(89 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.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.
It appears there might be a misunderstanding of the provided text. The document is a 510(k) premarket notification for a dental implant abutment, not an AI/ML medical device. Therefore, the information typically required for describing an AI/ML device's acceptance criteria and study data (like sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not present.
The document discusses the substantial equivalence of the DESS Dental Smart Solutions abutment to legally marketed predicate devices. The "performance data" section refers to non-clinical testing to demonstrate the device's physical properties and compatibility, not a study evaluating an AI algorithm's diagnostic or predictive performance.
Let's break down what can be extracted from the provided text relevant to the device's acceptance, and then explain why the AI/ML specific questions cannot be answered.
Understanding the Device and its "Acceptance":
The "acceptance" in this context refers to the FDA's determination that the new DESS Dental Smart Solutions abutments are "substantially equivalent" to predicate devices already on the market. This determination is based on the device having the same intended use and similar technological characteristics (design, materials, performance via non-clinical testing).
Here's a summary of the information available in the document:
1. Table of Acceptance Criteria (or rather, Equivalence Criteria) and Reported Device Performance:
The document doesn't present acceptance criteria in a quantitative table with performance metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device. Instead, "acceptance" is based on demonstrating substantial equivalence to predicate devices across several characteristics. The performance is shown through non-clinical testing to ensure safety and functionality.
| Characteristic | Subject Device (DESS Dental Smart Solutions, K231434) | Primary Predicate (K230143, DESS Dental Smart Solutions) | Reference Device (K213063, TLX SRAs and TLX Gold Abutments) | Reported Performance (Non-Clinical Data) |
|---|---|---|---|---|
| Intended 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. | DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Stated as "same intended use" as predicates. |
| Abutment Designs/Types | Multi-Unit, straight (0°), 17° angled, 30° angled | Multi-Unit, straight (0°), 17° angled, 30° angled | Multi-Unit, TLX SRA: 17°, 30°; TLX Gold: 0°, and up to 30° | Similar to predicates. |
| Prosthesis Attachment | Screw Retained | Screw Retained | Screw Retained | Similar to predicates. |
| Restoration | Multi-unit | Multi-unit | Multi-unit | Similar to predicates. |
| Prosthetic Interface Connections | Internal hex, External hex | Internal hex, Internal conical | Internal conical | Similar to predicates, with some variations noted and justified. |
| Abutment/Implant Platform Diameter | 2.9 - 5.7 mm | 3.0 - 4.5 mm | TLX SRA: 6 mm; TLX Gold: 4.0 (NT), 5.0 (RT), and 7.0 (WT) | Within similar ranges or justified compatibility. |
| Prosthetic Platform Diameter | 4.8 mm | 4.8 mm | TLX SRA: 4.6 mm; TLX Gold: not provided in 510(k) Summary | Similar to predicates. |
| Gingival Height | 1 mm - 5 mm | 1 mm - 5 mm | Not provided in 510(k) Summary | Similar to predicates. |
| Abutment Material | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-4V ELI (Titanium alloy) | TLX SRA: Ti-6Al-7Nb; TLX Gold: Ceramicor® | Similar (titanium alloys). Biocompatibility tested (ISO 10993-5 referenced). |
| Abutment Screw Material | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-7Nb | Similar (titanium alloys). |
| How Provided (Sterilization) | Non-sterile, and sterile by gamma irradiation | Non-sterile | TLX SRA: Sterile by gamma irradiation; TLX Gold: non-sterile | Both non-sterile and sterile options justified via reference devices/testing (e.g., K212538 for gamma, K22269 for moist heat). |
| Usage | Single patient, single use | Single patient, single use | Single patient, single use | Identical. |
| Mechanical Performance | Evaluated according to ISO 14801 (mechanical testing); Engineering analysis for new worst-case constructs. | Referenced | - | Demonstrated to not create a new worst-case or met ISO 14801. |
| MR Safety | Evaluated according to ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119. | - | - | Non-clinical analysis provided to evaluate metallic devices in MR environment. |
| Sterility & Shelf Life | Refer to K22269 (moist heat), K212538 (gamma irradiation, bacterial endotoxin, shelf life). | Referenced | - | Validated to SAL of 10^-6, met bacterial endotoxin limits, and 5-year shelf life after accelerated aging. |
Important Note: The "acceptance criteria" here are qualitative statements of substantial equivalence, backed by quantitative non-clinical engineering and materials testing, not performance metrics from a clinical study or an AI model's accuracy.
