(230 days)
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1.
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
The provided document, K231307 for Elos Accurate® Customized Abutment, is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial or a performance study for an AI/ML powered medical device would.
The "acceptance criteria" discussed in this document pertain to the device meeting the requirements for FDA 510(k) clearance by demonstrating substantial equivalence to predicate devices, primarily through engineering, dimensional, and non-clinical testing. There is no mention of a human-in-the-loop study, a multi-reader multi-case (MRMC) study, or an AI/ML algorithm-only standalone performance study.
Therefore, many of the requested fields regarding expert adjudication, MRMC studies, and ground truth establishment for AI/ML models are not applicable to the information contained within this 510(k) submission.
Here's an interpretation of the document's contents in relation to your request, with a focus on non-clinical testing and substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicates and meeting established material and dental implant abutment standards. The document doesn't present a table with numerical acceptance criteria and performance for a diagnostic AI algorithm. Instead, it lists various non-clinical tests and their successful outcomes as evidence of substantial equivalence and safety/effectiveness.
| Acceptance Criteria (Implied from testing performed) | Reported Device Performance (Summary from submission) |
|---|---|
| Mechanical Performance & Durability | |
| Compliance with ISO 14801 (Fatigue Testing) | Fatigue testing was conducted per ISO 14801 according to FDA guidance for Root-form Endosseous Dental Implants and Endosseous Dental Abutments. This demonstrates the device's ability to withstand cyclic loading similar to mastication forces. (Specific numerical data (e.g., load cycles, applied force) for this test is not provided in the summary but is implied to have met the standard to demonstrate equivalence to predicate.) |
| Dimensional Accuracy & Compatibility | Engineering and dimensional analyses were performed on original manufacturers' components (abutments, implants, & abutment screws) to determine compatibility. The nominal dimensions and tolerances of the Elos Accurate® Customized Abutment products were determined and met, ensuring proper fit with compatible implant systems as listed in Table 1 (pages 3, 7). The design library file has built-in limitations (e.g., material thickness not less than 0.4mm, gingival height not less than 0.5mm or exceed 5mm, max angulation not exceed 30°, post height not less than 4mm) which the digital workflow prevents users from exceeding, ensuring structural integrity. |
| Biocompatibility | |
| Compliance with ISO 10993-5 (Cytotoxicity) | Biocompatibility testing for cytotoxicity according to ISO 10993-5 was conducted. All tests on identically manufactured abutments and prosthetic screws (from the same material as subject device) showed the products to be non-cytotoxic. This data was leveraged from previous 510(k) clearances (K222044). |
| Sterilization | |
| Compliance with ISO 17665-1 & 17665-2 (Sterilization Validation) | Sterilization validation was performed, demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶. This was leveraged from Primary Predicate Device (K171799) as material, size, and geometry are substantially equivalent. The device is delivered non-sterile and intended to be sterilized by the dental clinic. |
| Magnetic Resonance (MR) Compatibility | |
| Compliance with ASTM F2052, F2119, F2213, F2182 (MR Conditional) | A range of tests per ASTM standards (F2052, F2119, F2213, F2182) was performed on a worst-case assembly. The device was assessed at 1.5 Tesla and 3 Tesla for displacement, torque, heating, and image artifact. The results proved the proposed devices are MR conditional for use when having an MRI scan. This evaluation was leveraged from prior K222044 clearance. |
| Digital Workflow Validation | |
| Validation of CAD/CAM Design & Manufacturing Workflow | The digital dentistry workflow validation was completed on a selected model of the subject product line, including a 3Shape scanner, 3Shape Abutment Designer Software (K155415), and CORiTEC Imes-Icore milling unit. The validation demonstrated the use with the 3Shape Abutment Designer™ Software (K151455) and confirmed the design library file (DME-file) includes and enforces design limits in accordance with the Instructions For Use. Testing also verified avoidance of damage to implant-abutment connection geometry during milling and locking of restriction zones in CAM software. |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of abutments or implants tested for each reported non-clinical test. The tests are general performance validations (e.g., fatigue, cytotoxicity, sterilization efficacy) and dimensional analyses that demonstrate compliance with relevant standards or a worst-case scenario. For example, fatigue testing often involves a small number of samples (e.g., 6 minimum per ISO 14801, though more are often used for statistical power) under specific loading conditions. Similarly, biocompatibility is performed on representative samples.
