(91 days)
No
The summary describes a digital dentistry workflow involving scanning, CAD software, and milling, but there is no mention of AI or ML being used for design, analysis, or any other function. The design limitations are built into the library files, not determined by AI/ML.
Yes
No
Explanation: The device description clearly states that the Elos Accurate® Hybrid Base™ and Elos Accurate® Customized Abutment are "intended for attaching to dental implants in order to provide basis for dental implant and a zirconia superstructure" or "single or multiple tooth prosthetic restorations." This indicates that the device is a prosthetic component, not a diagnostic tool. Diagnostic devices are used to identify a condition or disease, which is not the purpose of this device.
No
The device description clearly states that the devices are physical components (Hybrid Base in Titanium alloy and Abutment Blank in Titanium alloy) designed for attaching to dental implants. While software is used in the design and manufacturing process, the device itself is a physical medical device.
Based on the provided text, the devices described (Elos Accurate Hybrid Base and Elos Accurate Customized Abutment) are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of these devices is clearly stated as "attaching to dental implants in order to provide basis for dental implant and a zirconia superstructure" or "providing basis for single or multiple tooth prosthetic restorations." This is a mechanical and structural function within the body, not an analysis of biological specimens.
- Device Description: The description details the materials (Titanium alloy, Zirconia) and how the devices are manufactured and attached to dental implants. This aligns with a medical device used for structural support and restoration within the oral cavity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, these devices fall under the category of dental prosthetic components, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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:
| 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implants / jawbone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental clinic (for sterilization and placement of final restoration).
Laboratory/clinic (for designing zirconia superstructure).
FDA registered Elos Medtech approved milling facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data 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 modification of the connection geometry and locking of restriction zones from user editing in the CAM software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K231307, K151455, K173961, K181703, K191256, K080396, K120414
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
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 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.
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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5
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/S
Engvej 33
DK-3330 Goerloese
Denmark |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Lise Terkelsen
Regulatory Affairs Professional
Tel: +45 21 61 12 25
E-mail: lise.terkelsen@elosmedtech.com |
| | Søren Rangstrup
Manager of Product Development & Regulatory Affairs
Tel: +45 20 66 64 42
E-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 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. 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 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 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 Use
Subject Device
Elos Accurate® Customized
Abutment | Indications for Use
Reference Device (K231307)
Elos Accurate® Customized
Abutment | Indications for Use
Subject Device
Elos Accurate® Hybrid Base™ | Indications for Use
Primary Predicate Device
(K230317)
Elos Accurate® Hybrid Base™ | Discussion | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------|--------------------------------------|------------------------------|----------------------------------|--|
| 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: | 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® 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: | 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: | The Indication for use for the
subject device is similar to the
Primary Predicate Device,
beside table 1. which have been
replaced with for Customized
Abutment 3 new implant
systems and for Hybrid Base 1
new implant system, and the
approach for finalizing the
zirconia superstructure is the
same.
