(135 days)
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.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes 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 to the OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.
The subject device abutment designs include Healing Abutments, Temporary Abutments, Straight Abutments, Ti Base Abutments, AURUM Base Abutments with a screw channel design that allows easier instrument access to the abutment screw), C-Base Abutments, ELLIPTIBase CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight), DESSLoc Abutments (Locator-type abutments), and abutment screws.
The provided document is an FDA 510(k) clearance letter for the DESS Dental Smart Solutions, which are endosseous dental implant abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance data from studies against specific acceptance criteria.
Therefore, the document does not contain the information required to populate a table of acceptance criteria and proven device performance as typically expected for studies proving device efficacy or safety against performance metrics. It does not present specific quantitative performance data for the device.
Based on the content, here's what can be inferred or explicitly stated regarding the study that proves the device meets acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
As noted above, the document does not present a table of specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or other quantitative measures) and the device's reported performance against these criteria. The "Performance Data" section primarily describes non-clinical tests (MR compatibility, dimensional analysis, sterilization validation, shelf-life testing) that demonstrate that the device meets the design specifications and regulatory requirements for substantial equivalence, rather than clinical efficacy or diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance data. The non-clinical tests would have their own sample sizes for their specific assessments (e.g., a certain number of abutments for sterilization validation, a certain number of parts for dimensional analysis). These specific numbers are not provided in this summary.
- Data Provenance: The "reverse engineering dimensional analysis" was done for BlueSkyBio implant connections and for Strawmann bone level connections (referenced from previous submissions). For Alpha dent, a contractual agreement provided measurements. No specific country of origin is mentioned for the data itself, but Terrats Medical SL is based in Barcelona, Spain. The document states "No clinical data were included in this submission," indicating a reliance on non-clinical testing and substantial equivalence. The studies referenced are non-clinical in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is typically relevant for studies involving human interpretation or subjective assessment (e.g., imaging studies). Since "No clinical data were included in this submission," and the evaluation relies on non-clinical testing and engineering analyses, this concept of "experts establishing ground truth" as it pertains to medical image interpretation or clinical outcomes is not applicable here. Ground truth in this context would be engineering specifications and validated test methods.
4. Adjudication Method for the Test Set:
Not applicable, as there is no human interpretation or subjective assessment being adjudicated in the described non-clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states: "No clinical data were included in this submission." Therefore, an MRMC study comparing human readers with or without AI assistance was not performed or submitted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical dental implant abutment, not an AI algorithm or software that performs standalone analysis. The "DESS Dental Smart Solutions" in the product name refers to the brand of these physical components, not an intelligent software.
7. The Type of Ground Truth Used:
For the non-clinical tests described:
- Dimensional Analysis: The "ground truth" was established by reverse engineering dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment screws, or by contractual agreement providing measurements from the OEM manufacturer. This means the OEM specifications and existing components served as the reference.
- Sterilization: The ground truth for sterilization was meeting the sterility assurance level of 10-6 according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2 for moist heat, and ISO 11137-1 and ISO 11137-2 for gamma irradiation, and bacterial endotoxin testing according to ANSI/AAMI ST72.
- Material properties: Conformance to ASTM F136 for Ti-6Al-4V alloy and ASTM F1537 for Co-Cr-Mo alloy, and ISO 13356 for zirconia.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used.
