(463 days)
ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.
ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.
The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system. ICX-Implant System, from medentis medical GmbH. The ICX-Implant System includes a range of endosseous dental implants and prosthetic components. All implants have a selftapping apical thread with a tapered body and root-form designs with an internal hex implant/abutment connection. The implant body surface is blasted and acid-etched.
Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations.
The provided text is a 510(k) summary for the "ICX-Implant System." This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a standalone performance study.
Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria for AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test/training set in the context of an AI device.
The document does describe non-clinical performance data for the dental implant system itself (e.g., sterilization, biocompatibility, mechanical testing) to show its safety and effectiveness, but not for an AI component.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance:
-
Missing: The document does not define "acceptance criteria" in the context of an AI/algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of the ICX-Implant System and its components to predicate devices based on technological characteristics, materials, and indications for use.
-
The "Performance Data" section (Page 7) lists non-clinical tests performed, such as:
- Validation of gamma irradiation sterilization to a sterility assurance level (SAL) of 10⁻⁶.
- Bacterial endotoxin testing: < 20 EU/device.
- Validation of moist heat sterilization cycle to SAL of 10⁻⁶.
- Shelf life testing confirming seal integrity and sterility after 5 years.
- Biocompatibility testing (in vitro cytotoxicity).
- Characterization of implant surface (SEM, surface chemistry, hydrophilicity).
- Mechanical testing according to ISO 14801 (static and dynamic loading).
- Analysis of surface area and initial bone to implant contact area.
- MR compatibility testing (supporting MR Conditional labeling).
These are performance requirements for a dental implant and are confirmed to have been met, but they are not "acceptance criteria" for an AI algorithm's diagnostic performance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Missing: No information on test set size or data provenance for an AI/algorithm is provided. The document explicitly states: "No clinical data were included in this submission" (Page 8). The non-clinical tests listed above would have had specific sample sizes for those tests (e.g., number of implants for mechanical testing), but these are not detailed in the summary beyond stating the tests were performed "accordance with" relevant standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing: Not applicable as no AI/algorithm performance test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Missing: Not applicable as no AI/algorithm performance test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Missing: No MRMC study was done, as no AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: No standalone algorithm performance study was done, as no AI component is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Missing: Not applicable as no AI/algorithm performance is described. The "ground truth" for the implant itself is its conformance to material standards, mechanical properties, and biocompatibility, as verified by laboratory tests.
8. The sample size for the training set:
- Missing: No training set for an AI/algorithm is mentioned.
9. How the ground truth for the training set was established:
- Missing: No training set for an AI/algorithm is mentioned.
In summary:
This 510(k) pertains to a dental implant system (a physical device) and its components (e.g., abutments), not a software as a medical device (SaMD) or an AI-powered diagnostic/assistance tool. The entire submission is built on demonstrating substantial equivalence to existing, legally marketed predicate devices through a comparison of their technological characteristics, materials, and non-clinical performance data relevant to the physical implant and its function. It explicitly states that "No clinical data were included in this submission," further confirming that no human-in-the-loop or standalone diagnostic performance studies (which would be typical for AI/ML devices) were conducted or are required for this type of submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
medentis medical GmbH % Floyd Larson President PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
September 5, 2024
Re: K231566
Trade/Device Name: ICX-Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 7, 2024 Received: August 8, 2024
Dear Floyd Larson:
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.
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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.
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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
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Indications for Use
510(k) Number (if known)
Device Name ICX-Implant System
Indications for Use (Describe)
ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.
ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Beneficial Use (R-1, 31 CFR 336.1(b) and (d)) | Beneficial Use (R-1, 31 CFR 336.1(b) and (d)) | |
| Beneficial Use (R-1, 31 CFR 336.1(b) and (d)) | ||
| On-Site Containment Use (31 CFR 336.1(c)) | On-Site Containment Use (31 CFR 336.1(c)) | |
| On-Site Containment Use (31 CFR 336.1(c)) |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary medentis medical GmbH ICX-Implant System
September 5, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | medentis medical GmbHWalporzheimer Strasse 48-52Bad Neuenahr-Ahrweiler, 53474, GermanyTelephone +49 2641 9110-171Fax +49 2641 9110-120 |
|---|---|
| Official Contact | Alexander Scholz, CEO |
| Representative/Consultant | Floyd G. Larson, MS, MBAKevin A. Thomas, PhDPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: flarson@paxmed.com; kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | ICX-Implant System |
|---|---|
| Common Names | Endosseous dental implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Health Technology 1B (Dental and ENT Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K 130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA,
Reference Devices K133510, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentarios SA K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K222288, DESS Dental Smart Solutions, Terrats Medical SL K 193096, S.I.N. Dental Implant System, S.I.N. -Sistema de Implante Nacional S.A. K213063, TLX SRAs and TLX Gold Abutments, Institut Straumann AG
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K092035, Bicon Implants with a 2.5 mm Internal Connection, Bicon, L.L.C. K140440, Noris Medical Dental Implants System, Noris Medical, Ltd. K193046, Straumann® Retentive System - Novaloc TiN Abutments, Institut Straumann AG K153779, Abutment for Bridges, Altatec GmbH K203252, Multi-unit Abutments for CONELOG®, BioHorizons Implant Systems, Inc. K191123, Multi-unit Abutments, Medentika GmbH, Straumann USA, LLC K170131, TAV Medical Dental Implant System, Tav Medical Ltd. K233208, NobelProcera® Titanium ASC Abutment, Nobel Biocare AB K212108, Dynamic TiBase, Talladium España, SL
INDICATIONS FOR USE STATEMENT
ICX Implant Systems is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX Implant Systems is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.
ICX Implant Systems CAD-CAM abutments are intended for use with dental implants as a support for single-unit or multiple-unit prostheses in the maxilla or mandible of a partially or fully edentulous patient. All digitally designed abutments for use with ICX Implant Systems CAD-CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system. ICX-Implant System, from medentis medical GmbH. The ICX-Implant System includes a range of endosseous dental implants and prosthetic components. All implants have a selftapping apical thread with a tapered body and root-form designs with an internal hex implant/abutment connection. The implant body surface is blasted and acid-etched.
Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations.
Table 1. ICX-Implant System Overview contains an overview of the system images and features.
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| Implants | ||||||
|---|---|---|---|---|---|---|
| Implant Line | ICX-Premium | ICX-Diamond Premium | ICX-Active Master | ICX-Diamond Active Master | ICX-Active Liquid | |
| ImageNot to Scale | Image: ICX-Premium | Image: ICX-Diamond Premium | Image: ICX-Active Master | Image: ICX-Diamond Active Master | Image: ICX-Active Liquid | |
| Placement | Bone LevelTissue Level | Bone LevelTissue Level | Bone LevelTissue Level | Bone LevelTissue Level | Bone Level | |
| Collar Design | Micro-threaded collar | Micro-threaded collar | Threaded to top | Threaded to top | Threaded to top | |
| Packaging | Air | Saline | Air | Saline | Saline | |
| Material | Unalloyed titanium | Unalloyed titanium | Unalloyed titanium | Unalloyed titanium | Unalloyed titanium | |
| Body Ø (mm) | 3.43 - 4.8 | 3.43 - 4.8 | 3.43 - 4.8 | 3.43 - 4.8 | 3.43 - 4.8 | |
| Platform Ø (mm) | 3.3 - 3.7 | 3.3 - 3.7 | 3.3 - 3.7 | 3.3 - 3.7 | 3.3 - 3.7 | |
| EndosseousLengths* (mm) | 8 - 155 - 12.5 | 8 - 155 - 12.5 | 8 - 15 | 8 - 15 | 8 - 15 | |
| *Tissue Level implants have a 1.7 mm gingival collar (2.7 mm for 5 mm length). Overall length of Tissue Level implants is 1.7 mm (2.7 mm) greater than shown. | ||||||
| Healing Components, Abutments, Screws | ||||||
| ICX-Cover Screw ICX-Healing Cap ICX-Titanium Abutment ICX-Titanium Aesthetic Abutment ICX-Massive Abutment ICX-Universal Abutment ICX-Bar System Abutment ICX-Maximus Abutment ICX-UCLA Abutment ICX-Multi Abutment ICX-Adhesive Base Abutment (CAD/CAM) Healing Components, Abutments | ICX-3.3 Connection Screw ICX-3.3 Multi Connection Screw ICX Connection Screw Type A ICX Connection Screw Type B ICX Multi Connection Screw ICX Multi Prosthetics Screw ICX Maximus Connection Screw Screws |
Table 1. ICX-Implant System Overview
MATERIAL COMPOSITION
All subject device dental implants are manufactured from cold worked unalloyed titanium Grade 4 conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) and Grade 4B conforming to ISO 5832-2 Implants for surgery – Metallic materials – Part 2: Unalloyed titanium. The threaded endosseous surface of the implant is blasted and acid-etched from the implant collar to the apex.
