Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant and abutment system made of titanium/titanium alloy. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical, biological, and sterilization testing of the physical device.

Therapeutic

Yes
The device is described as a "Dental Implant System" whose intended use is "to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function", which falls under the definition of a therapeutic device as it treats a condition (missing teeth) and restores function.

Diagnostic

No

Explanation: The device description and intended use clearly state that the Implantswiss Dental Implant System and Abutment System are used for surgical placement and attachment of prosthetic appliances to restore chewing function. There is no mention of the device being used for diagnosis, disease detection, or medical condition assessment. The performance studies focus on mechanical and biological properties relevant to implantation, not diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components made of titanium/titanium alloy, including implants and abutments with specific dimensions and surface modifications. The performance studies also focus on physical testing of these components (biocompatibility, sterilization, fatigue, surface analysis).

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical implant and abutment system used to restore chewing function by providing a root form for prosthetic attachments in the jaw. This is a physical device used in vivo (within the body) for structural support.
Device Description: The description details the materials (titanium/titanium alloy), types (bone level, tissue level), dimensions, and surface modification of the implants and abutments. These are all characteristics of a physical implantable device.
Performance Studies: The performance studies focus on biocompatibility, sterilization, packaging, and fatigue testing. These are relevant tests for an implantable medical device, not for a diagnostic test that analyzes samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

In summary, the Implantswiss Dental Implant System and Implantswiss Dental Abutment System are medical devices intended for surgical implantation and prosthetic support, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants. Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

The Implantswiss Dental Implant and Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments.

The Implantswiss Dental Implants are provided as bone level or tissue level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process.

The Implantswiss Bone Level Implants have diameters of 3.3mm, 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The 3.3mm and 3.7mm diameter Bone Level Implants are composed of Titanium Ti6Al4V ELI – ASTM F136-13. The 4.3mm, 4.8mm and 5.5mm diameter Bone Level Implants are composed of Titanium Grade 4 – ASTM F67-13.

The Implantswiss Tissue Level Implants have diameters of 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 10mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The Tissue Level Implants are composed of Titanium Grade 4 – ASTM F67-13.

The Implantswiss Dental Abutment System consists of Couple, Angled, Solid, O-ring, Multi, Octa, Synocta, Healing, Locator and Multi-Unit Abutments.

Bone Level Couple Abutments have diameters Ø 3.7mm and Ø 4.5mm. Tissue Level Couple Abutments have diameters Ø 5.2mm and Ø 6.4mm.

Bone Level Angled Abutments with 15° angles have diameters Ø 3.7mm and Ø 4.5mm. Bone Level Angled Abutments with 25° angles have a diameter of Ø 4.5mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5mm.

Bone Level Solid Abutments have diameters of Ø 3.7mm and Ø 4.5mm. Tissue Level Solid Abutments have diameters of Ø 3.5mm and Ø 4.3mm.

Bone Level O-ring Abutments have diameters of Ø 2.9mm and Ø 4.5mm.

Bone Level Multi Abutments have diameters of Ø 3.7mm and Ø 4.5mm. Tissue Level Multi Abutments have a diameter of Ø 5.2mm.

Bone Level Octa Abutments have diameter of Ø 4.8mm. Tissue Leyel Octa Abutments have a diameter of Ø 3.5mm.

Tissue Level Synocta Abutments have a diameter of Ø 3.5mm.

Bone Level Healing Abutments have diameters of Ø 3.7mm and Ø 4.5mm. Tissue Level Healing Abutments have a diameter of Ø 5.2mm.

Bone Level Locator Abutments have diameter of Ø 3.86mm. Tissue Level Healing Locator have diameter of Ø 3.86 mm.

Bone Level Multi-Unit Abutments with 17 angle have a diameter Ø 4.8mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and lower jaw arches

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)

Performance testing of the Implantswiss Dental Implant and Implantswiss Dental Abutment followed the FDA guidance Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments.