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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 box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
Terrats Medical SL Sergio Muñoz RA Project Technician Mogoda, 75 Barbera del Valles Barcelona, 08210 SPAIN
February 14, 2025
Re: K243212
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: October 3, 2024 Received: January 16, 2025
Dear Sergio Muñoz:
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 (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
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Indications for Use
510(k) Number (if known) K243212
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 or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
Compatible Implant Systems
| Implant Body Diameter, mm | Implant Platform, mm | |
|---|---|---|
| BlueSkyBio BIO Conus 12 | 3.5, 4.0, 4.5 | 3.5/4.0 |
| BlueSkyBio BIO Max | 4.5, 5.0 | 4.5/5.0 |
| BlueSkyBio BIO Max | 4.3, 5.0 | RP (4.3/5.0) |
| BlueSkyBio BIO Internal Hex | 3.7,4.1,4.7,5.7,7.0 | 3.5 |
| BlueSkyBio BIO Quattro | 3.3 | 3.3 |
| BlueSkyBio BIO Quattro | 4.1/4.8 | 4.1/4.8 |
| BlueSkyBio BIO One Stage | 3.3, 4.1, 4.8 | RN (4.8) |
| BlueSkyBio BIO One Stage | 4.1, 4.8, 5.6 | WN (6.5) |
| Implant Active Konus | 3.3, 3.75, 4.2, 5.0, 6.0 | 2.8 |
| Implant Classic Konus | ||
| Implant Active Bio | ||
| Astra Tech EV | 3.0 | 3.0 |
| Astra Tech EV | 5.4 | 5.4 |
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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FORM FDA 3881 (8/14)
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510(k) Summary K243212 Terrats Medical SL DESS® Dental Smart Solutions February 14, 2025
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SLCarrer Mogoda, 75-99Barberà del Vallès 08210Barcelona, SpainTelephone +34 935 646 006 |
|---|---|
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Sergio Muñoz,Manuel Gomez, Melissa BurbageTerrats Medical SL |
Barberà del Vallès 08210 Barcelona, Spain +34 935 646 006 Telephone Email sergio.munoz(@)dessdental.com manuel.gomez(@dessdental.com melissa.burbage@enerxen.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 of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, |
| ENT and Dental Devices) | |
| Reviewing Division | Division of Dental and ENT Devices |
Primary Predicate Device
K170588, DESS Dental Smart Solutions, Terrats Medical SL
Additional Predicate Devices
K173908, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K212628, DESS Dental Smart Solutions, Terrats Medical SL K22288, DESS Dental Smart Solutions, Terrats Medical SL K240208, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices for OEM implant body clearances: K111287, Astra Implant Systems, Astra Tech AB K120414, Osseospeed Plus, Astra Tech AB K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC
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K060657. Modification to Blue Sky Bio Dental Implant System. Blue Sky Bio. LLC K051507, Modification to Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K210499, Alpha Dent Implants Dental Implants System, Alpha Dent Implants GmbH
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.
| Implant Body Diameter, mm | Implant Platform, mm | |
|---|---|---|
| BlueSkyBio BIO Conus 12 | 3.5, 4.0, 4.5 | 3.5/4.0 |
| 4.5, 5.0 | 4.5/5.0 | |
| BlueSkyBio BIO Max | 4.3, 5.0 | RP (4.3/5.0) |
| BlueSkyBio BIO Internal Hex | 3.7,4.1,4.7,5.7,7.0 | 3.5 |
| BlueSkyBio BIO Quattro | 3.3 | 3.3 |
| 4.1/4.8 | 4.1/4.8 | |
| BlueSkyBio BIO One Stage | 3.3, 4.1, 4.8 | RN (4.8) |
| 4.1, 4.8, 5.6 | WN (6.5) | |
| Implant Active Konus | 3,3; 3,75; 4,2; 5,0; 6,0 | 2.8 |
| Implant Classic Konus | ||
| Implant Active Bio | ||
| Astra Tech EV | 3.0 | 3.0 |
| 5.4 | 5.4 |
Compatible Implant Systems
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes 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 to the OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.
The subject device abutment designs include Healing Abutments, Temporary Abutments, Straight Abutments, Ti Base Abutments, AURUM Base Abutments with a screw channel design that allows easier instrument access to the abutment screw), C-Base Abutments, ELLIPTIBase CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight), DESSLoc Abutments (Locator-type abutments), and abutment screws.