- Data Provenance: The data comes from the manufacturer's (Elos Medtech Pinol A/S) internal testing and leverages data from previously cleared devices where material, size, and geometry are substantially equivalent. The provenance is therefore the manufacturer's testing facilities and associated regulatory submissions. There is no indication of different countries of origin for the data concerning these non-clinical tests. The tests are prospective in nature, as they are part of the premarket submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this medical device (dental abutment) is established by engineering specifications, material properties, performance standards (e.g., ISO, ASTM), and clinical safety and effectiveness data from the predicates. There is no AI/ML component described that would require expert human review or "ground truth" establishment in the context of diagnostic interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable as there is no human interpretation or diagnostic "test set" that would require adjudication.
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
This question is not applicable. The device is a physical dental abutment and its associated digital design workflow, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not a standalone AI algorithm. The digital dentistry workflow involves CAD software and CAM software, but these are tools for designing and manufacturing the physical abutment, not for automated diagnostic interpretation or decision-making in the clinical sense of an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance, as demonstrated in the submission, is based on:
- Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665 for sterilization).
- Engineering and dimensional analysis against established dental implant system specifications.
- Physical testing results (e.g., torque, heating, displacement) for MR compatibility.
- Validation of the digital workflow ensuring design constraints and manufacturing accuracy.
- The fundamental demonstration is substantial equivalence to existing legally marketed predicate devices, implying that their established safety and effectiveness forms the basis of the "ground truth" for this device's intended use.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML device that requires a training set for model development. The design software has built-in constraints ("design limitations" and "design limits in the library file"), which are more akin to pre-programmed rules and geometric parameters rather than a learned model from data.
9. How the ground truth for the training set was established
This question is not applicable. No AI/ML training set is mentioned or implied. The "ground truth" for the design limitations within the software (e.g., minimum material thickness) would be established by engineering principles, biomechanical studies (often in labs, not clinical trials), and clinical experience with dental prosthetics, which define safe and effective design parameters.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Elos Medtech Pinol A/S Lise Terkelsen Regulatory Affairs Specialist Engvei 33 Goerloese, DK-3330 DENMARK
December 21, 2023
Re: K231307
Trade/Device Name: Elos Accurate® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: November 22, 2023 Received: November 27, 2023
Dear Lise Terkelsen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.
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.
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3
For comprehensive regulatory information about mediation-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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Traditional 510(k) Premarket Notification: Elos Accurate® Customized Abutment Elos Medtech Pinol A/S
INDICATIONS FOR USE
510(k) Number: K231307 Device Name: Elos Accurate® Customized Abutment
Indications for Use
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1:
Table 1.
| Platform compatibility | Platform diameter[mm] | Implant Body diameter[mm] |
|---|---|---|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 |
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary Elos Accurate® Customized Abutment December 21st, 2023
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| I. | Company: | Elos Medtech Pinol A/SEngvej 33DK-3330 GoerloeseDenmark | |
|---|---|---|---|
| Contacts: | Lise TerkelsenRegulatory Affairs ProfessionalTel: +45 21 61 12 25E-mail: lise.terkelsen@elosmedtech.com | Søren RangstrupManager of Product Development & Regulatory AffairsTel: +45 20 66 64 42E-mail: soren.rangstrup@elosmedtech.com | |
| II. | Proprietary Trade Name: | Elos Accurate® Customized Abutment | |
| III. | Classification Name: | Endosseous Dental Implant Abutment | |
| IV. | Classification: | Class II, 21 CFR 872.3630 | |
| V. | Product Code(s): | NHA as the primary product codePNP as the secondary product code |
VI. Identification of Legally Marketed Devices:
The design features, materials and Indications for Use of the subject devices are substantially equivalent to the predicate devices noted below.
