(574 days)
Indications for Use for iPhysio® Profile Designer:
iPhysio® System Profile Designers are indicated to be placed in the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with comections. The healing abutments are intended for use up to 6 months.
Compatible Implant Systems:
| Manufacturer | Implant System | Implant Diameter (mm) | Platform Diameter (mm) | Platform Name |
|---|---|---|---|---|
| Nobel Biocare | NobelActive® | 3.5 | 3.5 | NP |
| Nobel Biocare | NobelActive® | 4.3, 5.0 | 4.3, 5.0 | RP |
| Nobel Biocare | NobelReplace® | 3.5 | 3.5 | NP |
| Nobel Biocare | NobelReplace® | 4.3, 5.0 | 4.3, 5.0 | RP |
| Nobel Biocare | NobelParallel™ | 3.75 | 3.5 | NP |
| Nobel Biocare | NobelParallel™ | 4.3, 5.0 | 4.3, 5.0 | RP |
| Straumann | Bone Level | 3.3 | 3.3 | NC |
| Straumann | Bone Level | 4.1, 4.8 | 4.1, 4.8 | RC |
| Straumann | Bone Level Tapered | 3.3 | 3.3 | NC |
| Straumann | Bone Level Tapered | 4.1, 4.8 | 4.1, 4.8 | RC |
| Zimmer Biomet | Trabecular Metal | 3.7, 4.1 | 3.5 | 3.5 |
| Zimmer Biomet | Trabecular Metal | 4.7 | 4.5 | 4.5 |
| Zimmer Biomet | Tapered Screw Vent | 3.7, 4.1 | 3.5 | 3.5 |
| Zimmer Biomet | Tapered Screw Vent | 4.7 | 4.5 | 4.5 |
Indications for Use for iPhysio® PEEK Temporary Abutment:
The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.
The iPhysio® System is a set of two-piece titanium healing abutments (iPhysio® Profile Designers) be screwed into the implant using compatible anodized titanium screws during the 1st or the 2nd surgical intervention. The iPhysio® Profile Designer abutment is manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and includes a zirconium nitride (ZrN) coating. iPhysio® Profile Designers are available in multiples anatomical shapes and gingival heights, and are compatible with Nobel BioCare (NobelActive®, NobelReplace®, NobelParallel™), Straumann (Bone Level / Bone Level Tapered), and Zimmer Biomet (Trabecular Metal, Tapered Screw-Vent®) implants. All iPhysio® Profile Designers are straight (0°). Supporting screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and are anodized to a color that aligns with its corresponding height. The iPhysio® Profile Designer healing abutment screw is for placing the iPhysio® Profile Designer in the implant in the patient's mouth.
The iPhysio® Profile Designer remains in place throughout the bone and gingival healing process as well as during the taking of a digital or conventional impression, preserving the emergence profile during the impression. The abutment is only removed once to place and finally screw in the final abutment. Anatomical healing, implant impression, and placement of the temporary crown may all be done without removing the iPhysio® Profile Designer.
A compatible PEEK temporary abutment may be clipped to the iPhysio® Profile Designer to which a non-load bearing temporary crown may be then placed for improved aesthetics during healing. To use the PEEK temporary abutment, the iPhysio® Profile Designer healing abutment screw is replaced with a compatible temporary abutment screw. The temporary crown is placed over the PEEK temporary abutment following modification of the abutment to the appropriate shape. The PEEK temporary abutment is connected onto the iPhysio® Profile Designer by a combination of friction and cement. All iPhysio® temporary abutments are manufactured from PEEK per ASTM F2026.
This document is part of a 510(k) summary for a medical device called "iPhysio® System." It details the comparison of the subject device to predicate devices to establish substantial equivalence, which is a key requirement for FDA clearance. The document focuses on non-clinical performance testing rather than studies involving human data or AI.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided directly from this document as it pertains to clinical performance and AI algorithm validation, which are not the primary focus of this 510(k) submission for this specific type of dental device.
