(91 days)
Elos Accurate Hybrid Base
The Elos Accurate® Hybrid Base The intended for attaching to dental inplants in order to provide basis for dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
The zirconia superstructures for use with the Elos Accurate® Hybrid Base "" 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, ceramic material, milling machine and associated tooling and accessories.
Elos Accurate Customized Abutment
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 Abutment is compatible with the implant systems listed in table 1: Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
Astra Tech 3.0 | Ø3. | Ø3
Astra Tech EV 3.0 | Ø3 | Ø3
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.
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ are both patient-specific components designed for attaching to dental implants, providing a basis for single or multiple tooth prosthetic restorations.
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ will be attached to the implant using the included Elos Prosthetic Screw.
The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the pre-manufactured prosthetic component, the Hybrid Base in Titanium alloy per ASTM F136, as the bottom-half, and the zirconia superstructure as the top-half, which the laboratory/clinic is designing by use of the 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455), which when assembled comprises the finished medical device. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) While the Elos Accurate® Customized Abutment is a one-piece abutment which consists of an Abutment 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 same applies to the Elos Accurate® Hybrid Base™ which fits directly to an endosseous dental implant. The customized shape of the abutment 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 library files for both Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ have built-in design limitations, and the user isn't allowed to exceed these limitations as follows:
Customized Abutments: | Hybrid Base abutments (zirconia part):
Min. wall thickness 0.4 mm | Min. wall thickness 0.5 mm
Gingival height min. 0.5mm or max. 5 mm | Gingival height min. 0.5mm or max. 5 mm
Max. angulation 20° or 30°. | Max. angulation 20°.
Min. post height* 4 mm | Min. post height* 4 mm
*The post height is defined as the cementable height of the abutment.
The Elos Accurate® Customized Abutment and the Elos Accurate® Hybrid Base™ are both 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 provided text describes the submission of a 510(k) premarket notification for the "Elos Accurate® Hybrid Base™" and "Elos Accurate® Customized Abutment" dental devices. The purpose of this submission is to demonstrate that these devices are substantially equivalent to previously marketed predicate devices. The document details the indications for use, product descriptions, a comparison of technological characteristics with predicate devices, and a summary of non-clinical testing.
Here's an analysis of the acceptance criteria and the study proving device conformity:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets in the document. Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "reported device performance" is primarily presented as the devices meeting the same or similar functional and safety standards as the predicate devices, with specific validations for expanded compatibility and design workflows.
The "Element of Comparison" table acts as a de facto set of acceptance criteria, where the subject device's characteristics are compared against the predicate devices, and "Substantial equivalent" is the reported "performance."
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Support of a prosthesis to restore chewing function | Substantial equivalent (Same as predicate) |
| Abutment Designs: | |
| Elos Accurate® Customized Abutment: 1 piece - abutment mounted on implant, fixed with screw | Substantial equivalent (Same as predicate) |
| Elos Accurate® Hybrid Base™: 2 piece - zirconia bonded to hybrid base mounted on implant, fixed with screw | Substantial equivalent (Same as predicate) |
| Prosthesis Attachment: | |
| Customized Abutment: Abutment screw-retained to implant | Substantial equivalent (Same as predicate) |
| Hybrid Base: Abutment screw-retained to implant, superstructure cement-retained | Substantial equivalent (Same as predicate) |
| Restoration: | |
| Customized Abutment: Single-unit | Substantial equivalent (Same as predicate) |
| Hybrid Base: Single-unit, Multi-unit | Substantial equivalent (Same as predicate) |
| Abutment/Implant Platform Diameter (mm): | |
| Customized Abutment: 3.0 – 4.5 | Customized Abutment: Implant diameter for the subject device is down to 3.0mm, which is smaller than the primary predicate device (3.2 – 7.0 for the predicate). Mechanical performance of the 3mm diameter components for both AstraTech & AstraTech EV is demonstrated in fatigue testing. |
| Hybrid Base: 3.4 – 4.5 | Hybrid Base: Substantial equivalent as Implant diameter for the subject device is within the range of the Primary Predicate Device K230317 (3.2 – 7.0 for the predicate). |
| Abutment Angle: | |
| Customized Abutment: up to 20° (AstraTech), up to 30° (Straumann BLX) | Substantial equivalent, as the max angulation is within the value used for Reference Device K231307 (up to 30° for the predicate). |
