Z-LOOK3 EVO SLM

K120793 · Z-Systems AG · DZE · Dec 21, 2012 · Dental

Device Facts

• Record ID: K120793
• Device Name: Z-LOOK3 EVO SLM
• Applicant: Z-Systems AG
• Product Code: DZE · Dental
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Z-Look3 Evo SLM implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Device Story

Z-Look3 Evo SLM is a one-piece, root-form, threaded dental implant; manufactured from yttria-stabilized zirconia (Y-TZP). Surface modified via medical grade Al2O grit blasting and laser modification to increase surface roughness and bone contact area. Available in diameters 3.6, 4.0, 5.0 mm and lengths 8, 10, 11.5, 13 mm. Intended for single or multiple tooth restorations. Implanted surgically into upper or lower jaw by dental professionals. Provides stable base for prosthodontic appliances; serves as metal-free alternative for patients with metal allergies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Yttria-stabilized zirconia (Y-TZP). Surface: Grit-blasted (Al2O) and laser-modified. Form factor: One-piece, root-form, threaded. Dimensions: 3.6-5.0 mm diameter, 8-13 mm length. Sterilization: Standard methods consistent with predicates.

Indications for Use

Indicated for patients requiring surgical implantation in the upper or lower jaw for attachment of prosthodontic appliances to replace missing teeth, including patients with metal allergies and associated chronic diseases.

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

• Z-Systems AG, Z-Look3 Dental Implant System (K062542)
• Nobel Biocare, Zirconia Implant (K061971)
• Oral Iceberg S.L., CeraRoot Implant System (K093595)
• Contour Healer, LLC, Contour Healer Temporary Abutment (K112099)
• Zimmer Dental Inc., Plastic Temporary Abutment (K092377)

Submission Summary (Full Text)

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Z-Look3 Evo SLM

#### 510(k) Summary : : :

# DEC 2 1 2012

# 510(k) Summary Z-Systems AG Z-Look3 Evo SLM K120793

October 22, 2012

## ADMINISTRATIVE INFORMATION

Manufacturer Name:

Z-Systems AG Bittertenstrasse 15 CH-4702 Oensingen, Switzerland Telephone: [phone] Fax: [phone]

Official Contact:

Representative/Consultant:

Rubino Di Girolamo

Linda K. Schulz BSDH, RDH Kevin A. Thomas PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego. CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail] .

# DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Classification Name: Common Name:

Classification Regulations: Product Code

Classification Panel: Reviewing Branch:

Z-Look3 Evo SLM Implant, endosseous, root-form Dental implant

21 CFR 872.3640 DZE

Dental Products Panel Dental Devices Branch

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Z-Look3 Evo SLM

# 510(k) Summary K120793

#### INTENDED USE

Z-Look3 Evo SLM implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

#### DEVICE DESCRIPTION

Z-Look3 Evo SLM is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). The Z-Look3 Evo SLM surface is grit blasted with medical grade Al20 and laser modified. Implants are available in three diameters (3.6, 4.0 and 5.0 mm) and four lengths (8, 10, 11.5 and13 mm). Z-Look3 Evo SLM implants are designed for single or multiple tooth restorations. Z-Look3 Evo SLM implants are a modification to Z-Look3 implants. The laser modified surface has been added to increase surface roughness and, therefore, the surface area available for contact with bone.

#### EQUIVALENCE TO MARKETED DEVICE

Z-Look3 Evo SLM is substantially equivalent in indications and design principles to the following predicate devices:

Z-Systems AG, Z-Look3 Dental Implant System, cleared under K062542;

Nobel Biocare, Zirconia Implant, cleared under K061971; and

Oral Iceberg S.L., CeraRoot Implant System, cleared under K093595;

Contour Healer, LLC. Contour Healer Temporary Abutment Cleared under K112099; Zimmer Dental Inc., Plastic Temporary Abutment, cleared under K092377.

The subject device and the predicate devices have the same intended use and use, have similar. technological characteristics and are made of the same materials. They encompass the same range of physical dimensions, including diameter and length of the implants. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall, Z-Look3 Evo SLM has the following similarities to the predicate devices:

- has the same intended use, .
- uses the same operating principle, .
- incorporates the same basic design, .
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### December 21, 2012

Z-Systems AG C/O Ms. Linda Schulz, BSDH, RDH Senior Regulatory Affairs Specialist PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K120793

Trade/Device Name: Z-Look3 Evo SLM Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 12, 2012 Received: December 13, 2012

#### Dear Ms. Schulz:

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.

Public Health Service

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

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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 vour 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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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# K120793

#### 510(k) Premarket Notification

### Z-Look3 Evo SLM

## Indications for Use

510(k) Number: K120793

Device Name:

Z-Look3 Evo SLM

Indications for Use:

Z-Look3 Evo SLM implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

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(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

K120793 510(k) Number:

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