The difference in implant
system compatibility is
substantiated by engineering
and dimensional analysis of
original manufactures'
components (abutments,
implants & screws) for
determination of compatibility
and new fatigue testing. | | | | | | | | |
| Table 1. | Table 1. | Table 1. | Table 1. | | | | | | | | | |
| Implant
Platform
compatibility | Platform
diamet
er [mm] | Implant Body
diameter
[mm] | Implant
Platform
compatibility | Platform
diameter
[mm] | Implant Body
diameter
[mm] | Implant
Platform
compatibility | Platform
diameter
[mm] | Implant Body
diameter
[mm] | Implant
Platform
compatibility | Platform
diameter
[mm] | Implant Body
diameter
[mm] | |
| Straumann
BLX 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 BLX
RB/WB | $Ø3.4/Ø3.5/Ø4.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5$ | Zimmer
Screw-vent
3.5 | 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 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. 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. | Zimmer
Screw-vent
4.5 | Ø4.5 | Ø4.7 | | | |
| Astra Tech EV
3.0 | Ø3 | Ø3 | Zimmer Screw-
vent 5.7 | Ø5.7 | Ø6.0 | | Zimmer
Screw-vent
5.7 | Ø5.7 | Ø6.0 | | | |
| 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. | | | Biomet 3i
Certain 3.4 | Ø3.4 | Ø3.25 | | Biomet 3i
Certain 3.4 | Ø3.4 | Ø3.25 | | | |
| | | | Biomet 3i
Certain 4.1 | Ø4.1 | Ø4 | Biomet 3i
Certain 4.1 | Ø4.1 | Ø4 | | | | |
| | | | Biomet 3i
Certain 5.0 | Ø5 | Ø5 | Biomet 3i
Certain 5.0 | Ø5 | Ø5 | | | | |
| | | | Biomet 3i
Certain 6.0 | Ø6 | Ø6 | Biomet 3i
Certain 6.0 | Ø6 | Ø6 | | | | |
| | | | Straumann
Standard RN | Ø4.8 | $Ø3.3/Ø4.1/Ø4.8$ | Straumann
Standard RN | Ø4.8 | $Ø3.3/Ø4.1/Ø4.8$ | | | | |
| | | | Straumann
Standard WN | Ø6.5 | Ø4.8 | Straumann
Standard
WN | Ø6.5 | Ø4.8 | | | | |
| | | | Neodent GM | $Ø3.5/Ø4.5/Ø5.5/Ø 6.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø7$ | 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 ET
Mini | Ø3.2/03.5 | Ø3.2/03.5 | Hiossen ET
Mini | Ø3.2/03.5 | Ø3.2/03.5 | | | | |
11
| Hiossen ET
Regular | Ø4/Ø4.5/Ø5/
Ø5.5/Ø6/Ø7 | Hiossen ET
Regular | 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. 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. | | 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. 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. | |
| Element of
Comparison | Subject Device | Reference device
K231307 | Subject Device | Primary Predicate
Device K230317 | Discussion |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Elos Accurate®
Customized Abutment | Elos Accurate®
Customized Abutment | Elos Accurate® Hybrid
Base™ | Elos Accurate® Hybrid
Base™ | |
| | 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 to
restore chewing function | Support of a prosthesis to
restore chewing function | Support of a prosthesis to
restore chewing function | Support of a prosthesis to
restore
chewing function | Substantial equivalent |
| Reason for
Predicate/Reference | Not applicable | Indication for Use,
Abutment Design and
manufacturing workflow | Not applicable | Indication for Use,
Abutment Design and
manufacturing workflow | N/A |
| Abutment Designs | 1 piece - abutment
mounted on to the implant
and fixed with a screw | 1 piece - abutment mounted
on to the implant and fixed
with a screw | 2 piece - zirconia bonded
to hybrid base mounted
on to the implant and
fixed with a screw | 2 piece - zirconia bonded
to hybrid base mounted
on to the implant and
fixed with a screw | Substantial equivalent |
| Prosthesis
Attachment | Abutment screw-retained
to implant | Abutment screw-retained to
implant | Abutment screw-retained
to implant
Superstructure cement-
retained | Abutment screw-retained
to implant
Superstructure cement-
retained | Customized Abutments are
substantial equivalent.
Hybrid Bases are
substantial equivalent. |
| Restoration | Single-unit | Single-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Customized Abutments are
substantial equivalent.
Hybrid Bases are
substantial 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 of
Comparison | Subject Device | Reference device
K231307 | Subject Device | Primary Predicate
Device K230317 | Discussion |
| Platform Diameter
(mm) | Elos Accurate®
Customized Abutment
Elos Medtech Pinol A/S | Elos Accurate®
Customized Abutment
Elos Medtech Pinol A/S | Elos Accurate® Hybrid
Base™
Elos Medtech Pinol A/S | Elos Accurate® Hybrid
Base™
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 |
| Zirconia
superstructure | | | 3M Lava zirconia | 3M Lava zirconia | Substantial equivalent |
| Surface | Abutment: Non-coated
Screw: Non-coated | Abutment: Non-coated
Screw: Non-coated | Abutment: Anodized | Abutment: Anodized | The surface of the Subject Abutment & screw is |
| Element of
Comparison | Subject Device | Reference device
K231307 | Subject Device | Primary Predicate
Device K230317 | Discussion |
| | Elos Accurate®
Customized Abutment
Elos Medtech Pinol A/S | Elos Accurate®
Customized Abutment
Elos Medtech Pinol A/S
Medicarb coating | Elos Accurate® Hybrid
Base™
Elos Medtech Pinol A/S
Screw: Non-coated | Elos Accurate® Hybrid
Base™
Elos Medtech Pinol A/S
Screw: Non-coated,
Medicarb coated | Substantial equivalent to
Primary Predicate Device
K230317.