Subject device healing components. (cover screws and healing caps) are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or PEEK-Classix™ by Invibio.
Subject device abutments are manufactured from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for
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Surgical Implant Applications (UNS R56401), cobalt-chromium alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539), or gold alloy (Ceramicor). The ICX-Multi Interim Abutment is manufactured from PEEK-Classix™ by Invibio. The burn-out sleeve packaged with the ICX-UCLA Abutments and ICX-CoCr Abutment is manufactured from polyoxymethylene (POM). The retention rings that are used with the denture housing are manufactured from nylon (Grilamid).
The material for manufacture of zirconia superstructures for Adhesive Base Abutments is yttria-stabilized zirconia (Y-TZP) from Dental Direkt GmbH (K150196, K142987, K170885, K183569). The cement recommended in labeling for bonding of superstructures is Panavia F 2.0 cement by Kuraray Medical, Inc. cleared under K032455.
The subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
SURFACE TREATMENTS
The threaded endosseous surface of the subject device implants is grit-blasted and acid-etched from the implant collar to the apex. The subject device Maximus abutments have a titanium nitride (TiN) coating applied to the coronal end of the abutment. Some subject device abutments are anodized for color coding purposes.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
- validation of gamma irradiation sterilization for subject devices provided sterile to the end user to a . sterility assurance level of 10 by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose;
- . bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing on samples from sterilized product to demonstrate all sterile product meets a limit of < 20 EU/device;
- . validation of the recommended moist heat sterilization cycle by the overkill method to a sterility assurance level (SAL) of 10° according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, and ISO/TR 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1;
- shelf life testing, including testing of samples after 5 years of real time aging according to ASTM . F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration and F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials, and sterility testing of product;
- . biocompatibility testing of samples representing all subject device material (including zirconia from Dental Direkt GmbH) and manufacturing processes according to ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity, and ISO 10993-12
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Biological evaluation of medical devices – Part 12: Sample preparation and reference materials, including ;
- characterization of the implant acid-etched surface included scanning electron microscopy (SEM) . and surface chemistry analysis;
- Characterization of TiN coated and anodized surfaces; ●
- Characterization of super hydrophilicity by contact angle measurements before and after aging; ●
- mechanical testing according to ISO 14801 Dentistry Implants Dynamic loading test for ● endosseous dental implants;
- . analysis of the surface area and initial bone to implant contact area of short implants and comparison with a reference device;
- MR compatibility testing to support labeling as MR Conditional
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
Substantial Equivalence of Indication for Use Statement (IFUS)
The Indications for Use Statement (IFUS) of the subject device implants compared to those of the primary predicate and reference devices are detailed below in Table of Substantial Equivalence – Indications for Use Statement. The IFUS for the subject device is substantially equivalent to that of the primary predicate K130222 and reference device K133510, K163194, K222288, K193096, K213063, and K092035. There is a difference in terminology used, however, the intended use is the same. All implants are intended to be used with dental implants for support for prosthetic restoration for edentulous or partially edentulous patients. Delayed loading indications have been added for the short implants (endosseous length less than 7 mm). The digitally designed abutments are to be sent to a validated milling center for manufacture similar to reference devices K163194, K22288 and K193096.
