BEGO SEMADOS S-LINE

K090716 · Bego Implant Systems GmbH & Co. KG · DZE · Oct 6, 2009 · Dental

Device Facts

• Record ID: K090716
• Device Name: BEGO SEMADOS S-LINE
• Applicant: Bego Implant Systems GmbH & Co. KG
• Product Code: DZE · Dental
• Decision Date: Oct 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)

Device Story

BEGO Semados® S-Line is a threaded endosseous dental implant system featuring TiPure™155 surface treatment. Designed for subgingival placement in upper or lower jaws via one- or two-stage surgical procedures. Used by dental professionals for tooth replacement and prosthetic support. Provides structural foundation for single crowns, bridges, or partial/complete dentures. Benefits patients by restoring oral function and aesthetics in edentulous or partially edentulous sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Threaded endosseous dental implant; TiPure™155 surface treatment; titanium-based construction; designed for one- or two-stage surgical placement.

Indications for Use

Indicated for patients requiring dental restorations in the upper or lower jaw, including single tooth replacement, bridgework abutments, or treatment for partial or complete edentulism.

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

• XIVE Dental Implant System® (K032158)

Submission Summary (Full Text)

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K090716

Premarket notification 510(k) submission BEGO Semados® S-Line

05

CT - 6 2009

#### 510(k) Summary 05

owner's name:

address:

BEGO Implant Systems GmbH& Co KG Wilhelm Herbst Strasse 1 28359 Bremen

[phone]

Germany

phone:

fax numbers:

Martin Ellerhorst

[phone]

name of contact person:

date the summary was prepared:

2009-09-10

Establishment Registration number:

pending

name of the device:

trade or proprietary name:

the classification name:

BEGO Semados S-Line BEGO Semados S-Line implant, endosseous, root-form (21 CFR 872.3640 Product Code DZE)

> Date: Revision: Page:

2009-09-10 ్లాల 18/ 217

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K090716

2.0

05

Legally marketed device to which your firm is claiming equivalence Company:

Friadent GmbH

Device:

XIVE Dental Implant System®

510(k) No.: K032158

## Device Description

BEGO Semados® S-Line with TiPure"155 Surface is a dental implant system that can be placed subgingivally in both the upper and lower jaw using a one- or two-stage surgical procedure.

### Indications:

The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)

> 2009-09-10 Date: Revision: 19/ 217 Page:

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an eagle-like symbol with three lines extending from its back, resembling wings or feathers. The image is black and white and appears to be a scan or photocopy due to its slightly grainy texture.

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

Mr. Martin Ellerhorst Head of Technical Department BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Straße 1 28359 Bremen GERMANY

OCT - 6 2009

Re: K090716

Trade/Device Name: BEGO Semados S-Line Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 10, 2009 Received: September 18, 2009

Dear Mr. Ellerhorst:

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. 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.

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. Ellerhorst

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Nh for

Susan Runner, D.D.S., M.A. Acting Division 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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K090716

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# Indications for Use

510(k) Number (if known): __ K090716__________________________________________________________________________________________________________________________________________

Device Name: BEGO Semados® S-Line

Indications:

The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)

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

Kai Muluy

(Division Sign-Off) Division of Anesthesiology, Gr. aral Hospital Infection Control, Dental Devices

510(k) Number: K090716

2009-09-10 Date: Revision: ਜ 1.7/ 217 Page: