KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5

K082200 · SOADCO, S.L. · DZE · Nov 25, 2008 · Dental

Device Facts

• Record ID: K082200
• Device Name: KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
• Applicant: SOADCO, S.L.
• Product Code: DZE · Dental
• Decision Date: Nov 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Klockner Essential implant system is especially designed for surgical insertion into the bone to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories. The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection. Immediate loading is appropriate for the Essential Cone 1.5 implants when good primary stability is achieved with appropriate occlusal loading. 8mm Implants are not indicated for use as single implants and for immediate load.

Device Story

Endosseous dental implant system; designed for surgical insertion into jawbone to replace tooth roots; provides support for dental prosthetics. Features internal octagonal conical connection. Available in diameters 3.5mm, 4.0mm, 4.5mm, 4.8mm; lengths 8mm-16mm. Used by dental surgeons in clinical settings. Immediate loading permitted if primary stability and occlusal loading conditions met. 8mm implants restricted from single-tooth use and immediate loading. Device restores mastication system.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Endosseous dental implant; internal octagonal conical connection; diameters 3.5-4.8mm; lengths 8-16mm. Material and surface treatment identical to predicate.

Indications for Use

Indicated for surgical insertion into bone to replace tooth roots and support dental prosthetics. 8mm implants are contraindicated for single-tooth replacement and immediate loading.

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 model Essential Cone (K080224)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the text "SOAD" in a stylized font. The letters are filled with a pattern of smaller text and shapes, giving them a textured appearance. The letter "O" is designed to resemble a globe, with continents and oceans visible. Below the globe is the text "Klockner".

NOV 2 5 2008

# PREMARKED NOTIFICATION [510 (K)] SUMMARY

1. DENTIFICATION

2. DEVICE NAME

3. PREDICATE DEVICE

4. DESCRIPTION

5. INTENDED USE

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

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Image /page/1/Picture/0 description: The image shows a logo with the text "SOAD" in bold, black letters. To the right of the text is a globe graphic, also in black. Below the globe, the word "KUDOS" is written in a smaller font size. The logo appears to be for an organization or company, possibly related to global issues or international relations.

### 1. IDENTIFICATION

- Denomination: KLOCKNER dental implants

- Manufacturer name and address:

SOADCO, S.L. Avgda. Fiter i Rossell, 4bis - Local 2 ESCALDES - ENGORDANY AD-700 (ANDORRA)

- Contact person: Maria Mitjaneta
- Telephone and Fax numbers: (376) 800 590 / Fax- (376) 800 594

- Date: 07/29/08

#### 2. DEVICE NAME

TRADE NAME: KLOCKNER essential dental implants system model Essential Cone 1.5

COMMON NAME: Dental endosseous implant

CLASSIFICATION NAME: Endosseous implant (21 CFR 872.3640)

## 3. PREDICATE DEVICE / LEGALLY MARKETED DEVICE

NAME: Dental endosseous implant

LEGALLY MARKETED DEVICE: Klockner dental implants model Essential Cone (K080224)

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Image /page/2/Picture/0 description: The image shows a logo with the text "SOAD" in bold, sans-serif font. To the right of the text is a stylized globe graphic, and below that is the text "Klockner". The entire logo is surrounded by a textured, almost pixelated background, giving it a distressed or vintage appearance. The logo is black and white.

#### 4. DESCRIPTION

The Klockner Essential Cone 1.5 implant system consists of a implants to restore the mastication system. The different EC 1.5 are available in four different diameters: 3.5mm, 4.0mm, 4.5mm and 4.8mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

#### 5. INTENDED USE OF THE DEVICE

The Klockner Essential implant system is especially designed for surgical insertion into the bone to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.

The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection.

Immediate loading is appropriate for the Essential Cone 1.5 implants when good primary stability is achieved with appropriate occlusal loading.

#### 6, BASIS FOR SUBSTANTIAL EQUIVALENCE

The subject implants are substantially equivalent to the previously cleared Klockner Essential Cone (EC) dental implants system cleared in K080224 because the intended use, the composition and the endosseous surface treatment are identical to the Klockner Essential predicate devices. The design principles are the same as the Klockner Essential predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2008

Ms. Maria Mitjaneta Quality Assurance Manager SOADCO, S.L. Avgda Fiter I Rossell, 4 Bis Local 2 Escaldes-Engordany Andorra AD-700

Re: K082200

Trade/Device Name: Klockner Essential Implant System Models Essential Cone 1.5 Regulation Number: 872,3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 10, 2008 Received: November 12, 2008

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 complics with other requirements of the Act or any l'edcral 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Saytie H. Mchintonms.

Chiu S. Lin. Ph. D 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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#### 510(k) Number (if known): K082200

Device Name: KLOCKNER ESSENTIAL IMPLANT SYSTEM MODELS ESSENTIAL CONE 1.5

Indications For Use:

The Klockner Essential implant system is especially designed for surgical insertion into the bone to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.

The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection. Immediate loading is appropriate for the Essential Cone 1.5 implants when good primary stability is achieved with appropriate occlusal loading.

8mm Implants are not indicated for use as single implants and for immediate load.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Rebbatz DDS for Dr. Susan Renner

sion of Anesthesiology, General Hospital tion Control, Dental Devices

510(k) Number: K082200