(90 days)
No
The device description and performance studies focus on mechanical properties, materials, and physical testing, with no mention of software, algorithms, or data processing related to AI/ML.
No
The device is described as an abutment for dental implants, used to attach restorations and restore masticatory function, which is a supportive and restorative purpose rather than direct therapeutic treatment.
No
The device is an angled abutment used for the attachment of dental restorations to implants. Its function is to restore masticatory function, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states the device is manufactured from titanium and is a physical abutment used in dental procedures, 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 "attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient." This describes a surgical and restorative dental procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical abutment made of titanium, designed to connect a dental restoration to an implant. This is a physical medical device used in a surgical/restorative context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the LOCATOR Angled Abutment is a medical device, specifically a dental implant component, but it does not fit the definition of an In Vitro Diagnostic device.
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 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.
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)
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.
TiN coating performance was tested per ASTM F1044 and ASTM F1147.
Packaging and shipping validation testing was completed where the LOCATOR Angled Abutment worst case device and packaging were undamaged after the test.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K052600, K062749, K163194, K013227, K072589, K071370
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
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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.
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)
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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 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 |
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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 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
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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 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. |
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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.