Substantial Equivalence of Technological Characteristics - Implants
The subject device implant offers two (2) implant placement types: bone level and tissue level, similar to the primary predicate K130222. The subject device implant has an internal connection similar to the primary predicate K130222, however, the subject device has an internal hex and primary predicate K 130222 has an internal octagon. Any risks that may be associated with different implant placement levels and implant/abutment connection, have been mitigated by mechanical testing
The subject device implants have body diameters ranging from 3.43 mm. The smallest subject device body diameter is similar to that of the primary predicate K130222.. The largest and smallest subject device diameters are similar to those of primary predicate K130222.
The subject device implant length of 8 mm to 15 mm is similar to the primary predicate K 130222 (implants with 8 mm to 16 mm length) and the reference device K133510 (implants with 9 mm to 19 lengths).
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The subject device includes short implants (defined as implants with endosseous length less than 7 mm) with endosseous lengths of 5 mm and 6.5 mm. The short implants are available only with one implant line, the ICX-Premium TL and ICX-Diamond Premium TL tissue level implant. Both implant lengths are offered with a 4.8 mm implant diameter. These dimensions are similar to those of the reference device K092035 with implants having a 5 mm length and a 4.0 mm implant diameter. A surface area evaluation and bone to implant contact computation have been conducted comparing the short subject device implants to the reference device.
The subject device implants are manufactured from the same material (unalloyed titanium Grade 4) and have the same endosseous surface treatment (grit-blasted and acid-etched) as the reference device K133510. Any risks that may be associated with the surface treatment have been mitigated by biocompatibility evaluation and surface treatment evaluation.
The subject device implants are provided sterile to the user, for single patient, single use, the same as the primary predicate and reference devices.
Substantial Equivalence of Technological Characteristics - Prosthetic Components
The technological characteristics of the subject device abutments are compared to the reference devices, shown below in Tables 2-10 Table of Substantial Equivalence – Technological Characteristics. Table 3. Table of Substantial Equivalence - Technological Characteristics. The primary predicate K130222 is not being used to evaluate these characteristics, as it is included only for evaluation of the implants. The reference device K092035 is not being used to evaluate these characteristics, as it is included only for evaluation of surface area of short implants.
The subject device healing component offers diameters that range from 2.6 mm to 8.0 mm with a threaded connection. The range of diameters is similar to those of the reference devices. The subject device healing components are used only for healing purposes and are placed out of occlusion, therefore mechanical strength is not a risk that requires mitigation.
The subject device abutments are provided in diameters that range from 3.7 mm with a hex connection and angulation of 0°, 15°, and 25°. The diameters, connections, and angulations are similar to those of the reference device abutments.
The subject device overdenture abutments are provided in diameters that range from 4.5 mm to 7.0 mm with a hex connection. The subject device diameters are similar to those of the reference device K133510. The subject device overdenture abutments are not intended for angulation or angle correction, and therefore mechanical strength is not a risk requiring mitigation.
The subject device UCLA abutments are provided in diameters that range from 4.4 mm to 5.0 mm with a hex and non-hex connection. The subject device diameters are similar to those of the reference device K193096. The subject device UCLA abutments are two-part cast-on abutments consisting of a cobaltchromium alloy or gold base and a polyoxymethylene (POM) burn-out sleeve. The POM burn-out sleeve can be cast in cobalt-chromium alloy or nickel-chromium alloy. This is similar to those of the reference device K193096 and K213063. The subject device UCLA abutments are not intended for angulation or angle correction.
The subject device Multi abutments are provided in diameter of 4.8 mm with a hex, non-hex, and threaded connection and angulation of 0°, 17° and 30°. The subject device diameters, connection, and
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angulation are similar to those of the reference device K222288. The subject device abutment does not have a diameter smaller or larger, or an angulation greater than those of the reference device K22288.
The subject device base abutments are provided in diameters ranging from 4.4 mm to 5.1 mm with a hex and non-hex connection and angulation up to 15° using a base manufactured from titanium alloy or Co-Cr alloy and a zirconia superstructure. The subject device diameters, connection, and material are similar to those of the reference devices K163194 and K222288. The subject device abutment does not have a diameter smaller or larger, a greater angulation, or material different than those of the reference device K136194 and K222288. The two-pieces of the Ti Base abutment which compose the final abutment consist of the pre-manufactured titanium base component composed of titanium alloy and the CAD/CAM patient matched superstructure composed of zirconia.
