Who is the manufacturer of Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment?

Elos Medtech Pinol A/S filed the 510(k) submission for Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment (K241722).

What is the FDA product code for Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment?

Elos Accurate® Hybrid Base™ (K230317).

Who can help prepare an FDA 510(k) submission like Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment

K241722 · Elos Medtech Pinol A/S · NHA · Sep 13, 2024 · Dental

Device Facts

Record ID	K241722
Device Name	Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment
Applicant	Elos Medtech Pinol A/S
Product Code	NHA · Dental
Decision Date	Sep 13, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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® 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.

Device Story

Patient-specific dental abutments; Hybrid Base (two-piece: titanium base + zirconia superstructure) or Customized Abutment (one-piece titanium). Inputs: digital scan files from intra-oral scanners. Transformation: CAD software (3Shape Abutment Designer) designs patient-specific geometry within pre-set library limitations; CAM software/milling unit fabricates components. Output: customized abutment or hybrid base interface. Used in dental clinics/laboratories; operated by dental professionals. Healthcare providers use output to restore chewing function; provides foundation for prosthetic crowns/bridges. Benefits: patient-specific fit for implant-supported restorations.

Clinical Evidence

Bench testing only. Evidence includes engineering/dimensional analysis, fatigue testing (ISO 14801), biocompatibility (ISO 10993-5), sterilization validation (ISO 17665), and MRI safety (ASTM F2052, F2119, F2213, F2182). Digital workflow validation confirmed CAD/CAM software restrictions prevent design outside specified limits.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136). Hybrid Base uses zirconia superstructure (3M Lava Plus). Sensing/Actuation: Mechanical connection to endosseous implants. Connectivity: Digital workflow integration (Intra-oral scanners, CAD/CAM). Sterilization: Steam (132°C). Software: Rule-based design library (DME-file) with hard-coded geometric constraints.

Indications for Use

Indicated for patients requiring single or multiple tooth prosthetic restorations supported by dental implants. Compatible with specific Straumann BLX and Astra Tech implant systems. No specific age or gender contraindications provided.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Elos Accurate® Hybrid Base™ (K230317)

Reference Devices

Elos Accurate® Customized Abutment (K231307)
3Shape Abutment Designer Software (K151455)
Straumann BLX Implant System (K173961)
Straumann BLX Line Extension (K181703)
Straumann BLX Ø3.5 mm Implants (K191256)
OSSEOSPEED NARROW (K080396)
OSSEOSPEED PLUS (K120414)
Lava Plus Zirconia (K011394)
Multilink Hybrid Abutment Cement (K130436)
Panavia V5 (K150704)

