(135 days)
No
The document describes dental abutments and prosthetic components, focusing on compatibility, materials, and sterilization. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No.
The device is described as an abutment intended to support prosthetic restorations for dental implants, which is a structural component rather than a device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device is described as dental abutments and prosthetic components used to support prosthetic restorations, not to diagnose a condition.
No
The device description clearly states that the submission is for adding physical components (abutments and abutment screws) to a dental implant system. The performance studies also focus on physical properties and sterilization of these components. There is no mention of software as the primary or sole component of the device.
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 abutments are for providing support for prosthetic restorations in the mouth, which is a surgical/dental procedure, not an in vitro diagnostic test.
- Device Description: The description focuses on the physical components (abutments, screws) and their compatibility with dental implants. There is no mention of analyzing samples from the body or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Use in a laboratory setting
The device is a dental prosthetic component used in a clinical setting for supporting dental restorations.
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 or 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 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.
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 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
§ 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 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
3
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 SL
Carrer Mogoda, 75-99
Barberà del Vallès 08210
Barcelona, Spain
Telephone +34 935 646 006 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Sergio Muñoz,
Manuel Gomez, Melissa Burbage
Terrats 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 Konus | ||||||||||||||
| Implant Classic Konus | ||||||||||||||
| Implant 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 Konus | ||||||||||||||
| Implant Classic Konus | ||||||||||||||
| Implant 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