Primary Predicate Device:
- . K222044 / SE 11/30/2022 - Elos Accurate® Customized Abutment
Reference Devices:
- K 190299 / SE 06/26/2019 Elos Accurate® Customized Abutment ●
- K151455 / SE 06/09/2016 3 Shape Abutiment Designer Software .
- K171799 / SE 01/15/2018 Elos Accurate® Customized Abutment ●
- . K013227 / SE 11/19/2001 - Zimmer Screw-vent 3.5, Zimmer Screw-vent 4.5, Zimmer Screw-vent 5.7
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- . K122300 / SE 01/30/2013 - Biomet 3i Certain 3.4, Biomet 3i Certain 4.1, Biomet 3i Certain 5.0, Biomet 3i Certain 6.0
- K150938 / SE 07/24/2015 Straumann Standard RN, Straumann Standard WN •
- K163194, K180536, K201225 / SE 07/14/2017, 08/30/2018, 09/04/2020 Neodent . GM
- . K140934, K153332 / SE 11/12/2014, 10/27/2016 - Hiossen ET Mini, Hiossen ET Regular
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VII. Product Description:
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
The Elos Accurate library file has built-in design limitations, and the user isn't allowed to exceed these limitations. The material thickness should not be less than 0.4. The gingival height should not be less than 0.5mm or exceed 5 mm. The maximum angulation should not exceed 30°. The post height should not be less than 4 mm.
VIII. Indications for Use:
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1:
| Table | 1. |
|---|---|
| Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] |
|---|---|---|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø5/Ø6/Ø7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 |
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All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentisty workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
IX. Summary of the Technological Characteristics:
The subject devices have similar Indications for Use, intended use, designs, sizes and configurations, materials, and principles of operation as the primary predicate and reference device Elos Accurate® Customized Abutment Device (K222044, K190299). In order to determine nominal dimensions and tolerances of the Elos Accurate® Customized Abutment products, measuring- and dimensional analyses of original manufacturers' components (abutments, implants & abutment screws) have been made.
Comparing to the primary predicate and reference devices, the specific language (wording) of the Indications for Use Statements is a combination of these two.The primary predicate K222044 includes an indication with a digital dentistry manufacturing workflow and the reference K190299 includes an indication with an approved milling facility workflow. This difference has no impact on the final customized abutment design.
The clamping of some of the subject devices during milling is equivalent to the devices in K222044 and the clamping of some of the subject devices during milling is equivalent to devices in K190299. This difference has no impact on the final customized abutment design.
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| Element ofComparison | Indications for Use | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject Device | The Elos Accurate® Customized Abutments are intended for attaching to dentalimplants in order to provide basis for single or multiple tooth prosthetic restorations.The Elos Accurate® Customized Abutment will be attached to a dental implantusing the included Elos Prosthetic screw.The Elos Accurate® Customized Abutments are compatible with the implantsystems listed in table 1:Table 1. | |||||||||||||||||||||||||||||||||||||||
| Elos Accurate®CustomizedAbutment | ||||||||||||||||||||||||||||||||||||||||
| Platform compatibility Platform diameter [mm] Implant Body diameter [mm] Zimmer Screw-vent 3.5 Ø3.5 Ø3.7/Ø4.1 Zimmer Screw-vent 4.5 Ø4.5 Ø4.7 Zimmer Screw-vent 5.7 Ø5.7 Ø6.0 Biomet 3i Certain 3.4 Ø3.4 Ø3.25 Biomet 3i Certain 4.1 Ø4.1 Ø4 Biomet 3i Certain 5.0 Ø5 Ø5 Biomet 3i Certain 6.0 Ø6 Ø6 Straumann Standard RN Ø4.8 Ø3.3/Ø4.1/Ø4.8 Straumann Standard WN Ø6.5 Ø4.8 Neodent GM Ø3.5/Ø4.5/Ø5.5/Ø6.5 Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 Hiossen ET Mini Ø3.2/Ø3.5 Ø3.2/Ø3.5 Hiossen ET Regular Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 | ||||||||||||||||||||||||||||||||||||||||
| All digitally designed CAD/CAM customizations for the Elos Accurate®Customized Abutments are either intended to be sent and manufactured at aFDA registered Elos Medtech approved milling facility or to be designedand manufactured according to digital dentistry workflow. The workflowsystem integrates multiple components of the digital dentistry workflow:scan files from Intra-Oral Scanners, CAD software, CAM software, millingmachine and associated tooling and accessories. | ||||||||||||||||||||||||||||||||||||||||