Related Devices

K233857 — Neodent Implant System Custom Abutments · JJGC Indústria e Comércio de Materiais Dentários S.A. · May 2, 2024
K160626 — ATLANTIS Abutment for HIOSSEN ET implant · Dentsply Sirona · Aug 29, 2016
K190097 — Straumann CARES Screw-Retained Bridges and Bars · Institut Straumann AG · Jun 26, 2019
K191890 — Elos Accurate Customized Abutment · Elos Medtech Pinol A/S · Feb 6, 2020
K160436 — CreoDent Solidex Custom Abutment · Creodent Prosthetics, Ltd. · Sep 29, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font. September 13, 2024 Elos Medtech Pinol A/S Lise Terkelsen Regulatory Affairs Professional Engvej 33 Goerloese. 3330 DENMARK Re: K241722 Trade/Device Name: Elos Accurate® Hybrid Base™: Elos Accurate® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: June 14, 2024 Received: June 14, 2024 Dear Lise Terkelsen: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) #### K241722 Device Name Elos Accurate Hybrid Base; Elos Accurate Customized Abutment #### Indications for Use (Describe) Elos Accurate Hybrid Base The Elos Accurate® Hybrid Base The intended for attaching to dental inplants in order to provide basis for dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | Table 1. | | | |-----------------------------------|---------------------------|---------------------------------| | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | | Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 | The zirconia superstructures for use with the Elos Accurate® Hybrid Base "" are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, ceramic material, milling machine and associated tooling and accessories. ## Elos Accurate Customized Abutment The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutment is compatible with the implant systems listed in table 1: Table 1. | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | |-----------------------------------|---------------------------|---------------------------------| | Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 | | Astra Tech 3.0 | Ø3. | Ø3 | | Astra Tech EV 3.0 | Ø3 | Ø3 | All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ ## 510(k) Summary K241722 Elos Accurate® Hybrid Base™, Elos Accurate® Customized Abutment September 13, 2024 This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR § 807.92. | I. Company: | Elos Medtech Pinol A/S Engvej 33 DK-3330 Goerloese Denmark | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Contacts: | Lise Terkelsen Regulatory Affairs Professional Tel: +45 21 61 12 25 E-mail: lise.terkelsen@elosmedtech.com | | | Søren Rangstrup Manager of Product Development & Regulatory Affairs Tel: +45 20 66 64 42 E-mail: soren.rangstrup@elosmedtech.com | | II. Proprietary Trade Name: | Elos Accurate® Hybrid Base™ Elos Accurate® Customized Abutment | | III. Classification Name: | Endosseous Dental Implant Abutment | Product Code(s): NHA as the primary product code PNP as the secondary product code #### VI. Identification of Legally Marketed Devices: The design features, materials and Indications for Use of the subject devices are substantially equivalent to the predicate device noted below. ## Primary Predicate Device: - K230317 / SE 09/01/2023 Elos Accurate® Hybrid Base™ ● ### Reference Devices: V. - K231307 / SE 12/21/2023 Elos Accurate® Customized Abutment ● - K151455 / SE 06/09/2016 3Shape Abutment Designer Software ● - K173961 / SE 06/05/2018 Straumann BLX Implant System ● - . K181703 / SE 12/28/2018 - Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutment - K191256 / SE 12/27/2019 Straumann BLX Ø3.5 mm Implants ● {6}------------------------------------------------ - K080396 / SE 04/30/2008 OSSEOSPEED NARROW . - . K120414 / SE 07/31/2012 – OSSEOSPEED PLUS {7}------------------------------------------------ #### VII. Product Description: The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ are both patientspecific components designed for attaching to dental implants, providing a basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ will be attached to the implant using the included Elos Prosthetic Screw. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the pre-manufactured prosthetic component, the Hybrid Base in Titanium alloy per ASTM F136, as the bottom-half, and the zirconia superstructure as the top-half, which the laboratory/clinic is designing by use of the 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455), which when assembled comprises the finished medical device. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) While the Elos Accurate® Customized Abutment is a one-piece abutment which consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The same applies to the Elos Accurate® Hybrid Base™ which fits directly to an endosseous dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate library files for both Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ have built-in design limitations, and the user isn't allowed to exceed these limitations as follows: | Customized Abutments: | Hybrid Base abutments (zirconia part): | |-----------------------------------------|-----------------------------------------| | Min. wall thickness 0.4 mm | Min. wall thickness 0.5 mm | | Gingival height min. 0.5mm or max. 5 mm | Gingival height min. 0.5mm or max. 5 mm | | Max. angulation 20° or 30°. | Max. angulation 20°. | | Min. post height* 4 mm | Min. post height* 4 mm | *The post height is defined as the cementable height of the abutment. The Elos Accurate® Customized Abutment and the Elos Accurate® Hybrid Base™ are both delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. #### VIII. Indications for Use: Customized Abutment The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. {8}------------------------------------------------ The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1: Tahle 1 | Table 1. | | | |-----------------------------------|---------------------------|---------------------------------| | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | | Straumann BLX RB/ WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 | | Astra Tech 3.0 | Ø3. | Ø3 | | Astra Tech EV 3.0 | Ø3 | Ø3 | All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories. ## Hybrid