(207 days)
No
The summary describes a physical dental prosthetic component and a digital workflow for designing a superstructure, but there is no mention of AI or ML being used in the design, manufacturing, or function of the device. The digital workflow relies on standard CAD/CAM software and design libraries with pre-defined limits.
No
The device is an interface component for dental implant restorations and does not actively treat a disease or condition.
No
This device, the Elos Accurate® Hybrid Base™, is intended for attaching to dental implants to provide a basis for prosthetic restorations. It acts as an interface between a dental implant and a zirconia superstructure. Its function is to facilitate the attachment of a restoration, not to diagnose a medical condition.
No
The device description explicitly states it consists of a "pre-manufactured prosthetic component in Titanium alloy" and is a "two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half". This indicates the device includes physical hardware components. While it utilizes digital libraries and software for design, the core medical device is a physical implant component.
Based on the provided text, the Elos Accurate® Hybrid Base™ is not an In Vitro Diagnostic (IVD) device.
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 about a person's health.
- Elos Accurate® Hybrid Base™ Function: The text clearly states the device is intended for "attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations." It acts as an interface between a dental implant and a zirconia superstructure, both of which are physical components placed within the mouth.
- No Specimen Analysis: The device does not analyze any biological specimens to diagnose, monitor, or screen for diseases or conditions.
The device is a dental prosthetic component, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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 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] |
|---|---|---|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |
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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device 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 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 bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.
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 (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 (min. GH of 0.5mm)
-
- 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 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.
The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.
Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental implants
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental clinic, Laboratory/Clinician, 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
A design limitation test is performed with the purpose of demonstrating in 3Shape Dental System design software, that the user cannot design the zirconia superstructure for Elos Accurate Hybrid base outside the limitations built in the digital libraries relevant for this submission, provided by Elos Medtech.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted (either in subject- or predicate submission) included:
- fatigue testing was performed on the subject devices 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.
- . engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) was performed on the subject devices for determination of compatibility.
- . Sterilization validation according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10-6.
- . 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 predicate K201860 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 included design limits in accordance with Electronic Package insert - Instruction For Use, Surgical & Prosthetic Guide - In Lab Milling. The 3Shape Abutment Designer™ Software (K151455) prevents designing outside the specified design limits in the library file. Since the subject device use identical design and manufacturing workflow (as for the Primary Predicate Device K201860), including identical design limits build in the design library file (DME-file), the subject device does not represent any new worst case, than the worst case documented in K201860. Hence the new variants are thereby covered by existing workflow validation submitted in K201860.
- 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 K191919). All tests showed the products to be non-cytotoxic.
- . MR Conditional labeling testing is being leveraged from predicate devices in K222044 and the subject devices do not present a new worst-case for the leveraged testing.
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.
K191919, K222044, K013227, K122300, K163194, K180536, K201225, K140934, K153332, K150938
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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
Elos Medtech Pinol A/S Lise Terkelsen Regulatory Affairs Professional Engvei 33 Goerloese, 3330 DENMARK
Re: K230317
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: August 4, 2023 Received: August 7, 2023
Dear Lise Terkelsen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.
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) 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 (QS) 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 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
2
Traditional 510(k) Premarket Notification: Elos Accurate® Hybrid Base™ CONFIDENTIAL Elos Medtech Pinol A/S
INDICATIONS FOR USE
510(k) Number: K230317 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] |
|--------------------------------|---------------------------|--------------------------------|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |
Table 1.
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 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)
3
K230317
510(k) Summary Elos Accurate® Hybrid BaseTM Aug. 315, 2023
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| I. Company: | Elos Medtech Pinol A/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 Affair |
| | Tel: +45 20 66 64 42 |
| | E-mail: soren.rangstrup@elosmedtech.com |
| II. Proprietary Trade Name: | Elos Accurate® Hybrid Base™ |
| III. Classification Name: | Endosseous Dental Implant Abutment |
| IV. Classification: | Class II, 21 CFR 872.3630 |
| V. Product Code(s): | Primary: NHA |
| | Secondary: PNP |
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:
- K201860 / SE 02/19/2021 Elos Accurate® Hybrid Base™ .
Reference Devices:
- K191919 / SE 02/10/2020 Elos Accurate® Hybrid Base™ ●
- K222044 / SE 30/11/2022 Elos Accurate® Customized Abutunent .
- K013227 / SE 19/11/2001 ZimmerBiomet ●
- K122300 / SE 30/01/2013 - ZimmerBiomet
- K 163194 / SE 14/07/2014 JJGC Industria e Comercio de Materiais Dentarios SA .