Mechanical perfomance is
demonstrated in fatigue
testing. |
| Design Workflow | 3Shape intra oral scanner
Trios (3Shape A/S),
3Shape Abutment
Designer Software
(3Shape A/S) - K151455 | 3Shape intra oral scanner
Trios (3Shape A/S),
3Shape Abutment
Designer Software
(3Shape A/S) - K151455 | 3Shape intra oral scanner
Trios (3Shape A/S),
3Shape Abutment
Designer Software
(3Shape A/S) - K151455 | 3Shape intra oral scanner
Trios (3Shape A/S),
3Shape Abutment
Designer Software
(3Shape A/S) - K151455 | Substantial equivalent |
| Manufacturing
Workflow | 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 Hybrid
Abutment Cement,
Ivoclar Vivadent AG
(K130436) or Panavia V5
by KURARAY
NORITAKE DENTAL
(K150704) | Multilink Hybrid
Abutment Cement,
Ivoclar Vivadent AG
(K130436) or Panavia V5
by KURARAY
NORITAKE DENTAL
(K150704) | Substantial equivalent |
| Sterilization | The recommended
sterilization procedure is
full cycle pre-vacuum
steam sterilization at a
temperature of 132 °C | The recommended
sterilization procedure is full
cycle pre-vacuum steam
sterilization at a temperature
of 132 °C (270°F) for 4 | The recommended
sterilization procedure is
full cycle pre-vacuum
steam sterilization at a
temperature of 132 °C | The recommended
sterilization procedure is
full cycle pre-vacuum
steam sterilization at a
temperature of 132 °C | Substantial equivalent |
| Element of
Comparison | Subject Device
Elos Accurate®
Customized Abutment
Elos Medtech Pinol A/S
(270°F) for 4 minutes. Dry
time: 20 minutes. | Reference device
K231307
Elos Accurate®
Customized Abutment
Elos Medtech Pinol A/S
minutes. Dry time: 20
minutes. | Subject Device
Elos Accurate® Hybrid
Base™
Elos Medtech Pinol A/S
(270°F) for 4 minutes.
Dry time: 20 minutes | Primary Predicate
Device K230317
Elos Accurate® Hybrid
Base™
Elos Medtech Pinol A/S
(270°F) for 4 minutes.
Dry time: 20 minutes | Discussion |
| Operating principle | The primary function is to
connect the dental implant
(which is anchored in the
jawbone) to the prosthetic
crown or bridge. After an
implant has
osseointegrated, the
abutment is screwed into
the implant. It provides the
foundation onto which the
prosthetic tooth is
attached. | The primary function is to
connect the dental implant
(which is anchored in the
jawbone) to the prosthetic
crown or bridge. After an
implant has osseointegrated,
the abutment is screwed into
the implant. It provides the
foundation onto which the
prosthetic tooth is attached. | The primary function is to
connect the dental implant
(which is anchored in the
jawbone) to the prosthetic
crown or bridge. After an
implant has
osseointegrated, the
abutment is screwed into
the implant. It provides
the foundation onto which the
prosthetic tooth is
attached. | The primary function is to
connect the dental implant
(which is anchored in the
jawbone) to the prosthetic
crown or bridge. After an
implant has
osseointegrated, the
abutment is screwed into
the implant. It provides
the foundation onto which the
prosthetic tooth is
attached. | Substantial equivalent |
12
13
14
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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
16
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.