(171 days)
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.
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.
The provided text is a 510(k) summary for the Implantswiss Dental Implant System and Implantswiss Dental Abutment System. It outlines the regulatory clearance process, device description, indications for use, and a comparison to predicate devices, including performance testing.
However, it does not contain information about acceptance criteria or a study that uses a machine learning or AI model. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing (biocompatibility, sterilization, mechanical testing) for dental implants and abutments, which are physical medical devices, not AI-driven software.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.
I will provide the information that is applicable based on the text provided, highlighting where the requested AI/ML specific details are not relevant.
Acceptance Criteria and Study for Implantswiss Dental Implant System & Abutment System
This device clearance (K181266) is for physical dental implants and abutments, not a software or AI/ML device. Therefore, the "acceptance criteria" and "study" refer to non-clinical performance evaluations relevant to the material properties, design, and intended use of these dental devices.
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative "acceptance criteria" in a table format for each test. Instead, it refers to compliance with established international standards and FDA guidance documents. The "reported device performance" is a statement of consistency with these standards.
| Acceptance Criteria (Reference to Standard/Guidance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1:2009 (Evaluation and testing within risk management process) | Conducted according to ISO 10993-1:2009 and FDA Guidance document "Use of International Standard ISO 10993-1..." for each subject device fixture. |
| Cytotoxicity (in vitro) ISO 10993-5:2009 | Tests conducted: Cytotoxicity, Sensitization, Irritation/Intracutaneous Toxicity, Implantation test, Chemical Analysis (SVOC, VOC). (Explicit "performance" results not detailed, but implied as compliant for clearance.) |
| Sensitization ISO 10993-10:2010 | |
| Irritation/Intracutaneous Toxicity ISO 10993-10:2010 | |
| Implantation test ISO 10993-6:2016 | |
| Chemical Analysis (IS0 10993-12, Method 8270D, 8260C) | |
| Sterilization & Shelf Life: | |
| Gamma Ray Sterilization ISO 11137-1 & ISO 11737-2 | Validated to ensure SAL of 10^-6. |
| LAL testing (USP <85>) | Conducted in accordance with USP <85>. |
| Steam Gravity Sterilization (ISO 17665-1, ISO 17665-2, ISO 11737-2) for non-sterile abutments | Validated to achieve an SAL of 10^-6. |
| Packaging integrity (ASTM F1886, ASTM F1929-15, BS EN 868-5:2009) | Demonstrated that sterility is maintained over 2-year shelf life period for implants. Tests performed: Visual Inspection, Dye Penetration, Seal Peel Strength Test, Sterility Test. |
| Mechanical Testing: | |
| ISO 14801 Dentistry - Dynamic fatigue test | Results consistent with FDA Class II Special Controls guidance and ISO 14801 for worst-case bone level implant/abutment combinations. |
| Surface analysis (SEM, EDS) | SEM found that the implant surface had a homogeneous structure after the SRA process. |
| Consistency with FDA Class II Special Controls guidance document | Non-clinical performance testing supports substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not explicitly provided in the summary. For mechanical and biocompatibility testing, it is generally conducted on a sample of devices (e.g., a specific number of implants/abutments) to demonstrate compliance with standards. The summary states "worst-case" testing was performed.
- Data Provenance: Not applicable in the context of device performance testing for physical implants. These are lab-based tests of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context refers to standard-compliant test methods and material properties, not expert-curated clinical data for an AI/ML model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is relevant to expert panel consensus for clinical data, not materials and mechanical testing.
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
Not applicable. This device is a physical dental implant and abutment system, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device clearance is established by internationally recognized standards (ISO standards), FDA guidance documents, and validated test methods (e.g., for biocompatibility, mechanical fatigue, sterilization parameters). Material specifications (e.g., ASTM F-67, ASTM F-136) also serve as a form of "ground truth" for material composition.
8. The sample size for the training set
Not applicable. There is no AI/ML training set for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set for this physical device.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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
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.
