iPhysio® System

K232383 · Euroteknika · NHA · Mar 4, 2025 · Dental

Device Facts

• Record ID: K232383
• Device Name: iPhysio® System
• Applicant: Euroteknika
• Product Code: NHA · Dental
• Decision Date: Mar 4, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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.

Device Story

The iPhysio® System consists of two-piece titanium healing abutments (Profile Designers) and PEEK temporary abutments. Profile Designers are screwed into compatible endosseous dental implants to protect the internal configuration and shape soft tissue during healing. They remain in place during impression taking, allowing for anatomical healing and temporary crown placement without removal. PEEK temporary abutments clip onto the Profile Designer to support non-load-bearing temporary crowns for improved aesthetics. Used in dental clinics by dentists/specialists. The system benefits patients by preserving emergence profiles and simplifying the restorative workflow. Output is a stabilized soft tissue environment and temporary prosthetic support.

Clinical Evidence

No clinical data was included in this submission. Bench testing included reverse engineering analysis, ZrN coating characterization (SEM, elemental analysis, hardness/scratch/tensile testing), MR compatibility (ASTM F2503-20), fatigue testing (ISO 14801:2016), and biocompatibility (ISO 10993-1, -5, -6, -10, -11, -17, -18, -23). Sterilization validated per ISO 11137-2 (gamma) and ISO 17665-1 (steam).

Technological Characteristics

Profile Designer: Ti-6Al-4V ELI (ISO 5832-3) with Zirconium Nitride (ZrN) coating. PEEK Temporary Abutment: PEEK (ASTM F2026). Connection: Internal. Sterilization: Gamma irradiation (sterile components) or steam (non-sterile components). Dimensions: Profile Designer height 7.2-10.6mm; PEEK abutment modifiable. Connectivity: None (mechanical).

Indications for Use

Indicated for patients requiring endosseous dental implant healing abutments to protect implant inner configurations and stabilize soft tissue during healing (up to 6 months). PEEK temporary abutments are indicated for supporting prosthetic structures (up to 6 months) in single- or two-stage procedures, placed out of occlusion.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Straumann® Ceramic Healing Abutments (K192893)
• Neodent Implant System - Zirconia Implant System (K231803)
• Paltop Conical Implant System (K220200)

Reference Devices

• Sigma Biomedical TRATE Dental Implant System (K220022)
• Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments (K173374)
• Terrats Medical SL DESS Dental Smart Solutions (K212628)
• Nobel Biocare AB NobelActive Internal Connection Implant (K071370)
• Nobel Biocare LLC USA NobelReplace Hexagonal Implant (K073142)
• Nobel Biocare AB NobelParallel™ Conical Connection (K173418)
• Straumann USA BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM (K121131)
• Straumann USA Bone Level Tapered Implant (K140878)
• Straumann USA Dental Implant System (K083550)
• Zimmer Dental Tapered Screw Vent T Implant, HA Coated; Tapered Screw-Vent M Implant, HA Coated (K133339)

Submission Summary (Full Text)

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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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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.

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# K232383 510(k) SUMMARY:
iPhysio® System