All subject device abutments (healing components, abutments, and ball abutments) are made from titanium alloy (ASTM F136), cobalt-chromium alloy (ASTM F1537), gold alloy (Ceramicor), and PEEK-CLASSIX™, which is same as the reference devices.
Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use.
- . uses the same operating principle,
- . incorporates the same basic design,
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. ●
The basis for the belief of medentis medical GmbH that the subject device is substantially equivalent to the predicate devices is summarized in the following tables, Table of Substantial Equivalence -Indications for Use Statement and Tables 3-11 Table of substantial Equivalence – Technological Characteristics.
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| Indications for Use Statement | |
|---|---|
| Subject device | ICX Implant Systems is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX Implant Systems is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.ICX Implant Systems CAD-CAM abutments are intended for use with dental implants as a support for single-unit or multiple-unit prostheses in the maxilla or mandible of a partially or fully edentulous patient. All digitally designed abutments for use with ICX Implant Systems CAD-CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center. |
| Primary predicate device | Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). |
| Reference devices | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.Indications for Use for GM implants and conventional abutments: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. |
| Indications for Use for GM Titanium Base abutments: Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.Indications for Use for GM Pro Peek Abutments: The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability | |
| Indications for Use Statement | |
| K222288DESS Dental SmartSolutionsTerrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunctionwith endosseous dental implants in the maxillary or mandibular arch to providesupport for prosthetic restorations.All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to a Terrats Medical validated milling centerfor manufacture.For complete Indications for Use statement on OEM Compatibility see 510(k)Summary for K222288 in Section 12 |
| K193096S.I.N. Dental ImplantSystemS.I.N. -Sistema deImplante Nacional S.A. | S.I.N. Dental Implant System is intended for placement in the maxillary ormandibular arch to provide support for single-unit or multi-unit restorations. Whena one-stage surgical approach is applied, the S.I.N. Dental Implant System isintended for immediate loading when good primary stability is achieved and withappropriate occlusal loading. All digitally-designed custom abutments for use withInterface CAD-CAM abutments are to be sent to a S.I.N.-validated milling centerfor manufacture |
| K213063TLX SRAs and TLX GoldAbutmentsInstitut Straumann AG | TLX SRAs Straumann® abutments are indicated to be placed into Straumann®dental implants to provide a support structure for the functional and esthetic oralrehabilitation of edentulous or partially edentulous patients with crowns, bridges,or full-arch prostheses.TLX Gold Abutments Straumann® abutments are indicated to be placed intoStraumann® dental implants to provide a support structure for the functional andesthetic oral rehabilitation of edentulous or partially edentulous patients withcrowns, bridges or full-arch prostheses. Copings are indirectly connected to theendosseous dental implant and are indicated for use as an aid in prostheticrehabilitations. |
| K092035Bicon Implants with2.5mm Internal ConnectionBicon, L.L.C. | The Bicon implant is designed for use in edentulous sites in the mandible ormaxilla for support of a complete denture prosthesis, a final or intermediateabutment for fixed bridgework or for partial dentures, or as a single toothreplacement. |