Biocompatibility testing was conducted according to ISO 10993-1:2009"Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices Fixture has been conducted the following biocompatibility test:

Cytotoxicity (in vitro) ISO 10993-5:2009.
Sensitization- ISO 10993-10:2010. - ISO 10993-12:2012
Irritation/ Intracutaneous Toxicity - ISO 10993-10:2010
. Implantation test - ISO 10993-6:2016
ISO 10993-12:2012
. Chemical Analysis - IS0 10993-12
Semivolatile Organics (SVOC) Method:8270D
Volatile Organic Compounds (VOC) Method: 8260C

Implantswiss Dental Implants are sterilized using a gamma ray sterilization process ISO 11137-1 and ISO 11737-2 that has been validated to ensure a SAL of 106. LAL testing was conducted in accordance with USP .

The Implantswiss Dental Abutment System is provided non-sterile. The recommended end-user steam gravity sterilization method and sterilization parameters have been validated to achieve an SAL of 10-6 according to ISO 17665-1. ISO 17665-2 and ISO 11737-2.

Packaging testing of accelerated aged and real-time aged product demonstrated that the sterility of the Implantswiss Dental Implant System is maintained over the 2-year shelf life period. Below tests are performed:
-Visual Inspection ASTM F1886
-Dye Penetration ASTM F1929-15
-Seal Peel Strength Test BS EN 868-5:2009
-Sterility test

Fatigue testing, in accordance with ISO 14801 Dentistry- Implants-Dynamic fatigue test for Endosseous Dental Implants, was performed on the worst-case bone level Implantswiss Dental Implant mated with the worst case Implantswiss Dental Abutment. Results of the fatigue testing found that the worst case (bone level) dental implant/abutment combinations was consistent with FDA Class II Special Controls guidance and ISO 14801.

Fatigue testing, in accordance with ISO 14801 Dentistry- Implants-Dynamic fatigue test for Endosseous dental implants, referenced in K160221 was performed on the worst-case tissue level Implance Dental Implant (K160221) mated with the worst case Implance Dental Abutment (K160221). Results of the fatigue testing found that the worst case (tissue level) dental implant/abutment combinations was consistent with FDA Class II Special Controls guidance and ISO 14801.

Surface analysis of the implant body after the SRA process was conducted using Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Spectroscopy(EDS). SEM found that the implant surface had a homogeneous structure.

Non-clinical performance testing consistent with the FDA's Class II Special Controls guidance document and ISO 14801 support the substantial equivalence of the Implantswiss Dental Implant System and the Implantswiss Dental Abutment System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160221

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K150938, K150295, K072570

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 1, 2018

Novodent SA % H. Semih Oktay, PhD President CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, Maryland 21401

Re: K181266

Trade/Device Name: Implantswiss Dental Implantswiss Dental Abutment System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 27, 2018 Received: October 2, 2018

Dear H. Semih Oktay, PhD:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K181266

Device Name

Implantswiss Dental Implant System, Implantswiss Dental Abutment System

Indications for Use (Describe)

Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

SUBMITTER

NOVODENT SA

Y-PARC Technopole Avenue des Sciences 11 CH-1400 Yverdon-les-Bains Switzerland Office: +41 24 524 28 28 +41 24 524 28 25

Official Correspondent: H. Semih Oktay, Ph.D.

CardioMed Device Consultants, LLC

1783 FOREST DRIVE #254 ANNAPOLIS, MD 21401 USA Phone: (410) 674-2060 Email: soktay@cardiomedllc.com

Date of Summary: November 1, 2018

DEVICE

Proprietary name	Implantswiss Dental Implant System
	Implantswiss Dental Abutment System
Common Name	Implant, Endosseous, Root-Form
Classification Name	Endosseous Dental Implant
Regulatory Class	II
Primary Product Code	DZE
Subsequent Product Code	NHA
Regulation Number	21 CFR 872.3640

PREDICATE DEVICE

Primary Predicate Device:

Implance Dental Implant System, Implance Dental Abutment System - K160221

4

Reference Devices:

Straumann Dental Implant System - K150938

LOCATOR RTx - K150295

NobelActive Multi Unit Abutment - K072570