{5}------------------------------------------------
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.
Indication 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 splintedinterforminal 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.
Substantial Equivalence Comparison
The Implantswiss Dental Implant System is comparable to the K160221- Implance Dental Implant System, Implance Dental Abutment System as the primary predicate and the reference predicate device Straumann Dental Implant System (K150938).
The Implantswiss Dental Abutment System is comparable to the primary predicate devices Implance Dental Abutment System (K160221) and reference predicate devices LOCATOR RTx (K150295) and NobelActive Multi Unit Abutment (K072570).
{6}------------------------------------------------
| Implantswiss DentalImplant System,Implantswiss DentalAbutment System | Primary PredicateImplance Dental ImplantSystem,Implance DentalAbutment System | Reference PredicateStraumann Dental ImplantSystem | |
|---|---|---|---|
| 510k # | K181266 | K160221 | K150938 |
| Manufacturer | Novodent SA | AGS Medikal Urunleri Ith.Ihr. Tic. Ltd. Sti. | Straumann USA, LLC |
| Indication | Implantswiss DentalImplant System is indicatedto use for surgicalplacement in the upper andlower jaw arches, toprovide a root form meansfor single and multipleunits' prosthetic applianceattachment to restore apatient's chewing function.Implantswiss DentalImplant can be placed witha conventional two stagesurgical process with anoption for transmucosalhealing or they can beplaced in a single stagesurgical process forimmediate loading.Immediate loading isrestricted to the anteriormandible based on foursplinted-interforminalplaced implants.Implantswiss DentalAbutment System is usedwith a dental implant toprovide support toprosthetic restorations suchas crown, bridge andoverdentures in partially orfully edentulous patients.Octa and Multi-UnitAbutment models thatcontain an abutment postheight less than 4 mm areindicated only for multi-unit loading, such as abridge or overdenture. | Implance Dental ImplantSystem is indicated to usefor surgical placement in theupper and lower jaw arches,to provide a root form meansfor single and multiple units'prosthetic applianceattachment to restore apatient's chewing function.Implance Dental Implantcan be placed with aconventional two stagesurgical process with anoption for transmucosalhealing or they can beplaced in a single stagesurgical process forimmediate loading.Immediate loading isrestricted to the anteriormandible based on foursplinted-interforminalplaced implants.Implance Dental AbutmentSystem is used with adental implant to providesupport to prostheticrestorations such as crown,bridge and overdentures inpartially or fully edentulouspatients. Octa Abutmentmodels that contain anabutment post height lessthan 4 mm are indicatedonly for multi-unit loading,such as a bridge oroverdenture. | Straumann Dental Implants areindicated for oral endostealimplantation in the upper andlower jaw and for thefunctional and esthetic oralrehabilitation of edentulousand partially dentate patients.Straumann dental implants canalso be used for immediate orearly implantation followingextraction or loss of naturalteeth. Implants can be placedwith immediate function onsingle-tooth and or multipletooth applications when goodprimary stability is achievedand appropriate occlusalloading, to store chewingfunction. The prostheticrestorations used are singlecrowns, bridge and partial orfull dentures, which areconnected to the implants bythe corresponding elements(abutments). |
Implantswiss Dental Implant System Substantial Equivalence Comparison
{7}------------------------------------------------