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DESS Dental Smart Solutions
Table 1 – Summary of Subject Device Abutment Designs
| Compatible Implant Systems | DESS Abutment System | Healing Abutment | Temporary Abutment | Straight abutments | Ti Base | AURUM Base | C-Base | ELLIPTIBase | CoCr Base | Pre-Milled Blank | Multi-Unit Abutment Straight | Multi-Unit Abutment Angled | DESSLoc Abutment | Screws |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BlueSkyBio BIO Conus 12 | Internal Hex Conic | X | X | X | X | X | X | X | X | X | X | X | X | X |
| BlueSkyBio BIO Internal Hex | Internal Hex USA | X | X | X | X | X | X | X | X | X | X | X | X | X |
| BlueSkyBio BIO Quattro | Conical BL | X | X | X | X | X | X | X | X | X | X | X | X | X |
| BlueSkyBio BIO One Stage | Octagon | X | X | X | X | X | X | X | X | X | X | X | ||
| BlueSkyBio BIO Max | Active Hex | X | X | X | X | X | X | X | X | X | ||||
| Alpha dent.Implant Active KonusImplant Classic KonusImplant Active Bio | Alpha Dent | X | X | X | ||||||||||
| Astra Tech EV | Conic EVo | X |
Table 2 – Summary of Subject Device Abutment Sizes
| Compatible Implant Systems | Implant Body Ø | Implant Platform Ø | Healing Abutment | Temporary Abutment | Straight abutments | Ti Base | AURUM Base | C-Base | ELLIPTIBase | CoCr Base | Pre-Milled Blank | Multi-Unit Abutment Straight | Multi-Unit Abutment Angled | DESSLoc Abutment |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BlueSkyBio BIO Conus 12 | 3.5, 4.0, 4.5 | 3.5/4.0 | X | X | X | X | X | X | X | X | X | X | X | |
| 4.5, 5.0 | 4.5/5.0 | X | X | X | X | X | X | X | X | X | X | X | ||
| BlueSkyBio BIO Internal Hex | 3.7, 4.1, 4.7, 5.7, 7.0 | 3.5 | X | X | X | X | X | X | X | X | X | X | X | X |
| 3.3 | NC | X | X | X | X | X | X | X | X | X | X | X | X | |
| BlueSkyBio BIO Quattro | 4.1, 4.8, 5.6 | RC | X | X | X | X | X | X | X | X | X | X | X | X |
| 3.3, 4.1, 4.8 | RN (4.8) | X | X | X | X | X | X | X | X | X | X | X | ||
| BlueSkyBio BIO One Stage | 4.1, 4.8, 5.6 | WN (6.5) | X | X | X | X | X | X | X | X | X | X | X | |
| BlueSkyBio BIO Max | 4.3, 5.0 | RP (3.9) | X | X | X | X | X | X | X | X | X | X | X | |
| Alpha dent.Implant Active KonusImplant Classic KonusImplant Active Bio | 3.3, 3.75, 4.2, 5.0, 6.0 | 2.8 | X | X | ||||||||||
| Astra Tech EV | 3.0 | 3.0 | X | |||||||||||
| 5.4 | 5.4 | X |
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SUBJECT DEVICE DESIGNS
Healing Abutments are provided for BlueSkyBio BIO Conus implants with 3.5/4.0 and 4.5/5.0 platforms, BlueSkyBio BIO Max implants with a NP (3.5) and RP(3.9) platforms, BlueSkyBio BIO Internal Hex implants with 3.5 platform, BlueSkyBio BIO Quattro implants with NC and RC platforms and BlueSkyBio BIO One Stage implants with RN (4.8) and WN (6.5) platforms The Healing Abutments are provided in gingival heights from 3 mm to 5 mm to aid in contouring the gingiva during healing. All healing abutments are marked to identify their gingival height and compatible implant platform. Healing abutments are made of titanium alloy (Ti-6AI-4V).
Temporary Abutments are provided for BlueSkyBio BIO Conus implants with 3.5/4.0 and 4.5/5.0 platforms, BlueSkyBio BIO Max implants with a NP (3.5) and RP (3.9) platforms, BlueSkyBio BIO Internal Hex implants with 3.5 platform, BlueSkyBio BIO Quattro implants with NC and RC platforms and BlueSkyBio BIO One Stage implants with RN (4.8) and WN (6.5) platforms. Temporary Abutments are available for single-unit and multipleunit restorations, the former with engaging connections to the implants and the latter with non-engaging connections. All Temporary Abutments have a gingival height of 1.5 mm and are made of titanium alloy (Ti-6A1-4V).
Straight abutments are designed for single-unit and multiple-unit cement-retained restorations and have a SelectGrip® surface to aid in bonding retention. Straight abutments are manufactured from titanium alloy (Ti-6Al-4V).
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 twopieces 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 a 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.
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
All zirconia superstructures are for straight abutments only.
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, C-Base, ELLIPTIBase 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, C-Base and ELLIPTIBase 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.
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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 component composed of titanium alloy and the CAD-CAM patient matched superstructure composed of zirconia. The design of the AURUM Base 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 ranging from 4.5 mm, and a gingival height (in the base) of 0.3 mm or 1.2 mm. When used for a single-unit restoration the AURUM Base is to be used with a superstructure to create a minimum post height (length above the abutment collar/gingival height) of 4.0 mm
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 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
All zirconia superstructures are for straight abutments only.
By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar. to which the restorations attach.)
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 maybe placed. The ceramic superstructure produced through CAD-CAM is the swopiece 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 post is 4.68 mm high. The gingival height of the abutment (distance from implant platform to abutment platform) 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-6A1-4V) with anodization and a SelectCrip® surface. When used for a direct crown, a POM burn-out sleeve, an exempt laboratory component that is not a subject of this submission, 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 for single-unit restoration (length above the abutment collar/gingival height)- 4.7 mm Minimum gingival height – 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.)
ELLIPTIBase is available in an engaging design. When used for a single-unit restoration the ELLIPTIBase is to be used with a patient matched superstructure or hybrid abutment crown composed of zirconia to create a minimum post height of 4.0 mm. ELLIPTIBase is made of titanium alloy (Ti-6Al-4V ELI) with a gold anodized surface.
The design parameters for the CAD/CAM zirconia superstructure to be used on ELLIPTIBase are:
Minimum wall thickness - 0.4 mm
Minimum post height for single-unit restorations (length above the abutment collar/gingival height) – 4.0 mm
Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
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By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.)
CoCr Base are provided in engaging and non-engaging designs. The two-pieces of the CoCr Base abutment which compose the final abutment consists of the pre-manufactured CoCr base component composed of CoCr alloy and the CAD-CAM patient matched superstructure composed of zirconia. CoCr Base Abutments also may be used as part of a welded multi-unit construct, intended to be used with the included exempt POM burnout sleeve for waxup and casting of a bridge from a non-precious metal alloy. When used for a direct crown, CoCr Base may be used with a POM burn out sleeve, an exempt laboratory component not a subject of this submission, that is available for laboratory fabrication of the prosthesis. CoCr Base are not intended for angulation correction when used with a POM burn-out sleeve.
CoCr Base Abutments have a gingival height of 1.5 mm, a prosthetic platform diameter of 4.5 mm and are made from Co-Cr-Mo alloy. CoCr Base Abutments are not intended for angulation correction. When used for a direct crown, Ti Base Abutments may be used with a POM burn out sleeve, an exempt laboratory component not a subject of this submission, that is available for labrication of the prosthesis. Ti 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 CoCr Base are:
Minimum wall thickness – 0.4 mm
Minimum post height for single-unit restorations (length above the abutment collar/gingival height) – 4.5 mm Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.)
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 CAD-CAM Pre-Milled Blank Abutments are: Minimum wall thickness - 0.45 mm Minimum post height - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Maximum Angulation - 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.)
Multi-Unit Abutments are designed for attachment of multi-unit screw-retained restorations and are provided in straight (0°). The Multi-Unit Abutments are manufactured from titanium alloy (Ti-6Al-4V).
The straight Multi-Unit Abutments are provided for BlueSkyBio Bio Conus 12, BIO Max, Bio internal Hex and Bio Quattro. 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 4.5 mm.
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DESSLoc Abutments is 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. 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 OEM implant bodies, OEM abutment screws) or by a contractual agreement and working relationship between Terrats Medical SL and the OEM implant manufacturer. For the BlueSkyBio implant connections, reverse engineering is provided.
In the case of Alpha dent, a contractual agreement has been made where all measurements have been provided. In the Straumann bone level connection the reverse engineering analysis was provided in previous submissions.
