IPD Dental Implant Abutments

K222215 · Implant Protesis Dental 2004, S.L. · NHA · Oct 21, 2022 · Dental

Device Facts

• Record ID: K222215
• Device Name: IPD Dental Implant Abutments
• Applicant: Implant Protesis Dental 2004, S.L.
• Product Code: NHA · Dental
• Decision Date: Oct 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

Device Story

IPD Dental Implant Abutments are titanium alloy components (healing, temporary, cementing, or Ti-base) that attach to endosseous dental implants. The system includes titanium screws (Ti, TiN-coated, or TPA) to secure the prosthesis. Used by dental clinicians in clinics, the device provides a foundation for prosthetic restorations. Ti-base abutments are designed via a digital dentistry workflow (intra-oral scanner, CAD software, milling machine) to support a zirconia superstructure, which is cemented to the Ti-base. The final assembly is screw-retained to the implant. The device benefits patients by restoring dental function and aesthetics in edentulous or partially edentulous arches.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including sterilization validation (ISO 17665-1), biocompatibility (ISO 10993-5/10), dimensional analysis, digital workflow validation, and static/dynamic fatigue testing (ISO 14801).

Technological Characteristics

Materials: Titanium alloy (ISO 5832-3), TiN coating, or anodized. Design: Healing, temporary, cementing, and Ti-base abutments. Connectivity: Digital library files for CAD/CAM integration. Sterilization: Non-sterile, intended for end-user steam sterilization. Energy: Mechanical. Form factor: Various diameters/platforms compatible with Brånemark, Straumann, and Tapered Screw-Vent systems.

Indications for Use

Indicated for patients undergoing oral implant surgery requiring support for single or multiple dental prosthetic restorations in the maxillary or mandibular arch. Compatible with specific Brånemark, Straumann Tissue Level, and Tapered Screw-Vent implant systems.

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

• Elos Accurate® Hybrid Base™ (K201860)

Reference Devices

• DESS Dental Smart Solutions (K170588)
• IH Implant System (K153521)
• DESS Dental Smart Solutions (K173908)
• Brånemark System Dental Implant Products (K022562)
• Straumann® Tissue Level / ITI Synocta Meso Abutments (K130222)
• Tapered Screw-Vent® X Implant (K113756)
• 3Shape Abutment Designer™ Software (K151455)
• DD Bio Z (K142987)
• Multilink® Automix (K123397)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

10/21/2022

Implant Protesis Dental 2004 S.L Francesc Fumanal Regulatory Affairs Manager Cami del Mig. 71. Mataro, Barcelona 08302 SPAIN

Re: K222215

Trade/Device Name: IPD Dental Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: July 19, 2022 Received: July 25, 2022

Dear Francesc Fumanal:

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

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

{1}------------------------------------------------

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

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

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.

for Andrew 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K222215

Device Name IPD DENTAL IMPLANT ABUTMENTS

#### Indications for Use (Describe)

IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter |
|------------------------------|-----------------------|-------------------|
| Brånemark | 3.5 | NP (3.5 mm) |
| | 3.75 / 4.0 | RP (4.1 mm) |
| | 5.0 | WP (5.1 mm) |
| Straumann® Tissue Level | 3.3 / 4.1 / 4.8 | RN (4.8 mm) |
| | 4.8 | WN (6.5 mm) |
| Tapered Screw-Vent® | 3.7 / 4.1 | 3.5 mm |
| | 4.7 | 4.5 mm |
| | 6.0 | 5.7 mm |

#### Compatible Implant Systems

The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, ceramic material, milling machine and associated tooling and accessories.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 12pt;"> <span style="font-family: Symbol;"> <span style="color: black;">☑</span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) SUMMARY

#### I. SUBMITTER

#### IMPLANT PROTESIS DENTAL 2004, S.L

Camí del Mig, 71. 1º 2ª 08302 Mataró (Barcelona), Spain.

#### Contact Person:

Francesc Fumanal [phone] [e-mail]

Date prepared: October 21, 2022.