| Primary PredicateDevice (K222044) | The Elos Accurate® Customized Abutments are intended for attaching to dentalimplants in order to provide basis for single or multiple tooth prosthetic restorations.The Elos Accurate® Customized Abutment will be attached to a dental implantusing the included Elos Prosthetic screw.The Elos Accurate® Customized Abutments are compatible with the implantsystems listed in table 1:Table 1. | |||||||||||||||||||||||||||||||||||||||
| Platform compatibility Platformdiameter[mm] Implant Bodydiameter[mm] Nobel Replace NP 3.5 3.5 Nobel Replace RP 4.3 4.3 Nobel Replace WP 5 5 Nobel Replace 6.0 6 6 Nobel CC 3.0 3 3 Nobel CC NP 3.5 3.5 & 3.75 Nobel CC RP 3.9 4.3 & 5 |
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| Nobel CC WP | 5.1 | 5.5 | ||
|---|---|---|---|---|
| Straumann Bone Level | 3.3 | 3.3 | ||
| Straumann Bone Level | 4.1 & 4.8 | 4.1 & 4.8 | ||
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 | ||
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 | ||
| Astra Tech EV 3.6 | 3.6 | 3.6 | ||
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 | ||
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 | ||
| Astra Tech EV 5.4 | 5.4 | 5.4 | ||
| Brånemark NP | 3.5 | 3.3 | ||
| Brånemark RP | 4.1 | 3.75.4 & 5 | ||
| Brånemark WP | 5.1 | 5 & 6 | ||
| Reference Devices(K190299)Elos Accurate®CustomizedAbutment | multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine andassociated tooling and accessories.The Elos Accurate® Customized Abutments are intended for attaching to dentalimplants in order to provide basis for single or multiple tooth prosthetic restorations.The Elos Accurate® Customized Abutment will be attached to a dental implantusing the included Elos Prosthetic screw.The Elos Accurate® Customized Abutments are compatible with the implantsystems listed in table 1: | |||
| Table 1.Platform compatibility | Platform diameter[mm] | diameter[mm] | Implant Body | |
| Nobel Replace NP | 3.5 | 3.5 | ||
| Nobel CC 3.0 | 3 | 3 | ||
| Nobel CC RP | 3.9 | 4.3 & 5 | ||
| Nobel CC WP | 5.1 | ર ર | ||
| Straumann Bone Level NC | 3.3 | 3.3 | ||
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 | ||
| All digitally designed CAD/CAM customizations for the Elos Accurate® |
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| Element ofComparison | Subject Device | Primary Predicate deviceK222044 | Reference DeviceK190299 |
|---|---|---|---|
| Elos Accurate® CustomizedAbutmentElos Medtech Pinol A/S | Elos Accurate® CustomizedAbutment Elos Medtech PinolA/S | Elos Accurate® CustomizedAbutmentElos Medtech Pinol A/S | |
| Intended Use | Support of a prosthesis torestorechewing function | Support of a prosthesis torestorechewing function | Support of a prosthesis torestorechewing function |
| Reason forPredicate/Reference | Not applicable | Abutment DesignEngineering and DimensionalanalysisDigital dentistry workflow | Abutment DesignEngineering and dimensionalanalysis |
| Abutment Designs | Customized abutmentmounted on the implant fixedwith a screw | Customized abutment mountedon the implant fixed with ascrew | Customized abutment mountedon the implant fixed with ascrew |
| ProsthesisAttachment | Abutment screw-retained toimplant | Abutment screw-retained toimplant | Abutment screw-retained toimplant |
| Restoration | Single-unit | Single-unit | Single-unit |
| Abutment/ImplantPlatform Diameter(mm) | 3.2 - 7.0 | 3.0 - 6.0 | 3.0 - 5.5 |
| Abutment Angle | Up to 30° maximum | Up to 30° maximum | Up to 30° maximum |
| Materials | |||
| Abutment | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
| Screw | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
| Surface | Non-coated,Medicarb coating on screw | Non-coated,Medicarb coating on screw | Non-coated,Medicarb coating on screw |
| Design Workflow | 3Shape scanner (3Shape A/S),3Shape Abutment DesignerSoftware (3Shape A/S) -K151455 | 3Shape scanner (3Shape A/S),3Shape Abutment DesignerSoftware (3Shape A/S) -K151455 | Elos Medtech approved millingfacility. |
| ManufacturingWorkflow | CORITEC milling unit (imes-icore) | CORITEC milling unit (imes-icore) | Elos Medtech approved millingfacility |
The data included in this submission demonstrate substantial equivalence to the predicate device and/or reference device listed above.