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, 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 reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate that the subject device abutments are compatible with the Blue Sky Bio implants;
- 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 ANSI/AAMI/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 sterilization 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 ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of < 20 EU/device; and shelf life testing of samples after accelerated aging equivalent to five (5) years of real time aging according to ASTM F1980, with testing of the packaging sterile barrier and sterility testing of product.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
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The subject device abutments are substantially equivalent in intended use to the primary predicate device K170588, and the additional predicate devices, K173908, K212628, K222288, and K240208. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Except for the list of compatible OEM implants and sizes, the Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of K170588, K173908, K191986, K212628, K22288, and K240208.The lists of the specific OEM implant compatibilities in the IFUS differ between the subject device and the primary predicate and the reference devices.
The primary predicate device K170588, and the additional predicate devices, K173908, K212628, K222288, and K240208, are in support of substantial equivalence of the subject device designs, material, manufacturing, and biocompatibility.
All subject device abutments and screws are similar to or identical in design, materials, and technological characteristics to corresponding abutments of the primary predicate device K170588, and the additional predicate devices, K173908, K191986, K212628, K222288, and K240208. The subject submission, K170588, K173908, K191986, K212628, K222288, and K240208 all include abutments manufactured from Ti-6A1-4V alloy conforming to ASTM F136. The subject abutments are anodized by a process that is identical to that used on abutments cleared in K170588, K173908, K191986,K212628, and K240208. Subject Ti Base Abutments, AURUM Base Abutments, and C-Base Abutments have a SelectGrip® surface to aid in bonding retention that is identical to the surface used on abutments cleared in K170588, K173908, K212628, K22288, and K240208.
The subject device DESSLoc Abutments are provided with a ZrN surface. The zirconium-nitride surface is identical to that used on abutments cleared in K222288, and K240208. The subject abutments screws are manufactured from Ti-6Al-4V alloy.
The subject device abutment and abutment screws have similar or identical ranges of abutment-implant platform diameter, prosthetic platform diameter, and angulation as the components cleared in K170588, K173908, K191986, K212628, K222288, and K240208. All zirconia superstructures for use with the subject device Ti Base Abutments, AURUM Base Abutments, and C-Base abutments is the same zirconia material used for components cleared in K240208. The cement recommended for bonding of superstructures is Multi-Link cement by Ivoclar Vivadent (K130436). Selected subject device components are provided sterile by gamma irradiation and are packaged in a PETG blister with a Tyyek® Iid. This is the same sterilization, packaging, and 5-year shelf life that was referenced in the additional primary predicate K240208. For the subject devices provided non-sterile, the previously validated moist heat cycle, referenced from the primary predicate K170588, K173908, K191986, K212628, K222288, and K240208 is applicable to the non-sterile subject devices.
CONCLUSION
Any differences in the technological characteristics between the subject device, the predicate device, and reference devices do not raise different questions of safety or effectiveness. The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.
- Overall, the subject device has the following similarities to the primary predicate device and the reference devices: ● have the same intended use,
- use the same operating principles, ●
- incorporate the same basic designs,
- incorporate the same or very similar materials, and ●
- have similar packaging and are sterilized using the same materials and processes.
The basis for the belief of Terrats Medical SL that the substantially equivalent to the predicate devices is summarized in the following Table of Substantial Equivalence.