Regarding the AI/ML Specific Questions:
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. This document is for a physical medical device (dental implant abutment), not an AI/ML algorithm. There is no "test set" in the context of data for an AI/ML model. The "testing" refers to mechanical, material, and sterilization validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices. This device's performance is assessed through engineering standards and material properties. Compatibility with implant systems is established through design agreements and reverse engineering data (referenced from K170588).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies or for establishing ground truth labels for AI/ML datasets.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. MRMC studies are for evaluating diagnostic efficacy, particularly with AI assistance. This device is a passive prosthetic component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is its adherence to engineering standards (e.g., ISO 14801 for mechanical properties, ASTM for materials/MR safety) and its demonstrated compatibility with specified implant systems, rather than a clinical ground truth like disease presence.
8. The sample size for the training set:
- Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no AI model or training set.
Conclusion from the document:
The provided document describes a 510(k) submission for a Class II medical device, DESS Dental Smart Solutions abutments. The "acceptance criteria" revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through:
- Identical intended use.
- Similar technological characteristics: This includes materials (Titanium alloy), design (multi-unit, screw-retained), and geometric parameters (diameters, gingival heights).
- Performance via non-clinical testing: This includes mechanical testing (ISO 14801), MR safety testing (ASTM standards), sterilization validation (ANSI/AAMI/ISO standards), bacterial endotoxin testing (ANSI/AAMI ST72), shelf-life testing (ASTM F1980), and biocompatibility testing (ISO 10993-5).
- Compatibility with specified implant systems: This is supported by contractual agreements with OEMs (ZimVie/Terrats Medical SL) and referenced reverse engineering data.
The document explicitly states: "No clinical data were included in this submission." This further confirms that the evaluation framework is entirely non-clinical and does not involve AI/ML performance metrics, studies with human readers, or expert ground truthing as one would see for an AI-powered diagnostic tool.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Terrats Medical SL % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 EL Camino Real Suite 400 San Diego, California 92130
Re: K231434
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: May 17, 2023 Received: May 17, 2023
Dear Kevin Thomas:
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 (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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
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 Ouality 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.
| Implant Systems Compatibility | Implant Body Ø, mm | Implant Platform Ø, mm |
|---|---|---|
| Internal Hex Connections | ||
| Zimmer 3.1mmD Eztetic™ | 3.1 | 2.9 |
| Zimmer Screw-Vent® | 3.7 | 3.5 |
| 4.7 | 4.5 | |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 | |
| TSX™ Implant System | 3.7, 4.1, 4.7 | 3.5 |
| 5.4, 6.0 | 4.5 | |
| TSX™ Implant System, 3.1mmD | 3.1 | 2.9 |
| External Hex Connections | ||
| Biomet 3i OSSEOTITE® Implants | 3.25 | 3.4 |
| 3.75 | 4.1 | |
| 4.0 | 4.1 |
Implant Systems Compatibility
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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510(k) Summary K231434 Terrats Medical SL DESS Dental Smart Solutions August 7, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SLCarrer Mogoda, 75-99Barberà del Vallès 08210Barcelona, Spain |
|---|---|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email kthomas@paxmed.comflarson@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 DEVICE INFORMATION
Primary Predicate Device K230143, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices K142082, Zimmer 3.1mmD Dental Implant System, Zimmer Dental, Inc. K013227, Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc. K220978, TSX™ Implants, Biomet 3i LLC K063286, OSSEOTITE® Dental Implants, Implant Innovations, Inc. K111216, OSSEOTTE® 2 - Dental Implants, Biomet 3i, Inc. K212538, DESS Dental Implants, Terrats Medical SL
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K170588. DESS Dental Implants. Terrats Medical SL K22269, DESS Dental Implants, Terrats Medical SL K213063, TLX SRAs and TLX Gold Abutments, Straumann USA, LLC
The reference devices K142082, K013227, K072589, K220978, K063286, K111216 are for OEM implant body clearances. The reference device K212538 is for sterilization, packaging, and shelf life for devices provided sterile to the end user. The reference device K170588 is for compatibility with the Zimmer Screw-Vent", Zimmer Tapered Screw-Vent®, and Biomet 3i OSSEOTITE® implants. The reference device K22269 is for referenced moist heat sterilization and biocompatibility data. The reference device K213063 is for the technological characteristic of multiunit abutments provided sterile.
