(574 days)
No
The summary describes physical dental abutments and their materials, compatibility, and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to protect the inner configuration of the implant, maintain, stabilize, and form the soft tissue during the healing process, which are therapeutic functions.
No
This device, the iPhysio® System Profile Designer, is a healing abutment intended to protect an implant, maintain soft tissue, and support prosthetic structures during the healing process. It provides physical support and protection, rather than collecting or interpreting data for diagnostic purposes.
No
The device description clearly states that the iPhysio® System is a set of two-piece titanium healing abutments and compatible PEEK temporary abutments, which are physical medical devices. The summary details the materials, manufacturing, and physical testing of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The iPhysio® System Profile Designers and PEEK Temporary Abutments are described as physical components used in dental implant procedures. Their intended use is to protect the implant, shape soft tissue, and support temporary prosthetic structures within the patient's mouth.
- Lack of Biological Sample Analysis: The documentation does not mention any analysis of biological samples from the patient. The device is a physical implant component.
- Performance Studies: The performance studies focus on the physical and material properties of the device (reverse engineering, coating characterization, fatigue testing, biocompatibility, sterilization, shelf life) and its compatibility with existing implant systems. There are no studies related to analyzing biological markers or diagnostic information from patient samples.
Therefore, the iPhysio® System components are medical devices used in vivo (within the body) for structural and healing support in dental implant procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth, upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing Summary:
Test: Reverse Engineering Analysis
Test Method Summary: 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.
Results: PASS Device met all predetermined acceptance criteria
Test: ZrN Coating Characterization
Test Method Summary: 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
Results: PASS Coating met all predetermined acceptance criteria
Test: MR Compatibility Testing
Test Method Summary: 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"
Results: PASS Device is MR Conditional
Test: Fatigue Testing
Test Method Summary: All subject device abutments are straight (0°), are intended to be placed in occlusion, and are not intended to correct angled implants. As such, there would be no forces applied to them and thus, dynamic fatigue testing is not applicable.
Results: Not applicable.
Test: Fatigue Testing
Test Method Summary: 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
Results: PASS Device met all predetermined acceptance criteria
Biocompatibility:
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:
- 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
Results: 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.
Sterilization:
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.
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.
K192893 Straumann® Ceramic Healing Abutments
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.
K220022 Sigma Biomedical TRATE Dental Implant System, K173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments, K212628 Terrats Medical SL DESS Dental Smart Solutions, K231803 JJGC Industria e Comercio de Materiais Dentarios SA Neodent Implant System - Zirconia Implant System, K220200 Paltop Advanced Dental Solutions, Ltd Paltop Conical Implant System
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
§ 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.)
0
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
3
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 | ||||