However, I can extract the information related to acceptance criteria for the non-clinical performance testing and the reported results:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)
| Test | Test Method Summary | Acceptance Criteria (Implied by Result) | Reported Device Performance |
|---|---|---|---|
| Reverse Engineering Analysis | Reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility. Relevant dimensions and tolerances from subject device screw and abutment connections were analyzed for compatibility with FDA cleared implants as specified in the device labeling. | "Device met all predetermined acceptance criteria" | PASS (compatibility confirmed) |
| ZrN Coating Characterization | Per FDA Guidance "Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Class II Special Controls Guidance Document for Industry and FDA Staff": • ZrN Coating Cross Section SEM Imaging Test Report• ZrN Coating Elemental Analysis and SEM Imaging Test Report• ZrN Coating Hardness Abrasion Scratch Test• ZrN Coating Tensile Shear and Abrasion Test | "Coating met all predetermined acceptance criteria" | PASS (coating properties confirmed) |
| MR Compatibility Testing | Per ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment and FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | Test results should lead to "MR Conditional" labeling | PASS (Device is MR Conditional) |
| Fatigue Testing (Temporary Abutments) | Fatigue testing was conducted to evaluate the temporary abutments in a worst-case test configuration. The test setup was based on a modified version of ISO 14801:2016. | "Device met all predetermined acceptance criteria" | PASS (withstood worst-case loading) |
| Biocompatibility | Evaluated per ISO 10993-1 and FDA Guidance for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediate Pyrogenicity, Implantation, Subacute/subchronic toxicity, chronic toxicity, and carcinogenicity via chemical characterization and toxicological risk assessment. | "Found to be biocompatible for their intended contact level and duration" | PASS (Biocompatible) |
| Sterilization Validation | Gamma sterilization validation per ISO 11137-2 for SAL 10^-6 for worst-case packaging. Steam sterilization per ISO 17665-1 for SAL 10^-6 for non-sterile components. Sterile packed components tested per ISO 11607-1 for shelf life. | SAL specified (10^-6) for sterility, validation of labeled shelf life | PASS (Sterility and shelf life validated) |
Note: The document explicitly states "Device met all predetermined acceptance criteria" or "Coating met all predetermined acceptance criteria" for several tests, which implies the acceptance criteria were established prior to testing and the device successfully met them. The specific numerical or qualitative thresholds for these criteria are not detailed in this summary for each test but are generally understood to align with relevant international standards (e.g., ISO 14801 for fatigue).
The following points cannot be answered from the provided text, as this is a 510(k) summary for a dental implant accessory, primarily relying on non-clinical (bench) testing and substantial equivalence arguments, rather than clinical trials or AI/image analysis studies.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The "tests" referred to are non-clinical bench tests (e.g., mechanical fatigue, material characterization), not clinical studies with human patient data. Sample sizes would refer to the number of physical device units tested for each non-clinical performance test. Data provenance in this context would be the lab where the bench tests were performed, which is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth, in the context of diagnostic AI or clinical studies, refers to disease labels or interpretations. For non-clinical bench testing, the "ground truth" is adherence to established engineering standards and material properties, validated by testing methodologies. No human experts are establishing "ground truth" in the clinical sense for these types of tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations in clinical or imaging studies. This document describes bench testing, where outcomes are determined by physical measurements and adherence to engineering standards.
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
- No. This document explicitly states: "No clinical data was included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed as part of this submission. The device (dental healing abutment) does not involve AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. As noted above, this device is a physical dental implant component, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. For this submission, which relies on non-clinical testing, the "ground truth" is adherence to established engineering specifications, material standards (e.g., ISO 5832-3 for titanium alloy, ASTM F2026 for PEEK), and performance test methods (e.g., ISO 14801 for fatigue testing).
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a "training set."
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
March 4, 2025
Euroteknika % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K232383
Trade/Device Name: iPhysio® System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 7, 2025 Received: February 7, 2025
Dear Justin Gracyalny:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
{2}------------------------------------------------
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) K232383
Device Name iPhysio® System
Indications for Use (Describe)
Indications for Use for iPhysio® Profile Designer:
iPhysio® System Profile Designers are indicated to be placed in the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with comections. The healing abutments are intended for use up to 6 months.
Compatible Implant Systems:
| Manufacturer | Implant System | Implant Diameter (mm) | Platform Diameter (mm) | Platform Name |
|---|---|---|---|---|
| Nobel Biocare | NobelActive® | 3.5 | 3.5 | NP |
| Nobel Biocare | NobelActive® | 4.3, 5.0 | 4.3, 5.0 | RP |
| Nobel Biocare | NobelReplace® | 3.5 | 3.5 | NP |
| Nobel Biocare | NobelReplace® | 4.3, 5.0 | 4.3, 5.0 | RP |
| Nobel Biocare | NobelParallel™ | 3.75 | 3.5 | NP |
| Nobel Biocare | NobelParallel™ | 4.3, 5.0 | 4.3, 5.0 | RP |
| Straumann | Bone Level | 3.3 | 3.3 | NC |
| Straumann | Bone Level | 4.1, 4.8 | 4.1, 4.8 | RC |
| Straumann | Bone Level Tapered | 3.3 | 3.3 | NC |
| Straumann | Bone Level Tapered | 4.1, 4.8 | 4.1, 4.8 | RC |
| Zimmer Biomet | Trabecular Metal | 3.7, 4.1 | 3.5 | 3.5 |
| Zimmer Biomet | Trabecular Metal | 4.7 | 4.5 | 4.5 |
| Zimmer Biomet | Tapered Screw Vent | 3.7, 4.1 | 3.5 | 3.5 |
| Zimmer Biomet | Tapered Screw Vent | 4.7 | 4.5 | 4.5 |
Indications for Use for iPhysio® PEEK Temporary Abutment:
The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.
Type of Use (Select one or both, as applicable)
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.
{4}------------------------------------------------
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{5}------------------------------------------------
K232383 510(k) SUMMARY:
iPhysio® System
| Date Prepared | March 4, 2025 | ||||
|---|---|---|---|---|---|
| Euroteknika | |||||
| 726 Rue Du General De Gaulle | |||||
| Sponsor | Sallanches Haute-Savoie, France 74700 | ||||
| +33 6 83 01 50 23 | |||||
| Secure BioMed Evaluations | |||||
| Justin Gracyalny, MSE | |||||
| Linda Braddon, Ph.D. | |||||
| 510(k) Contact | 7828 Hickory Flat Highway, Suite 120 | ||||
| Woodstock, GA 30188 | |||||
| 770-837-2681 | |||||
| Regulatory@SecureBME.com | |||||
| Trade Name | iPhysio® System | ||||
| Common Name | Abutment, Implant, Dental Endosseous | ||||
| Code - | NHA | ||||
| Classification | 21 CFR §872.3630: Class II | ||||
| PredicateDevice | K192893 Straumann® Ceramic Healing Abutments | ||||
| ReferenceDevices | K220022 Sigma Biomedical TRATE Dental Implant SystemK173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing AbutmentsK212628 Terrats Medical SL DESS Dental Smart SolutionsK231803 JJGC Industria e Comercio de Materiais Dentarios SA NeodentImplant System - Zirconia Implant SystemK220200 Paltop Advanced Dental Solutions, Ltd Paltop Conical Implant System | ||||
| ReferenceDevices forCompatibleOEM ImplantSystem | K071370 Nobel Biocare AB NobelActive Internal Connection ImplantK073142 Nobel Biocare LLC USA NobelReplace Hexagonal ImplantK173418 Nobel Biocare AB NobelParallel™ Conical ConnectionK121131 Straumann USA BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND10MM, 12, 14MMK140878 Straumann USA Bone Level Tapered ImplantK083550 Straumann USA Dental Implant SystemK133339 Zimmer Dental Tapered Screw Vent T Implant, HA Coated; TaperedScrew-Vent M Implant, HA Coated | ||||
| DeviceDescription | The iPhysio® System is a set of two-piece titanium healing abutments (iPhysio®Profile Designers) be screwed into the implant using compatible anodizedtitanium screws during the 1st or the 2nd surgical intervention. The iPhysio®Profile Designer abutment is manufactured from titanium alloy (Ti-6Al-4V ELI)per ISO 5832-3 and includes a zirconium nitride (ZrN) coating. iPhysio® ProfileDesigners are available in multiples anatomical shapes and gingival heights, andare compatible with Nobel BioCare (NobelActive®, NobelReplace®,NobelParallel™), Straumann (Bone Level / Bone Level Tapered), and ZimmerBiomet (Trabecular Metal, Tapered Screw-Vent®) implants. All iPhysio® Profile |
{6}------------------------------------------------
| Designers are straight (0°). Supporting screws are manufactured from titanium | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| alloy (Ti-6Al-4V ELI) per ISO 5832-3 and are anodized to a color that aligns with | ||||||||||
| its corresponding height. The iPhysio® Profile Designer healing abutment screw | ||||||||||
| is for placing the iPhysio® Profile Designer in the implant in the patient's mouth. | ||||||||||
| The iPhysio® Profile Designer remains in place throughout the bone and gingival | ||||||||||
| healing process as well as during the taking of a digital or conventional | ||||||||||
| impression, preserving the emergence profile during the impression. The | ||||||||||
| abutment is only removed once to place and finally screw in the final abutment. | ||||||||||
| Anatomical healing, implant impression, and placement of the temporary crown | ||||||||||
| may all be done without removing the iPhysio® Profile Designer. | ||||||||||
| A compatible PEEK temporary abutment may be clipped to the iPhysio® Profile | ||||||||||
| Designer to which a non-load bearing temporary crown may be then placed for | ||||||||||
| improved aesthetics during healing. To use the PEEK temporary abutment, the | ||||||||||
| iPhysio® Profile Designer healing abutment screw is replaced with a compatible | ||||||||||
| temporary abutment screw. The temporary crown is placed over the PEEK | ||||||||||
| temporary abutment following modification of the abutment to the appropriate | ||||||||||
| shape. The PEEK temporary abutment is connected onto the iPhysio® Profile | ||||||||||
| Designer by a combination of friction and cement. All iPhysio® temporary | ||||||||||
| abutments are manufactured from PEEK per ASTM F2026. | ||||||||||
| Indications for | Indications for Use for iPhysio® Profile Designer: | |||||||||
| Use Statement | iPhysio® System Profile Designers are indicated to be placed in the patient's | |||||||||
| mouth at the end of the implant placement to protect the inner configuration of the | ||||||||||
| implant and maintain, stabilize and form the soft tissue during the healing process. | ||||||||||
| The healing abutments should be used only with compatible implant connections. | ||||||||||
| The healing abutments are intended for use up to 6 months. | ||||||||||
| Compatible Implant Systems: | ||||||||||
| Implant | Platform | |||||||||
| Manufacturer | Implant System | Diameter | Diameter | Platform | ||||||
| (mm) | (mm) | Name | ||||||||
| NobelActive® | 3.5 | 3.5 | NP | |||||||
| 4.3, 5.0 | 4.3, 5.0 | RP | ||||||||
| Nobel Biocare | NobelReplace® | 3.5 | 3.5 | NP | ||||||
| 4.3, 5.0 | 4.3, 5.0 | RP | ||||||||
| NobelParallel™ | 3.75 | 3.5 | NP | |||||||
| 4.3, 5.03.3 | 4.3, 5.03.3 | RPNC | ||||||||
| Bone Level | 4.1, 4.8 | 4.1, 4.8 | RC | |||||||
| Straumann | Bone Level | 3.3 | 3.3 | NC | ||||||
| Tapered | 4.1, 4.8 | 4.1, 4.8 | RC | |||||||
| 3.7, 4.1 | 3.5 | 3.5 | ||||||||
| Zimmer | Trabecular Metal | 4.7 | 4.5 | 4.5 | ||||||
| Biomet | Tapered Screw- | 3.7, 4.1 | 3.5 | 3.5 | ||||||
| Vent® | 4.7 | 4.5 | 4.5 | |||||||
{7}------------------------------------------------
| Indications for Use for iPhysio® PEEK Temporary Abutment: |
|---|
| The iPhysio® System PEEK Temporary Abutment is an abutment placed on the |
| iPhysio® System Profile Designer to provide support for prosthetic structures for |
| up to 6 months. It can be used in single- or two-stage procedures and is intended |
| to be placed out of occlusion. |
{8}------------------------------------------------
Comparison of Technological Characteristics – Healing Abutment
| Characteristic | Subject DeviceEuroteknikaiPhysio® System | Primary PredicateStraumannCeramic HealingAbutmentsK192893 | Reference DeviceSigma BiomedicalTRATE Dental ImplantSystemK220022 | Reference DeviceBiomet 3iTSV™ BellaTek®Encode® HealingAbutmentsK173374 | Reference DeviceTerrats Medical SLDESS Dental SmartSolutionsK212628 | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purpose | Subject Device | Same indications; Similarcomponents (screwretained healing abutment) | Similar healing abutmentsizes | Similar impression takingprocess | Similar materials ofconstruction and healingabutment coating | ||||||||||||||||||||||||||||||||||||||||
| ProductClassification | Class II872.3630Primary: NHA | Class II872.3630Primary: NHA | Class II872.3630Primary: DZE, NHA | Class II872.3630Primary: NHA | Class II872.3630Primary: NHA | ||||||||||||||||||||||||||||||||||||||||
| Indications forUse | Indications for Use for iPhysio® Profile Designer:iPhysio® System Profile Designers are indicated tobe placed in the patient's mouth at the end of theimplant placement to protect the inner configurationof the implant and maintain, stabilize and form thesoft tissue during the healing process. The healingabutments should be used only with compatibleimplant connections. The healing abutments areintended for use up to 6 months.Compatible Implant Systems:ManufacturerImplantSystemImplantDiameter(mm)PlatformDiameter(mm)PlatformNameNobelActive®3.54.3, 5.03.54.3, 5.0NPRPNobel BiocareNobelReplace®3.54.3, 5.03.54.3, 5.0NPRPNobelParallel™3.754.3, 5.03.54.3, 5.0NPRPStraumannBone Level3.34.1, 4.83.34.1, 4.8NCRCBone LevelTapered3.34.1, 4.83.34.1, 4.8NCRCZimmerBiometTrabecularMetal3.7, 4.14.73.54.53.54.5Tapered Screw-Vent®3.7, 4.14.73.54.53.54.5 | Straumann® CeramicHealing abutments areindicated to be placed inthe patient's mouth at theend of the implantplacement to protect theinner configuration of theimplant and maintain,stabilize and form the softtissue during the healingprocess. Healing abutmentsshould be used only withsuitable implantconnections. The healingcomponents are intended tobe used up to 6 months | TRATE Dental ImplantSystem is indicated for usein surgical and restorativeapplications for placementin the bone of the upper orlower jaw to providesupport for prostheticdevices, such as artificialteeth, in order to restorethe patient's chewingfunction. TRATE DentalImplant System isindicated also forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading | The TSV™ BellaTek®Encode® HealingAbutments are intended foruse as an accessory toendosseous dental implantsduring endosseous andgingival healing to preparegingival tissue for aacceptance of a finalabutment and restoration. | DESS Dental SmartSolutions abutments areintended to be used inconjunction withendosseous dentalimplants in the maxillaryor mandibular arch toprovide support forprosthetic restorations.All digitally designedcustom abutments for usewith DESS Bases orBlanks are to be sent to aTerrats Medical validatedmilling center formanufacture | ||||||||||||||||||||||||||||||||||||||||
| DeviceClassificationName | Endosseous Dental Implant Abutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | ||||||||||||||||||||||||||||||||||||||||
| Intended Use | Protect the inner configuration of the implant andmaintain, stabilize and form the soft tissue duringthe healing process. | Protect the innerconfiguration of theimplant and maintain,stabilize and form the softtissue during the healingprocess. | Protect the innerconfiguration of theimplant and maintain,stabilize and form the softtissue during the healingprocess. | Protect the innerconfiguration of theimplant and maintain,stabilize and form the softtissue during the healingprocess. | Protect the innerconfiguration of theimplant and maintain,stabilize and form the softtissue during the healingprocess. | ||||||||||||||||||||||||||||||||||||||||
| Sterilization | Sterile, Gamma IrradiationSAL 10-6 | Sterile, Ethylene OxideSAL 10-6 | Sterile, End User SteamSterilizedSAL 10-6 | Sterile, Gamma IrradiationSAL 10-6 | Non-Sterile, End UserSteam SterilizedSAL 10-6 |
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| Characteristic | Subject DeviceEuroteknikaiPhysio® System | Primary PredicateStraumannCeramic HealingAbutmentsK192893 | Reference DeviceSigma BiomedicalTRATE Dental ImplantSystemK220022 | Reference DeviceBiomet 3iTSVTM BellaTek®Encode® HealingAbutmentsK173374 | Reference DeviceTerrats Medical SLDESS Dental SmartSolutionsK212628 | Characteristic | Subject DeviceEuroteknikaiPhysio® System | Additional PredicateJJGC Industria e Comercio de MateriaisDentarios SANeodent Implant System - Zirconia ImplantSystemK231803 | Additional PredicatePaltop Advanced Dental Solutions, LtdPaltop Conical Implant SystemK220200 |
|---|---|---|---|---|---|---|---|---|---|