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Table of Substantial equivalence
| Comparison | Subject device | Primary Predicate Device | Additional Primary | Additional Primary | Additional Primary | Additional Primary | Additional Primary |
|---|---|---|---|---|---|---|---|
| Device | Device | Device | Device | Device | |||
| DESS Dental Smart | K170588 | K173908 | K191986 | K212628 | K222288 | K240208 | |
| Solutions | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | |
| Terrats Medical SL | Solutions | Solutions | Solutions | Solutions | Solutions | Solutions | |
| Terrats Medical SL | Terrats Medical SL | Terrats Medical SL | Terrats Medical SL | Terrats Medical SL | |||
| Product code | NHA | NHA | NHA | NHA | NHA | NHA | NHA |
| Abutment designs, OEM | Abutment designs, OEM | Abutment designs, OEM | Abutment designs, OEM | Abutment designs, OEM | Abutment designs, OEM | ||
| Reason for | n/a | compatibilities, materials, | compatibilities, materials, | compatibilities, materials, | compatibilities, materials, | compatibilities, materials, | compatibilities, materials, |
| predicate/reference | manufacturing, | manufacturing, | manufacturing, | manufacturing. | manufacturing, | manufacturing, | |
| biocompatibility | biocompatibility | biocompatibility | biocompatibility | biocompatibility | biocompatibility | ||
| Intented Use | Functional and esthetic | Functional and esthetic | Functional and esthetic | Functional and esthetic | Functional and esthetic | Functional and esthetic | Functional and esthetic |
| rehabilitation of the | rehabilitation of the | rehabilitation of the | rehabilitation of the | rehabilitation of the | rehabilitation of the | rehabilitation of the | |
| edentulous mandible or | edentulous mandible or | edentulous mandible or | edentulous mandible or | edentulous mandible or | edentulous mandible or | edentulous mandible or | |
| maxilla | maxilla | maxilla | maxilla | maxilla | maxilla | maxilla | |
| DESS Dental SmartSolutions abutments are | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | DESS Dental Smart | |
| intended to be used in | Solutions abutments are | Solutions abutments are | Solutions abutments are | Solutions abutments are | Solutions abutments are | Solutions abutments are | |
| conjunction with endosseous | intended to be used in | intended to be used in | intended to be used in | intended to be used in | intended to be used in | intended to be used in | |
| dental implants in the | conjunction with endosseous | conjunction with endosseous | conjunction with endosseous | conjunction with endosseous | conjunction with endosseous | conjunction with endosseous | |
| maxillary or mandibular arch | dental implants in the | dental implants in the | dental implants in the | dental implants in the | dental implants in the | dental implants in the | |
| to provide support for | maxillary or mandibular arch | maxillary or | maxillary or | maxillary or | maxillary or | maxillary or | |
| prosthetic restorations. | to provide support for | mandibular arch to provide | mandibular arch to provide | mandibular arch to provide | mandibular arch to provide | mandibular arch to provide | |
| prosthetic restorations. | support for prostheticrestorations. | support for prosthetic | support for prostheticrestorations. | support for prostheticrestorations. | support for prostheticrestorations. | ||
| All digitally designed | All digitally designed | All digitally designed | All digitally designed | All digitally designed | All digitally designed | ||
| custom abutments for use | All digitally designed | custom abutments for use | custom abutments for use | custom abutments for use | custom abutments for use | custom abutments for use | |
| Indications for Use | with DESS Ti Base | custom abutments for use | with Ti Base abutments or | with Ti Base abutments or | with Ti Base abutments or | with Ti Base abutments or | with Ti Base abutments or |
| Statement | abutments or Pre-Milled | with DESS Ti Base | Pre-Milled Blank abutments | Pre-Milled Blank abutments | Pre-Milled Blank abutments | Pre-Milled Blank abutments | Pre-Milled Blank abutments |
| Blank abutments are to be | abutments or Pre-Milled | are to be sent to a Terrats | are to be sent to a Terrats | are to be sent to a Terrats | are to be sent to a Terrats | are to be sent to a Terrats | |
| sent to a Terrats Medical | Blank abutments are to be | Medical validated milling | Medical validated milling | Medical validated milling | Medical validated milling | Medical validated milling | |
| validated milling center for | sent to a Terrats Medical | center for manufacture. | center for manufacture. | center for manufacture. | center for manufacture. | center for manufacture. | |