| Date Prepared | March 4, 2025 | | | | |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | Euroteknika | | | | |
| | 726 Rue Du General De Gaulle | | | | |
| Sponsor | Sallanches Haute-Savoie, France 74700 | | | | |
| | [phone] | | | | |
| | 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 | | | | |
| | [e-mail] | | | | |
| Trade Name | iPhysio® System | | | | |
| Common Name | Abutment, Implant, Dental Endosseous | | | | |
| Code - | NHA | | | | |
| Classification | 21 CFR §872.3630: Class II | | | | |
| Predicate<br>Device | K192893 Straumann® Ceramic Healing Abutments | | | | |
| Reference<br>Devices | K220022 Sigma Biomedical TRATE Dental Implant System<br>K173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments<br>K212628 Terrats Medical SL DESS Dental Smart Solutions<br>K231803 JJGC Industria e Comercio de Materiais Dentarios SA Neodent<br>Implant System - Zirconia Implant System<br>K220200 Paltop Advanced Dental Solutions, Ltd Paltop Conical Implant System | | | | |
| Reference<br>Devices for<br>Compatible<br>OEM Implant<br>System | K071370 Nobel Biocare AB NobelActive Internal Connection Implant<br>K073142 Nobel Biocare LLC USA NobelReplace Hexagonal Implant<br>K173418 Nobel Biocare AB NobelParallel™ Conical Connection<br>K121131 Straumann USA BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND<br>10MM, 12, 14MM<br>K140878 Straumann USA Bone Level Tapered Implant<br>K083550 Straumann USA Dental Implant System<br>K133339 Zimmer Dental Tapered Screw Vent T Implant, HA Coated; Tapered<br>Screw-Vent M Implant, HA Coated | | | | |
| Device<br>Description | The iPhysio® System is a set of two-piece titanium healing abutments (iPhysio®<br>Profile Designers) be screwed into the implant using compatible anodized<br>titanium screws during the 1st or the 2nd surgical intervention. The iPhysio®<br>Profile Designer abutment is manufactured from titanium alloy (Ti-6Al-4V ELI)<br>per ISO 5832-3 and includes a zirconium nitride (ZrN) coating. iPhysio® Profile<br>Designers are available in multiples anatomical shapes and gingival heights, and<br>are compatible with Nobel BioCare (NobelActive®, NobelReplace®,<br>NobelParallel™), Straumann (Bone Level / Bone Level Tapered), and Zimmer<br>Biomet (Trabecular Metal, Tapered Screw-Vent®) implants. All iPhysio® Profile | | | | |

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| | | | 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<br>3.3 | 4.3, 5.0<br>3.3 | RP<br>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 | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |

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| 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. |

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## Comparison of Technological Characteristics – Healing Abutment