| SystemComponents | Dental implant and closingscrew | Dental implant and closingscrew | Dental implant and transferpiece |
|---|---|---|---|
| Design | Threaded root-form boneor tissue level implant withhybrid and straight designsand Morse taper internalhexagon or internaloctagonal abutmentinterfaceTissue Level Dentalimplant' machined lengthis 2.65 mm | Threaded root-form bone ortissue level implant withhybrid and straight designsand Morse taper internalhexagon or internaloctagonal abutmentinterface | Implant-Abutmentconnection for Bone Level:-Narrow CrossFit (NC)-Regular CrossFit (RC)Implant-Abutmentconnection for Tissue Level:-Narrow Neck CrossFit(NNC)-Regular Neck (RN)-Wide Neck (WN)Tissue Level Dental implant'machined length is 1.8 and2.8 mm respectively NarrowNeck CrossFit (NNC) andboth Regular Neck (RN) andWide Neck (WN) |
| Implant SizesBone Level | 3.3x8, 3.3x10, 3.3x12,3.3x143.7x8, 3.7x10, 3.7x12,3.7x144.3x8, 4.3x10, 4.3x12,4.3x144.8x8, 4.8x10, 4.8x12,4.8x145.5x8, 5.5x10, 5.5x12 | 3.3x8, 3.3x10, 3.3x12,3.3x143.7x8, 3.7x10, 3.7x12,3.7x144.3x8, 4.3x10, 4.3x12,4.3x144.8x8, 4.8x10, 4.8x12,4.8x145.5x8, 5.5x10, 5.5x12 | 3.3x8, 3.3x10, 3.3x12,3.3x14, 3.3x164.1x6, 4.1x8, 4.1x10, 4.1x12,4.1x14, 4.1x164.8x6, 4.8x8, 4.8x10, 4.8x12,4.8x14, 4.8x16 |
| Implant SizesTissue Level | 3.7x8, 3.7x10, 3.7x12,3.7x144.3x8, 4.3x10, 4.3x12,4.3x144.8x8, 4.8x10, 4.8x12,4.8x145.5x8, 5.5x10, 5.5x12 | 3.7x8, 3.7x10, 3.7x12,3.7x144.3x8, 4.3x10, 4.3x12,4.3x144.8x8, 4.8x10, 4.8x12,4.8x145.5x8, 5.5x10, 5.5x12 | 3.3x8, 3.3x10, 3.3x12,3.3x14, 3.3x164.1x6, 4.1x8, 4.1x10, 4.1x12.4.1x14, 4.1x164.8x6, 4.8x8, 4.8x10, 4.8x12,4.8x14, 4.8x16 |
| Materials | Commercially PureTitanium Grade 4 &Titanium Ti6Al4V ELI | Titanium Grade 4 &Titanium Ti6Al4V | Commercially Pure TitaniumGrade 4Transfer piece-titanium-6aluminum-7niobium alloy(TAN) |
| Surfacetreatment | Sandblasted Rough Acid-etched (SRA) surface | Resorbable Blast Media(RBM) surface treatment | Sandblasting Large grit Acidetching (SLA) surfacetreatment |
| Sterilization | Gamma | Gamma | Gamma |
| Standards forTitanium | ASTM F-67 &ASTM F-136 | ASTM F-67 &ASTM F-136-13 | ASTM F-67 |
{8}------------------------------------------------
The Implantswiss Dental Implant System is the same or similar to the primary predicate Implance Dental Implant System with respect to indication for use, design, size and dimensions and material composition.
The Implantswiss Dental Implant System maximum implant diameter is the same as the primary predicate Implance Dental Implant System.
The Implantswiss Dental Implant System differs from the primary predicate with respect to the surface treatment.
The Implantswiss Dental Implant System is the same or similar to the reference predicate Straumann Dental Implant System with respect to indication for use, design, material composition and surface treatment. The Implantswiss Dental Implant System has the same surface modification which is sandblasted and following double acid-etching with reference predicate Straumann Dental Implant System (K150938). The Implantswiss Dental Implant System differs with respect to maximum implant diameter and minimum/maximum lengths. The Implantswiss Dental Implant has a maximum implant diameter of 5.5 mm while the reference predicate has a maximum implant diameter of 4.8 mm.
The Implantswiss Tissue Level Dental Implant's machined neck (cuff height) length is 2.65 mm while reference predicate Tissue Level Dental Implant's machined neck length is 1.8 and 2.8 mm respectively Narrow Neck CrossFit and both Regular Neck and Wide Neck. Minimum/maximum implant lengths for the Implantswiss Dental Implant System are 8 mm - 14 mm versus 6mm - 16mm for the reference predicate.
{9}------------------------------------------------
| Subject Device | Reference Predicate Device | |
|---|---|---|
| Manufacturer | NOVODENT SA | AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. |
| Trade Name | Implantswiss Dental Implant System | Implance Dental Implant System |
| 510(k) No. | K181266 | K160221 |
| Indication | Implantswiss Dental Implant System isindicated to use for surgical placement inthe upper and lower jaw arches, toprovide a root form means for single andmultiple units' prosthetic applianceattachment to restore a patient's chewingfunction. Implantswiss Dental Implantcan be placed with a conventional twostage surgical process with an option fortransmucosal healing or they can beplaced in a single stage surgical processfor immediate loading. Immediateloading is restricted to the anteriormandible based on four splinted-interforminal placed implants.Implantswiss Dental Abutment System isused with a dental implant to providesupport to prosthetic restorations such ascrown, bridge and overdentures inpartially or fully edentulous patients.Octa and Multi-Unit Abutment modelsthat contain an abutment post height lessthan 4 mm are indicated only for multi-unit loading, such as a bridge oroverdenture | Implance Dental Implant System is indicatedto use for surgical placement in the upper andlower jaw arches, to provide a root formmeans for single and multiple units' prostheticappliance attachment to restore a patient'schewing function.Implance Dental Implant can be placed witha conventional two stage surgical processwith an option for transmucosal healing orthey can be placed in a single stage surgicalprocess for immediate loading. Immediateloading is restricted to the anterior mandiblebased on four splinted-interforminal placedimplants.Implance Dental Abutment System is usedwith a dental implant to provide support toprosthetic restorations such as crown, bridgeand overdentures in partially or fullyedentulous patients. Octa Abutment modelsthat contain an abutment post height lessthan 4 mm are indicated only for multi-unitloading, such as a bridge or overdenture. |
| Material | Bone Level: Titanium Ti6Al4V ELIASTM F-136Tissue Level: Commercially PureTitanium Grade 4 ASTM F-67Screw: Titanium Ti6Al4V ELI ASTMF136 | Bone Level: Titanium Ti6Al4V ASTM F-136Tissue Level: Titanium Grade 4 ASTM F-67Screw: Titanium Ti6Al4V ASTM F136 |
| SurfaceTreatment | Machine Surface | Machine Surface |
| Sterile | Steam Sterilization by user(Delivered non sterile) | Steam Sterilization by user(Delivered non sterile) |
| CoupleAbutmentDesign | Image: Couple Abutment Design | Image: Couple Abutment Design |
| CoupleAbutmentDiameters(mm) | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mmTissue Level Implant: Ø 5.2 mm, Ø 6.4 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mmTissue Level Implant: Ø 5.2 mm, Ø 6.4 mm |
| AngledAbutmentDesign | Image: Angled Abutment Design | Image: Angled Abutment Design |
| AngledAbutmentDiameters(mm) | Bone Level Implant (15°): Ø 3.7 mm,Bone Level Implant (25°): Ø 4.5 mm,Tissue Level Implant (15°): Ø 3.5 mm | Bone Level Implant (15°): Ø 3.7 mm,Bone Level Implant (15°, 25°): Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mm |
| SolidAbutmentDesign | Image: Solid Abutment Design | Image: Solid Abutment Design |
| SolidAbutmentDiameters(mm) | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mmTissue Level Implant: Ø 3.5 mm, Ø 4.3 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mmTissue Level Implant: Ø 3.5 mm, Ø 4.3 mm |
| O-ringAbutmentDesign | Image: O-ring Abutment Design | Image: O-ring Abutment Design |