Table 2. Table of Substantial Equivalence – Indications for Use Statement
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| Subject Device | Primary Predicate | Reference Device | Reference Device | |||
|---|---|---|---|---|---|---|
| Feature | ICX-Implant Systemmedentis medical GmbH. | K130222Straumann® Dental Implant SystemSLActive and Roxolid Product Families | K133510Neodent Implant SystemJJGC Industria e Comercio deMateriais Dentarios SA | K092035Bicon Implants with 2.5mmInternal ConnectionBicon ,L.L.C. | ||
| Product Code | DZE, NHA | DZE & NHA | DZE & NHA | DZE | ||
| Reason for Predicate/Reference Device | n/a | Tissue and bone level implants | Implant material and surfacetreatment, ball abutment | Surface area comparison | ||
| Implant Placement | Bone Level | Tissue Level | Bone level | Tissue Level | Bone level | Bone Level |
| Prosthetic InterfaceConnection | Internal Hex | Internal octagon | External hex | Morse Taper | ||
| Body Diameter, mm | 3.43, 3.9, 4.25, 4.8 | 2.9, 3.3, 4.1, 4.8 | Titamax Smart - 3.3, 3.75, 4.0, 4.5,5.0Titamax Smart EX - 3.75, 4.0 | 4.0, 4.5From marketing material, notstated in 510(k) Summary | ||
| Platform Diameter, mm | 3.3, 3.7 | Same as body | 3.5, 4.8 | 3.3, 4.5 | 3.5 | |
| Endosseous Lengths,mm | 8, 10, 12.5, 15(no 15 mmlength for 3.3 Ø) | 5, 6.5, 8, 10, 12.5(5 & 6.5 mm onlyfor 4.8 Ø) | 8, 10, 12, 14, 16,18(no 8 mm for 2.9 Ø) | 4, 6, 8, 10, 12, 14(no 4, 6, 8 mm for3.3 Ø) | Titamax Smart - 9, 11, 13, 15, 17Titamax Smart EX - 9, 11, 13, 15,17, 19 | 5, 8, 11(no 5 mm for 4 Ø) |
| Implant Material | Unalloyed titanium | Zirconium alloy (Roxolid), 15%zirconium and 85% titanium | Unalloyed titanium | Titanium alloy (Ti6Al-4V) | ||
| Implant EndosseousSurface | Aluminum Oxide (Al2O3) Blasted, AcidEtched | Large grit sandblasted, acid-etched | Grit blasted, acid etched | Grit blasted, acid etched, andhydroxylapatite | ||
| Stored | Air and Saline | Air and Saline | Air and saline | Air |
Table 3. Table of Substantial Equivalence – Technological Characteristics Implants
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| Feature | Subject DeviceK231566 | Reference DeviceK133510 | Reference DeviceK163194 | Reference DeviceK193096 |
|---|---|---|---|---|
| ICX-Implant System | Neodent Implant System | Neodent Implant System -GM Line | S.I.N. Dental Implant System | |
| medentis medical GmbH. | JJGC Industria e Comerciode Materiais Dentarios SA | JJGC Indústria e Comérciode Materiais Dentários SA | S.I.N. -Sistema de ImplanteNacional S.A. | |
| Coronal Ø, mm | 2.6-3.7 | Not stated | 4.5, 6 | 3.65 |
| Connection | Threaded / taper | Hex | Threaded / taper | Threaded / taper |
| Gingival Height, mm | 0 - 2 | Not stated | 0.8-5.5 | 2-4 |
| Material | Titanium alloy | Titanium alloy | Titanium alloy | Titanium Alloy |
| Surface treatment | Anodized, None | None | Anodized, None | Anodized, None |
| Used with implants | BL, TL | BL | BL | BL |
| How Provided | ||||
| Sterility | Sterile | Non-sterile | Sterile | Sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 4. Table of Substantial Equivalence – Technological Characteristics Cover Screws
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| Healing Caps | |||
|---|---|---|---|
| Subject DeviceK231566 | Reference DeviceK163194 | Reference DeviceK222288 | |
| Feature | ICX-Implant Systemmedentis medical GmbH. | Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários SA | DESS Dental Smart SolutionsTerrats Medical SL |
| Coronal Ø, mm | 3.9/4.7 - 8.0 | 3.3 - 6.5 | 3.0 - 7.7 |
| Gingival Height, mm | 1.0 - 6.0(PEEK customizable1.24 - 10.46) | 0.8 - 5.5 | Not stated |
| Connection | Threaded, hex | Threaded, hex | Threaded |
| Material | Titanium alloy, PEEK | Titanium alloy, PEEK | Titanium Alloy |