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.
| Implant Systems Compatibility | Implant Body Ø, mm | Implant Platform Ø, mm |
|---|---|---|
| Internal Hex Connections | ||
| Zimmer 3.1mmD Eztetic™ | 3.1 | 2.9 |
| Zimmer Screw-Vent® | 3.7 | 3.5 |
| 4.7 | 4.5 | |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 | |
| TSX™ Implant System | 3.7, 4.1, 4.7 | 3.5 |
| 5.4, 6.0 | 4.5 | |
| TSX™ Implant System, 3.1mmD | 3.1 | 2.9 |
| External Hex Connections | ||
| Biomet 3i OSSEOTITE® Implants | 3.25 | 3.4 |
| 3.75 | 4.1 | |
| 4.0 | 4.1 |
| Implant Systems Compatibility | |||
|---|---|---|---|
| -- | -- | ------------------------------- | -- |
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants.
This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.
A summary of the subject device abutment designs and the compatible OEM implants is provided in the table Summary of Subject Device Multi-Unit Abutment Designs on the following page.
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| Subject Device Multi-Unit Abutments | |||||
|---|---|---|---|---|---|
| Connection andCompatible Implant Line | Angulation | Implant-AbutmentPlatform Ø, mm | Gingival Height,mm | New Components,Provided Sterileand Nonsterile | Previously ClearedComponents,Now provided Sterile |
| Internal Hex Connections | |||||
| Zimmer 3.1mmD Eztetic™TSXTM Implant System,3.1mmD | 0° | 2.9 | 1, 2, 3, 4, 5 | X | |
| 17° | 2.5, 3.5 | X | |||
| 30° | 3.5, 4.5 | X | |||
| Zimmer Screw-Vent®TSXTM Implant System | 0° | 3.5, 4.5 | 1, 2, 3, 4, 5 | X | X |
| 17° | 2.5, 3.5 | X | X | ||
| 30° | 3.5, 4.5 | X | X | ||
| Zimmer Tapered Screw-Vent® | 0° | 3.5, 4.5, 5.7 | 1, 2, 3, 4, 5 | X | X |
| 17° | 2.5, 3.5 | X | X | ||
| 30° | 3.5, 4.5 | X | X | ||
| External Hex Connections | |||||
| Biomet 3i OSSEOTITE®Implants | 17° | 3.4 | 2, 3, 4 | X | |
| 30° | 4.1 | 3, 4, 5 | X |
Summary of Subject Device Multi-Unit Abutment Designs
Subject device components that will be provided sterile include:
new (not previously cleared) multi-unit abutment screw compatible with Zimmer 3.1mmD Eztetic and TSX™ Implant System, 3.1mmD implants; new multi-unit abutments compatible with Screw-Vent", Tapered Screw-Vent", and TSX™ implants with implant platform diameters of 4.5 mm; new multi-unit abutments compatible with Biomet 3i OSSEOTITE® implants; previously cleared multi-unit abutments compatible with Screw-Vent", Tapered Screw-Vent®, and TSX™ implants with implant platform diameters of 3.5 mm and 4.5 mm; and previously cleared prosthetic components compatible with all subject device multi-unit abutments.
Subject device components that will be provided non-sterile include:
new (not previously cleared) multi-unit abutment screw compatible with Zimmer 3.1mmD Eztetic and TSX™ Implant System, 3.1mmD implants; new multi-unit abutments with Screw-Vent", and TSX™ implants with implant platform diameters of 4.5 mm and new multi-unit abutments compatible with Biomet 3i OSSEOTITE® implants.
