BIODENTA DENTAL IMPLANT SYSTEM

K093630 · Biodenta Swiss AG · DZE · Jun 3, 2010 · Dental

Device Facts

• Record ID: K093630
• Device Name: BIODENTA DENTAL IMPLANT SYSTEM
• Applicant: Biodenta Swiss AG
• Product Code: DZE · Dental
• Decision Date: Jun 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Biodenta dental implants intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. Specific indications for small diameter (Ø 3.5 mm) implants: It is recommended not to place small implants with "NP" platform in the molar or premolar region.

Device Story

BIODENTA Dental Implant System consists of endosseous root-form dental implants, abutments, and surgical/prosthetic instruments. Implants are surgically placed in maxillae or mandibles to support prosthetic restorations. System features internal octagon abutment connection, 45° shoulder angle, and anodized titanium oxide (BST) surface. Used by dental clinicians in clinical settings to restore patient dentition. Device provides structural support for single/multiple tooth restorations, bridgework, or overdentures, benefiting patients by replacing missing teeth and restoring oral function.

Clinical Evidence

Bench testing only. Performance testing confirmed compliance with device specifications and verified that all functions operate as designed.

Technological Characteristics

Material: Titanium Grade 4. Design: Root form, tissue level endosseous implant. Connection: Internal octagon. Surface: Anodized titanium oxide (BST surface). Shoulder angle: 45°. Neck: Smooth, 1.5 mm height.

Indications for Use

Indicated for partially or fully edentulous patients requiring surgical placement of endosseous implants in mandibles or maxillae to support single/multiple tooth restorations, fixed/removable bridgework, or overdentures. Contraindication: Small diameter (Ø 3.5 mm) implants with "NP" platform should not be placed in molar or premolar regions.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Straumann AG, Implant System Standard Plus (K081419)
• Nobel Biocare, TIUNITE IMPLANTS (K050705)

Submission Summary (Full Text)

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510(k) Submission: Reply to review results BIODENTA Dental Implant System 510(k) Summary

K093630

## JUN - 3 2010

Image /page/0/Picture/4 description: The image shows a black and white pattern with the number 1 in bold black font on the right side. The background is a dense, pixelated pattern of black and white squares, creating a textured effect. The number 1 stands out prominently against this background due to its size and solid black color.

## 510(k) Summary

| owner's name: | Bio |
|--------------------------------------------------------------------|------|
| address | Tra |
| | 944 |
| | Swi |
| phone | +41 |
| fax numbers | + 41 |
| name of contact person: | Mr. |
| date the summary was prepared: | 200 |
| name of the device | BIO |
| trade or proprietary name: | BIO |
| the classification name: | imp |
| | (21 |
| Legally marketed device to which your firm is claiming equivalence | The |
| | the |
| | gen |
| Company | Stra |
| Device | Imp |
| 510(k) No. | K08 |

#### denta Swiss AG

mstrasse 16

42 Berneck itzerland

1 71 747 11 11

1 71 747 1112

. David Eiler

09-11-30

ODENTA Dental Implant System

DDENTA Dental Implant System

plant, endosseous, root-form

CFR 872.3640 Product Code DZE)

e following predicate device is used to show substantial equivalence concerning the neral design the implant system

aumann AG

plant System Standard Plus

81419

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

510(k) Submission: Reply to review results BIODENTA Dental Implant System 510(k) Summary

K093630

Furthermore for the surface that is used for the BIODENTA Dental Implant System we consider the following product as predicate device:

Image /page/1/Picture/3 description: The image shows a form with the title "Legally marketed device to which your firm is claiming equivalence". The form has fields for "Company", "Device", and "510(k) No.". The form appears to be used for documenting information about a legally marketed device.

The following predicate device is used to show the substantial equivalence concerning the surface of the implant

Nobel Biocare

TIUNITE IMPLANTS

K050705

#### Indications for Use

Biodenta dental implants intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

Specific indications for small diameter (Ø 3.5 mm) implants: It is recommended not to place small implants with "NP" platform in the molar or premolar region.

#### Device Description:

The BIODENTA Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The technological characteristics of the BIODENTA Dental Implant System are equivalent to those of the predicate devices:

| Element of<br>comparison | BIODENTA Dental Implant System<br>new device | Implant System Standard Plus<br>K081419 predicate device |
|--------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| System | Root form tissue level Implant | Root form tissue level Implant |
| Diameter/<br>Platform<br>(length)<br>in mm | 3.5 / 3.7 (8-14)<br>4.1 / 4.8 (8-14)<br>4.8 / 4.8 (8-14)<br>4.8 / 5.5 (8-12) | 3.3 / 4.8 (8-14)<br>4.1 / 4.8 (6-14)<br>4.8 / 4.8 (6-14)<br>4.8 / 6.5 (6-12) |
| Material | Titanium Grade 4 | Titanium Grade 4 |

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510(k) Submission: Reply to review results BIODENTA Dental Implant System 510(k) Summary

ts
K093630

| Element of comparison | | |
|-----------------------|--------------------------------|--------------------------------------|
| | BIODENTA Dental Implant System | Implant System Standard Plus K081419 |
| Abutment Connection | Internal octagon | Internal octagon |
| Neck height | 1.5 mm | 1.8 mm |
| Surface Neck | Smooth | Smooth |
| Shoulder angle | 45° | 45° |

The endosseous implants of the BIODENTA Dental Implant System are equipped with a Anodized Titanium oxide surface called: BST Surface .

The clinical data and the test results demonstrate that the BIODENTA Dental Implant System is as safe and effective as the legally marketed device Straumann AG, Implant System Standard Plus.

#### Summary of Nonclinical Testing:

.

Based on the risk analysis, performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed.

> Section Page / of 8/41 1.0 Revision 2010-03-25 Date

3003

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## JUN - 3 2010

David Eiler Biodenta Swiss AG Tramstrasse 16 Berneck Switzerland 9442

Re: K093630

Trade/Device Name: Biodenta Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 12, 2010 Received: May 14, 2010

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 Devices marke 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against mission 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 misledding.

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. David 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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

fi. Susan Sunos

4) Anthony D. Watson, B.S., M.S., M.B.A.

Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows a square shape. The square is surrounded by text on all four sides. The text appears to be in a foreign language, possibly Arabic.

510(k) Submission: Reply to review results BIODENTA Dental Implant System 2-Indications for use form

K093630

Indications for Use

510(k) Number (if known): ___

Device Name: BIODENTA Dental Implant System

Biodenta dental implants intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

Specific indications for small diameter (Ø 3.5 mm) implants: It is recommended not to place small implants with "NP" platform in the molar or premolar region.

Prescription Use __ x (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)

Page _1_ of _1_

, of )

Susan Burns

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K003167