| Diameters(mm) | Bone Level Implant: Ø 2.9 mm, Ø 4.5 mm, | Bone Level Implant: Ø 2.9 mm, Ø 3.42 mm, Ø 3.5 mm, Ø 4.5 mm,Tissue Level Implant: Ø 3.5 mm |
| MultiAbutmentDesign | Image: Multi Abutment Design | Image: Multi Abutment Design |
| Diameters(mm) | Bone Level Implant: Ø 3.7 mm, Ø 4.5mmTissue Level Implant: Ø 5.2 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mmTissue Level Implant: Ø 5.2 mm |
| OctaAbutmentDesign | Image: Octa Abutment Design | Image: Octa Abutment Design |
| Diameters(mm) | Bone Level Implant: Ø 4.8 mmTissue Level Implant: Ø 3.5 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm,Ø 5.5 mm, Ø 6.5 mmTissue Level Implant: Ø 3.7 mm, Ø 6.4 mm |
| SyonctaAbutmentDesign | Image: Syoncta Abutment Design | Image: Syoncta Abutment Design |
| Diameters(mm) | Tissue Level Implant: Ø 3.5 mm | Tissue Level Implant: Ø 3.5 mm |
| HealingAbutmentDesign | Image: Healing Abutment Design | Image: Healing Abutment Design |
| Diameters(mm) | Bone Level Implant: Ø 3.7 mm, Ø 4.5mmTissue Level Implant: Ø 5.2 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm,Ø 5.5 mm, Ø 6.5 mmTissue Level Implant: Ø 3.7 mm, Ø 6.4 mm |
| BriefComparison | The subject device is similar in size andfeatures as the predicate device(K160221). |
Implantswiss Dental Abutment System Substantial Equivalence Comparison
{10}------------------------------------------------
{11}------------------------------------------------
Implantswiss Locator abutment
| Subject Device | Reference Predicate Device | |
|---|---|---|
| Manufacturer | NOVODENT SA | Zest Anchors, LLC |
| Trade Name | Implantswiss Dental ImplantSystem | LOCATOR RTx |
| 510(k) No. | K181266 | K150295 |
| Indication for Use | Implantswiss Dental ImplantSystem is indicated to use forsurgical placement in the upperand lower jaw arches, to provide aroot form means for single andmultiple units' prostheticappliance attachment to restore apatient's chewing function.Implantswiss Dental Implant canbe placed with a conventional twostage surgical process with anoption for transmucosal healing orthey can be placed in a singlestage surgical process for | The LOCATOR® RTx AttachmentSystem is designedfor use with overdentures orpartial dentures, retained inwhole or in part, by endosseousimplants in the mandible ormaxilla. LOCATOR®RTxAttachment System is compatiblewith the following implant systems.Implant Manufacturer - SystemBioHorizons - Internal Hex (3.0, 3.5,4.5, 5.7mm) External Hex (3.5, 4.0,5.0mm)Biomet 3i - Certain Internal (3.4, 4.1,5.0, 6.0 mm) External Hex (3.4, 4.1,5.0, 6.0 mm) |
| immediate loading. Immediateloading is restricted to the anteriormandible based on four splinted-interforminal placed implants.Implantswiss Dental AbutmentSystem is used with a dentalimplant to provide support toprosthetic restorations such ascrown, bridge and overdentures inpartially or fully edentulouspatients. Octa and Multi-UnitAbutment models that contain anabutment post height less than 4mm are indicated only for multi-unit loading, such as a bridge oroverdenture. | Camlog - Camlog and Conelog (3.3,3.8, 4.3, 5.0 mm) iSy (3.8, 4.4, 5.0mm)Dentsply - Ankylos (3.5, 4.5, 5.5, 7.0mm) XiVE/FRIALIT-2 (3.4, 3.8, 4.5,5.5 mm) Astra Tech OsseoSpeed EV(3.6, 4.2, 4.8mm)MIS Implants - Internal Hex (3.75,4.5 mm)Nobel Biocare - Replace: Internal(3.5, 4.3, 5.0, 6.0 mm) MobelActive:Internal Conical (3.0, 3.5, 4.3, 5.0mm) Branemark: External Hex (3.3,3.75, 4.0, 5.0 mm)Straumann - Tissue Level (3.5, 4.8,6.5 mm) Bone Level (3.3, 4.1, 4.8mm)Zimmer - Tapered Screw Vent:Internal Hex (3.5, 4.5, 5.7 mm) Spline(3.25, 4.0, 5.0 mm) Swiss Plus:Internal Octagon (3.8, 4.8 mm) | |