| Abutment / ScrewMaterial | Abutment: ZrN coated Titanium alloyScrew: Titanium alloy | Abutment: Y-TZPScrew: Ti-6Al-7Nb orTAN (screw) | Abutment: Titanium alloyScrew: Titanium alloy | Abutment: Titanium alloyScrew: Titanium alloy | Abutment:ZrN coated and uncoatedTitanium alloy (Ti-6Al-4VELI)Screw: Titanium alloy (Ti-6Al-4V) with and withouta diamond like coating | Purpose | Subject Device | Similar cylindrical pillar design (temporaryabutment) | Similar intended use and technological characteristics(SAS Abutment) |
| Abutment Shape | 4 abutment forms• A: Incisors, Canines, and Premolars• B: Premolar, Molar, and Maxillary CentralIncisors• C: Molar• D: Premolars | Circular Design | Circular Design | Circular Design withVarious EmergenceProfiles3.8, 5.0, 5.6, 6.0, and6.8mm | Not applicable tocomparison | Product Classification | Class II872.3630Primary: NHA | Class II872.3630Primary: NHA | Class II872.3630Primary: DZE, NHA |
| Implant AbutmentConnection | Internal | Internal | Internal | Internal | Not applicable tocomparison | Device ClassificationName | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment |
| Abutment Sizes | Total Height:7.2 - 10.6 mmAbutment Length:4.3 – 7.7 mmAbutment Width:4.3 – 6.6 mm | Total Height:NC: 8 to 11 mmRC: 8 to 12 mmAbutment Diameter:NC: Ø3.6 & 4.8 mmRC: Ø4.5, 5.0, 6.0, and 6.5mm | Abutment Diameter: 4mm,5mm | Platform Diameter:3.5, 4.5, 5.7mm | Not applicable tocomparison | Indications for Use | Indications for Use for iPhysio® PEEK TemporaryAbutment:The iPhysio® System PEEK Temporary Abutmentis an abutment placed on the iPhysio® SystemProfile Designer to provide support for prostheticstructures for up to 6 months. It can be used insingle- or two-stage procedures and is intended to beplaced out of occlusion. | Indications for Use for PEEK CR Abutment forZirconia Implant System:The PEEK CR Abutment is indicated to be used onNeodent Implants to provide support for prostheticstructures for up to 6 months. They can be used insingle- or two-stage procedures and they areintended to be placed out of occlusion. | The Paltop Conical Implant System is indicated foruse in surgical and restorative applications forplacement in the bone of the upper or lower jaw toprovide support for prosthetic devices, such asartificial teeth, in order to restore the patient'schewing function. Narrow diameter implants areintended for placement in the mandibular central,lateral incisor and maxillary lateral incisor regions ofpartially edentulous jaws where the horizontal spaceis limited by the adjacent teeth and roots. The PaltopConical Implant System is also indicated forimmediate loading when good primary stability isachieved and with appropriate occlusal loading. |
| Abutment Angle | Straight (0°) | Straight (0°) | Straight (0°) | Straight (0°) | Not applicable tocomparison | Intended Use | Support of a temporary provisional prosthesis placedout of occlusion | Support of a temporary provisional prosthesis placedout of occlusion | Support of a temporary provisional prosthesis placedout of occlusion |
| AbutmentGingival Heights(mm) | 1mm, 2mm, 3mm, and 4mm | 2.0, 3.0, and 4.5 mm | 0.5mm - 7mm | 3, 5, and 7mm | Not applicable tocomparison | Sterilization | Non-Sterile, End User Steam SterilizedSAL 10-6 | Sterile, Ethylene OxideSAL 10-6 | Non-Sterile, End User Steam SterilizedSAL 10-6 |
| Abutment Methodof Attachment | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Design | Cylindrical pillar that snaps to healing abutment | Two-piece cylindrical abutment with through hole tofixate the screw and abutment base | Cap that snaps to screw-retained titanium abutment |
| ImpressionCompatibility | Does not require removal of iPhysio® ProfileDesigner abutment when taking digital /conventional impressions | Requires removal ofhealing abutment whentaking impressions | Requires removal ofhealing abutment whentaking impressions | Does not require removalof healing abutment whentaking digital /conventional impressions | Not applicable tocomparison | Implant-AbutmentInterface | Snaps to healing abutment and supported by cement | Straight internal connectionindexing features (ZiLock) | Snaps to healing abutment and supported by cement |
