(463 days)
K 130222
No
The summary does not mention AI, ML, or any related technologies. The device description and performance studies focus on the physical properties, sterilization, biocompatibility, and mechanical performance of the dental implant and abutment system.
Yes
The device is an implant system with prosthetic components indicated for supporting dental restorations in edentulous patients, which is a therapeutic intervention.
No
The provided text describes a dental implant and abutment system used to support dental restorations in patients who are partially or fully edentulous. It is a device intended for surgical implantation and structural support, not for diagnosing a medical condition.
No
The device description clearly states it is an endosseous dental implant and abutment system, which are physical hardware components. The performance studies also focus on physical characteristics and testing of these hardware components (sterilization, biocompatibility, mechanical testing, etc.). While there is mention of CAD CAM abutments, the core device is the physical implant system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the ICX-Implant System is an "endosseous dental implant and abutment system." These are devices surgically placed within the bone to support dental restorations.
- Intended Use: The intended use describes supporting dental restorations in the mouth of patients. This is a direct treatment/restoration function, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Testing: The document does not mention any testing of biological samples or providing diagnostic information. The performance studies focus on sterilization, biocompatibility, mechanical strength, and surface characteristics – all related to the physical properties and safety of the implant and abutment.
Therefore, the ICX-Implant System is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and mandibular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical 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
§ 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.
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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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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 GmbH
Walporzheimer Strasse 48-52
Bad Neuenahr-Ahrweiler, 53474, Germany
Telephone +49 2641 9110-171
Fax +49 2641 9110-120 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Alexander Scholz, CEO |
| Representative/Consultant | Floyd G. Larson, MS, MBA
Kevin A. Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235
Fax: +1 858-792-1236
Email: 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 | |
| Image | ||||||
| Not to Scale | Image: ICX-Premium | Image: ICX-Diamond Premium | Image: ICX-Active Master | Image: ICX-Diamond Active Master | Image: ICX-Active Liquid | |
| Placement | Bone Level | |||||
| Tissue Level | Bone Level | |||||
| Tissue Level | Bone Level | |||||
| Tissue Level | Bone Level | |||||
| Tissue 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 | |
| Endosseous | ||||||
| Lengths* (mm) | 8 - 15 | |||||
| 5 - 12.5 | 8 - 15 | |||||
| 5 - 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