| Predicate | |||||
| Device | K192893 Straumann® Ceramic Healing Abutments | ||||
| Reference | |||||
| Devices | K220022 Sigma Biomedical TRATE Dental Implant System | ||||
| K173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments | |||||
| K212628 Terrats Medical SL DESS Dental Smart Solutions | |||||
| K231803 JJGC Industria e Comercio de Materiais Dentarios SA Neodent | |||||
| Implant System - Zirconia Implant System | |||||
| K220200 Paltop Advanced Dental Solutions, Ltd Paltop Conical Implant System | |||||
| Reference | |||||
| Devices for | |||||
| Compatible | |||||
| OEM Implant | |||||
| System | K071370 Nobel Biocare AB NobelActive Internal Connection Implant | ||||
| K073142 Nobel Biocare LLC USA NobelReplace Hexagonal Implant | |||||
| K173418 Nobel Biocare AB NobelParallel™ Conical Connection | |||||
| K121131 Straumann USA BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND | |||||
| 10MM, 12, 14MM | |||||
| K140878 Straumann USA Bone Level Tapered Implant | |||||
| K083550 Straumann USA Dental Implant System | |||||
| K133339 Zimmer Dental Tapered Screw Vent T Implant, HA Coated; Tapered | |||||
| Screw-Vent M Implant, HA Coated | |||||
| Device | |||||
| Description | 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 |
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, 5.0 | ||||||||||
| 3.3 | 4.3, 5.0 | |||||||||
| 3.3 | RP | |||||||||
| NC | ||||||||||
| 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 Device
Euroteknika
iPhysio® System | Primary Predicate
Straumann
Ceramic Healing
Abutments
K192893 | Reference Device
Sigma Biomedical
TRATE Dental Implant
System
K220022 | Reference Device
Biomet 3i
TSV™ BellaTek®
Encode® Healing
Abutments
K173374 | Reference Device
Terrats Medical SL
DESS Dental Smart
Solutions
K212628 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose | Subject Device | Same indications; Similar
components (screw
retained healing abutment) | Similar healing abutment
sizes | Similar impression taking
process | Similar materials of
construction and healing
abutment coating | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product
Classification | Class II
872.3630
Primary: NHA | Class II
872.3630
Primary: NHA | Class II
872.3630
Primary: DZE, NHA | Class II
872.3630
Primary: NHA | Class II
872.3630
Primary: NHA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Indications for
Use | Indications for Use for iPhysio® Profile Designer:
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:
ManufacturerImplant
SystemImplant
Diameter
(mm)Platform
Diameter
(mm)Platform
NameNobelActive®3.5
4.3, 5.03.5
4.3, 5.0NP
RPNobel BiocareNobelReplace®3.5
4.3, 5.03.5
4.3, 5.0NP
RPNobelParallel™3.75
4.3, 5.03.5
4.3, 5.0NP
RPStraumannBone Level3.3
4.1, 4.83.3
4.1, 4.8NC
RCBone Level
Tapered3.3
4.1, 4.83.3
4.1, 4.8NC
RCZimmer
BiometTrabecular
Metal3.7, 4.1
4.73.5
4.53.5
4.5Tapered Screw-
Vent®3.7, 4.1
4.73.5
4.53.5
4.5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Straumann® Ceramic
Healing abutments 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. Healing abutments
should be used only with
suitable implant
connections. The healing
components are intended to
be used up to 6 months | TRATE Dental Implant
System is indicated for use
in surgical and restorative
applications for placement
in the bone of the upper or
lower jaw to provide
support for prosthetic
devices, such as artificial
teeth, in order to restore
the patient's chewing
function. TRATE Dental
Implant System is
indicated also for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading | The TSV™ BellaTek®
Encode® Healing
Abutments are intended for
use as an accessory to
endosseous dental implants
during endosseous and
gingival healing to prepare
gingival tissue for a
acceptance of a final
abutment and restoration. | DESS Dental Smart
Solutions abutments are
intended to be used in
conjunction with
endosseous dental
implants in the maxillary
or mandibular arch to
provide support for
prosthetic restorations.
