(228 days)
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] |
|---|---|---|
| Nobel Replace NP | 3.5 | 3.5 |
| Nobel Replace RP | 4.3 | 4.3 |
| Nobel Replace WP | 5 | 5 |
| Nobel Replace 6.0 | 6 | 6 |
| Nobel OC 3.0 | 3 | 3 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel OC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
| Astra Tech 3.0 | 3 | 3 |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| Astra Tech EV 3.0 | 3 | 3 |
| Astra Tech EV 3.6 | 3.6 | 3.6 |
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 |
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 |
| Astra Tech EV 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended 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, ceramic material, milling machine and associated tooling and accessories.
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 the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottom-half and the zirconia superstructure as the top-half.
The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (i.e. 3Shape Abutment Designer Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:
- Minimum wall thickness 0.5 mm
- Minimum post height 4.0 mm (for single unit restorations)
- Maximum gingival height 5.0 mm
- Maximum angulation 20°
The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436) and the final prosthetic restoration is attached to the implant using a Prosthetic screw. The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
The provided text describes the regulatory clearance of a dental device, the "Elos Accurate® Hybrid Base™", through a 510(k) premarket notification. This process is based on demonstrating substantial equivalence to previously marketed predicate devices, rather than proving safety and effectiveness through clinical trials with acceptance criteria traditionally associated with new drug or high-risk device approvals.
Therefore, the document does not contain information on acceptance criteria for device performance in the classical sense (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device), nor does it describe a study to prove the device meets these types of acceptance criteria.
Instead, the "acceptance criteria" here refer to the regulatory requirements for demonstrating substantial equivalence. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing and analyses performed to support this substantial equivalence claim.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent or different from a typical AI/diagnostic device performance study:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't define quantitative performance acceptance criteria like sensitivity/specificity for a diagnostic. The "acceptance criteria" for this 510(k) submission are met by demonstrating:
| Acceptance Criterion (Regulatory) | Reported "Performance" / Evidence Presented |
|---|---|
| Intended Use Equivalence | Subject device has the same intended use as predicate: "attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations." |
| Operating Principle Equivalence | Uses the same operating principle as predicate. |
| Basic Design Equivalence | Incorporates the same basic design (two-piece abutment, titanium alloy base, zirconia superstructure). |
| Material Equivalence | Incorporates same or very similar materials (Ti-6Al-4V alloy for Hybrid Base and screw, 3M Lava Plus Zirconia for superstructure, specific cement). |
| Sterilization Process Equivalence | To be sterilized using the same processes (non-sterile delivery, final restoration sterilized at dental clinic). |
| Dimensional and Compatibility Equivalence | Engineering and dimensional analyses of original manufacturers' components (abutments, implants & abutment screws) were made to determine nominal dimensions and tolerances and ensure compatibility with listed implant systems. |
| Fatigue Resistance (Mechanical Performance) | Fatigue testing per ISO 14801 was performed according to FDA guidance. |
| Biocompatibility | Biocompatibility testing for cytotoxicity according to ISO 10993-5 was performed. Previous 510(k) cleared products sharing identical manufacturing processes and materials also showed non-cytotoxicity. |
| Digital Workflow Validation | Validation of the digital dentistry workflow (scanner, design software, milling unit) with the subject product line, ensuring design limits are enforced by the software. |
2. Sample Sized Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., a set of medical images). The "testing" refers to mechanical and biocompatibility tests of the device components.
- For fatigue testing (ISO 14801): The sample size for this mechanical test is not explicitly stated in the provided text.
- For biocompatibility (cytotoxicity ISO 10993-5): "a complete restoration produced via the described validated workflow was performed." The exact number of samples tested is not specified.
- For engineering and dimensional analysis: The number of components analyzed is not specified.
- Data Provenance: The document does not mention human subject data or data provenance like country of origin or retrospective/prospective studies. The testing is described as non-clinical (mechanical, material, software validation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable as the document describes non-clinical testing of a dental implant component, not a diagnostic or AI device requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
- This question is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable as the device is not an AI software intended to assist human readers. It is a physical dental implant component.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical component, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests:
- Mechanical Integrity (Fatigue): Ground truth is defined by the performance standards of ISO 14801, which sets limits for mechanical failure under specific loading conditions.