#### II. DEVICE

| Device name: | IPD DENTAL IMPLANT ABUTMENTS |
|----------------------|------------------------------------------------------|
| Common Name: | ENDOSSEOUS DENTAL IMPLANT ABUTMENT |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Regulatory Class: | Class II |
| Product Code(s): | Primary: NHA; Secondary: PNP. |

#### III. PREDICATE DEVICE(S):

| Primary Predicate: | K201860 Elos Accurate® Hybrid Base™ |
|--------------------|-------------------------------------|
| Reference Devices: | K170588 DESS Dental Smart Solutions |
| | K153521 IH Implant System |
| | K173908 DESS Dental Smart Solutions |

| Compatible Implant Systems | | |
|----------------------------|-------------------------|-----------------------|
| Clearance | Device | Manufacturer |
| K022562 | Brånemark | Nobel Biocare AB |
| K130222 | Straumann® Tissue Level | Institut Straumann AG |
| K112160 | Tapered Screw-Vent® | Zimmer Biomet Dental |

{4}------------------------------------------------

#### IV. DEVICE DESCRIPTION

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations.

Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems.

IPD Dental Implant Abutments submission includes the following categories of dental abutment designs:

- Healing abutments; -
- -Temporary abutments;
- Cementing titanium abutments; -
- -Titanium base (interface) abutments;

The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant. Specifically:

- Ti Screw: Used during restoration fabrication.
- TiN Screw: Used in finished restorations, with TiN coating.
- TPA Screw: Used in finished angulated restorations, with TiN coating.

All subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:

{5}------------------------------------------------

Traditional 510(k) - K222215

| Compatible<br>Implant<br>System | Type of<br>connection | Implant<br>Diameter<br>(mm) | Platform<br>Diameter | Device<br>category | Healing<br>Abutment | Cementing<br>/<br>Temporary<br>Abutments | Ti Base<br>(Interface)<br>Abutment |
|---------------------------------|-----------------------|-----------------------------|-------------------------------------------|----------------------------------------|----------------------------------|--------------------------------------------------------|-------------------------------------------------|
| | | | | Material<br>IPD<br>Abutment<br>Systems | Titanium<br>alloy, ISO<br>5832-3 | Titanium<br>alloy,<br>ISO 5832-3,<br>Temp.<br>Anodized | Titanium<br>alloy,<br>ISO 5832-3,<br>TiN coated |
| Brånemark | External | 3.5<br>3.75 / 4.0<br>5.0 | NP (3.5 mm)<br>RP (4.1 mm)<br>WP (5.1 mm) | AA | 3.5<br>4.1<br>5.1 | 3.5<br>4.1<br>5.1 | 3.5<br>4.1<br>5.1 |
| Straumann®<br>Tissue<br>Level | Internal | 3.3/4.1/4.8<br>4.8 | RN (4.8 mm)<br>WN (6.5 mm) | DA | 4.8 | 4.8<br>6.5 | 4.8<br>6.5 |
| Tapered<br>Screw-<br>Vent® | Internal | 3.7 / 4.1<br>4.7<br>6.0 | 3.5 mm<br>4.5 mm<br>5.7 mm | FA | 3.5<br>4.5 | 3.5<br>4.5<br>5.7 | 3.5<br>4.5<br>5.7 |

Table 5.1. Summary of IPD abutments categories with compatibilized OEM Implant Systems.

The abovementioned Compatible Implant Systems received FDA-clearance with the following 510(k) concurrence numbers: Brânemark K022562 (aka Various Brånemark System Dental Implant Products); Straumann® Tissue Level K130222 (aka ITI Synocta Meso Abutments), and Tapered Screw-Vent K113756 (aka Tapered Screw-Vent® X Implant).

Ti Base (Interface) abutments are used as an interface between the dental implant and the zirconia superstructure. They are attached (screw-retained) to the implant and cemented to the zirconia superstructure.

The Ti Base (Interface) is a two-piece abutment composed of the Ti Base (Interface) as the bottomhalf and the zirconia superstructure as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDAcleared design software (e.g., 3Shape Abutment Designer™ Software cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care or at a dental laboratory.

The design and fabrication of the zirconia superstructure for Ti Bases (Interfaces) will be conducted using a digital dentistry workflow requiring the use of the following equipment:

Scanner: 3D Scanner D850 Design Software: 3Shape Abutment Designer Software, K151455. Zirconia Material: DD Bio Z, K142987 Milling machine: Brand: Dental Concept System Model: DC1 Milling System Cement: Multilink® Automix, K123397

{6}------------------------------------------------

Ti Base (Interface) abutments design parameters for the zirconia superstructure are defined as follows:

| Minimum wall thickness: | 0.43 mm |
|---------------------------------------------------|---------|
| Minimum post height for single-unit restorations: | 4.75 mm |
| Maximum gingival height: | 6.0 mm |
| Maximum angulation (Occlusal channel) | 20° |

All CAD/CAM superstructures are for straight abutments only.

