BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT

K123491 · Biodenta Swiss AG · NHA · May 30, 2013 · Dental

Device Facts

• Record ID: K123491
• Device Name: BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT
• Applicant: Biodenta Swiss AG
• Product Code: NHA · Dental
• Decision Date: May 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biodenta Dental Implant System Mutti-Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

Device Story

The Biodenta Dental Implant System - Multi-Use Abutment is a prosthetic component system designed for use with endosseous dental implants. It functions as an interface between the dental implant and the final prosthesis. The system includes straight and angulated (0°, 18°, 30°) abutments, ball attachments, temporary abutments, burn-out cylinders, and impression posts. It is used by dental professionals in a clinical setting to support screw-retained restorations. The device is attached to the implant via an internal hexagon connection and secured with an abutment screw. By providing a stable platform for crowns, bridges, or overdentures, the device facilitates prosthetic rehabilitation, restoring function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

Bench testing only. Fatigue testing was conducted in accordance with the FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments'. Testing evaluated the worst-case scenario for the abutment and implant system, demonstrating sufficient mechanical strength for the intended clinical application.

Technological Characteristics

Materials: Titanium alloy. Design: Straight and angulated (0°, 18°, 30°) abutments with internal hexagon connection. Dimensions: 4.5-5.0 mm diameter; 2.0-5.0 mm cuff heights. Connectivity: Mechanical interface to endosseous dental implants. Sterilization: Delivered non-sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring terminal or intermediate abutment support for fixed or removable crowns, bridgework, or to retain overdentures in the mandible or maxilla.

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

• Biodenta Dental Implant System – Bone Level (K111003)
• NobelActive Multi Unit Abutment (K072570)
• Low Profile Abutment (K092341)

Submission Summary (Full Text)

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Multi-Use Abutment 5 - 510(k) Summary

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# MAY 3 0 2013

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## 510(k) Summary

| Owner's name: | Biodenta Swiss AG |
|-----------------------------|-----------------------------------------------------|
| Address: | Tramstrasse 16<br>9442 Berneck<br>Switzerland |
| Phone: | [phone] |
| Fax number: | + 41 71 747 11 12 |
| Contact person: | Mr. David Eiler, Regulatory Manager |
| Date summary prepared: | February 26, 2013 |
| Trade / proprietary name: | Biodenta Dental Implant System - Multi-Use Abutment |
| Common name: | Endosseous dental implant abutment |
| Device classification name: | Abutment, Implant, Dental, Endosseous |
| Product code: | NHA |
| Regulation number: | 21 CFR 872.3630 |

Legally marketed device to which equivalence is claimed (predicate device):

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| 1. Company: | Biodenta Swiss AG |
|----------------|---------------------------------------------|
| Device name: | Biodenta Dental Implant System – Bone Level |
| 510(k) number: | K111003 |
| 2. Company: | Nobel Biocare AB |
| Device name: | NobelActive Multi Unit Abutment |
| 510(k) number: | K072570 |

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K123491

Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Multi-Use Abutment 5 - 510(k) Summary

Image /page/1/Picture/2 description: The image shows the logo for "biodenta." The logo consists of the word "biodenta" in a bold, sans-serif font, with a registered trademark symbol to the right of the "a." Above the word is a graphic of three curved lines, resembling a stylized wave or swoosh design. The overall design is simple and modern.

| 3. Company: | Biomet 3i |
|----------------|----------------------|
| Device name: | Low Profile Abutment |
| 510(k) number: | K092341 |

### Indications for Use:

Biodenta Dental Implant System Multi Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

#### Device Description:

The Biodenta Dental Implant System - Multi-Use Abutment is an extension to the Biodenta Dental Implant System Bone Level (K111003), which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.

The Biodenta Dental Implant System - Multi-Use Abutment includes 0°, 18°, and 30° abutments for screw retained restorations. Each angulation is available with 2, 3, 4, and 5 mm cuff height for both Biodenta Bone Level implant platform types (B1 and B2). The angulated abutments include hexed and non-hexed versions for single unit or multi unit restorations respectively. Abutment diameters are from 4.5 - 5.0 mm.

The system includes a ball attachment abutment with a diameter of 4.5 mm and height of 5.5 mm, and temporary abutments with a diameter of 4.0 mm and height of 12.5 mm, which are to be attached onto the Multi-Use Abutment. Burn out cylinders are provided. The system includes 2 diameters of abutment and 1 diameter of prosthetic screws. Short and long impression posts for open and closed tray impression taking, and a protective cap for the Multi-Use Abutment is included.

### Non-clinical Testing Data:

Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff. The worst case scenario for the Biodenta Dental Implant System - Multi Use-Abutment and implant was tested. The results show that the Biodenta Dental Implant System - Multi Use-Abutment has sufficient mechanical strength for the intended clinical application.

### Equivalence to marketed device:

Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Dental Implant System - Multi-Use Abutment is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System – Multi-Use Abutment 5 - 510(k) Summary

Image /page/2/Picture/2 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a stylized graphic of three curved lines, resembling a stylized leaf or wave. To the right of the word "biodenta" is a small, superscripted "R" in a circle, indicating a registered trademark.