| Hybrid Base: 20° maximum | Substantial equivalent (Same as predicate). |
| Gingival Height: Up to 5 mm | Substantial equivalent (Same as predicate). |
| Materials: | |
| Abutment: Ti-6Al-4V alloy | Substantial equivalent (Same as predicate). |
| Screw: Ti-6Al-4V alloy | Substantial equivalent (Same as predicate). |
| Zirconia superstructure: 3M Lava zirconia (for Hybrid Base) | Substantial equivalent (Same as predicate). |
| Surface: | |
| Customized Abutment: Abutment/Screw: Non-coated | The surface of the Subject Abutment & screw is substantial equivalent to Primary Predicate Device K230317. Mechanical performance is demonstrated in fatigue testing (Note: Predicate K231307 mentions "Medicarb coating" for the screw, while K230317 mentions "non-coated, Medicarb coated"). |
| Hybrid Base: Abutment: Anodized; Screw: Non-coated | The surface of the Subject Abutment & screw is substantial equivalent to Primary Predicate Device K230317. Mechanical performance is demonstrated in fatigue testing (Note: Predicate K230317 also mentions "non-coated, Medicarb coated" for the screw, which is partially different but deemed equivalent due to testing). |
| Design Workflow: 3Shape scanner, 3Shape Abutment Designer Software (K151455) | Substantial equivalent (Same as predicate). New digital libraries were validated as part of the subject submission, including: Scanner (3Shape >10um accuracy), Design library file (DME-file) with built-in limits, Design Software (3Shape Abutment Designer K151455). Testing of design limits conducted to show avoidance of designing outside specified limits. |
| Manufacturing Workflow: CORITEC milling unit (imes-icore) | Substantial equivalent (Same as predicate). |
| Adhesive material (for Hybrid Base): Multilink Hybrid Abutment Cement (K130436) or Panavia V5 (K150704) | Substantial equivalent (Same as predicate). |
| Sterilization: Full cycle pre-vacuum steam sterilization at 132 °C (270°F) for 4 mins, 20 mins dry time | Substantial equivalent (Same as predicate). Sterilization and Dry-time studies leveraged from K230317/K231317 (material, size, geometry are substantially equivalent). |
| Operating principle: Connect dental implant to prosthetic crown/bridge | Substantial equivalent (Same as predicate). |
2. Sample size used for the test set and data provenance
The document does not specify a "test set" in the context of an AI/human performance study. Instead, the testing described is primarily engineering and material characterization:
- Fatigue testing per ISO 14801: This testing involves multiple samples to assess mechanical durability. While the exact number of samples isn't given, standard ISO 14801 typically requires a significant number of samples tested to failure or for a specified number of cycles.
- Biocompatibility testing for cytotoxicity (ISO 10993-5): This testing would use biological samples or cell lines. The document states it's leveraged from previously cleared products (K230317/K231317) on "identically manufactured abutments and prosthetic screws manufactured from the same material."
- Sterilization validation (ISO 17665-1 & ISO 17665-2): Involves using Biological Indicators (BIs) or other validation methods, typically multiple cycles and samples. Leveraged from K230317/K231317.
- MRI Conditional Safety Evaluations (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182): A "worst-case assembly" was tested, implying at least one, but possibly multiple, physical assemblies to cover various MRI conditions. Leveraged from K230317/K231317.
- Digital dentistry workflow validation: Conducted on "selected model of subject product lines," implying a representative set of designs.
Data Provenance: The data comes from non-clinical testing performed by the manufacturer (or leveraged from prior submissions by the same manufacturer, Elos Medtech Pinol A/S). The origin is Denmark (company location). The testing is prospective for the current submission but leverages retrospective data from previous clearances.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not applicable to this submission. The device is a physical dental abutment, not an AI/diagnostic device that generates an output requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical, mechanical, and biological properties, which are established through standardized engineering and laboratory tests, not expert consensus on diagnostic images.
4. Adjudication method for the test set
This is not applicable as there is no test set involving expert interpretation or a diagnostic outcome 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 is not applicable as the device is a physical dental abutment, not an AI-assisted diagnostic tool or software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical dental abutment. The "digital dentistry workflow" involves software (3Shape Abutment Designer Software) but this is used for design and manufacturing, not for standalone diagnostic performance assessment.
7. The type of ground truth used
The "ground truth" for this engineering-focused submission is established through:
- Engineering and dimensional analysis: Measurements and specifications of various components (abutments, implants, screws).