- Biocompatibility (Cytotoxicity): Ground truth is defined by the standards of ISO 10993-5, determining if the material elicits a cytotoxic response.
- Dimensional Accuracy/Compatibility: Ground truth is defined by engineering specifications and measurements of existing implant systems and the device itself.
8. The Sample Size for the Training Set
- This question is not applicable as there is no "training set" of data in the context of machine learning for this physical device.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reasons as point 8.
In summary, the provided text details a regulatory submission for a physical dental device, focusing on demonstrating substantial equivalence through non-clinical testing (mechanical, material, digital workflow validation) rather than complex diagnostic performance studies common for AI or imaging devices.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Elos Medtech Pinol A/S Tina Poulsen Head of Compliance Engvej 33 Goerloese, DK-3330 DENMARK
Re: K201860
Trade/Device Name: Elos Accurate® Hybrid Base™ Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: January 8, 2021 Received: January 11, 2021
Dear Tina Poulsen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Premarket Notification: Elos Accurate® Hybrid Base™ (K201860) Elos Medtech Pinol A/S
INDICATIONS FOR USE
510(k) Number: K201860 Device Name: Elos Accurate® 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] |
|---|---|---|
| Nobel Replace NP | 3.5 | 3.5 |
| Nobel Replace RP | 4.3 | 4.3 |
| Nobel Replace WP | 5 | 5 |
| Nobel Replace 6.0 | 6 | 6 |
| Nobel CC 3.0 | 3 | 3 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel CC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
| Astra Tech 3.0 | 3 | 3 |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| Astra Tech EV 3.0 | 3 | 3 |
| Astra Tech EV 3.6 | 3.6 | 3.6 |
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 |
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 |
| Astra Tech EV 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |
Table 1.
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended 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, ceramic material, milling machine and associated tooling and accessories.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary Elos Accurate® Hybrid BaseTM February 19th, 2021
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Company: | Elos Medtech Pinol A/SEngvej 33DK-3330 GoerloeseDenmark |
|---|---|
| ---------- | --------------------------------------------------------------------- |
| Contacts: | Tina Friis Poulsen |
|---|---|
| Head of Compliance | |
| Tel: +45 27 77 11 17 | |
| E-mail: tina.poulsen@elosmedtech.com |
| Proprietary Trade Name: | Elos Accurate® Hybrid Base™ |
|---|---|
| Classification Name: | Endosseous Dental Implant Abutment |
| Classification: | Class II, 21 CFR 872.3630 |
| Product Code(s): | Primary: NHASecondary: PNP |
Identification of Legally Marketed Devices:
The design features, materials and Indications for Use of the subject devices are substantially equivalent to the predicate devices noted below.
Primary Predicate Device:
- . K191919 / SE 02/10/2020 - Elos Accurate® Hybrid Base™
Reference Devices:
- K180899 / SE 11/01/2018 Universal Base Abutment ●
- K171799 / SE 01/15/2018 Elos Accurate® Customized Abutment ●
- K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG .
- K151455. 3Shape A/S 3Shape Abutment Designer Software ●
- K964739 / SE 03/31/1997 Prosthetic Attachment Screw ●
- K011394, 3M Lava Plus Zirconia ●
Product Description:
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 zircoma superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos
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Accurate@ Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottom-half and the zirconia superstructure as the top-half.
The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (i.e. 3Shape Abut nent Designer IM Software, K151455) which facilitates the design of a patient specific zircoma superstructure by the laboratory/clinician. The Elos Accurate® Hybrid BaseTM fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zircoma superstructure must be designed according to following limits:
-
- Minimum wall thickness 0.5 mm
-
- Minimum post height 4.0 mm (for single unit restorations)
-
- Maximum gingival height 5.0 mm
-
- Maximum angulation 20°
The laboratory designed superstructure is attached to the Elos Accurate@ Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abument, K130436) and the final prosthetic restoration is attached to the implant using a Prosthetic screw. The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Indications for Use:
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prostletic 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] |
|---|---|---|
| Nobel Replace NP | 3.5 | 3.5 |
| Nobel Replace RP | 4.3 | 4.3 |
| Nobel Replace WP | 5 | 5 |
| Nobel Replace 6.0 | 6 | 6 |
| Nobel OC 3.0 | 3 | 3 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel OC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
| Astra Tech 3.0 | 3 | 3 |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| Astra Tech EV 3.0 | 3 | 3 |
| Astra Tech EV 3.6 | 3.6 | 3.6 |
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 |
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 |
| Astra Tech EV 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be designed and manufactured according to digital dentistry workflow system
{5}------------------------------------------------
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.