| Abutment Loading | Not intended to be load bearing | Not intended to be loadbearing | Not intended to be loadbearing | Not intended to be loadbearing | Not applicable tocomparison | Temporary AbutmentMaterial | PEEK | PEEK | PEEK |
| Characteristic | Subject DeviceEuroteknikaiPhysio® System | Primary PredicateStraumannCeramic HealingAbutmentsK192893 | Reference DeviceSigma BiomedicalTRATE Dental ImplantSystemK220022 | Reference DeviceBiomet 3iTSVTM BellaTek®Encode® HealingAbutmentsK173374 | Reference DeviceTerrats Medical SLDESS Dental SmartSolutionsK212628 | Abutment GingivalHeights | Component snaps on top of healing abutment.Gingival height determined via healing abutment (1-4mm) | 1.5mm, 2.5mm, 3.5mm, 4.5mm | Component snaps on top of healing abutment.Gingival height is determined via healing abutment(1-5mm). |
| CompatibleImplants | Nobel Biocare NobelActive®: Narrow Platform(NP) and Regular Platform (RP)Nobel Biocare NobelReplace® CC: NarrowPlatform (NP) and Regular Platform (RP)Nobel Biocare NobelParallel™ CC: NarrowPlatform (NP) and Regular Platform (RP)Straumann Bone Level (BL) and Bone LevelTapered (BLT) Ø3.3: Narrow CrossFit®Connection (NC)Straumann Bone Level (BL) and Bone LevelTapered (BLT) Ø4.1 and Ø4.8: Regular CrossFit®Connection (RC)Zimmer Biomet Screw Vent / Tapered Screw- | Straumann Dental ImplantSystems: NarrowCrossFit® (NC) andRegular CrossFit® (RC) | TRATE Dental ImplantSystem Implants: Narrowand Regular Standard | Tapered Screw-Vent®,Screw-Vent® andTrabecular Metal implantsystems | Not applicable tocomparison | Abutment Diameters | 3.0mm | 4.0mm, 4.5mm | 4.5mm |
| Modifiable by End User toFinal Geometry | Yes | Yes | Yes |
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Comparison of Technological Characteristics – PEEK Temporary Abutment
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Equivalence to Marketed Devices
There are no significant technological differences between the subject and predicate devices. The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Additional reference devices not discussed below are identified only for OEM implant system compatibility.
Healing Abutments
The subject device healing abutments are substantially equivalent in intended use to the primary predicate device cleared in K192853 and the additional predicate devices cleared in K220022, K173374, and K212628. All subject device abutments are substantially equivalent in design, materials, and technological characteristics to the additional predicate devices. Minor differences include:
- . The inclusion of a ZrN coating is similar to K212628 and supporting coating characterization testing supports that the coating fulfills all necessary requirements for its intended use. As such, this difference does not raise new concerns for safety or effectiveness.
- The subject device healing abutment is offered of various geometrical forms depending on the . location of the abutment in the mouth. The predicate devices are only offered in a circular form. As shown via the engineering analyses, these differences in forms do not impact device compatibility. As such, this difference does not raise new concerns for safety or effectiveness.
- The subject and predicate device healing abutments are compatible with different implants. ● Reverse engineering analyses support that the subject device was shown to be compatible with all devices as listed in the labeling and indications for use. As such, this difference does not raise new concerns for safety or effectiveness.
- The Indications for Use Statement (IFU) for the subject device is substantially equivalent to ● that of the primary predicate K192853. Any differences in the indications are simply to indicate the list of compatible implants.
In conclusion, any technological differences between the subject and predicate devices do not raise new concerns for safety or effectiveness.