- Mechanical testing: Fatigue testing per ISO 14801 to assess durability and strength under simulated physiological loading.
- Biocompatibility testing: Standardized testing (ISO 10993-5) to confirm non-cytotoxicity.
- Sterilization validation: Standardized testing (ISO 17665-1 & ISO 17665-2) to confirm sterility.
- MRI compatibility testing: Standardized testing (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182) to confirm MR conditional status.
- Design software validation: Testing that the software (3Shape Abutment Designer) adheres to "built-in design limitations" and prevents users from exceeding them.
8. The sample size for the training set
This is not applicable. The submission is not for an AI/machine learning device that requires a training set. The descriptions of "design limitations" and "digital dentistry workflow validation" refer to the validation of software and manufacturing processes, not the training of an algorithm in the machine learning sense.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for the reasons outlined above. The "design limits" mentioned for the digital dentistry workflow are predefined by Elos Medtech based on engineering principles and safety considerations for dental prosthetics.
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September 13, 2024
Elos Medtech Pinol A/S Lise Terkelsen Regulatory Affairs Professional Engvej 33 Goerloese. 3330 DENMARK
Re: K241722
Trade/Device Name: Elos Accurate® Hybrid Base™: 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: June 14, 2024 Received: June 14, 2024
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.
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.
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3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K241722
Device Name
Elos Accurate Hybrid Base;
Elos Accurate Customized Abutment
Indications for Use (Describe)
Elos Accurate Hybrid Base
The Elos Accurate® Hybrid Base The intended for attaching to dental inplants in order to provide basis for dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
| Table 1. | ||
|---|---|---|
| Implant Platformcompatibility | Platform diameter[mm] | Implant Body diameter[mm] |
| Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base "" 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, ceramic material, milling machine and associated tooling and accessories.
Elos Accurate Customized Abutment
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 Abutment is compatible with the implant systems listed in table 1: Table 1.
| Implant Platformcompatibility | Platform diameter[mm] | Implant Body diameter[mm] |
|---|---|---|
| Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 |
| Astra Tech 3.0 | Ø3. | Ø3 |
| Astra Tech EV 3.0 | Ø3 | Ø3 |
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary K241722 Elos Accurate® Hybrid Base™, Elos Accurate® Customized Abutment September 13, 2024
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® Hybrid Base™Elos Accurate® Customized Abutment |
| III. Classification Name: | Endosseous Dental Implant Abutment |
Product Code(s): NHA as the primary product code PNP 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 device noted below.
Primary Predicate Device:
- K230317 / SE 09/01/2023 Elos Accurate® Hybrid Base™ ●
Reference Devices:
V.
- K231307 / SE 12/21/2023 Elos Accurate® Customized Abutment ●
- K151455 / SE 06/09/2016 3Shape Abutment Designer Software ●
- K173961 / SE 06/05/2018 Straumann BLX Implant System ●
- . K181703 / SE 12/28/2018 - Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutment
- K191256 / SE 12/27/2019 Straumann BLX Ø3.5 mm Implants ●
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VII. Product Description:
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ are both patientspecific components designed for attaching to dental implants, providing a basis for single or multiple tooth prosthetic restorations.
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ will be attached to the implant using the included Elos Prosthetic Screw.
The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the pre-manufactured prosthetic component, the Hybrid Base in Titanium alloy per ASTM F136, as the bottom-half, and the zirconia superstructure as the top-half, which the laboratory/clinic is designing by use of the 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455), which when assembled comprises the finished medical device. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) While the Elos Accurate® Customized Abutment is a one-piece abutment which consists of an Abutment 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 same applies to the Elos Accurate® Hybrid Base™ which fits directly to an endosseous dental implant. The customized shape of the abutment 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 library files for both Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ have built-in design limitations, and the user isn't allowed to exceed these limitations as follows:
| Customized Abutments: | Hybrid Base abutments (zirconia part): |
|---|---|
| Min. wall thickness 0.4 mm | Min. wall thickness 0.5 mm |
| Gingival height min. 0.5mm or max. 5 mm | Gingival height min. 0.5mm or max. 5 mm |
| Max. angulation 20° or 30°. | Max. angulation 20°. |
| Min. post height* 4 mm | Min. post height* 4 mm |
*The post height is defined as the cementable height of the abutment.
The Elos Accurate® Customized Abutment and the Elos Accurate® Hybrid Base™ are both 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.
VIII. Indications for Use:
Customized Abutment
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.
