxilla and used with other implant system parts. This is consistent with a surgical or prosthetic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro to analyze biological samples. This device is designed to be implanted in vivo.
N/A
Intended Use / 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.
Product codes
NHA
Device Description
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.
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)
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).
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.
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.
K190040, K072878, K173961, K191256, K181703, K210855, K212533
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 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.
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.
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
INSTRUCTIONS
Submission Number (if known)
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
Name | Implant
Platform Name | Platform
Diameter (Ø)
mm | Connection
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 |
| 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 |
| (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, | |
| 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 |
| K191256 | |
| K181703 | |
| K210855 | |
| K212533 |
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, 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
Name | Implant
Platform Name | Platform
Diameter (Ø)
mm | Connection
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
/ Feature | LOCATOR
Angled Abutment
(Subject Device –
K233587) | Locator High
Retention
Attachment
System
(Predicate Device
– K213391) | Straumann BLX
Line Extension –
New abutments
(Reference
Device #1 –
K190040) | LOCATOR
Implant Anchor
Abutment
(Reference
Device #2 –
K072878) | Comparison |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reason for
predicate or
reference | n/a | Fixed arch
restoration indication | Abutment
angulation feature | Design of abutment
attachment features | Predicate is
unchanged and
reference device is
added for angulation
feature. |
| 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. The
LOCATOR Angled
Abutment is
compatible with
Straumann BLX
Implant System
RB/WB Ø 3.5, 3.75,
4.0, 4.5, 5.0, 5.5, 6.5 | The High Retention
Attachment System is
designed to support
fixed, partial or full arch
restorations on
endosseous dental
implants in the mandible
or maxilla for the
purpose of restoring
masticatory function. It is
used in fixed hybrid
restorations that can be
attached with a snap-in
system. | The Straumann
Retentive System
is indicated for the
attachment of full
or partial dentures
on Straumann
dental implants. | The Locator Implant
Anchor Abutment for
Endosseous Dental
Implants is appropriate
for use with
overdentures or partial
dentures retained in
whole or in part by
endosseous implants in
the mandible or maxilla. | Similar: The subject
and predicate devices
have a similar
indication for use. |
| Restoration
Type | Fixed and removable | Fixed | Fixed and
removable | Removable | Similar: In addition to
a Fixed restoration
type as indicated for
the predicate device,
the subject device is
also indicated for a
removable 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 | Same: The
subject and
predicate devices
have the same
FDA product code |
| DESIGN | | | | | |
| Abutment
Height | 2.5 mm to 7.5 mm | N/A | 1.5mm to
6.5mm | 0 - 6.0 mm | Similar.
Predicate,
reference, and
subject abutment
height are similar. |
| Abutment
Type | Angled | N/A | Straight and
Angled | Straight | Similar.
Predicate,
reference, and
subject abutment
angles are similar. |
| Abutment
Angled | 15° | N/A | 0° and 15° | 0° | Similar.
Predicate,
reference, and
subject abutment
angles are
similar. |
| Abutment
Screw | M1.6 x 0.35 Thread,
.069" Thread Depth,
Ø.062" Screw Body
Diameter,
90° Screw Head Taper | N/A | M1.6 x 0.35 Thread,
.069" Thread Depth,
Ø.062" Screw Body
Diameter,
90° Screw Head
Taper | N/A | Same.
Predicate
reference of critical
abutment screw
features are the
same. |
| Materials | | | | | |
| Abutment
And
Abutment
Screw
Material | Ti-6Al-4V ELI | N/A | TAV (Ti-6Al-4V) | Ti-6Al-4V ELI | Same: subject,
predicate, and
reference devices
are made from the
same material -
titanium (Ti-6Al-
4V) |
| Device
Material
Surface
Treatment | TiN | N/A | TiN | TiN | Same. Predicate
and subject device
use identical
surface treatment
process |
| Sterilization | | | | | |
| Sterile | Moist heat end user
sterilization | Moist heat end
user sterilization | Moist heat end
user sterilization | Moist heat end
user sterilization | Same. Predicate
and subject device
are both supplied
non-sterile |
7
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).
8
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.