The design dimensions and tolerances of subject device abutments and screws for the Zimmer 3.1mmD Eztetic and TSX™ Implant Systems have been established on the basis of a contractual agreement and working relationship between ZimVie and Terrats Medical SL to ensure that the abutments are designed to fit the corresponding implants. Compatibility of the subject abutments and screws for Screw-Vent®, Tapered Screw-Vent®, and TSX™ implant lines was provided in the prior Terrats Medical SL submission K170588. Compatibility of the subject abutments and screws for the Biomet 3i OSSEOTITE® external hex implants was provided in the prior Terrats Medical SL submission K170588.
Multi-Unit Abutments
The Multi-Unit Abutments are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight, angled 30°. The design of the straight Multi-Unit Abutments is similar to that of straight Multi-Unit Abutments cleared in the primary predicate device K230143 with the exception of the implant connections and platform diameters. The straight Multi-Unit Abutment is provided only in a non-engaging. threaded design that attaches directly to the implant. All straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm. Straight Multi-Unit Abutments are provided only for the compatible internal hex implants listed in the table above. The gingival height of the straight Multi-Unit Abutment ranges from 1 mm to 5 mm in 1 mm increments.
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510(k) Summary Page 4 of 7
The angled Multi-Unit Abutments are provided in an engaging design that requires an abutment screw, with angulations of 17° and 30°. The angled Multi-Unit Abutments are provided for the compatible internal hex connection implants and the compatible external hex connection implants listed in the table above (on page 3). All angled Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with gingival heights from 2.5 mm to 4.5 mm. The designs of the angled Multi-Unit Abutments are similar to those of the angled Multi-Unit Abutments cleared in the primary predicate device K230143.All Multi-Unit Abutments, straight and angled, are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.
Screws
This submission includes two (2) abutment screws to be used with the subject device abutment screw for the compatible internal hex implants with a platform diameter of 2.9 mm; and another abutment screw for all compatible external hex implants (with platforms of 3.4 mm). The screws have a hex or hexalobular instrument interface and are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- provided in this submission was non-clinical analysis to evaluate the metallic subject devices and compatible . dental implants in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021);
- provided in this submission was engineering analysis to demonstrate that the subject device abutments compatible ● with the Screw-Vent", Tapered Screw-Vent", and TSX™ implants do not create a new worst-case construct in terms of mechanical testing according to ISO 14801;
- . provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments compatible with the Zimmer 3.1mmD Eztetic and TSX™ implants, and the performance of the subject device abutments compatible with the Biomet 3i OSSEOTITE® Implants;
- referenced from K22269 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 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 K212538 was gamma irradiation 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; 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;
- . referenced from K22269 was biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the abutment material ASTM F136; and
- . referenced from K170588 was reverse engineering compatibility data for the Zimmer Screw-Vent", Zimmer Tapered Screw-Vent®, Zimmer TSX™, and Biomet 3i OSSEOTITE® implant lines.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
All abutment screws are similar or identical in design, materials, and technological characteristics to those cleared in the primary predicate device K230143, except for threads and lengths that accommodate the new compatibilities.
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Subiect device components that are provided non-sterile are to be sterilized by the same moist heat evelerenced from the primary predicate K230143. The subject devices that are provided non-sterile are packaged in either a PETG blister pack or a PET bag, the same packaging referenced from the primary predicate K230143.
Subject device components that are provided sterile by gamma irradiation are packaged in a PETG blister with a Tyvek® Iid. This is the same sterilization, packaging, and 5-year shelf life as validated in the reference device K212538.
