Z5MLB, Z5MLC

K131701 · Z-Systems AG · DZE · Sep 5, 2013 · Dental

Device Facts

• Record ID: K131701
• Device Name: Z5MLB, Z5MLC
• Applicant: Z-Systems AG
• Product Code: DZE · Dental
• Decision Date: Sep 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Z mlb implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Z5mlb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. 2 smlc implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Zamle implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Device Story

One-piece, root-form, threaded dental implants; manufactured from yttria-stabilized zirconia (Y-TZP). Designed for surgical implantation into edentulous upper/lower jaws to support full or partial dentures. Used by dental clinicians in clinical settings. Provides alternative for patients with metal allergies. Implants available in specific diameters (3.6mm, 4.0mm) and lengths (8mm, 10mm).

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Yttria-stabilized zirconia (Y-TZP). Design: One-piece, root-form, threaded. Dimensions: 3.6-4.0mm diameter, 8-10mm length. Sterilization: Standardized processes consistent with predicate devices.

Indications for Use

Indicated for patients requiring denture attachment in edentulous upper or lower jaws, including those 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-Look3 Evo SLM (K120793)
• Z-Look3 Dental Implant System (K062542)
• CeraRoot Implant System (K093595)
• MDI MII 2.9 Implants (K081653)
• IMTEC Sendax MDI and MDI Plus (K031106)
• MILOTM Dental Implant System (K050970)
• Spectra Dental Implant System (K061319)
• Ace Surgical Secure™ Locator® 3.25 mm Implant System (K093518)

Submission Summary (Full Text)

{0}------------------------------------------------

Z5mlb and Z5mlc

# 510(k) Summary

# Z-Systems AG

# Z5mlb and Z5mlc

June 10, 2013

# ADMINISTRATIVE INFORMATION

| Manufacturer Name | Z-Systems AG<br>Bittertenstrasse 15<br>702 Oensingen<br>Switzerland |
|---------------------------|---------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Official Contact | Thomas Hug, Ph.D. |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH |
| | Floyd G. Larson, MS, MBA |
| | PaxMed International, LLC |
| | 12264 El Camino Real, Suite 400 |
| | San Diego, CA 92130 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail]<br>[e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Z5mlb and Z5mlc |
|----------------------------|--------------------------------|
| Common Name | Dental Implant |
| Classification Name | Implant, endosseous, root-form |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |

SEP 0 5 2013

{1}------------------------------------------------

### INTENDED USE

#### Zsmlb:

Z mlb implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Z5mlb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

### Z<mlc:

2 smlc implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Zamle implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

## DEVICE DESCRIPTION

The purpose of this submission is to expand the Z-Look3 Evo SLM implant line (K 120793) to include two implant designs indicated for denture attachment. The Z5mlb and Z5mlc are onepiece, root-form, threaded implants made from yttria-stabilized zirconia (Y -TZP). Zsmlb and 25mlc implants are designed for full or partial denture restorations. Z5mlb implants are provided in two diameters (3.6 and 4.0 mm) and two endosseous lengths (8 and 10 mm). Zsmlc implants are provided in one diameter (4.0 mm) and one endosseous length (10 mm).

# EQUIVALENCE TO MARKETED DEVICE

Z-Systems AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's requlation of medical devices Z5mlb and Z5mlc are substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Z-Systems AG, Z-Look3 Evo SLM, K120793;

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

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

IMTEC Corp., MDI MII 2.9 Implants, K081653;

IMTEC Corp., IMTEC Sendax MDI and MDI Plus, K031106;

Intra-Lock International, Inc., MILOTM Dental Implant System, K050970;

Implant Direct, Spectra Dental Implant System K061319; and

Ace Surgical Supply Co., Inc., Ace Surgical Secure™ Locator® 3.25 mm Implant System, K093518.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter, length, and surface

{2}------------------------------------------------

treatment. 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, Z5mlb and Z5mlc 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 o
- has similar packaging and is sterilized using the same materials and processes .

{3}------------------------------------------------

Public Health Service

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

#### September 5, 2013

Z-Systems AG C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K131701

Trade/Device Name: Zsmlb and Zsmlc Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant · Regulatory Class: II Product Code: DZE Dated: June 10, 2013 Received: June 11, 2013

#### 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.

{4}------------------------------------------------

Page 2 - Ms. Schulz

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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.

**Mary S. Runner -S**

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number: K131701

Zgmlb and Z5mlc Device Name:

Zsmlb:

Zemlb implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. 2 milb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Zsmlc:

Zsmlc implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Zamic implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

Page 1 of 1

Lauren M. Giles - - - .. for AIS 2013.09.04 15:31:10 -04'00'

(Division Sign-Off) Tivision of Anesthesiology, General Hospital fection Control, Dental Devices

510(k) Number: ≤13\70\