- K180536 / SE 30/08/2018 JJGC Industria e Comercio de Materiais Dentarios SA ●
4
- . K201225 / SE 09/04/2020 - JJGC Industria e Comercio de Materiais Dentarios SA
- K140934 / SE 11/12/2014 - Hiossen Inc.
- . K153332 / SE 27/10/2016 - Hiossen Inc.
- K150938 / SE 24/07/2015 - Institut Straumann AG
VII. 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 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 bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.
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 (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 (min. GH of 0.5mm)
-
- 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 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.
The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.
Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.
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.
VIII. 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 prosthetic restorations. The Hybrid Base™ is used as an interface
5
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:
| Table 1. | ||
|---|---|---|
| Implant Platform | ||
| compatibility | Platform diameter | |
| [mm] | Implant Body diameter | |
| [mm] | ||
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard | ||
| WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ | |
| Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 |
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 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 Hiossen, Neodent, Zimmer, Biomet and Straumann implant system platforms. 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 zirconia superstructure for the subject device is either according to a digital dentistry workflow (identical to Primary Predicate Device K201860) or to be sent and manufactured at an FDA registered Elos Medtech approved milling facility (identical
6
to Reference Device K191919). The subject device does not represent any new worst case, and is thereby covered by existing workflow validation submitted in K201860, except the additional new digital libraries were validated as part of the subject submission, which included following:
-
Scanner: 3Shape scanner (accuracy >10μm)
-
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)
-
Zirconia Material: 3M Lava Plus Zirconia (K011394)
-
Milling Unit: CORiTEC, imes-icore milling unit
-
Adhesive material: Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG (K130436) or Panavia V5 by KURARAY NORITAKE DENTAL (K150704)
7
| Indications for Use
Subject Device | | Indications for Use
Primary Predicate Device (201860) | | Indications for Use
Reference Device (K191919) | | Discussion | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------------|
| Elos Accurate® Hybrid Base™ | | Elos Accurate® Hybrid Base™ | | 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: | | 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 (K201860)
and Reference Device (K191919), beside table 1.
which have been extended with 5 new implant
systems, and the approach for finalizing the
zirconia superstructure have been merged for the
Primary Predicate Device (K201860) and
Reference Device (K191919) so the zirconia
superstructure either can be manufactured at a
FDA registered Elos Medtech approved milling
facility or to be designed and manufactured
according to digital dentistry workflow.
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. | | | | |
| 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] |
| Zimmer | 03.5 | 03.7/04.1 | Nobel Replace NP | 3.5 | 3.5 | Nobel Replace NP | 3.5 | 3.5 |
| Zimmer | 04.5 | 04.7 | Nobel Replace RP | 4.3 | 4.3 | Nobel Replace RP | 4.3 | 4.3 |
| Zimmer | 05.7 | 06.0 | Nobel Replace WP | 5 | 5 | Nobel Replace WP | 5 | 5 |
| Biomet 3i | 03.4 | 03.25 | Nobel Replace 6.0 | 6 | 6 | Nobel Replace 6.0 | 6 | 6 |
| Biomet 3i | 04.1 | 04 | Nobel CC 3.0 | 3 | 3 | Nobel CC 3.0 | 3 | 3 |
| Biomet 3i | 05 | 05 | Nobel CC NP | 3.5 | 3.5 & 3.75 | Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Biomet 3i | 06 | 06 | Nobel CC RP | 3.9 | 4.3 & 5 | Nobel CC RP | 3.9 | 4.3 & 5 |
| Straumann | 04.8 | 03.3/04.1/04.8 | Nobel CC WP | 5.1 | 5.5 | Nobel CC WP | 5.1 | 5.5 |
| Straumann | 06.5 | 04.8 | Straumann Bone | 3.3 | 3.3 | Straumann Bone | 3.3 | 3.3 |
| Neodent GM | 03.5/04.5/05.5/0
6.5 | 03.5/03.75/04/04.3/0
5/0 6/0 7 | Straumann Bone | 4.1 & 4.8 | 4.1 & 4.8 | Straumann Bone | 4.1 & 4.8 | 4.1 & 4.8 |
| Hiossen ET
Mini | 03.2/03.5 | 03.2/03.5 | Astra Tech 3.0 | 3 | 3 | Astra Tech 3.0 | 3 | 3 |
| Hiossen ET
Regular | 04/04.5/05/
05.5/06/07 | 04/04.5/05/
05.5/06/07 | Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 | 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 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| | | | Astra Tech EV 3.0 | 3 | 3 | Astra Tech EV 3.0 | 3 | 3 |
| | | | Astra Tech EV 3.6 | 3.6 | 3.6 | Astra Tech EV 3.6 | 3.6 | 3.6 |
| | | | Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 | 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 4.8 | 4.8 | 4.2 & 4.8 |