| Surface treatment | Anodized, None | Anodized, None | None |
| Used with implants | BL | BL | BL |
| How Provided | |||
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 5. Table of Substantial Equivalence – Technological Characteristics Healing Caps
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| Subject Device | Reference DeviceReference Device | Reference Device | Reference Device | ||
|---|---|---|---|---|---|
| K231566 | K140440 | K163194 | K222288 | K233208 | |
| Feature | ICX-Implant Systemmedentis medical GmbH. | Noris Medical DentalImplants SystemNoris Medical, Ltd. | Neodent Implant System -GM LineJJGC Indústria e Comérciode Materiais Dentários SA | DESS Dental SmartSolutionsTerrats Medical SL | NobelProcera® TitaniumASC AbutmentNobel Biocare AB |
| Prosthetic Platform Ø,mm | 3.7 - 6.5 | Not stated | 3.3-4.8 | 4,5 - 6.5 | 3.13 - 6.0 |
| Gingival Height for BLimplants, mm | 0.3 – 5.6 | 0.5 - 4.0 | 0.8-5.5 | 0.4 - 6.0 | 0.3 min. |
| Gingival Height for TLimplants, mm | N/A (GH is in implant) | N/A | N/A | ||
| Angulation | 0°, 15°, 25° | 0°, 17°, 30° | up to 15° | 0°, 17°, 30° | 0° to 30° |
| Connection | Engaging, Non-engaging | Engaging, Non-engaging | Engaging, Non-engaging | Engaging, Non-engaging | Engaging |
| Restoration retention | Cement | Cement | Cement | Cement | Cement |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Surface treatment | Anodized, None | Anodized, None | Anodized, None | Anodized, None | Anodized, None |
| Used with implants | BL, TL | BL | BL | BL, TL | BL |
| How Provided | |||||
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 6. Table of Substantial Equivalence – Technological Characteristics ICX-Titanium Abutment, ICX-Titanium Aesthetic Abutment
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| Subject Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| K231566 | K133510 | K163194 | K222288 | |
| Feature | ICX-Implant System | Neodent Implant System | Neodent Implant System - GMLine | DESS Dental SmartSolutions |
| medentis medical GmbH. | JJGC Industria e Comerciode Materiais Dentarios SA | JJGC Indústria e Comércio deMateriais Dentários SA | Terrats Medical SL | |
| Prosthetic Platform Ø,mm | N/A | 3.3. - 5.0 | 3.3-4.8 | 3.5-6.5 |
| Gingival Height, mm | 1.14 - 2.8 | 2-5 | 0.8-5.5 | 3.5-6.5 |
| Post height, mm | 4.0 - 11. | Not stated | Not stated | Not stated |
| Angulation | None (0°) | 0°, 17°, 30° | up to 15° | 0° |
| Connection | Non-engaging | Engaging | Engaging | Engaging, Non-engaging |
| Restoration retention | Cement | Cement | Cement | Cement |
| Used with implants | BL, TL | BL | BL | BL |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Surface Treatment | Anodized, None | None | ||
| How Provided | ||||
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 7. Table of Substantial Equivalence – Technological Characteristics ICX-Massive Abutment, ICX-Universal Abutment
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| Subject DeviceK231566 | Reference DeviceK193046 | Reference DeviceK133510 | Reference DeviceK153779 | |
|---|---|---|---|---|
| Feature | ICX-Implant System | Straumann® Retentive System- Novaloc TiN Abutments | Neodent Implant System | Abutments for Bridges |
| medentis medical GmbH. | Institut Straumann AG | JJGC Industria e Comercio deMateriais Dentarios SA | Altatec GmbH | |
| Gingival Height, mm | 1 - 5 | 1 - 6 | 2-5 | 0.4 - 2.2 |
| Connection | Engaging, non-engaging | Non-engaging | Non-engaging | Non-engaging |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Surface Treatment | TiN coating | TiN coating | TiN coating | None |
| Insert | Nylon Inserts | Nylon Inserts | Nylon Inserts | N/A |
| Used with implants | BL, TL | BL, TL | BL | BL |
| How Provided | ||||
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 8. Table of Substantial Equivalence – Technological Characteristics ICX Maximus Abutment (Overdenture Attachment System), ICX-Bar System Abutment