All digitally designed
custom abutments for use
with DESS Bases or
Blanks are to be sent to a
Terrats Medical validated
milling center for
manufacture |
| Device
Classification
Name | Endosseous Dental Implant Abutment | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intended Use | Protect the inner configuration of the implant and
maintain, stabilize and form the soft tissue during
the healing process. | Protect the inner
configuration of the
implant and maintain,
stabilize and form the soft
tissue during the healing
process. | Protect the inner
configuration of the
implant and maintain,
stabilize and form the soft
tissue during the healing
process. | Protect the inner
configuration of the
implant and maintain,
stabilize and form the soft
tissue during the healing
process. | Protect the inner
configuration of the
implant and maintain,
stabilize and form the soft
tissue during the healing
process. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterilization | Sterile, Gamma Irradiation
SAL 10-6 | Sterile, Ethylene Oxide
SAL 10-6 | Sterile, End User Steam
Sterilized
SAL 10-6 | Sterile, Gamma Irradiation
SAL 10-6 | Non-Sterile, End User
Steam Sterilized
SAL 10-6 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
9
| Characteristic | Subject Device
Euroteknika
iPhysio® System | Primary Predicate
Straumann
Ceramic Healing
Abutments
K192893 | Reference Device
Sigma Biomedical
TRATE Dental Implant
System
K220022 | Reference Device
Biomet 3i
TSVTM BellaTek®
Encode® Healing
Abutments
K173374 | Reference Device
Terrats Medical SL
DESS Dental Smart
Solutions
K212628 | Characteristic | Subject Device
Euroteknika
iPhysio® System | Additional Predicate
JJGC Industria e Comercio de Materiais
Dentarios SA
Neodent Implant System - Zirconia Implant
System
K231803 | Additional Predicate
Paltop Advanced Dental Solutions, Ltd
Paltop Conical Implant System
K220200 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment / Screw
Material | Abutment: ZrN coated Titanium alloy
Screw: Titanium alloy | Abutment: Y-TZP
Screw: Ti-6Al-7Nb or
TAN (screw) | Abutment: Titanium alloy
Screw: Titanium alloy | Abutment: Titanium alloy
Screw: Titanium alloy | Abutment:
ZrN coated and uncoated
Titanium alloy (Ti-6Al-4V
ELI)
Screw: Titanium alloy (Ti-
6Al-4V) with and without
a diamond like coating | Purpose | Subject Device | Similar cylindrical pillar design (temporary
abutment) | Similar intended use and technological characteristics
(SAS Abutment) |
| Abutment Shape | 4 abutment forms
• A: Incisors, Canines, and Premolars
• B: Premolar, Molar, and Maxillary Central
Incisors
• C: Molar
• D: Premolars | Circular Design | Circular Design | Circular Design with
Various Emergence
Profiles
3.8, 5.0, 5.6, 6.0, and
6.8mm | Not applicable to
comparison | Product Classification | Class II
872.3630
Primary: NHA | Class II
872.3630
Primary: NHA | Class II
872.3630
Primary: DZE, NHA |
| Implant Abutment
Connection | Internal | Internal | Internal | Internal | Not applicable to
comparison | Device Classification
Name | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment |
| Abutment Sizes | Total Height:
7.2 - 10.6 mm
Abutment Length:
4.3 – 7.7 mm
Abutment Width:
4.3 – 6.6 mm | Total Height:
NC: 8 to 11 mm
RC: 8 to 12 mm
Abutment Diameter:
NC: Ø3.6 & 4.8 mm
RC: Ø4.5, 5.0, 6.0, and 6.5
mm | Abutment Diameter: 4mm,
5mm | Platform Diameter:
3.5, 4.5, 5.7mm | Not applicable to
comparison | Indications for Use | 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. | Indications for Use for PEEK CR Abutment for
Zirconia Implant System:
The PEEK CR Abutment is indicated to be used on
Neodent Implants to provide support for prosthetic
structures for up to 6 months. They can be used in
single- or two-stage procedures and they are
intended to be placed out of occlusion. | The Paltop Conical Implant System is indicated for
use in surgical and restorative applications for
placement in the bone of the upper or lower jaw to
provide support for prosthetic devices, such as
artificial teeth, in order to restore the patient's
chewing function. Narrow diameter implants are
intended for placement in the mandibular central,
lateral incisor and maxillary lateral incisor regions of
partially edentulous jaws where the horizontal space
is limited by the adjacent teeth and roots. The Paltop