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The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1: Tahle 1
| Table 1. | ||
|---|---|---|
| Implant Platformcompatibility | Platform diameter[mm] | Implant Body diameter[mm] |
| Straumann BLX RB/ WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 |
| Astra Tech 3.0 | Ø3. | Ø3 |
| Astra Tech EV 3.0 | Ø3 | Ø3 |
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. 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.
Hybrid Base
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
| Implant Platformcompatibility | Platform diameter[mm] | Implant Body diameter[mm] |
|---|---|---|
| Straumann BLX RB/ WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
IX. Summary of the Technological Characteristics:
The subject devices provide additional restorative options for connection to existing implant platforms. The subject devices have similar Indications for Use, intended use, designs, sizes and configurations, materials, and principles of operation as the predicate device. In order to determine nominal dimensions and tolerances of the Elos Accurate® Hybrid Base™ and 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 device, the specific language (wording) of the Indications for Use Statements is identical except for implant system compatibility. The implant system
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compatibility of the subject device is extended to include compatibility to the Straumann BLX and Astra Tech EV Implant system platforms for Customized Abutment and Straumann BLX for Hybrid Base. The difference in implant system compatibility is substantiated by engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility and new fatigue testing.
The approach of designing and manufacturing the Customized Abutment or zirconia superstructure (Hybrid Base) for the subject device is either according to a digital dentistry workflow or to be sent and manufactured at an FDA registered Elos Medtech approved milling facility (identical to Primary Predicate Device K230317). The subject device does not represent any new worst case, and is thereby covered by existing workflow validation submitted in K230317 and K231307. except the additional new digital libraries were validated as part of the subject submission, which included following:
-
Scanner: 3Shape scanner (accuracy >10um)
-
Design library file (DME-file) provided by Elos Medtech which includes design limits in accordance with "Instruction For Use"
-
Design Software: 3Shape Abutment Designer Software (K151455)
-
Milling Unit: CORiTEC, imes-icore milling unit
-
Zirconia Material: 3M Lava Plus Zirconia (K011394) (only relevant for Elos Accurate Hybrid Base)
-
Adhesive material: Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG (K130436) or Panavia V5 by KURARAY NORITAKE DENTAL (K150704) (only relevant for Elos Accurate Hybrid Base)
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| Indications for UseSubject DeviceElos Accurate® CustomizedAbutment | Indications for UseReference Device (K231307)Elos Accurate® CustomizedAbutment | Indications for UseSubject DeviceElos Accurate® Hybrid Base™ | Indications for UsePrimary Predicate Device(K230317)Elos Accurate® Hybrid Base™ | Discussion | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The Elos Accurate® Customized Abutments areintended for attaching to dental implants in order toprovide basis for single or multiple tooth prostheticrestorations. The Elos Accurate® CustomizedAbutment will be attached to a dental implant usingthe included Elos Prosthetic screw.The Elos Accurate® Customized Abutment iscompatible with the implant systems listed in table 1: | The Elos Accurate® Customized Abutments areintended for attaching to dental implants in order toprovide basis for single or multiple tooth prostheticrestorations. The Elos Accurate® CustomizedAbutment will be attached to a dental implant usingthe included Elos Prosthetic screw.The Elos Accurate® Customized Abutments arecompatible with the implant systems listed in table 1: | The Elos Accurate® Hybrid Base™ is intended forattaching to dental implants in order to provide basisfor single or multiple tooth prosthetic restorations.The Hybrid Base™ is used as an interface between adental implant and a zirconia superstructure and willbe attached to the implant using a prosthetic screwand attached to the zirconia superstructure bycementing.The Elos Accurate® Hybrid Base™ is compatiblewith the implant systems listed in table 1: | The Elos