Base The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | |-----------------------------------|---------------------------|---------------------------------| | Straumann BLX RB/ WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 | The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. #### IX. Summary of the Technological Characteristics: The subject devices provide additional restorative options for connection to existing implant platforms. The subject devices have similar Indications for Use, intended use, designs, sizes and configurations, materials, and principles of operation as the predicate device. In order to determine nominal dimensions and tolerances of the Elos Accurate® Hybrid Base™ and Elos Accurate® Customized Abutment products, measuring- and dimensional analyses of original manufacturers' components (abutments, implants & abutment screws) have been made. Comparing to the primary predicate device, the specific language (wording) of the Indications for Use Statements is identical except for implant system compatibility. The implant system {9}------------------------------------------------ compatibility of the subject device is extended to include compatibility to the Straumann BLX and Astra Tech EV Implant system platforms for Customized Abutment and Straumann BLX for Hybrid Base. The difference in implant system compatibility is substantiated by engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility and new fatigue testing. The approach of designing and manufacturing the Customized Abutment or zirconia superstructure (Hybrid Base) for the subject device is either according to a digital dentistry workflow or to be sent and manufactured at an FDA registered Elos Medtech approved milling facility (identical to Primary Predicate Device K230317). The subject device does not represent any new worst case, and is thereby covered by existing workflow validation submitted in K230317 and K231307. except the additional new digital libraries were validated as part of the subject submission, which included following: - Scanner: 3Shape scanner (accuracy >10um) - Design library file (DME-file) provided by Elos Medtech which includes design limits in accordance with "Instruction For Use" - Design Software: 3Shape Abutment Designer Software (K151455) - Milling Unit: CORiTEC, imes-icore milling unit - Zirconia Material: 3M Lava Plus Zirconia (K011394) (only relevant for Elos Accurate Hybrid Base) - Adhesive material: Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG (K130436) or Panavia V5 by KURARAY NORITAKE DENTAL (K150704) (only relevant for Elos Accurate Hybrid Base) {10}------------------------------------------------ | Indications for Use Subject Device Elos Accurate® Customized Abutment | Indications for Use Reference Device (K231307) Elos Accurate® Customized Abutment | Indications for Use Subject Device Elos Accurate® Hybrid Base™ | Indications for Use Primary Predicate Device (K230317) Elos Accurate® Hybrid Base™ | Discussion | | | | | | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------|--------------------------------------|------------------------------|----------------------------------|--| | The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutment is compatible with the implant systems listed in table 1: | The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1: | The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | The Indication for use for the subject device is similar to the Primary Predicate Device, beside table 1. which have been replaced with for Customized Abutment 3 new implant systems and for Hybrid Base 1 new implant system, and the approach for finalizing the zirconia superstructure is the same. The difference in implant system compatibility is substantiated by engineering and dimensional analysis of original manufactures' components (abutments, implants & screws) for determination of compatibility and new fatigue testing. | | | | | | | | | | Table 1. | Table 1. | Table 1. | Table 1. | | | | | | | | | | | Implant Platform compatibility | Platform diamet er [mm] | Implant Body diameter [mm] | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | | | Straumann BLX RB/WB | $Ø3.4/Ø3.5/04.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5$ | Zimmer Screw- vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 | Straumann BLX RB/WB | $Ø3.4/Ø3.5/Ø4.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5$ | Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 | | | Astra Tech 3.0 | Ø3 | Ø3 | Zimmer Screw- vent 4.5 | Ø4.5 | Ø4.7 | The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. | Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 | | | | | Astra Tech EV 3.0 | Ø3 | Ø3 | Zimmer Screw- vent 5.7 | Ø5.7 | Ø6.0 | | Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 | | | | | All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories. | | | Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 | | Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 | | | | | | | | Biomet 3i Certain 4.1 | Ø4.1 | Ø4 | Biomet 3i Certain 4.1 | Ø4.1 | Ø4 | | | | | | | | | Biomet 3i Certain 5.0 | Ø5 | Ø5 | Biomet 3i Certain 5.0 | Ø5 | Ø5 | | | | | | | | | Biomet 3i Certain 6.0 | Ø6 | Ø6 | Biomet 3i Certain 6.0 | Ø6 | Ø6 | | | | | | | | | Straumann Standard RN | Ø4.8 | $Ø3.3/Ø4.1/Ø4.8$ | Straumann Standard RN | Ø4.8 | $Ø3.3/Ø4.1/Ø4.8$ | | | | | | | | | Straumann Standard WN | Ø6.5 | Ø4.8 | Straumann Standard WN | Ø6.5 | Ø4.8 | | | | | | | | | Neodent GM | $Ø3.5/Ø4.5/Ø5.5/Ø 6.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø7$ | Neodent GM | $Ø3.5/Ø4.5/Ø5.5/Ø 6.5$ | $Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7$ | | | | | | | | | Hiossen ET Mini | Ø3.2/03.5 | Ø3.2/03.5 | Hiossen ET Mini | Ø3.2/03.5 | Ø3.2/03.5 | | | | | {11}------------------------------------------------ | Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories. | | The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. | | | Element of Comparison | Subject Device | Reference device K231307 | Subject Device | Primary Predicate Device K230317 | Discussion | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Elos Accurate® Customized Abutment | Elos Accurate® Customized Abutment…