Conical Implant System is also indicated for
immediate loading when good primary stability is
achieved and with appropriate occlusal loading. |
| Abutment Angle | Straight (0°) | Straight (0°) | Straight (0°) | Straight (0°) | Not applicable to
comparison | Intended Use | Support of a temporary provisional prosthesis placed
out of occlusion | Support of a temporary provisional prosthesis placed
out of occlusion | Support of a temporary provisional prosthesis placed
out of occlusion |
| Abutment
Gingival Heights
(mm) | 1mm, 2mm, 3mm, and 4mm | 2.0, 3.0, and 4.5 mm | 0.5mm - 7mm | 3, 5, and 7mm | Not applicable to
comparison | Sterilization | Non-Sterile, End User Steam Sterilized
SAL 10-6 | Sterile, Ethylene Oxide
SAL 10-6 | Non-Sterile, End User Steam Sterilized
SAL 10-6 |
| Abutment Method
of 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 to
fixate the screw and abutment base | Cap that snaps to screw-retained titanium abutment |
| Impression
Compatibility | Does not require removal of iPhysio® Profile
Designer abutment when taking digital /
conventional impressions | Requires removal of
healing abutment when
taking impressions | Requires removal of
healing abutment when
taking impressions | Does not require removal
of healing abutment when
taking digital /
conventional impressions | Not applicable to
comparison | Implant-Abutment
Interface | Snaps to healing abutment and supported by cement | Straight internal connection
indexing features (ZiLock) | Snaps to healing abutment and supported by cement |
| Abutment Loading | Not intended to be load bearing | Not intended to be load
bearing | Not intended to be load
bearing | Not intended to be load
bearing | Not applicable to
comparison | Temporary Abutment
Material | PEEK | PEEK | PEEK |
| Characteristic | Subject Device
Euroteknika
iPhysio® System | Primary Predicate
Straumann
Ceramic Healing
Abutments
K192893 | Reference Device
Sigma Biomedical
TRATE Dental Implant
System
K220022 | Reference Device
Biomet 3i
TSVTM BellaTek®
Encode® Healing
Abutments
K173374 | Reference Device
Terrats Medical SL
DESS Dental Smart
Solutions
K212628 | Abutment Gingival
Heights | 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). |
| Compatible
Implants | Nobel Biocare NobelActive®: Narrow Platform
(NP) and Regular Platform (RP)
Nobel Biocare NobelReplace® CC: Narrow
Platform (NP) and Regular Platform (RP)
Nobel Biocare NobelParallel™ CC: Narrow
Platform (NP) and Regular Platform (RP)
Straumann Bone Level (BL) and Bone Level
Tapered (BLT) Ø3.3: Narrow CrossFit®
Connection (NC)
Straumann Bone Level (BL) and Bone Level
Tapered (BLT) Ø4.1 and Ø4.8: Regular CrossFit®
Connection (RC)
Zimmer Biomet Screw Vent / Tapered Screw-
| Straumann Dental Implant
Systems: Narrow
CrossFit® (NC) and
Regular CrossFit® (RC) | TRATE Dental Implant
System Implants: Narrow
and Regular Standard | Tapered Screw-Vent®,
Screw-Vent® and
Trabecular Metal implant
systems | Not applicable to
comparison | Abutment Diameters | 3.0mm | 4.0mm, 4.5mm | 4.5mm |
| Modifiable by End User to
Final Geometry | Yes | Yes | Yes | | | | | | |
10
11
Comparison of Technological Characteristics – PEEK Temporary Abutment
12
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
13
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 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. | PASS | |
| Device met all | ||
| predetermined | ||
| acceptance criteria | ||
| 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 | PASS | |
| Coating met all | ||
| predetermined | ||
| acceptance criteria | ||
| 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" | PASS | |
| Device is MR | ||
| Conditional |
Performance testing for the subject device is summarized in the table below:
14
| Test | Test Method Summary | Results |
|---|---|---|
| Fatigue Testing | All subject device abutments are straight (0°), are intended to be placed in | |
| occlusion, and are not intended to correct angled implants. As such, there | ||
| would be no forces applied to them and thus, dynamic fatigue testing is not | ||
| applicable. | ||
| Fatigue Testing | 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 | PASS | |
| Device met all | ||
| predetermined | ||
| acceptance 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.