The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (i.e. Multilink® Automix, K123397). The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.

### V. INDICATIONS FOR USE

IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter |
|------------------------------|-----------------------|-------------------|
| Brånemark | 3.5 | NP (3.5 mm) |
| Brånemark | 3.75 / 4.0 | RP (4.1 mm) |
| Brånemark | 5.0 | WP (5.1 mm) |
| Straumann® Tissue Level | 3.3 / 4.1 / 4.8 | RN (4.8 mm) |
| Straumann® Tissue Level | 4.8 | WN (6.5 mm) |
| Tapered Screw-Vent® | 3.7 / 4.1 | 3.5 mm |
| Tapered Screw-Vent® | 4.7 | 4.5 mm |
| Tapered Screw-Vent® | 6.0 | 5.7 mm |

#### Compatible Implant Systems

The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is substantially equivalent in indications and design principles to the primary and reference predicate devices. Comparative tables of indications for use and relevant technological characteristics have been provided in the following pages.

{7}------------------------------------------------

Table 5.2. Indications for Use Statements.

| Indications for Use Statements | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------|
| Subject device | IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. | | |
| IPD Dental Implant Abutments (Implant Protesis Dental 2004 SL) | Compatible Implant Systems | | |
| | Implant System Compatibility | Implant Diameter (mm)<br>Platform Diameter | |
| | Brånemark | 3.5<br>3.75 / 4.0<br>5.0<br>NP (3.5 mm)<br>RP (4.1 mm)<br>WP (5.1 mm) | |
| | Straumann® Tissue Level | 3.3 / 4.1 / 4.8<br>4.8<br>RN (4.8 mm)<br>WN (6.5 mm) | |
| | Tapered Screw-Vent® | 3.7 / 4.1<br>4.7<br>6.0<br>3.5 mm<br>4.5 mm<br>5.7 mm | |
| The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. | | | |
| Primary Predicate Device | | | |
| K201860<br>Elos Accurate® Hybrid Base™ | The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hyblid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | | |
| | Table 1. | | |
| | Implant Platform compatibility | Platform diameter [mm]<br>Implant Body diameter [mm] | |
| | Nobel Replace NP | 3.5<br>3.5 | |
| | Nobel Replace RP | 4.3<br>4.3 | |
| Nobel Replace WP | 5 | 5 | |
| Nobel Replace 6.0 | 6 | 6 | |
| Nobel CC 3.0 | 3 | 3 | |
| Nobel CC NP | 3.5 | 3.5 & 3.75 | |
| Nobel CC RP | 3.9 | 4.3 & 5 | |
| Nobel CC WP | 5.1 | 5.5 | |
| Straumann Bone Level NC | 3.3 | 3.3 | |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 | |
| Astra Tech 3.0 | 3 | 3 | |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 | |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 | |
| Astra Tech EV 3.0 | 3 | 3 | |
| Astra Tech EV 3.6 | 3.6 | 3.6 | |
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 | |
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 | |
| Astra Tech EV 5.4 | 5.4 | 5.4 | |
| Brånemark NP | 3.5 | 3.3 | |
| Brånemark RP | 4.1 | 3.75, 4 & 5 | |
| Brånemark WP | 5.1 | 5 & 6 | |
| The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. | | | |
| Reference Devices | | | |
| K170588<br>DESS Dental Smart Solutions (Terrats Medical) | 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.<br>All digitally designed custom abutments for use with Ti Base abutments or Pre-milled (Blank) abutments are to be sent to a Terrats Medical validated milling center for manufacture. | | |
| Compatible Implant Systems | | | |
| | Compatible Implant System | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
| | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 |
| | FRIADENT XIVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 |
| | NobelActive® | 3.5, 4.3, 5.0 | NP, RP |
| | NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP |
| | Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP |
| | Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP |
| | Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC |
| | Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN |
| | Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
| K153521<br>IH Implant System<br>(Sewonmedix) | IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading. | | |
| K173908<br>DESS Dental Smart Solutions<br>(Terrats Medical) | DESS Dental Smart Solutions are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.<br><br>All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture. | | |
| | Compatible Implant Systems | | |
| | Implant System Compatibility | Implant Body | Implant Platform |
| | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 |
| | FRIADENT XIVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 |
| | NobelActive® | 3.5, 4.3, 5.0 | NP, RP |
| | NobelReplace® Conical | 3.5, 4.3, 5.0 | NP, RP |
| | NobelReplace® Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP |
| | Branemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP |
| | Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC |
| | Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN |
| | Tapered Screw-Vent®…