Accurate® Hybrid Base™ is intended forattaching to dental implants in order to provide basisfor single or multiple tooth prosthetic restorations.The Hybrid Base™ is used as an interface between adental implant and a zirconia superstructure and willbe attached to the implant using a prosthetic screwand attached to the zirconia superstructure bycementing.The Elos Accurate® Hybrid Base™ is compatiblewith the implant systems listed in table 1: | The Indication for use for thesubject device is similar to thePrimary Predicate Device,beside table 1. which have beenreplaced with for CustomizedAbutment 3 new implantsystems and for Hybrid Base 1new implant system, and theapproach for finalizing thezirconia superstructure is thesame.The difference in implantsystem compatibility issubstantiated by engineeringand dimensional analysis oforiginal manufactures'components (abutments,implants & screws) fordetermination of compatibilityand new fatigue testing. | ||||||||
| Table 1. | Table 1. | Table 1. | Table 1. | |||||||||
| ImplantPlatformcompatibility | Platformdiameter [mm] | Implant Bodydiameter[mm] | ImplantPlatformcompatibility | Platformdiameter[mm] | Implant Bodydiameter[mm] | ImplantPlatformcompatibility | Platformdiameter[mm] | Implant Bodydiameter[mm] | ImplantPlatformcompatibility | Platformdiameter[mm] | Implant Bodydiameter[mm] | |
| StraumannBLX RB/WB | $Ø3.4/Ø3.5/04.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5$ | Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 | Straumann BLXRB/WB | $Ø3.4/Ø3.5/Ø4.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5$ | ZimmerScrew-vent3.5 | Ø3.5 | Ø3.7/Ø4.1 | |
| Astra Tech 3.0 | Ø3 | Ø3 | Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 | The zirconia superstructures for use with the ElosAccurate® Hybrid Base™ are either intended to besent and manufactured at a FDA registered ElosMedtech approved milling facility or to be designedand manufactured according to digital dentistryworkflow. The workflow system integrates multiplecomponents of the digital dentistry workflow: scanfiles from Intra-Oral Scanners, CAD software, CAMsoftware, ceramic material, milling machine andassociated tooling and accessories. | ZimmerScrew-vent4.5 | Ø4.5 | Ø4.7 | |||
| Astra Tech EV3.0 | Ø3 | Ø3 | Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 | ZimmerScrew-vent5.7 | Ø5.7 | Ø6.0 | ||||
| All digitally designed CAD/CAM customizations forthe Elos Accurate® Customized Abutments areeither intended to be sent and manufactured at a FDAregistered Elos Medtech approved milling facility orto be designed and manufactured according to digitaldentistry workflow. The workflow system integratesmultiple components of the digital dentistryworkflow: scan files from Intra-Oral Scanners, CADsoftware, CAM software, milling machine andassociated tooling and accessories. | Biomet 3iCertain 3.4 | Ø3.4 | Ø3.25 | Biomet 3iCertain 3.4 | Ø3.4 | Ø3.25 | ||||||
| Biomet 3iCertain 4.1 | Ø4.1 | Ø4 | Biomet 3iCertain 4.1 | Ø4.1 | Ø4 | |||||||
| Biomet 3iCertain 5.0 | Ø5 | Ø5 | Biomet 3iCertain 5.0 | Ø5 | Ø5 | |||||||
| Biomet 3iCertain 6.0 | Ø6 | Ø6 | Biomet 3iCertain 6.0 | Ø6 | Ø6 | |||||||
| StraumannStandard RN | Ø4.8 | $Ø3.3/Ø4.1/Ø4.8$ | StraumannStandard RN | Ø4.8 | $Ø3.3/Ø4.1/Ø4.8$ | |||||||
| StraumannStandard WN | Ø6.5 | Ø4.8 | StraumannStandardWN | Ø6.5 | Ø4.8 | |||||||
| Neodent GM | $Ø3.5/Ø4.5/Ø5.5/Ø 6.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø7$ | Neodent GM | $Ø3.5/Ø4.5/Ø5.5/Ø 6.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7$ | |||||||
| Hiossen ETMini | Ø3.2/03.5 | Ø3.2/03.5 | Hiossen ETMini | Ø3.2/03.5 | Ø3.2/03.5 |
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| Hiossen ETRegular | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 | Hiossen ETRegular | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 |
|---|---|---|---|
| All digitally designed CAD/CAM customizations forthe Elos Accurate® Customized Abutments areeither intended to be sent and manufactured at a FDAregistered Elos Medtech approved milling facility orto be designed and manufactured according to digitaldentistry workflow. The workflow system integratesmultiple components of the digital dentistryworkflow: scan files from Intra-Oral Scanners, CADsoftware, CAM software, milling machine andassociated tooling and accessories. | The zirconia superstructures for use with the ElosAccurate® Hybrid Base™ are either intended to besent and manufactured at a FDA registered ElosMedtech approved milling facility or to be designedand manufactured according to digital dentistryworkflow. The workflow system integrates multiplecomponents of the digital dentistry workflow: scanfiles from Intra-Oral Scanners, CAD software, CAMsoftware, ceramic material, milling machine andassociated tooling and accessories. |