The risks associated with use of the subject device angled multi-unit abutments in combination with the compatible implants are mitigated by mechanical testing performed according to ISO 14801.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject device and the primary predicate device encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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| Subject Device | Indications for Use Statement | ||
|---|---|---|---|
| K231434DESS Dental SmartSolutionsTerrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in maxillary or mandibular arch to provide support for prosthetic restorations. | ||
| Implant Systems Compatibility | Implant Body Ø, mm | Implant Platform Ø, mm | |
| Internal Hex Connections | |||
| Zimmer 3.1mmD Eztetic™ | 3.1 | 2.9 | |
| 3.7 | 3.5 | ||
| Zimmer Screw-Vent® | 4.7 | 4.5 | |
| 3.7, 4.1 | 3.5 | ||
| Zimmer Tapered Screw-Vent® | 4.7 | 4.5 | |
| 6.0 | 5.7 | ||
| 3.7, 4.1, 4.7 | 3.5 | ||
| TSX™ Implant System | 5.4, 6.0 | 4.5 | |
| TSX™ Implant System, 3.1mmD | 3.1 | 2.9 | |
| External Hex Connections | |||
| 3.25 | 3.4 | ||
| Biomet 3i OSSEOTITE® Implants | 3.75 | 4.1 | |
| 4.0 | 4.1 | ||
| Primary PredicateDevice | Indications for Use Statement | ||
| K230143DESS Dental SmartSolutionsTerrats Medical SL | DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | ||
| Compatible Implant Systems | Implant Body Ø, mm | Implant Platform Ø, mm | |
| Internal Hex Connection | |||
| 3.7 | 3.5 | ||
| Legacy1 | 4.2 | 3.5 | |
| 4.7 | 4.5 | ||
| 3.7 | 3.5 | ||
| Legacy2, simplyLegacy2, | 4.2 | 3.5 | |
| Legacy3, simplyLegacy3, | 4.7 | 4.5 | |
| Legacy4 | 5.2 | 4.5 | |
| Internal Conical Connection | |||
| 3.2 | 3.0 | ||
| 3.7 | 3.0 | ||
| InterActive | 4.3 | 3.4 | |
| 5.0 | 3.4 | ||
| 3.2 | 3.0 | ||
| 3.7 | 3.0 | ||
| 4.2 | 3.0 | ||
| Simply Iconic™ | 4.7 | 3.0 | |
| 4.7 | 3.4 | ||
| Terrats Medical SL | 5.2 | 3.4 |
Table of Substantial Equivalence – Indications for Use Statement
{9}------------------------------------------------
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| K231434DESS Dental Smart SolutionsTerrats Medical SL | K230143DESS Dental Smart SolutionsTerrats Medical SL | K213063TLX SRAs and TLX GoldAbutmentsStraumann USA, LLC | |
| Reason for Predicate /Reference Device | Not applicable | Designs, materials, manufacturing | Reference for multi-unitabutments provided sterile |
| Product Codes | NHA | NHA | NHA |
| Intended Use | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla | Functional and estheticrehabilitation of the edentulousmandible or maxilla |
| Abutment Designs | |||
| Abutment Types | Multi-Unit | Multi-Unit | Multi-Unit |
| Prosthesis Attachment | Screw Retained | Screw Retained | Screw Retained |
| Restoration | Multi-unit | Multi-unit | Multi-unit |
| Prosthetic InterfaceConnections | Internal hex, External hex | Internal hex, Internal conical | Internal conical |
| Abutment/Implant PlatformDiameter | 2.9 - 5.7 mm | 3.0 - 4.5 mm | TLX SRA: 6 mmTLX Gold: 4.0 (NT), 5.0 (RT),and 7.0 (WT) |
| Prosthetic Platform Diameter | 4.8 mm | 4.8 mm | TLX SRA: 4.6 mmTLX Gold: not provided in510(k) Summary |
| Gingival Height | 1 mm - 5 mm | 1 mm - 5 mm | Not provided in 510(k)Summary |
| Abutment Angulation, degrees | Straight (0°), 17°, 30° | Straight (0°), 17°, 30° | TLX SRA: 17°, 30°TLX Gold: 0°, and up to 30° |
| Abutment Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | TLX SRA: Ti-6Al-7NbTLX Gold: Ceramicor® |
| Abutment Screw Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-7Nb |
| How Provided | |||
| Sterilization | Non-sterile, and sterile by gammairradiation | Non-sterile | TLX SRA: Sterile by gammairradiationTLX Gold: non-sterile |
| Usage - All Components | Single patient, single use | Single patient, single use | Single patient, single use |
Table of Substantial Equivalence – Technological Characteristics
§ 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.)