KLOCKNER DENTAL IMPLANT, MODEL S3M

K052654 · SOADCO, S.L. · DZE · Jan 30, 2006 · Dental

Device Facts

• Record ID: K052654
• Device Name: KLOCKNER DENTAL IMPLANT, MODEL S3M
• Applicant: SOADCO, S.L.
• Product Code: DZE · Dental
• Decision Date: Jan 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

S3M Klockner implants are a dental implant which consist of a small conical fixture (the root-form configuration). This implant enabling to be used as a support fitting when the gap to be replaced is not sufficient for a standard fitting (Ø 4.2 mm shoulder), or in areas of aesthetic concern, where the long-term preservation of the papilla is very important, such as the upper lateral incisors and lower incisors.

Device Story

S3M Klockner implant is a Grade 3 commercially pure titanium root-form endosseous dental implant; 3.1mm diameter; 8-14mm length. Device surgically placed into drilled bone receptacle under gingiva; gingiva sutured over fixture. Used by dentists to substitute tooth roots; secure dentures; support bridges or multiple-tooth restorations. Indicated for immediate placement and function when primary stability is achieved. Provides prosthetic support in edentulous/partially edentulous patients; specifically designed for narrow spaces or aesthetic zones requiring papilla conservation. Clinical benefit includes restoration of chewing function and secure prosthetic retention.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with FDA guidance 'Information for premarket notification submissions for screw type endosseous implants' (Dec 9, 1996). Additional evidence includes finite element analysis. No clinical trial data presented.

Technological Characteristics

Material: Grade 3 commercially pure titanium. Surface: Shot-peened and passivated. Configuration: Conical root-form endosseous fixture. Diameter: 3.1mm. Length: 8-14mm. Energy source: N/A (mechanical). Connectivity: N/A. Sterilization: Not specified.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring dental root-form endosseous implants for prosthetic restoration support, specifically in reduced-space sites (insufficient for 4.2mm diameter implants) or areas requiring papilla preservation, such as upper lateral incisors and lower incisors.

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

• KLOCKNER DENTAL IMPLANTS (S3)
• NARROW NECK ITI STRAUMANN

Submission Summary (Full Text)

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JAN 30 2006

K052654

# 1. IDENTIFICATION

- Denomination:KLOCKNER dental implants

- Manufacturer name and address: SOADCO, S.L. Avgda. Fiter i Rossell, 4bis - Local nº2 ESCALDES - ENGORDANY (ANDORRA)

- Contact person: Maria Mitjaneta

- Telephone and Fax numbers: (376) 800 590 / Fax- (376) 800 594

- Date: 09/12/05

# 2. DEVICE NAME

TRADE NAME: KLOCKNER implant System Models: \$3M

COMMON NAME: Dental Implant

CLASSIFICATION NAME: Root-form Endosseous Dental Implant (per 21CFR Part 872.3640)

# 3. PREDICATE DEVICE / LEGALLY MARKETED DEVICE

NAME: Dental endosseous implants

LEGALLY MARKETED DEVICE: S3 KLOCKNER DENTAL IMPLANTS NARROW NECK ITI STRAUMANN

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K052654

#### 4.DESCRIPTION

The S3M Klockner implant are an endosseous implant, are a device made of Grade 3 commercially pure titanium , which consist of a small conical fixture (the root-form configuration), perhans eigth to fourteen millimetres in length that have a shot peening process and a pasivated surface. Are available in diameter 3.1mm.

### 5.INTENDED USE OF THE DEVICE

S3M Klockner implants are a dental implant which consist of a small conical fixture (the root-form configuration)placed into a tiny receptacle channel which has been drilled into the bone under the gingiva (gum) at the desired location.

The gingiva is elevated from the underlying bone, the channel is cut, the fixture is placed, and the gingiva is sutured.

In its simplist form, the implant is used to substituiting the roots of teeth, to secure a denture. This is a wonderful remedy for an edentulous patient whose ridges do not allow the secure places and of a denture. In other uses the implant becomes the support for two or more (sometime many) implants of or to support a bridge or multiple bridge. This implant is indicated for reduced spaces when this is insufficient for a conventional attachment (Ø4,2 mm) or in areas which is very important this iss is and the conservation of the papila, in special in cases of single lateral incisers in the uspeciality and lateral and central incisors in the lower jaw.

## 6.BASIS FOR SUBSTANTIAL EQUIVALENCE

The subject Klockner implant are substantially equivalent to the previously cleared KLOCKNER DENTAL IMPLANTS(S3), NARROW NECK STRAUMANN implants. The intended use is identical to the predicate device. S3M Klockner implants are surgically placed in the maxillary of mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients, in special for sites with poor space between teeth.

The implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropiate occlusion of mailips tooling, in order to restore chewing function. In the case of edentulous patients many implants must be used.

The Klockner implants have the same material composition and the same surface treatment as previously cleared predicate dental implants, this surface treatment does not introduce new issues for biocompatibility. Mechanical testing was done in accordance with the FDA gidance «Infornation for premarket notification submissions for screw type endosseous implants» issued on December 9, 1996. Results from an independent laboratory showed that the surface treatment to have sufficient osseointegration. Additional test reports include finite elements analysis.

The proposed S3M klockner implants and accesories are identical to the curently marketed Klockner dental implants and accesories and similar in design, materials, and intended use to S3 Klockner dental implant and other legally marketed dental implant systems that are indicated for reduced space and to support other implants.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle emblem. The seal is in black and white.

Public Health Service

JAN 3 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maria Mitjaneta Quality Assurance Manager SOADCO, S.L. Avgda Fiter I Rossell, 4Bis Local nº2 ESCALDES- ENGORDANY (ANDORRA)

Re: K052654

Trade/Device Name: KLOCKER DENTAL IMPLANT S3M Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 16, 2006 Received: January 23, 2006

Dear Ms. Mitjaneta:

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 such 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 - Ms. Mitjaneta

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, plcase note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

Chiu Lin, Ph.D.

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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K052654

510(k) Number (if known): K010132

## Device Name:KLOCKNER DENTAL IMPLANT S3M

Indications For Use:

S3M Klockner implants are a dental implant which consist of a small conical fixture (the root-form configuration). This implant enabling to be used as a support fitting when the gap to be replaced is not sufficient for a standard fitting (Ø 4.2 mm shoulder), or in areas of aesthetic concern, where the long-term preservation of the papilla is very important, such as the upper lateral incisors and lower incisors.

Susan Roaper

ingy, Cambral Hospital,

K052654

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use