| Element ofComparison | Subject Device | Reference deviceK231307 | Subject Device | Primary PredicateDevice K230317 | Discussion |
|---|---|---|---|---|---|
| Elos Accurate®Customized Abutment | Elos Accurate®Customized Abutment | Elos Accurate® HybridBase™ | Elos Accurate® HybridBase™ | ||
| Elos Medtech Pinol A/S | Elos Medtech Pinol A/S | Elos Medtech Pinol A/S | Elos Medtech Pinol A/S | ||
| Intended Use | Support of a prosthesis torestore chewing function | Support of a prosthesis torestore chewing function | Support of a prosthesis torestore chewing function | Support of a prosthesis torestorechewing function | Substantial equivalent |
| Reason forPredicate/Reference | Not applicable | Indication for Use,Abutment Design andmanufacturing workflow | Not applicable | Indication for Use,Abutment Design andmanufacturing workflow | N/A |
| Abutment Designs | 1 piece - abutmentmounted on to the implantand fixed with a screw | 1 piece - abutment mountedon to the implant and fixedwith a screw | 2 piece - zirconia bondedto hybrid base mountedon to the implant andfixed with a screw | 2 piece - zirconia bondedto hybrid base mountedon to the implant andfixed with a screw | Substantial equivalent |
| ProsthesisAttachment | Abutment screw-retainedto implant | Abutment screw-retained toimplant | Abutment screw-retainedto implantSuperstructure cement-retained | Abutment screw-retainedto implantSuperstructure cement-retained | Customized Abutments aresubstantial equivalent.Hybrid Bases aresubstantial equivalent. |
| Restoration | Single-unit | Single-unit | Single-unitMulti-unit | Single-unitMulti-unit | Customized Abutments aresubstantial equivalent.Hybrid Bases aresubstantial equivalent. |
| Abutment/Implant | 3.0 – 4.5 | 3.2 – 7.0 | 3.4 – 4.5 | 3.2 – 7.0 | Customized Abutment:Implant diameter for the |
| Element ofComparison | Subject Device | Reference deviceK231307 | Subject Device | Primary PredicateDevice K230317 | Discussion |
| Platform Diameter(mm) | Elos Accurate®Customized AbutmentElos Medtech Pinol A/S | Elos Accurate®Customized AbutmentElos Medtech Pinol A/S | Elos Accurate® HybridBase™Elos Medtech Pinol A/S | Elos Accurate® HybridBase™Elos Medtech Pinol A/S | subject device is down to 3.0mm, which is smaller than the primary predicate device. The Mechanical perfomance of the 3 mm diameter components for both AstraTech & AstraTech EV is demonstrated in fatigue testing.Hybrid Base:Substantial equivalent as Implant diameter for the subject device is within the range of the Primary Predicate Device K230317 |
| Abutment Angle | AstraTech 3.0: Up to 20°AstraTech EV 3.0: Up to 20° Straumann BLX: Up to 30° | Up to 30° | 20° maximum | 20° maximum | Customized Abutment:Substantial equivalent, as the max angulation is within the value used for Reference Device K231307.Hybrid Base:Substantial equivalent |
| Gingival Height | Up to 5 mm | Up to 5 mm | Up to 5 mm | Up to 5 mm | Substantial equivalent |
| Materials | |||||
| Abutment | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Substantial equivalent |
| Screw | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Substantial equivalent |
| Zirconiasuperstructure | 3M Lava zirconia | 3M Lava zirconia | Substantial equivalent | ||
| Surface | Abutment: Non-coatedScrew: Non-coated | Abutment: Non-coatedScrew: Non-coated | Abutment: Anodized | Abutment: Anodized | The surface of the Subject Abutment & screw is |
| Element ofComparison | Subject Device | Reference deviceK231307 | Subject Device | Primary PredicateDevice K230317 | Discussion |
| Elos Accurate®Customized AbutmentElos Medtech Pinol A/S | Elos Accurate®Customized AbutmentElos Medtech Pinol A/SMedicarb coating | Elos Accurate® HybridBase™Elos Medtech Pinol A/SScrew: Non-coated | Elos Accurate® HybridBase™Elos Medtech Pinol A/SScrew: Non-coated,Medicarb coated | Substantial equivalent toPrimary Predicate DeviceK230317.Mechanical perfomance isdemonstrated in fatiguetesting. | |
| Design Workflow | 3Shape intra oral scannerTrios (3Shape A/S),3Shape AbutmentDesigner Software(3Shape A/S) - K151455 | 3Shape intra oral scannerTrios (3Shape A/S),3Shape AbutmentDesigner Software(3Shape A/S) - K151455 | 3Shape intra oral scannerTrios (3Shape A/S),3Shape AbutmentDesigner Software(3Shape A/S) - K151455 | 3Shape intra oral scannerTrios (3Shape A/S),3Shape AbutmentDesigner Software(3Shape A/S) - K151455 | Substantial equivalent |
| ManufacturingWorkflow | CORITEC milling unit(imes-icore) | CORITEC milling unit(imes-icore) | CORITEC milling unit(Imes-Icore) | CORITEC milling unit(imes-icore) | Substantial equivalent |
| Adhesive material | Multilink HybridAbutment Cement,Ivoclar Vivadent AG(K130436) or Panavia V5by KURARAYNORITAKE DENTAL(K150704) | Multilink HybridAbutment Cement,Ivoclar Vivadent AG(K130436) or Panavia V5by KURARAYNORITAKE DENTAL(K150704) | Substantial equivalent | ||
| Sterilization | The recommendedsterilization procedure isfull cycle pre-vacuumsteam sterilization at atemperature of 132 °C | The recommendedsterilization procedure is fullcycle pre-vacuum steamsterilization at a temperatureof 132 °C (270°F) for 4 | The recommendedsterilization procedure isfull cycle pre-vacuumsteam sterilization at atemperature of 132 °C | The recommendedsterilization procedure isfull cycle pre-vacuumsteam sterilization at atemperature of 132 °C | Substantial equivalent |
| Element ofComparison | Subject DeviceElos Accurate®Customized AbutmentElos Medtech Pinol A/S(270°F) for 4 minutes. Drytime: 20 minutes. | Reference deviceK231307Elos Accurate®Customized AbutmentElos Medtech Pinol A/Sminutes. Dry time: 20minutes. | Subject DeviceElos Accurate® HybridBase™Elos Medtech Pinol A/S(270°F) for 4 minutes.Dry time: 20 minutes | Primary PredicateDevice K230317Elos Accurate® HybridBase™Elos Medtech Pinol A/S(270°F) for 4 minutes.Dry time: 20 minutes | Discussion |
| Operating principle | The primary function is toconnect the dental implant(which is anchored in thejawbone) to the prostheticcrown or bridge. After animplant hasosseointegrated, theabutment is screwed intothe implant. It provides thefoundation onto which theprosthetic tooth isattached. | The primary function is toconnect the dental implant(which is anchored in thejawbone) to the prostheticcrown or bridge. After animplant has osseointegrated,the abutment is screwed intothe implant. It provides thefoundation onto which theprosthetic tooth is attached. | The primary function is toconnect the dental implant(which is anchored in thejawbone) to the prostheticcrown or bridge. After animplant hasosseointegrated, theabutment is screwed intothe implant. It providesthe foundation onto which theprosthetic tooth isattached. | The primary function is toconnect the dental implant(which is anchored in thejawbone) to the prostheticcrown or bridge. After animplant hasosseointegrated, theabutment is screwed intothe implant. It providesthe foundation onto which theprosthetic tooth isattached. | Substantial equivalent |
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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
- . 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.
- . The digital dentistry workflow validation was completed on selected model of subject product lines with a digital dentistry workflow including a 3Shape scanner, 3Shape Abutment Designer Software (K155415) and CORiTEC Imes-Icore milling unit. The validations were provided for the subject abutment 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 – Customized Abutment and Electronic Package insert - Instruction For Use, Surgical & Prosthetic Guide – Hybrid Base. The 3Shape Abutment Designer™ Software (K151455) prevents designing outside the specified design limits in the library file. Testing of design limits was conducted to show avoidance of designing outside the specified design limits.
- . 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 (K230317/K231317). All tests showed the products to be non-cytotoxic.
- Sterilization validation according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of . 10-6. The sterilization and Dry-time studies can be leveraged from K230317/K231317 to the subject Elos Accurate® Customized Abutments and Elos Accurate Hybrid Base as material, size and geometry are substantial equivalent.
- . 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 K230317/K231317 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 Customized Abutment, validation testing of CAM restriction zones was conducted to show avoidance of damage or
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modification of the connection geometry and locking of restriction zones from user editing in the CAM software.
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 device.
§ 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.)