(213 days)
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutments are compatible with the following implant systems:
Ref. No. Platform compatibility Implant diameter
AB-BRA411213-US Nobel Biocare® / Brånemark® RP 3.75 mm & 4 mm
AB-BRA351213-US Nobel Biocare® / Brånemark® NP 3.3 mm
AB-BRA511213-US Nobel Biocare® / Brånemark® WP 5 mm
All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an Elos Medtech approved milling facility.
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an 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 Brånemark® endosseous dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® customized abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
The provided document is a 510(k) summary for a medical device (Elos Accurate® Customized Abutment). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, the requested information, particularly regarding acceptance criteria and the study that proves the device meets the acceptance criteria with specific performance metrics, sample sizes of test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, is not fully available in this type of regulatory document.
However, I can extract the information related to the non-clinical testing performed to support substantial equivalence, which serves a similar function in demonstrating device safety and effectiveness.
Here's an organized breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative table with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the non-clinical testing aims to demonstrate that the subject device's mechanical, material, and biological properties are equivalent to or better than the predicate device and comply with relevant international standards and FDA guidance.
| Test Performed | Acceptance Criteria Implied (Based on Standards/Guidance) | Reported Device Performance / Conclusion |
|---|---|---|
| Fatigue Testing | Compliance with ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) to demonstrate mechanical strength and ability to withstand 20° angulation. | Test substantiates an angulation of 20° and the mechanical strength for the subject device. |
| Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity). | Biocompatibility testing for cytotoxicity was conducted. (Implied successful completion and compliance, as no issues are reported and substantial equivalence is claimed). |
| Sterilization Validation | Compliance with ISO 17665-1 & ISO 17665-2, demonstrating a Sterility Assurance Level (SAL) of 10^-6. | Sterilization validation demonstrated a SAL of 10^-6. |
| Engineering and Dimensional Analysis | Compatibility with original manufacturers' components (abutments, implants & abutment screws) and determination of nominal dimensions and tolerances. | Data demonstrated engineering- and dimensional analysis for compatibility. (Implied successful fit and function with specified implant systems). The subject device has the same intended use, operating principle, basic design, similar materials, and sterilization processes as the predicate. |
| Abutment Screw DLC Coating Evaluation | Compliance with FDA "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) to support substantial equivalence to the DLC coated abutment screw reference device. | Evaluation of the abutment screw DLC coating supported substantial equivalence to the DLC coated abutment screw reference device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For engineering and biocompatibility tests, sample sizes are typically determined by relevant standards (e.g., ISO, ASTM), but specific numbers are not disclosed here. The document describes tests on the device itself, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes non-clinical testing of a physical medical device, not a diagnostic algorithm requiring expert-established ground truth from medical images or patient data.
4. Adjudication Method
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the document describes non-clinical testing of a physical medical device, not a diagnostic algorithm or AI assistance requiring human reader evaluation.
6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)
This information is not applicable as the document relates to a physical medical device (dental abutment), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665-1 & -2 for sterilization).
- Compliance with FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments").
- Physical measurements and engineering analysis compared against established specifications and predicate devices.
8. Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
January 23, 2018
Elos Medtech Pinol A/S Tina Poulsen RA/OA Manager Engvej 33 Goerloese, DK-3330 DENMARK
Re: K171799
Trade/Device Name: Elos Accurate® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 11, 2017 Received: December 14, 2017
Dear Tina Poulsen:
This letter corrects our substantially equivalent letter of January 15, 2018.
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. 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}------------------------------------------------
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE
510(k) Number: K171799 Device Name: 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 Abutments are compatible with the following implant systems:
| Ref. No. | Platform compatibility | Implant diameter |
|---|---|---|
| AB-BRA411213-US | Nobel Biocare® / Brånemark® RP | 3.75 mm & 4 mm |
| AB-BRA351213-US | Nobel Biocare® / Brånemark® NP | 3.3 mm |
| AB-BRA511213-US | Nobel Biocare® / Brånemark® WP | 5 mm |
All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an Elos Medtech approved milling facility.
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)
{3}------------------------------------------------
510(k) Summary Elos Accurate® Customized Abutment K171799 January 17, 2017
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| I. | Company: | Elos Medtech Pinol A/SEngvej 33DK-3330 GoerloeseDenmark |
|---|---|---|
| Contact: | Tina Friis PoulsenRA / QA ManagerTel: +45 27 77 11 17Fax: +45 48 21 64 69Email: tina.poulsen@elosmedtech.com | |
| II. | Proprietary Trade Name: | Elos Accurate® Customized Abutment |
| III. | Classification Name: | Endosseous Dental Implant Abutment |
| IV. | Classification: | Class II, 21 CFR 872.3630 |
| V. | Product Code(s): | NHA |
VI. Identification of Legally Marketed Devices:
The design features, materials and Indications for Use of the subject devices are substantially equivalent to the predicate devices noted below.
Primary Predicate Device:
- . K150203 / SE 10/23/2015 - Medentika PreFace CAD/CAM Abutments
Reference Devices:
- K992538 / SE 11 /23/1999 AMORPHOUS DIAMOND COATED SCREW ●
- K062749 / SE 11/29/2006 SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL . 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM
- K022562 / SE 10/11/2002 - VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION
VII. Product Description:
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic
{4}------------------------------------------------
restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an 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 Brånemark® endosseous dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® customized abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
VIII. Indications for Use:
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutments are compatible with the following implant systems:
| Ref. No. | Platform compatibility | Implant diameter |
|---|---|---|
| AB-BRA411213-US | Nobel Biocare® / Brånemark® RP | 3.75 mm & 4 mm |
| AB-BRA351213-US | Nobel Biocare® / Brånemark® NP | 3.3 mm |
| AB-BRA511213-US | Nobel Biocare® / Brånemark® WP | 5 mm |
All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an Elos Medtech approved milling facility.