## Summary Substantial Equivalence Comparison to predicate devices:

| | Subject Device | | Predicate Devices | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Biodenta Swiss AG | Biodenta Swiss AG | Nobel Biocare AB | Biomet 3i |
| Device Name | Biodenta Dental<br>Implant System -<br>Multi-Use Abutment | Biodenta Dental<br>Implant System -<br>Bone Level | NobelActive Multi<br>Unit Abutment | Low Profile Abutment |
| 510(k)<br>Number | New device | K111003 | K072570 | K092341 |
| Intended use | Biodenta Dental<br>Implant System Multi<br>Use Abutments are<br>intended for terminal<br>or intermediate<br>abutment support for<br>fixed or removable<br>crown, bridgework<br>and to retain<br>overdentures. | Biodenta bone level<br>dental implants are<br>intended for surgical<br>placement in<br>mandibles or maxillae<br>to support single or<br>multiple tooth<br>restorations or terminal<br>or intermediate<br>abutment support for<br>fixed or removable<br>bridgework and to<br>retain overdentures. | NobelActive Multi Unit<br>Abutment is a pre-<br>manufactured<br>prosthetic component<br>directly connected to<br>the endosseous<br>dental implant and is<br>intended for use as<br>an aid in prosthetic<br>rehabilitation. | BIOMET 3i Low Profile<br>Abutments are intended for<br>use as accessories to<br>endosseous dental implant<br>to support a prosthetic<br>device in a partially or<br>completely edentulous<br>patient. A dental abutment is<br>intended for use to support<br>single and multiple tooth<br>prosthesis, in the mandible<br>or maxilla. The prosthesis is<br>screw retained to the<br>abutment. |
| Restorations | Screw retained | Screw retained &<br>cemented | Screw retained | Screw Retained |
| Abutment<br>Type | Straight & Angled | Straight & Angled | Straight & Angled | Straight & Angled |
| Abutment<br>Angle | 0°, 18°, 30° | 0° - 15° | 0°, 17°, 30° | 0°, 17°, 30° |
| Implant to<br>Abut. Connect | Internal Hexagon | Internal Hexagon | Internal Hexagon | Internal Hexagon |
| Abutment<br>fixation | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw |
| Compatible<br>Implants<br>Diameter | 3.5 mm<br>4.1 mm<br>4.8 mm | 3.5 mm<br>4.1 mm<br>4.8 mm | 3.5 mm<br>4.3 mm<br>5.0 mm | 3.25 mm<br>4.0 mm<br>5.0 mm<br>6.0 mm |
| Abutment<br>cuff height | 2.0 - 5.0 mm ( 0°)<br>2.2 - 5.2 mm (18°)<br>2.0 - 5.0 mm (30°) | 5.7 - 9.8 mm | 1.5 - 4.5 mm ( 0°)<br>2.5 - 3.5 mm (17°)<br>3.5 - 4.5 mm (30°) | 1.0 - 4.0 mm ( 0°)<br>2.0 - 4.0 mm (17°)<br>3.0 - 5.0 mm (30°) |
| Abutment<br>Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Sterilization | Delivered<br>non sterile | Delivered<br>non sterile | Delivered<br>non sterile | Delivered<br>non sterile |
| Reusable | No | No | No | No |

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Premarket Notification / 510(k) Submission . Biodenta Dental Implant System - Multi-Use Abutment 5 - 510(k) Summary ،

Image /page/3/Picture/2 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a stylized graphic that resembles three curved lines stacked on top of each other. To the right of the word "biodenta" is the registered trademark symbol.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2013

Mr. David Eiler Regulatory Manager Biodenta Swiss AG Tramstrasse 16 Berneck, Switzerland 9442

Re: K123491

Trade/Device Name: Biodenta Dental Implant System Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 15. 2013 Received: May 16, 2013

Dear Mr. Eiler:

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 Eederal 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. 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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Page 2 – Mr. Eiler

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/5/Picture/7 description: This image shows a letter that is signed by Mary S. Runner and Kwame Ulmer. The letter is signed digitally by Mary S. Runner on May 30, 2013, at 11:26:12 -04'00'. Kwame Ulmer is the Acting Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health.

Enclosure

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Multi-Use Abutment 4 - Indications for Use Statement

Image /page/6/Picture/1 description: The image shows the logo for "biodenta". Above the word "biodenta" is a graphic of three curved lines stacked on top of each other. To the right of the word "biodenta" is a circled R symbol.

### Indications for Use

510(k) Number (if known): _K123491

Device Name: Biodenta Dental Implant System - Multi-Use Abutment

Indications for Use:

Biodenta Dental Implant System Mutti-Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

by Mary S. Runner - S Mary S. Ru COLLA 2300.100.1.1=1300087950 ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ દિવેલ 2013.05.30 09:59:13 -04'00

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| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |

417349 510(k) Number,

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