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 devices. In order to determine nominal dimensions and tolerances of the Elos Accurate® Hybrid Base™ 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 equivalent except for implant system compatibility and the approach for finalizing the zirconia superstructures. The implant system compatibility of the subject device is extended to include compatibility to the Braanemark implant system platform. 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 (leveraged from K171799) and new fatigue testing (provided with this subject 510(k)).
The subject devices and the primary predicate device are both intended to be used in a digital dentistry workflow which include scanning of patients' teeth setup, designing a zirconia. superstructure, manufacturing the superstructure and cementation of the superstructure to the Elos Accurate® Hybrid Base™
For the Primary Predicate Device (K1919) the digitally designed zirconia superstructures are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.
For the subject device, the design and fabrication of the zirconia superstructure will be conducted using a digital dentistry workflow requiring the use of following equipment:
- Scanner: 3Shape in scanner (accuracy >10um)
- Design Software: 3Shape Abutinent Designer Software (K151455)
- Zirconia Material: 3M Lava Plus Zirconia (K011394)
- Milling Unit: CORiTEC, Imes-Icore milling unit.
- Adhesive material: Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG (K130436)
Both the Reference Devices of K180899 and K151455 are intended to use a digital dentistry workflow by a dental practitioner or dental laboratory outside of an FDA registered approved milling facility to design and manufacture the superstructure component that composes the top half of a two-piece abutment. Thus, the Reference Devices of K180899 and K151455 account for the differences in indications compared to the Primary Predicate Device (K191919) to support substantial equivalence of the digital dentistry workflow of the subject device for the design and fabrication of the zirconia superstructure (K011394) cemented to the Hybrid Base™ for forming a two-piece abutment.
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| Indications for Use | Indications for Use | Indications for Use | Indications for Use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject DeviceElos Accurate® Hybrid Base™ | Primary Predicate Device (K191919)Elos Accurate® Hybrid Base™ | Reference Device (K180899)Universal Base Abutment | Reference Device (K151455)3Shape Abutment Designer™ Software | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| The Elos Accurate® Hybrid Base™ is intendedfor attaching to dental implants in order toprovide basis for single or multiple toothprosthetic restorations. The Hybrid Base™ isused as an interface between a dental implant anda zirconia superstructure and will be attached tothe implant using a prosthetic screw and attachedto the zirconia superstructure by cementing.The Elos Accurate® Hybrid Base™ iscompatible with the implant systems listed intable 1: | The Elos Accurate® Hybrid Base™ is intendedfor attaching to dental implants in order toprovide basis for single or multiple toothprosthetic restorations. The Hybrid Base™ isused as an interface between a dental implant anda zirconia superstructure and will be attached tothe implant using the included prosthetic screwand attached to the zirconia superstructure bycementing.The Elos Accurate® Hybrid Base™ iscompatible with the implant systems listed inTable 1. | The Universal Base Abutments arepremanufactured prosthetic components directlyconnected to endosseous dental implants and areintended for use as an aid in prostheticrehabilitation. The Universal Base Abutmentsconsist of two major parts. Specifically, thetitanium base and mesostructured componentsmake up a two-piece abutment. The systemintegrates multiple components of the digitaldentistry workflow: scan files from Intra-OralScanners, CAD software, CAM software,ceramic material, milling machine and associatedtooling and accessories.Compatible Implant platforms listed in table 1. | The 3Shape Abutment Designer Software isintended as an aid to the restoration ofchewing function in partially or fullyedentulous mandibles and maxillae. The3Shape Abutment Designer Software isintended for use by a dental practitioner ordental laboratory staff for designing thepatient specific component of a two-piece,one-piece, or hybrid dental implantabutment. The single or multi-unit abutmentdesign is intended to be used by themanufacturer of an endosseous dentalimplant abutment to create the final device. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Table 1. Implant Platformcompatibility Platformdiameter[mm] Implant Bodydiameter[mm] Nobel Replace NP 3.5 3.5 Nobel Replace RP 4.3 4.3 Nobel Replace WP 5 5 Nobel Replace 6.0 6 6 Nobel CC 3.0 3 3 Nobel CC NP 3.5 3.5 & 3.75 Nobel CC RP 3.9 4.3 & 5 Nobel CC WP 5.1 5.5 Straumann Bone 3.3 3.3 Straumann Bone 4.1 & 4.8 4.1 & 4.8 Astra Tech 3.0 3 3 Astra Tech 3.5/4.0 3.5 & 4 3.5 & 4 Astra Tech 4.5/5.0 4.5 & 5 4.5 & 5 Astra Tech EV 3.0 3 3 Astra Tech EV 3.6 3.6 3.6 Astra Tech EV 4.2 4.2 3.6 & 4.2 Astra Tech EV 4.8 4.8 4.2 & 4.8 Astra Tech EV 5.4 5.4 5.4 Brånemark NP 3.5 3.3 Brånemark RP 4.1 3.75, 4 & 5 Brånemark WP 5.1 5 & 6 | Table 1. Implant Platformcompatibility Platformdiameter[mm] Implant Bodydiameter[mm] Nobel Replace NP 3.5 3.5 Nobel Replace RP 4.3 4.3 Nobel Replace WP 5 5 Nobel Replace 6.0 6 6 Nobel CC 3.0 3 3 Nobel CC NP 3.5 3.5 & 3.75 Nobel CC RP 3.9 4.3 & 5 Nobel CC WP 5.1 5.5 Straumann Bone Level 3.3 3.3 Straumann Bone Level 4.1 & 4.8 4.1 & 4.8 Astra Tech 3.0 3 3 Astra Tech 3.5/4.0 3.5 & 4 3.5 & 4 Astra Tech 4.5/5.0 4.5 & 5 4.5 & 5 Astra Tech EV 3.0 3 3 Astra Tech EV 3.6 3.6 3.6 Astra Tech EV 4.2 4.2 3.6 & 4.2 Astra Tech EV 4.8 4.8 4.2 & 4.8 Astra Tech EV 5.4 5.4 5.4 | Table 1. Implant Platformcompatibility Platformdiameter[mm] Implant Bodydiameter[mm] Brånemark NP 3.5 3.3 Brånemark RP 4.1 3.75, 4 & 5 Brånemark WP 5.1 5 & 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| The zirconia superstructures for use with the ElosAccurate® Hybrid Base™ are only intended to | All digitally designed zirconia superstructures foruse with the Elos Accurate® Hybrid Base™ areonly intended to be sent and manufactured at an |
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| Indications for Use | Indications for Use | Indications for Use | Indications for Use |
|---|---|---|---|
| Subject Device | Primary Predicate Device (K191919) | Reference Device (K180899) Universal Base Abutment | Reference Device (K151455) 3Shape Abutment Designer™ Software |
| Elos Accurate® Hybrid Base™ | Elos Accurate® Hybrid Base™FDA registered Elos Medtech approved milling facility. | ||
| be designed and manufactured according todigital dentistry workflow. The workflow systemintegrates multiple components of the digitaldentistry workflow: scan files from Intra-OralScanners, CAD software, CAM software,ceramic material, milling machine and associatedtooling and accessories. |
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| Element of Comparison | Subject Device | PrimaryPredicate Device | ReferenceK171799 | ReferenceK180899 |
|---|---|---|---|---|
| Elos Accurate®Hybrid Base™Elos Medtech PinolA/S | K191919Elos Accurate®Hybrid Base™Elos MedtechPinol A/S | Elos Accurate®CustomizedAbutmentElos MedtechPinol A/S | Universal BaseAbutmentNobel Biocare AB | |
| Intended Use | Support of aprosthesis to restorechewing function | Support of aprosthesis torestorechewing function | Support of aprosthesis torestorechewingfunction | Support of a prosthesisto restorechewing function |
| Reason forPredicate/Reference | Not applicable | Abutment DesignEngineering anddimensionalanalysis | Engineering anddimensionalanalysis | digital dentistryworkflow |
| Abutment Designs | 2 piece - zirconiabonded to hybridbase mounted on tothe implant andfixed with a screw | 2 piece - zirconiabonded to hybridbase mounted onto the implant andfixed with a screw | Customizedabutmentmounted on theimplant fixedwith a screw | 2 piece - zirconiabonded to UniversalBase Abutmentmounted on to theimplant and fixed witha screw |
