(228 days)
No
The summary describes a physical dental prosthetic component and a digital library file for use with existing CAD software. There is no mention of AI or ML being used in the design, manufacturing, or function of the device itself or the associated software.
No.
The Elos Accurate® Hybrid Base™ is an interface component used in dental implant restorations; its function is mechanical support. It does not provide any diagnostic, preventive, or active therapeutic action.
No
Explanation: The device 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 support a prosthetic restoration, not to diagnose a condition or disease.
No
The device description explicitly states the device consists of a "pre-manufactured prosthetic component in Titanium alloy per ASTM F136," which is a hardware component. While it includes a digital library file for software, the core device is a physical object.
Based on the provided information, the Elos Accurate® Hybrid Base™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations." This describes a device used in vivo (within the body) for structural support of dental prosthetics.
- Device Description: The description further clarifies its function as an "interface between a dental implant and a zirconia superstructure," and how it is attached using screws and cement. This reinforces its role as a physical component for dental restoration.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Elos Accurate® Hybrid Base™ does not perform any such function. It is a physical component used in a surgical and restorative procedure.
- Anatomical Site: The anatomical site is "dental implants," which are placed within the patient's jawbone. This is an in vivo application.
- Input Imaging Modality: While it uses "scan files from Intra-Oral Scanners," this is for designing the superstructure, not for analyzing biological specimens.
- Performance Studies: The performance studies focus on mechanical properties (fatigue), biocompatibility, and sterilization, which are relevant for implantable or surgically placed devices, not IVDs.
In summary, the Elos Accurate® Hybrid Base™ is a dental prosthetic component used in vivo and does not fit the definition of an In Vitro Diagnostic device.
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] |
|---|---|---|
| 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.
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 zircoma 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan files from Intra-Oral Scanners
Anatomical Site
dental implants
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner or dental laboratory staff / dental clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data 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.
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.
K180899, K171799, K130436, K151455, K964739, K011394
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 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.
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 (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
2
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)
3
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/S
Engvej 33
DK-3330 Goerloese
Denmark |
| ---------- | --------------------------------------------------------------------- |
|---|
| 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: NHA |
| Secondary: 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
4
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 Device | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Elos 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 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 the included 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 Universal Base Abutments are | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| premanufactured prosthetic components directly | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| connected to endosseous dental implants and are | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| intended for use as an aid in prosthetic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| rehabilitation. The Universal Base Abutments | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| consist of two major parts. Specifically, the | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| titanium base and mesostructured components | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| make up a two-piece abutment. The 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Compatible Implant platforms listed in table 1. | The 3Shape Abutment Designer Software is | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| intended as an aid to the restoration of | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| chewing function in partially or fully | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| edentulous mandibles and maxillae. The | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 3Shape Abutment Designer Software is | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| intended for use by a dental practitioner or | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| dental laboratory staff for designing the | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| patient specific component of a two-piece, | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| one-piece, or hybrid dental implant | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| abutment. The single or multi-unit abutment | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| design is intended to be used by the | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| manufacturer of an endosseous dental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| implant abutment to create the final device. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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 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 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 Platform | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| compatibility Platform | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| diameter | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| [mm] Implant Body | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| diameter | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| [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 Elos | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accurate® Hybrid Base™ are only intended to | All digitally designed zirconia superstructures for | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| use with the Elos Accurate® Hybrid Base™ are | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| only intended to be sent and manufactured at an |
7
| 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 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. |
8
| Element of Comparison | Subject Device | Primary
Predicate Device | Reference
K171799 | Reference
K180899 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Elos Accurate®
Hybrid Base™
Elos Medtech Pinol
A/S | K191919
Elos Accurate®
Hybrid Base™
Elos Medtech
Pinol A/S | Elos Accurate®
Customized
Abutment
Elos Medtech
Pinol A/S | Universal Base
Abutment
Nobel Biocare AB |
| Intended Use | Support of a
prosthesis to restore
chewing function | Support of a
prosthesis to
restore
chewing function | Support of a
prosthesis to
restore
chewing
function | Support of a prosthesis
to restore
chewing function |
| Reason for
Predicate/Reference | Not applicable | Abutment Design
Engineering and
dimensional
analysis | Engineering and
dimensional
analysis | digital dentistry
workflow |
| 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 | Customized
abutment
mounted on the
implant fixed
with a screw | 2 piece - zirconia
bonded to Universal
Base Abutment
mounted on to the
implant and fixed with
a screw |
| Prosthesis Attachment | Abutment screw-
retained to implant
Superstructure
cement-retained | Abutment screw-
retained to implant
Superstructure
cement-retained | Abutment
screw-retained
to implant | Abutment screw-
retained to implant
Superstructure cement-
retained |
| Restoration | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit |
| Abutment/Implant
Platform 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 Plus
Zirconia (K011394) | 3M Lava Plus
Zirconia
(K011394) | Not applicable | Enamic (K153645) |
| Surface | Anodized, non-
anodized,
Medicarb/DLC
coating on screw | Anodized, non-
anodized,
Medicarb coating
on screw | Non-anodized,
Medicarb
coating on
screw | DLC |
| Design Workflow | 3Shape intra oral
scanner Trios
(3Shape A/S),
3Shape Abutment
Designer Software
(3Shape A/S) -
K151455 | Elos Medtech
approved milling
facility. | Elos Medtech
approved
milling facility. | 3Shape intra oral
scanner Trios (3Shape
A/S), 3Shape
Abutment Designer
Software (3Shape A/S)
- K151455 |
| Manufacturing
Workflow | CORITEC milling
unit (Imes-Icore) | Elos Medtech
approved milling
facility. | Elos Medtech
approved | 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.