PEEK Temporary Abutments
The subject device PEEK temporary abutments are substantially equivalent in intended use to the additional predicate devices cleared in K231803 and K220200. All subject device PEEK temporary abutments are substantially equivalent in design, materials, and technological characteristics to the additional predicate devices. Minor differences include:
- . The subject device PEEK temporary abutment has a different mechanism of connection from the additional predicate devices. Bench testing including dynamic fatigue testing and abutment removal testing supports that the subject device temporary abutment can withstand worst case loading for the maximum indicated duration of use and the temporary abutment connection
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feature does not cause damage to either the implant or healing abutment. As such, this difference does not raise new questions of safety or effectiveness.
- . The subject device PEEK temporary abutment is indicated for a maximum duration of 180 days while K220200 is indicated for use for only 30 days. This difference is addressed via K231803 which is also indicated for a maximum use of 180 days. As such, this difference does not raise new questions of safety or effectiveness.
- . The subject device PEEK temporary abutment is a pillar that can be modified to shape prior to placement of the temporary prosthesis. K220200 is a cap that cannot be modified after placement. This technological difference is addressed via K231803 which also includes a PEEK pillar shaped abutment that can be modified to shape prior to placement of the temporary prosthesis. As such, this difference does not raise new questions of safety or effectiveness.
In conclusion, any technological differences between the subject and predicate devices do not raise new concerns for safety or effectiveness.
Non-Clinical Performance Testing Summary
| Test | Test Method Summary | Results |
|---|---|---|
| Reverse EngineeringAnalysis | Reverse engineering analysis of OEM implantbodies, OEM abutments, and OEM abutmentscrews to confirm compatibility. Relevantdimensions and tolerances from subject devicescrew and abutment connections were analyzedfor compatibility with FDA cleared implants asspecified in the device labeling. | PASSDevice met allpredeterminedacceptance criteria |
| ZrN CoatingCharacterization | Per FDA Guidance "Root-form EndosseousDental Implants and Endosseous DentalAbutments - Class II Special Controls GuidanceDocument for Industry and FDA Staff"• ZrN Coating Cross Section SEMImaging Test Report• ZrN Coating Elemental Analysis andSEM Imaging Test Report• ZrN Coating Hardness Abrasion ScratchTest• ZrN Coating Tensile Shear and AbrasionTest | PASSCoating met allpredeterminedacceptance criteria |
| MR CompatibilityTesting | Per ASTM F2503-20 Standard Practice forMarking Medical Devices and Other Items forSafety in the Magnetic Resonance Environmentand FDA Guidance Document "Testing andLabeling Medical Devices for Safety in theMagnetic Resonance (MR) Environment" | PASSDevice is MRConditional |
Performance testing for the subject device is summarized in the table below:
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| Test | Test Method Summary | Results |
|---|---|---|
| Fatigue Testing | All subject device abutments are straight (0°), are intended to be placed inocclusion, and are not intended to correct angled implants. As such, therewould be no forces applied to them and thus, dynamic fatigue testing is notapplicable. | |
| Fatigue Testing | Fatigue testing was conducted to evaluate thetemporary abutments in a worst-case testconfiguration. The test setup was based on amodified version of ISO 14801:2016 | PASSDevice met allpredeterminedacceptance criteria |
The subject device components were evaluated for biocompatibility according to ISO 10993-1 and 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". The following testing was performed to support the biocompatibility of the subject device:
- Cytotoxicity per ISO 10993-5 .
- Sensitization per ISO 10993-10 ●
- Irritation per ISO 10993-23
- Acute Systemic Toxicity per ISO 10993-11
- Material Mediate Pyrogenicity per ISO 10993-11, European Pharmacopoeia - 2.6.8. Pyrogens
- Implantation per ISO 10993-6
- Subacute / subchronic toxicity, chronic toxicity, and carcinogenicity were ● addressed via chemical characterization per ISO 10993-18 and toxicological risk assessment per ISO 10993-17
The iPhysio® Profile Designer and all supporting components were found to be biocompatible for their intended contact level and duration when tested in compliance with ISO 10993-1.
A gamma sterilization validation in compliance with ISO 11137-2 was performed confirming the applicable cycle will achieve a sterility assurance level (SAL) of 10th for the worst-case packaging configuration. A steam sterilization in compliance with ISO 17665-1 was performed confirming the applicable cycle will achieve a sterility assurance level (SAL) of 106 for the subject device non-sterile components. Sterile packed components were tested in accordance with ISO 11607-1 to validate the labeled shelf life.
Clinical Performance Testing Summary
No clinical data was included in this submission.
Conclusions
Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)