| manufacture. | validated milling center for | ||||||
| manufacture. | |||||||
| The complete Indications for | The complete Indications for | The complete Indications for | The complete Indications for | The complete Indications for | The complete Indications for | The complete Indications for | |
| Use Statement with OEM | Use Statement with OEM | Use Statement with OEM | Use Statement with OEM | Use Statement with OEM | Use Statement with OEM | Use Statement with OEM | |
| implantcompatibilities is provided in | implant compatibilities is | implant compatibilities is | implant compatibilities is | implant compatibilities is | implant compatibilities is | implant compatibilities is | |
| the Device Description | included in the 510(k) | included in the 510(k) | included in the 510(k) | provided in the 510(k) | provided in the 510(k) | provided in the 510(k) | |
| attachment in this | Summary for K170588. | Summary for K173908. | Summary for K191986. | Summary for K212628. | Summary for K222288. | Summary for K240208. | |
| submission | |||||||
| Designs | Healing abutment | Healing abutment | Healing abutment | Healing abutment | Healing abutment | Healing abutment | Healing abutment |
| Temporary abutment | Temporary abutment | Temporary abutment | Temporary abutment | Temporary abutment | Temporary abutment | Temporary abutment | |
| Cement-retained Straight | Cement-retained Straight | Cement-retained Straight | Cement-retained Straight | Cement-retained Straight | Cement-retained Straight | Cement-retained Straight | |
| Abutment | Abutment | Abutment | Abutment | Abutment | Abutment | Abutment | |
| Ti base Abutment | Ti base Abutment | Ti Base Abutments | Ti Base Abutments | Ti Base Abutments | Ti Base Abutments | Ti base Abutment | |
| Aurum Base abutment | Aurum Base abutment | Aurum Base abutment | Aurum Base abutment | Aurum Base abutment | Aurum Base abutment | Aurum Base abutment |
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| C-Base abutmentsElllipti base | C-Base abutments | C-Base abutments | C-Base abutments | Elllipti base | C-Base abutments | C-Base abutments | C-Base abutments |
|---|---|---|---|---|---|---|---|
| CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,StraightDESSLoc AbutmentsScrews | CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,StraightMulti-unit Abutments,Angled 17º and 30°DESSLoc AbutmentsScrews | CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,StraightMulti-unit Abutments,Angled 17° and 30°DESSLoc AbutmentsScrews | CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,Angled 17° and 30°DESSLoc AbutmentsScrews | CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,StraightDESSLoc AbutmentsScrews | CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,StraightMulti-unit Abutments,Angled 17° and 30°DESSLoc AbutmentsScrews | CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,StraightMulti-unit Abutments,Angled 17° and 30°DESSLoc AbutmentsScrews | CoCr Base AbutmentsPre-Milled BlankAbutmentsMulti-unit Abutments,StraightMulti-unit Abutments,Angled 17° and 30°DESSLoc AbutmentsScrews |
| Prosthesisattachment | Cement-retainedScrew-retained | ||||||
| Restoration | Single-unitMulti-unit | ||||||
| Abutment/ImplantPlatform Ø, mm | 2.8 - 6.5 | 3.4 - 5.7 | 2.52 - 6.5 | 3.4 - 5.7 | 2.3 - 6.0 | 3.0 - 7.5 | 2.52 - 6.5 |
| Prosthetic PlatformØ, mm | 3.85 - 6.8 | 4.9 - 5.9 | 4.5 - 6.5 | 4.9 - 5.9 | 4.5 - 6.5 | 4.5 - 6.5 | 4.5 - 6.5 |
| Abutment Angle | 0° | 0°, 17°, 30° | 0°, 17°, 30° | 0°, 17°, 30° | 0° | 0°, 17°, 30° | 0°, 17°, 30° |
| Material | |||||||
| AbutmentMaterial- Metalliccomponents | Ti-6Al-4V (ASTM F136)Co-Cr-Mo (ASTM F1537) | ||||||
| Abutment Surface | AnodizationSelectGrip® SurfaceZirconium nitride (ZrN)Zirconia (Y-TZP) | Anodization | Anodization | SelectGrip® surfaceTitanium nitride (TiN)Zirconia (Y-TZP) | AnodizationSelectGrip® SurfaceTitanium nitride (TiN)Zirconia (Y-TZP) | Anodization | AnodizationSelectGrip® SurfaceZirconium nitride (ZrN)Zirconia (Y-TZP) |
| AbutmentMaterial- Ceramiccomponents | Zirconia (Y-TZP) | SelectGrip® SurfaceTitanium nitride (TiN)Zirconia (Y-TZP) | SelectGrip® SurfaceTitanium nitride (TiN)Zirconia (Y-TZP) | Zirconia (Y-TZP) | SelectGrip® SurfaceZirconium nitride (ZrN)Zirconia (Y-TZP) | Zirconia (Y-TZP) | Zirconia (Y-TZP) |
| SuperstructureCement | Multi-Link cement, Ivoclar Vivadent, K130436 | ||||||
| Screw Material | Ti-6Al-4V alloy | ||||||
| How Provided | |||||||
| Sterilization | Sterile by gammairradiation, and Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Sterile by gammairradiation, and Non-steril |
| Usage – AllComponents | Single patient, single use |
§ 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.)