| | | | Astra Tech EV 5.4 | 5.4 | 5.4 | Astra Tech EV 5.4 | 5.4 | 5.4 |
| | | | Brånemark NP | 3.5 | 3.3 | Brånemark NP | 3.5 | 3.3 |
| | | | Brånemark RP | 4.1 | 3.75, 4 & 5 | Brånemark RP | 4.1 | 3.75, 4 & 5 |
| | | | Brånemark WP | 5.1 | 5 & 6 | Brånemark WP | 5.1 | 5 & 6 |
| 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. | | The zirconia superstructures for use with the Elos
Accurate® Hybrid Base™ are only intended 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. | | All digitally designed zirconia superstructures for use
with the Elos Accurate® Hybrid Base™ are only
intended to be sent and manufactured at a FDA
registered Elos Medtech approved milling facility. | | | | |
Uncontrolled Copy
8
| Element of
Comparison | Subject Device | Primary Predicate
Device K201860 | Reference
K191919 | Discussion |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Elos Accurate®
Hybrid Base™
Elos Medtech Pinol
A/S | Elos Accurate®
Hybrid Base™
Elos Medtech Pinol
A/S | Elos Accurate®
Hybrid Base™
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 | Substantial
equivalent |
| Reason for
Predicate/Reference | Not applicable | Indication for Use,
Abutment Design
and manufacturing
workflow | Indication for Use,
Abutment Design
and manufacturing
workflow | N/A |
| Abutment Designs | 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 | 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
Superstructure cement-
retained | Abutment screw-
retained to implant
Superstructure
cement-retained | Abutment screw-
retained to implant
Superstructure
cement-retained | Substantial
equivalent |
| Restoration | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Substantial
equivalent |
| Abutment/Implant
Platform Diameter
(mm) | 3.2 - 7.0 | 3.0-6.0 | 3.0 - 6.0 | Implant diameter
for the subject
device is up to
7.0mm, which is
larger than the
primary predicate
device. The larger
diameter does not
represent a new
worst case scenario
and thereby affect
the safety of the
product. |
| Abutment Angle | 20° maximum | 20° maximum | 20°maximum | Substantial
equivalent |
| Materials | | | | |
| -Abutment | 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 | Substantial
equivalent |
| -Zirconia
superstructure | 3M Lava zirconia | 3M Lava zirconia | 3M Lava zirconia | Substantial
equivalent |
| Surface | Abutment: Anodized
Screw: Non-coated,
Medicarb coated | Abutment: Anodized
Screw: Non-coated,
Medicarb coated | Abutment: Anodized,
non-anodized
Screw: Non-coated
Medicarb coated | The Subject
Abutment is
anodized as the
predicate abutment.
The MediCarb
coating is identical |
| | | | | to the predicate
devices.
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 | Elos Medtech
approved milling
facility. | Substantial
equivalent |
| Manufacturing
Workflow | CORITEC milling unit
(Imes-Icore) | CORITEC milling
unit (imes-icore) | Elos Medtech
approved milling
facility. | Substantial
equivalent |
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.
X. Discussion of the Non-Clinical Testing:
Non-clinical testing data submitted (either in subject- or predicate submission) included:
- fatigue testing was performed on the subject devices 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.
- . engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) was performed on the subject devices for determination of compatibility.
- . Sterilization validation according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10 .
- . 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 predicate K201860 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 included design limits in accordance with Electronic Package insert - Instruction For Use, Surgical & Prosthetic Guide - In Lab Milling. The 3Shape Abutment Designer™ Software (K151455) prevents designing outside the specified design limits in the library file. Since the subject device use identical design and manufacturing workflow (as for the Primary Predicate Device K201860), including identical design limits build in the design library file (DME-file), the subject device does not represent any new worst case, than the worst case documented in
10
K201860. Hence the new variants are thereby covered by existing workflow validation submitted in K201860. A design limitation test is performed with the purpose of demonstrating in 3Shape Dental System design software, that the user cannot design the zirconia superstructure for Elos Accurate Hybrid base outside the limitations built in the digital libraries relevant for this submission, provided by Elos Medtech.
- 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 K191919). All tests showed the products to be non-cytotoxic.
- . MR Conditional labeling testing is being leveraged from predicate devices in K222044 and the subject devices do not present a new worst-case for the leveraged testing.
XI. 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.