| Characteristic | Subject Device<br>Euroteknika<br>iPhysio® System | Primary Predicate<br>Straumann<br>Ceramic Healing<br>Abutments<br>K192893 | Reference Device<br>Sigma Biomedical<br>TRATE Dental Implant<br>System<br>K220022 | Reference Device<br>Biomet 3i<br>TSV™ BellaTek®<br>Encode® Healing<br>Abutments<br>K173374 | Reference Device<br>Terrats Medical SL<br>DESS Dental Smart<br>Solutions<br>K212628 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose | Subject Device | Same indications; Similar<br>components (screw<br>retained healing abutment) | Similar healing abutment<br>sizes | Similar impression taking<br>process | Similar materials of<br>construction and healing<br>abutment coating | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product<br>Classification | Class II<br>872.3630<br>Primary: NHA | Class II<br>872.3630<br>Primary: NHA | Class II<br>872.3630<br>Primary: DZE, NHA | Class II<br>872.3630<br>Primary: NHA | Class II<br>872.3630<br>Primary: NHA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Indications for<br>Use | Indications for Use for iPhysio® Profile Designer:<br>iPhysio® System Profile Designers are indicated to<br>be placed in the patient's mouth at the end of the<br>implant placement to protect the inner configuration<br>of the implant and maintain, stabilize and form the<br>soft tissue during the healing process. The healing<br>abutments should be used only with compatible<br>implant connections. The healing abutments are<br>intended for use up to 6 months.<br><br>Compatible Implant Systems:<br>ManufacturerImplant<br>SystemImplant<br>Diameter<br>(mm)Platform<br>Diameter<br>(mm)Platform<br>NameNobelActive®3.5<br>4.3, 5.03.5<br>4.3, 5.0NP<br>RPNobel BiocareNobelReplace®3.5<br>4.3, 5.03.5<br>4.3, 5.0NP<br>RPNobelParallel™3.75<br>4.3, 5.03.5<br>4.3, 5.0NP<br>RPStraumannBone Level3.3<br>4.1, 4.83.3<br>4.1, 4.8NC<br>RCBone Level<br>Tapered3.3<br>4.1, 4.83.3<br>4.1, 4.8NC<br>RCZimmer<br>BiometTrabecular<br>Metal3.7, 4.1<br>4.73.5<br>4.53.5<br>4.5Tapered Screw-<br>Vent®3.7, 4.1<br>4.73.5<br>4.53.5<br>4.5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Straumann® Ceramic<br>Healing abutments are<br>indicated to be placed in<br>the patient's mouth at the<br>end of the implant<br>placement to protect the<br>inner configuration of the<br>implant and maintain,<br>stabilize and form the soft<br>tissue during the healing<br>process. Healing abutments<br>should be used only with<br>suitable implant<br>connections. The healing<br>components are intended to<br>be used up to 6 months | TRATE Dental Implant<br>System is indicated for use<br>in surgical and restorative<br>applications for placement<br>in the bone of the upper or<br>lower jaw to provide<br>support for prosthetic<br>devices, such as artificial<br>teeth, in order to restore<br>the patient's chewing<br>function. TRATE Dental<br>Implant System is<br>indicated also for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading | The TSV™ BellaTek®<br>Encode® Healing<br>Abutments are intended for<br>use as an accessory to<br>endosseous dental implants<br>during endosseous and<br>gingival healing to prepare<br>gingival tissue for a<br>acceptance of a final<br>abutment and restoration. | DESS Dental Smart<br>Solutions abutments are<br>intended to be used in<br>conjunction with<br>endosseous dental<br>implants in the maxillary<br>or mandibular arch to<br>provide support for<br>prosthetic restorations.<br>All digitally designed<br>custom abutments for use<br>with DESS Bases or<br>Blanks are to be sent to a<br>Terrats Medical validated<br>milling center for<br>manufacture |
| Device<br>Classification<br>Name | Endosseous Dental Implant Abutment | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intended Use | Protect the inner configuration of the implant and<br>maintain, stabilize and form the soft tissue during<br>the healing process. | Protect the inner<br>configuration of the<br>implant and maintain,<br>stabilize and form the soft<br>tissue during the healing<br>process. | Protect the inner<br>configuration of the<br>implant and maintain,<br>stabilize and form the soft<br>tissue during the healing<br>process. | Protect the inner<br>configuration of the<br>implant and maintain,<br>stabilize and form the soft<br>tissue during the healing<br>process. | Protect the inner<br>configuration of the<br>implant and maintain,<br>stabilize and form the soft<br>tissue during the healing<br>process. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterilization | Sterile, Gamma Irradiation<br>SAL 10-6 | Sterile, Ethylene Oxide<br>SAL 10-6 | Sterile, End User Steam<br>Sterilized<br>SAL 10-6 | Sterile, Gamma Irradiation<br>SAL 10-6 | Non-Sterile, End User<br>Steam Sterilized<br>SAL 10-6 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Characteristic | Subject Device<br>Euroteknika<br>iPhysio® System | Primary Predicate<br>Straumann<br>Ceramic Healing<br>Abutments<br>K192893 | Reference Device<br>Sigma Biomedical<br>TRATE Dental Implant<br>System<br>K220022 | Reference Device<br>Biomet 3i<br>TSVTM BellaTek®<br>Encode® Healing<br>Abutments<br>K173374 | Reference Device<br>Terrats Medical SL<br>DESS Dental Smart<br>Solutions<br>K212628 | Characteristic | Subject Device<br>Euroteknika<br>iPhysio® System | Additional Predicate<br>JJGC Industria e Comercio de Materiais<br>Dentarios SA<br>Neodent Implant System - Zirconia Implant<br>System<br>K231803 | Additional Predicate<br>Paltop Advanced Dental Solutions, Ltd<br>Paltop Conical Implant System<br>K220200 |
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| Abutment / Screw<br>Material | Abutment: ZrN coated Titanium alloy<br>Screw: Titanium alloy | Abutment: Y-TZP<br>Screw: Ti-6Al-7Nb or<br>TAN (screw) | Abutment: Titanium alloy<br>Screw: Titanium alloy | Abutment: Titanium alloy<br>Screw: Titanium alloy | Abutment:<br>ZrN coated and uncoated<br>Titanium alloy (Ti-6Al-4V<br>ELI)<br>Screw: Titanium alloy (Ti-<br>6Al-4V) with and without<br>a diamond like coating | Purpose | Subject Device | Similar cylindrical pillar design (temporary<br>abutment) | Similar intended use and technological characteristics<br>(SAS Abutment) |
| Abutment Shape | 4 abutment forms<br>• A: Incisors, Canines, and Premolars<br>• B: Premolar, Molar, and Maxillary Central<br>Incisors<br>• C: Molar<br>• D: Premolars | Circular Design | Circular Design | Circular Design with<br>Various Emergence<br>Profiles<br>3.8, 5.0, 5.6, 6.0, and<br>6.8mm | Not applicable to<br>comparison | Product Classification | Class II<br>872.3630<br>Primary: NHA | Class II<br>872.3630<br>Primary: NHA…