IX. Summary of the Technological Characteristics:
The subject devices provide additional restorative options for connection to existing Nobel Biocare® Brånemark® implant platform (K022562 / SE 10/11/2002). The subject device has similar Indications for Use, intended use, designs, sizes and configurations, materials, and principles of operation as the primary predicate device Medentika PreFace CAD/CAM Abutments (K150203 / SE 10/23/2015). The subject device also include the Elos Prosthetic Screw with Medicarb coating equivalent to previously cleared reference device #1 (K992538 / SE 11 /23/1999). In order to determine nominal dimensions and tolerances of the Elos Accurate® Customized Abutment products, measuring- and dimensional analyses of original manufacturers' components (abutments, implants & abutment screws) have been made.
The specific language (wording) of the Indications for Use Statements are not identical. However, the subject device and corresponding primary predicates are all abutments intended for use with endosseous dental implants for support of single-tooth or multipletooth restorations in the upper or lower arch, and therefore, have the same intended use. The implant system compatibility of the subject device is limited to the Nobel Biocare® Branemark® NP, RP &WP platforms. However, these are also included for the predicate
{5}------------------------------------------------
device. Also, for the subject device, all digitally designed abutments are intended to be manufactured at an Elos Medtech approved milling facility which is equivalent to the predicate device.
| Element of Comparison | Indications for Use | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject Device (K171799)Elos Accurate® CustomizedAbutment | 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 following implant systems:Ref. No. Platform compatibility Implant diameter AB-BRA411213-US Nobel Biocare® / Brånemark® RP 3.75 mm & 4 mm AB-BRA351213-US Nobel Biocare® / Brånemark® NP 3.3 mm AB-BRA511213-US Nobel Biocare® / Brånemark® WP 5 mm | ||||||||||||||||||||||||||||||||||||||||||||
| Primary Predicate Device (K150203)Medentika PrefaceCAD/CAM Abutments | All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an Elos Medtech approved milling facility.Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.Implant System Compatibility Series Implant Diameter (mm) Platform Diameter (mm) Nobel BiocareReplace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, 4.3, 5.0, 6.0 Nobel BiocareNobelActive™ F 3.0, 3.5, 4.3, 5.0 3.0, 3.5, 3.9 (4.3),3.9 (5.0) Biomet 3i Osseotite®Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3i Osseotite® I 3.25, 3.75, 4.0,5.0 3.4, 4.1, 5.0 Nobel BiocareBrånemark K 3.3, 3.75, 4.0, 5.0 3.5, 4.1, 4.1, 5.1 Straumann Bone Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 Straumann Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8,6.5 Zimmer Tapered Screw-vent® R 3.3, 3.7, 4.1, 4.7,6.0 3.5, 4.5, 5.7 Astra TechOsseoSpeed™ S 3.0, 3.5, 4.0, 4.5,5.0 3.0, 3.5, 4.0, 4.5,5.0 Dentsply Friadent®Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, 3.8, 4.5, 5.5Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. |
{6}------------------------------------------------
| Subject Device (K171799) | Primary Predicate Device (K150203) | |
|---|---|---|
| Element of Comparison | Elos Accurate® Customized Abutment | Medentika Preface CAD/CAM Abutments |
| FDA Classification & Product Code | 21 CFR 872.3630: NHAEndosseous Dental Implant Abutment | 21 CFR 872.3630: NHAEndosseous Dental Implant Abutment |
| Base Materials | Elos Accurate® Customized Abutments:Titanium Alloy 6Al-4V ELI, medical grade 5Elos Prosthetic screws:Titanium Alloy 6Al-4V ELI, medical grade 5 | Medentika Preface CAD/CAM Abutments:Titanium Alloy 6Al-4V, medical grade 5Abutment screws:Titanium Alloy 6Al-4V, medical grade 5 |
| Surface Finish | Elos Accurate® Customized Abutment:Non-coatedElos Abutment screws:MediCarb (DLC) | Medentika Presafe CAD/CAM Abutments:Non-coatedAbutment screw:Non-coated |
| Implant interface | Internal Hexagon on abutment | Internal hexagon on abutment |
| Connection type | Flat top | Flat top |
| Abutment diameter | Ø3.5 - Ø5.1 mm | Ø3.5 - Ø5.1 mm |
| Prosthesis attachment | Cement-retained | Cement-retained |
| Restoration | Single-unit &Multi-unit | Single-unit & Multi-unit |
| Abutment Angle | Up to 20° | Up to 30° |
| Sterility | Provided non-sterile | Provided non-sterile |
| Sterilization method | Steam sterilization | Steam sterilization |
| Digital CAD Systems | 510(k) cleared CAD software | Straumann® CARES® CAD Software |
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
- are to be sterilized using the same processes. ●
The differences in surface finish and abutment angulation were further supported by:
- . evaluation of the abutment screw DLC coating on the subject device according 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,
{7}------------------------------------------------
2004 supporting substantial equivalence to the DLC coated abutment screw reference device.
- fatigue test conducted according to ISO 14801 that substantiates an angulation of 20° and . the mechanical strength for the subject device.
Discussion of the Non-Clinical Testing: X.
Non clinical testing data submitted 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.
- biocompatibility testing for cytotoxicity according to ISO 10993-5. ●
- sterilization validation were conducted according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10-6.
XI. Conclusions:
Based on the test results and additional supporting documentation provided in this premarket notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)