| Material | Abutments- Titanium Ti6Al4VELI ASTM F-136 | Abutments- Titanium Ti6Al4VELI ASTM F-136 |
| Sterile | Steam Sterilization by user(Delivered non sterile) | Steam Sterilization by user(Delivered non sterile) |
| LocatorAbutment Design | Image: Locator Abutment Design | Image: Locator Abutment Design |
| Diameters(mm) | Bone Level Implant: Ø 3.86 mmTissue Level Implant: Ø 3.86 mm | Diameter: Ø 3.0 mm to Ø 7.0 mmBone Level: Ø 3.3 mm, Ø 4.1 mm, Ø 4.8 mmTissue Level: Ø 3.5 mm, Ø 4.8 mm, Ø 6.5 mm |
| Brief Comparison | The Implantswiss Locator abutment is different than the LOCATORRTx, Reference Predicate Device (K150295) in the size of theabutment. |
{12}------------------------------------------------
{13}------------------------------------------------
| Subject Device | Reference Predicate Device | |
|---|---|---|
| Manufacturer | NOVODENT SA | Nobel Biocare AB |
| Trade Name | Implantswiss Dental ImplantSystem | NobelActive Multi UnitAbutment |
| 510(k) No. | K181266 | K072570 |
| Indication | Implantswiss Dental AbutmentSystem is used with a dentalimplant to provide support toprosthetic restorations such ascrown, bridge and overdentures inpartially or fully edentulouspatients. Implantswiss Multi-UnitSupports prosthetic restoration forbridge. | NobelActive Multi UnitAbutment is a pre-manufacturedprosthetic component directlyconnected to the endosseousdental implant and is intendedfor use as an aid in prostheticrehabilitation. |
| Material | Abutments and screws: TitaniumTi6Al4V ELI ASTM F-136 | Abutments and screws - Titaniumvanadium alloy |
| Sterile | Steam Sterilization by user(Delivered non sterile) | Steam Sterilization by user(Delivered non sterile) |
| Multi-UnitAbutment Design | Image: Multi-Unit Abutment Design | Image: Multi-Unit Abutment Design |
| Diameters | Ø 4.8 (17°) mm | Ø 4.8 (0°, 17°, 30°) mm |
| Brief Comparison | The Implantswiss Multi-Unit abutment is different than the ReferencePredicate Device (K072570) NobelActive Multi Unit Abutment, in theangulation of the abutment. |
Implantswiss Multi-Unit Abutment
The Implantswiss Dental Abutment System is the same or similar with respect to indication for use, material composition and basic design features as the predicate Implance Dental Abutments (K160221). The Implantswiss Locator abutment is different than the LOCATOR RTx, Reference Predicate Device (K150295) in the size of the abutment.
Multi-Unit abutments supports prosthetic restoration for bridge. Angular correction cannot be fabricated into the design of any of the Octa and Multi-Unit Abutment models when combined with casting plastic or cylinder during patient-specific customization. The Implantswiss Multi-Unit abutment is different than the Reference Predicate Device (K072570) NobelActive Multi Unit Abutment in the angulation of the abutment.
{14}------------------------------------------------
Summary of Non-clinical Testing
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
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
- Semi volatile Organics (SVOC) Method:8270D
- Volatile Organic Compounds (VOC) Method: 8260C
Sterilization and Shelf Life
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 <85>.
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.
{15}------------------------------------------------
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
Mechanical Testing
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.
Conclusion
Based on the similar designs, materials and applicable performance data, the Implantswiss Dental Implant System is substantially equivalent to the identified predicate devices.
§ 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.