| Prosthesis Attachment | Abutment screw-retained to implantSuperstructurecement-retained | Abutment screw-retained to implantSuperstructurecement-retained | Abutmentscrew-retainedto implant | Abutment screw-retained to implantSuperstructure cement-retained |
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit |
| Abutment/ImplantPlatform Diameter (mm) | 3.0-6.0 | 3.0-6.0 | 3.5-5.1 | 3.5-5.1 |
| Abutment Angle | 20° maximum | 20° maximum | 20°-30°maximum | 20° maximum |
| Ti Base Material | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
| Screw Material | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
| Superstructure Material | 3M Lava PlusZirconia (K011394) | 3M Lava PlusZirconia(K011394) | Not applicable | Enamic (K153645) |
| Surface | Anodized, non-anodized,Medicarb/DLCcoating on screw | Anodized, non-anodized,Medicarb coatingon screw | Non-anodized,Medicarbcoating onscrew | DLC |
| Design Workflow | 3Shape intra oralscanner Trios(3Shape A/S),3Shape AbutmentDesigner Software(3Shape A/S) -K151455 | Elos Medtechapproved millingfacility. | Elos Medtechapprovedmilling facility. | 3Shape intra oralscanner Trios (3ShapeA/S), 3ShapeAbutment DesignerSoftware (3Shape A/S)- K151455 |
| ManufacturingWorkflow | CORITEC millingunit (Imes-Icore) | Elos Medtechapproved millingfacility. | Elos Medtechapproved | CORITEC milling unit(Imes-Icore) |
{9}------------------------------------------------
The data included in this submission demonstrate substantial equivalence to the predicate device and/or reference device listed above.
Overall, the subject device has the following substantial equivalencies to the predicate device:
- . has the same intended use,
- . uses the same operating principle.
- . incorporates the same basic design,
- incorporates the same or very similar materials, and
- is to be sterilized using the same processes. ●
Discussion of the Non-Clinical Testing:
Non-clinical testing data submitted (either in subject- or predicate submission) included:
- fatigue testing per ISO 14801 according to FDA guidance for Industry and FDA Staff "Class II Special ● Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" dated May 12, 2004.
- biocompatibility testing for cytotoxicity according to ISO 10993-5. ●
- . engineering and dimensional analysis of original manufactures' components (abutments & abutment screws) for determination of compatibility.
- Sterilization validation according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10-9. .
The digital dentistry workflow validation was completed on selected models of subject product line with a digital dentistry workflow including a 3Shape scanner, 3Shape Abutment Designer Software (K155415) and CORiTEC Imes-Icore milling unit. The validation was provided for the subject abutment design library (not allowing the user to design outside the design limits set by Elos Medtech) to demonstrate use with the 3Shape Abuttment Designer™ Software (K151455). The design library file (DME-file) provided by Elos Medtech includes design limits in accordance with Electronic Package insert - Instruction For Use, Surgical & Prosthetic Guide - In Lab Milling. The 3 Shape Abutment Designer™ Software (K151455) prevents designing outside the specified design limits in the library file.
Biocompatibility was evaluated according to ISO 10993-1 and the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16. 2016. Based on this guidance and the common usage of the employed materials demonstrating biocompatibility via cytotoxicity testing was found sufficient. A cytotoxicity test according to ISO 10993-5 of a complete restoration produced via the described validated workflow was performed.
Cytotoxicity testing on identically manufactured hybrid bases and prosthetic screws along with zirconia superstructures manufactured from the same material is also leveraged from previously 510(k) cleared products (K171799 and K 191919). All tests showed the products to be noncytotoxic.
Conclusions:
Based on the test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)