Overall, the subject device has the following substantial equivalencies to the predicate device:
- . has the same intended use,
- . uses the same operating principle,
- incorporates the same basic design,
- incorporates the same or very similar materials, and ●
- . is to be sterilized using the same processes.
X. Discussion of the Non-Clinical Testing:
Non-clinical testing data submitted (either in subject- or predicate submission) included:
- Engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility
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- . Fatigue testing per ISO 14801 according to FDA guidance for Industry and FDA Staff "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" dated May 12, 2004.
- . Biocompatibility testing for cytotoxicity according to ISO 10993-5. Cytotoxicity testing on identically manufactured abutments and prosthetic screws manufactured from the same material is leveraged from previously 510(k) cleared products (K222044). All tests showed the products to be non-cytotoxic.
- Tests included covered: 0
- Elos Accurate® Customized Abutment representative for subject devices (test of primary predicate device)
- . Non-coated prosthetic screw representative for subject device (test of primary
- . predicate device)
- Medicarb coated prosthetic screw representative for subject device (test of :
- ﻴﺔ primary predicate device)
- .
- Sterilization validation according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10°. (The sterilization and Dry-time studies are conducted on the Primary Predicate Device (K171799) and can be leveraged to the subject Elos Accurate® Customized Abutments as material, size and geometry are substantial equivalent)
- The digital dentistry workflow validation was completed on selected model of subject . product line with a digital dentistry workflow including a 3Shape scanner, 3Shape Abutment Designer Software (K155415) and CORiTEC Imes-Icore milling unit. The validation was provided for the subject abutument design library (not allowing the user to design outside the design limits set by Elos Medtech) to demonstrate use with the 3Shape Abutment Designer™ Software (K151455). The design library file (DME-file) provided by Elos Medtech includes design limits in accordance with Electronic Package insert -Instruction For Use, Surgical & Prosthetic Guide - In Lab Milling. The 3Shape Abutment Designer™ Software (K151455) prevents designing outside the specified design limits in the library file.
- Tests included covered: 0
To verify that a worst-case assembly made of Elos Medtech devices was MR conditional, a range of tests was performed on the worst-case assembly according to ASTM F2052, ASTM F2119, ASTM F2213 and ASTM F2182. The device has been assessed at 1.5 Tesla and 3 Tesla for displacement, torque, heating and image artifact in the MRI scanner, which proved that the proposed devices are MR conditional to use when having an MRI scan. The MR conditional safety evaluations are being leveraged from prior K222044 clearance. The MR tested item is made from the same material titanium TiAl6V4 ELI and having equivalent geometry as the proposed devices. The MR tested item is representative of the subject devices since it was a much more worst-case than the subject devices.
- . To address the potential risk of damage to the implant-abutment connection geometry during the milling of the patient-matched portions of the abutument blanks, validation testing of CAM restriction zones was conducted, including verification to show avoidance of damage or modification of the connection geometry, and locking of restriction zones from user editing in the CAM software.
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XI. Conclusions:
Based on the test results and additional supporting documentation provided in this premarket notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.
§ 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.)