(90 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on mechanical and material properties, not algorithmic processing.
No
The device is a dental abutment intended to support prosthetic restorations on dental implants, not to treat a disease or condition.
No
The device, DESS Dental Smart Solutions abutments, is intended to provide support for prosthetic restorations in conjunction with dental implants. It is a prosthetic component, not a device used to diagnose a medical condition.
No
The device description clearly states that the submission is for physical components (abutments, abutment screws) and their compatibility with dental implants. The performance studies also focus on mechanical testing, sterilization, and dimensional analysis of physical devices, not software validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing support for prosthetic restorations in conjunction with dental implants. This is a mechanical function within the body.
- Device Description: The description details physical components like abutments and screws used in dental procedures.
- Lack of IVD Indicators: 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 treatment. The focus is entirely on the physical support of dental prosthetics.
- Performance Studies: The performance studies described are related to mechanical testing, MR safety, biocompatibility, sterilization, and shelf life – all typical for implantable or surgically placed devices, not IVDs.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a structural component.
N/A
Intended Use / Indications for Use
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Ti Base abutments and Pre-milled Blank Abutments are to be sent to a Terrats Medical validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants. This submission adds various abutments compatible with the Neodent GM implant line.
The subject device abutment designs include Healing Abutments, Ti Base Abutments, AURUM Base Abutments, C-Base Abutments, Multi-Unit Abutments (straight and angled), Cement-retained Abutments (straight and angled), Pre-Milled Blank Abutments, DESSLoc Abutments (Locator-type abutments), and abutment screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
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)
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- provided in this submission was non-clinical analysis to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued October 2023) including magnetically induced displacement force and torque;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments with angulation, including Ti Base Abutments, AURUM Base Abutments, C-Base Abutments, Multi-Unit Abutments, and Cement-retained Abutments, and Pre-Milled Blank Abutments compatible with the Neodent GM implant line;
- referenced from K240208, K233316, and K222288 was biocompatibility of the subject device components;
- referenced from K240208 was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 10-6 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSVAAMI/ISO TIR 17665-2; analysis showed that the subject devices do not create a new worst case for moist heat sterilization;
- referenced from K240208 was gamma irradiation validation to a sterility assurance level of 10-6 by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; analysis showed that the subject devices do not create a new worst case for gamma sterilization; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSVAAMI ST72 to demonstrate that all sterile product meets a limit of
§ 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 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 5, 2024
Terrats Medical SL % Rebecca Kattan Regulatory Specialist PaxMed International. LLC 12264 El Camino Real Suite 400 San Diego, California 92130
Re: K242340
Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 6, 2024 Received: August 7, 2024
Dear Rebecca Kattan:
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-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
DESS Dental Smart Solutions
Indications for Use (Describe)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Ti Base abutments and Pre-milled Blank Abutments are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System
| (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Neodent | ||
| (Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
Compatible Implant Systems
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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510(k) Summary K242340 Terrats Medical SL DESS Dental Smart Solutions November 5, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SL
Carrer Mogoda, 75-99
Barberà del Vallès 08210
Barcelona, Spain |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Rebecca E. Kattan, PhD
Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone +1 858-792-1235
Email rkattan@paxmed.com
kthomas@paxmed.com, flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | DESS Dental Smart Solutions |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE AND REFERENCE DEVICE INFORMATION
K240208, DESS Dental Smart Solutions, Terrats Medical SL K22288, DESS Dental Smart Solutions, Terrats Medical SL K170588, DESS Dental Smart Solutions, Terrats Medical SL K212628, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices for OEM implant body clearances K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A. K180536, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A. K201225, Neodent Implant System - GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais Dentários S.A.
The primary predicate device is K240208.
The reference device K212628 is for documentation of the subject device abutments with the corresponding Neodent GM implant bodies.
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INDICATIONS FOR USE STATEMENT
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System
| (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Neodent | ||
| (Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
Compatible Implant Systems
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants. This submission adds various abutments compatible with the Neodent GM implant line.
The subject device abutment designs include Healing Abutments, Ti Base Abutments, AURUM Base Abutments, C-Base Abutments, Multi-Unit Abutments (straight and angled), Cement-retained Abutments (straight and angled), Pre-Milled Blank Abutments, DESSLoc Abutments (Locator-type abutments), and abutment screws.
Subject Device Designs
Healing Abutments are provided in gingival heights from 0.8 mm to aid in contouring the gingiva during healing. Healing Abutments are made of titanium alloy (Ti-6Al-4V).