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| Feature | Subject Device | Reference Device | Reference Device |
|---|---|---|---|
| K231566 | K193096 | K213063 | |
| ICX-Implant System | S.I.N. Dental Implant System | Straumann TLX SRAs | |
| medentis medical GmbH | S.I.N. -Sistema de Implante Nacional S.A. | Straumann USA, LLC | |
| Prosthetic Platform Ø, mm | 4.4-5.0 | 3.8, 4.5 | 4.6 |
| Gingival Height, mm | 0.5 | 0.5, 1 | 3.5 |
| Connection | Hex, Non-hex | Hex | TorcFit |
| Material | Co-Cr alloy, Gold (Ceramicor) alloy | Co-Cr alloy | Gold (Ceramicor) alloy |
| Angulation | Straight only | Straight only | Straight only |
| Used with implants | BL, TL | BL | TL |
| How Provided | |||
| Sterility | Non-sterile | Non-sterile | Sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 9. Table of Substantial Equivalence – Technological Characteristics ICX-UCLA Abutments
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| Reference Device | |||||
|---|---|---|---|---|---|
| Subject Device | Reference Device | Reference Device | Reference Device | ||
| K231566 | K222288 | K203252 | K191123 | K233208 | |
| Feature | ICX-Implant System | DESS Dental SmartSolutions | Multi-unit Abutmentsfor CONELOG® | Medentika Multi-unitAbutments | NobelProcera® Titanium ASCAbutment |
| medentis medical GmbH. | Terrats Medical SL | BioHorizons ImplantSystems, Inc. | Medentika GmbHStraumann USA, LLC | Nobel Biocare AB | |
| Prosthetic Platform Ø, mm | 4.8 | 3.0 - 5.0 | 4.8 | 4.5 – 6.5 | 3.13 - 6.0 |
| Gingival Height, mm | 0.4 - 4.5 | Not stated | 2.0 - 4.0 | 0.6 - 5.5 | 0.3 min. |
| Angulation | 0°, 17°, 30° | 0°, 17°, 30° | 0°, 17°, 30° | 0°, 17°, 30° | 0° to 30° |
| Connection | Engaging, Non-engaging | Engaging, Non-engaging | Engaging | Engaging, Non-engaging | Engaging |
| Restoration retention | Screw | Screw | Screw | Screw | Screw |
| Material, MUA | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Materials, Prostheticcomponents | Titanium AlloyPEEKCoCr Alloy | Titanium Alloy | Titanium Alloy | Titanium AlloyGoldCobalt Chromium | N/A |
| Used with implants | BL, TL | BL | BL | BL, TL | BL |
| How Provided | |||||
| Sterility | Non-sterile | Non-sterile | Non-sterile | Sterile | Sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 10. Table of Substantial Equivalence – Technological Characteristics ICX-Multi Abutments
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| Feature | Subject Device | Reference Device | Reference Device |
|---|---|---|---|
| K231566 | K222288 | K212108 | |
| ICX-Implant System | DESS Dental Smart Solutions | Dynamic TiBase | |
| medentis medical GmbH. | Terrats Medical SL | Talladium España, SL | |
| Prosthetic Platform Ø, mm | 4.4 | 3.5 - 6.6 | 4.1 - 5.25 |
| Gingival Height of base, mm | 0 - 2.56 | 0.3 - 3.0 | 0.7 |
| Gingival Height ofsuperstructure, mm | 0.5 - 6.0 | 0.5 - 6.0 | 0 - 5.83 |
| Angulation, superstructure | up to 15° | up to 30° | up to 30° |
| Angulation, base | 0° | 0° | 0° |
| Minimum wall thickness ofsuperstructure, mm | 0.4 | 0.4 | 0.43 |
| Length of abutment post(length above the abutmentcollar/gingival height), mm | 4.0 | 4.2 - 4.7 | 4.0 |
| Connection | Engaging, Non-engaging | Engaging, Non-engaging | Not stated |
| Titanium Component (Base)Material | Titanium Alloy | Titanium Alloy, Co-Cr alloy | Titanium Alloy |
| Surface Treatment | Anodized, None | Anodized, None | Anodized |
| Superstructure | Zirconia, Cement | Zirconia, Cement | Zirconia, Cement |
| Used with implants | BL, TL | BL | BL |
| How Provided | |||
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use |
Table 11. Table of Substantial Equivalence – Technological Characteristics ICX-Adhesive Base Abutments (CAD-CAM)
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.