KLOCKNER VEGA DENTAL IMPLANT SYSTEM

K153098 · SOADCO, S.L. · DZE · Apr 8, 2016 · Dental

Device Facts

• Record ID: K153098
• Device Name: KLOCKNER VEGA DENTAL IMPLANT SYSTEM
• Applicant: SOADCO, S.L.
• Product Code: DZE · Dental
• Decision Date: Apr 8, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLOCKNER® VEGA® dental implant system is indicated to replace missing teeth in single and multiple unit applications within the mandible or maxilla. Implants can be for immediate placement and function in extraction sites and partially or completely healed alveolar ridge situations, when good primary stability is achieved and with appropriate occlusal loading. Different loading protocols (immediate, early or delayed) can be applied in partially or totally edentulous patients. The prosthetic restorations can be single-unit or multiple-unit restorations. The Ø 3.0 mm implants should only be used for unit restorations for maxillary lateral incisors and mandibular lateral and central incisors.

Device Story

Klockner Vega Dental Implant System consists of endosseous dental implants designed for surgical placement into the mandible or maxilla to support prosthetic restorations. System includes various implant diameters and lengths to accommodate different anatomical sites and loading protocols (immediate, early, or delayed). Used by dental surgeons in clinical settings to replace missing teeth. Implants provide a foundation for single or multiple-unit prosthetic restorations. Clinical benefit includes restoration of masticatory function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Endosseous dental implant system. Materials: Titanium alloy (Grade 5 ELI). Surface treatment: Titanium plasma spray or similar osseointegration-enhancing surface. Design: Threaded, tapered or cylindrical geometry. Sterilization: Gamma radiation. Connectivity: Mechanical connection to prosthetic abutments.

Indications for Use

Indicated for patients requiring replacement of missing teeth in mandible or maxilla. Applicable for single or multiple unit restorations in partially or totally edentulous patients. Ø 3.0 mm implants restricted to maxillary lateral incisors and mandibular lateral/central incisors. Suitable for immediate, early, or delayed loading protocols in extraction sites or healed alveolar ridges, provided primary stability is achieved.

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 Essential Cone Dental Implant System (K133667)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

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

April 8, 2016

SOADCO, S.L. Ms. Maria Mitianeta Quality Manager Avgda. Fiter I Rosell, 4 Bis - Local 2 Escaldes - Engordany, AD-700 ANDORRA

Re: K153098

Trade/Device Name: Klockner Vega Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 19, 2016 Received: March 2, 2016

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. 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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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 (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director 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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Image /page/2/Picture/1 description: The image shows the logo for SOAD for Klockner. The logo is in gray and features the letters "SOAD" in a stylized font. The "O" in SOAD contains a globe image. Below the letters is the text "for KLOCKNER" in a smaller font.

## INDICATIONS FOR USE

510(k) Number (if known): K153098

Device Name: Klockner Vega Dental Implant System

## Indications for Use:

The KLOCKNER® VEGA® dental implant system is indicated to replace missing teeth in single and multiple unit applications within the mandible or maxilla. Implants can be for immediate placement and function in extraction sites and partially or completely healed alveolar ridge situations, when good primary stability is achieved and with appropriate occlusal loading. Different loading protocols (immediate, early or delayed) can be applied in partially or totally edentulous patients. The prosthetic restorations can be single-unit or multiple-unit restorations.

The Ø 3.0 mm implants should only be used for unit restorations for maxillary lateral incisors and mandibular lateral and central incisors.

V 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)