Temporary Abutments are provided for single-unit and multiple-unit restorations, the former with engaging connections to the implants and the latter with non-engaging connections. All Temporary Abutments have a gingival height from 0.8 mm to 3.5 mm and are made of titanium alloy (Ti-6Al-4V), and with a prosthetic platform diameter of 3.5 mm or 4.5 mm.
Ti Base Abutments are provided in engaging and non-engaging designs for custom abutment fabrication of a CAD-CAM zirconia superstructure on which a crown may be placed. They also may support a ceramic hybrid abutment in which the crown is included in the design of the zirconia abutment ceramic superstructure.. The two-pieces of the Ti Base Abutment which compose the final abutment consists of the pre-manufactured titanium base component composed of titanium alloy and the CAD-CAM patient matched superstructure or hybrid abutment crown composed of zirconia. The cement recommended for bonding of superstructures is Multi-Link cement by Ivoclar Vivadent (K130436). Ti Base Abutments are manufactured from titanium alloy (Ti 6A14V) with the SelectGrip® surface.
Ti Base Abutments also may support a ceramic hybrid abutment in which the crown is included in the design of the zirconia abutment ceramic superstructure. When used for a direct crown, Ti Base abutments may be used with POM burn out sleeve, an exempt laboratory component not a subject of this submission, that is available for laboratory fabrication of the prosthesis. Ti Bases are not intended for angulation correction when used with a POM burn-out sleeve.
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The design parameters for the CAD-CAM zirconia superstructure to be used on Ti Base Abutments are: Minimum wall thickness - 0.4 mm Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.2 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Maximum angulation - for Ti Base with gingival height 0.8 mm or 2.5 mm - 30° for Ti Base with gingival height 3.5 mm or 4.5 mm - 0°
By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.)
All patient-specific custom abutment fabrication for Ti Base Abutments, AURUM Base Abutments, and C-Base Abutments (described below) is by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Ti Base, AURUM Base, and C-Base Abutments will be made at a Terrats Medical validated milling center under FDA quality system regulations, and the zirconia material will conform to ISO 13356.
AURUM Base Abutments are provided in engaging and non-engaging designs. The two-pieces of the AURUM Base Abutment which compose the final abutment consists of the pre-manufactured titanium base composed of titanium alloy and the CAD-CAM patient matched superstructure composed of zirconia. The design of the AURUM Base Abutment allows for easier instrument access to the abutment screw and allows for placement of the screw channel out of the esthetic region of the restoration. AURUM Base Abutments are provided with a prosthetic platform diameter of 4.0 mm, 4.5 mm, with gingival heights (in the base) of 0.8 mm, 1.5 mm, or 2.5 mm. When used for a single-unit restoration the AURUM Base is to be used with a superstructure to create a minimum post height of 4.0 mm.
AURUM Base Abutments are provided in two (2) designs, each for engaging and non-engaging connections. One design has a conical taper below the prosthetic platform that engages the compatible Neodent GM implant, this is the same design as cleared in K212628. The second design has a flat surface below the prosthetic platform that seats directly on the top of the compatible Neodent GM implant.
AURUM Base Abutments are manufactured from titanium alloy (Ti 6Al 4V) and anodized a gold color, and the SelectGrip® surface to aid in bonding retention. The AURUM Base Abutments, including the titanium alloy, anodization treatment, and SelectGrip® surface is similar to that of DESS AURUM Base Abutments cleared in K240208.
The design parameters for the CAD-CAM zirconia superstructure to be used on AURUM Base Abutments are: Minimum wall thickness - 0.4 mm Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Maximum angulation - 30°
C-Base Abutments are provided in engaging and non-engaging designs. C-Base Abutments are two-piece abutments designed to support a custom CAD-CAM zirconia superstructure on which a single-unit or multi-unit restoration may be placed. The ceramic superstructure produced through CAD-CAM is the second part of the two-piece abutment. The C-Base Abutment also may support a ceramic hybrid abutment in which the crown is included in the design of the zirconia abutment ceramic superstructure.
The C-Base Abutment prosthetic post is 4.68 mm, and the gingival height is 0.8 mm. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. C-Base Abutments are made of titanium alloy (Ti-6Al-4V) with anodization and a SelectGrip® surface.
C-Base Abutments also may support a ceramic hybrid abutment in which the crown is included in the design of the zirconia abutment ceramic superstructure. When used for a direct crown, C-Base abutments may be used with POM
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510(k) Summary Page 4 of 8
burn out sleeve an exempt laboratory component not a subject of this submission, that is available for laboratory fabrication of the prosthesis. C-Bases are not intended for angulation correction when used with a POM burn-out sleeve.
The design parameters for the CAD-CAM zirconia superstructure to be used on C-Base Abutments are:
Minimum wall thickness - 0.4 mm Minimum post height (length above the abutment collar/gingival height) - 4.7 mm Minimum gingival height - 0.5 mm Maximum gingival height – 6.0 mm
Maximum angulation - 30°
Multi-Unit Abutments: Straight and Angled are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight, angled 17°, and angled 30°. The designs of the subject Multi-Unit Abutments are similar to the designs of Multi-Unit Abutments cleared in K240208 and K222288. All Multi-Unit Abutments are manufactured from titanium alloy (Ti-6Al-4V).
The Straight Multi-Unit Abutments have a non-engaging, threaded design that attaches directly to the implant. Straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 0.8 mm to 5.5 mm.
The angled Multi-Unit Abutments are provided only in an engaging design that requires an abutment screw. The Multi-Unit Abutments angled 17° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height of 3.5 mm. The Multi-Unit Abutments angled 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height of 3.5 mm.
Cement-retained Straight and Angled (17°) Abutments are designed for single-unit and multiple-unit cementretained restorations and have a SelectGrip® surface to aid in bonding retention. The Cement-retained Straight and Angled Abutments are made of titanium alloy (Ti-6Al-4V).
Pre-Milled Blank Abutments are designed for custom abutment fabrication by a CAD-CAM process. All patientspecific custom abutment fabrication is by prescription on the order of the clinician. The Pre-Milled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm, and are provided in a solid cylindrical design and with a pre-milled screw-channel. The Pre-Milled Blank Abutments are manufactured from titanium alloy (Ti 6Al-4V).
The design parameters for the Pre-Milled Blank Abutments are:
Minimum wall thickness - 0.45 mm Minimum post height (length above the abutment collar/gingival height) – 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Maximum Angulation - 30°
DESSLoc Abutments are designed for overdenture attachment to attach directly to the implant. DESSLoc Abutments are made of titanium alloy (Ti-6Al-4V, and have a zirconium nitride (ZrN) coating, 2 um to 3 um thick, produced by a physical vapor deposition (PVD) process.
DESS Dental Smart Solutions Screws are designed to attach the abutment to the implant or the prosthesis to the abutment. There are a total of two (2) subject device screws compatible with the subject device components or previously cleared components. The new screws have designs that are similar to those of screws cleared in K240208, K222288, and K170588. Screws are made of titanium alloy (Ti-6Al-4V).
OEM Implant Compatibility
To ensure that the subject abutments and screws are designed to fit the corresponding OEM implants, the dimensions and tolerances of subject abutments and screws have been established by reverse engineering dimensional analysis of
8
OEM implant bodies, OEM abutments, and OEM abutment screws. The reverse engineering analysis of the Neodent GM implant bodies, abutments, and abutment screws was provided in the prior Terrats Medical submission K212628.
Materials
The subject device abutments are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. All zirconia superstructures for use with the subject device Ti Base, AURUM Base, and C-Base Abutments will conform to ISO 13356. The subject device screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. Abutments are colored gold by an anodization process that is identical to that used on abutments cleared in K240208. Ti Base Abutments, AURUM Base Abutments, and C-Base Abutments have a SelectGrip® surface to aid in bonding retention that is identical to that used on abutments cleared in K240208.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- . provided in this submission was non-clinical analysis to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued October 2023) including magnetically induced displacement force and torque;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance ● of the subject device abutments with angulation, including Ti Base Abutments, AURUM Base Abutments, C-Base Abutments, Multi-Unit Abutments, and Cement-retained Abutments, and Pre-Milled Blank Abutments compatible with the Neodent GM implant line;
- referenced from K240208, K233316, and K222288 was biocompatibility of the subject device components;
- referenced from K240208 was moist heat sterilization for subject devices provided non-sterile to the end user, ● validated to a sterility assurance level of 10° by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSVAAMI/ISO TIR 17665-2; analysis showed that the subject devices do not create a new worst case for moist heat sterilization;
- referenced from K240208 was gamma irradiation validation to a sterility assurance level of 10° by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; analysis showed that the subject devices do not create a new worst case for gamma sterilization; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSVAAMI ST72 to demonstrate that all sterile product meets a limit of