Z5m(t)

K150021 · Z-Systems AG · DZE · Jul 31, 2015 · Dental

Device Facts

• Record ID: K150021
• Device Name: Z5m(t)
• Applicant: Z-Systems AG
• Product Code: DZE · Dental
• Decision Date: Jul 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Device Story

Z5m(t) is a one-piece, root-form, threaded dental implant; manufactured from yttria-stabilized zirconia (Y-TZP); features tapered body, double thread design in coronal third, and self-tapping apex; laser-modified endosseous surface. Used by dental surgeons for single or multiple tooth restorations; implanted into upper or lower jaw to support prosthodontic appliances. Provides metal-free alternative for patients with metal allergies. Clinical benefit includes tooth replacement and restoration of oral function. Device is provided sterile.

Clinical Evidence

Bench testing only. No clinical data included. Testing included static and dynamic compression-bending (ISO 14801), sterilization validation (ISO 14937), and biocompatibility evaluation (ISO 10993-1).

Technological Characteristics

Material: Yttria-stabilized zirconia (Y-TZP). Design: One-piece, root-form, threaded, tapered body. Surface: Laser-modified. Dimensions: Diameters 4.0/5.0 mm; Lengths 8/10/12 mm. Sterilization: Validated per ISO 14937 (SAL 10^-6).

Indications for Use

Indicated for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth in patients, 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)

Reference Devices

• Z5c (K132881)
• Legacy3 6 mm Length Implants (K131097)

Submission Summary (Full Text)

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

July 31, 2015

Z-systems Ag c/o Ms. Linda Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K150021

> Trade/Device Name: Z5m(t) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 29, 2015 Received: July 1, 2015

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.

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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 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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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150021

Device Name

Z5m(t)

Indications for Use (Describe)

Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# Z-Systems AG

# Z5m(t)

July 23, 2015

## ADMINISTRATIVE INFORMATION

| Manufacturer Name | Z-Systems AG | | |
|---------------------------|----------------------------------|--------------------|--|
| | Bittertenstrasse 15 | | |
| | CH-4702 Oensingen<br>Switzerland | | |
| | Telephone | [phone] | |
| | Fax | [phone] | |
| Official Contact | Thomas Hug, PhD | | |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH | | |
| | Kevin A. Thomas, PhD | | |
| | PaxMed International, LLC | | |
| | 12264 El Camino Real, Suite 400 | | |
| | San Diego, CA 92130 | | |
| | Telephone | [phone] | |
| | Fax | [phone] | |
| | Email | [e-mail] | |
| | | [e-mail] | |

### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Z5m(t) |
|----------------------------|--------------------------------|
| 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 |

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#### INDICATIONS FOR USE

Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

#### PREDICATE AND REFERENCE DEVICES

Z-Systems AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Z5m(t) is substantially equivalent in indications and design principles to the following legally marketed devices:

Primary Predicate Z-Systems AG, Z-Look3 Evo SLM, K120793 Reference Devices Z-Systems AG, Z5c, K132881; and Implant Direct Sybron Manufacturing LLC, Legacy3 6 mm Length Implants, K131097.

#### DEVICE DESCRIPTION

Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.

#### PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 14937 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process: software validation: and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants.

- Sterilization parameters have been validated to an SAL of 10 . ·
- . No new biocompatibility testing has been performed, as the materials and manufacturing methods used for the subject device are identical to those used for the predicate device.
- The subject device does not represent a new worst case in mechanical testing. •
- No clinical data were included in this submission.

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| | Subject Device | Primary Predicate<br>Device | Reference Devices | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Z-Systems AG | Z-Systems AG | Z-Systems AG | Implant Direct Sybron<br>Manufacturing LLC |
| | Z5m(t) | Z-Look3 Evo SLM | Z5c | Legacy3 6 mm Length<br>Implants |
| | | K120793 | K132881 | K131097 |
| Indications<br>for Use | Z5m(t) implants are<br>designed for surgical<br>implantation into the<br>upper and lower jaw for<br>the attachment of<br>prosthodontic appliances<br>to replace missing teeth.<br>The Z5m(t) implant<br>system is also suitable for<br>patients with metal<br>allergies and the chronic<br>diseases resulting from<br>them. | Z-Look3 Evo SLM<br>implants are designed for<br>surgical implantation into<br>the upper and lower jaw<br>for the attachment of<br>prosthodontic appliances<br>to replace missing teeth.<br>The Z-Look3 Evo SLM<br>implant system is also<br>suitable for patients with<br>metal allergies and the<br>chronic diseases resulting<br>from them. | Z5c implants are designed<br>for surgical implantation<br>into the upper and lower<br>jaw for the attachment of<br>prosthodontic appliances<br>to replace missing teeth.<br>Z5c implant system is<br>also suitable for patients<br>with metal allergies and<br>the chronic diseases<br>resulting from them. Z5c<br>implants are intended for<br>delayed loading. | Lcgacy3 6mm Length<br>consists of two-piece<br>implants for one-stage or<br>two-stage surgical<br>procedures. These<br>implants are intended for<br>use in partially and fully<br>edentulous upper and<br>lower jaws in support of<br>single or multiple-unit<br>restorations and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. Implants can<br>be indicated for<br>immediate loading when<br>good primary stability has<br>been achieved and with<br>appropriate occlusal<br>loading. |
| Design | One-piece,<br>implant/abutment | One-piece,<br>implant/abutment | Two-piece,<br>implant/abutment | Two-piece,<br>implant/abutment |
| Implant<br>Diameter, mm | 4.0, 5.0 | 3.6, 4.0, 5.0 | 4.0, 5.0 | 3.7, 4.2, 4.7, 5.2, 5.7, 7.0 |
| Implant<br>Length, mm | 8, 10, 12 | 8, 10, 11.5, 13 | 8, 10, 12 | 6 |
| Material | | | | |
| Implant,<br>Abutment | Y-TZP<br>Laser treated surface | Y-TZP<br>Laser treated surface | Y-TZP<br>Laser treated surface | Titanium |

This submission expands the Z-System Implant line to include a tapered version of the Z5m (previously named Z-Look3 Evo SLM) originally cleared in K120793. The modification includes a tapered implant body, a double thread design and a self-tapping apex. The primary predicate has a straight body and a single thread design. Both the subject device and the predicate device have the same abutment portion of the one-piece implant.

Z5m(t) diameters and lengths are the same as the reference device Z5c implant diameters and lengths cleared in K132881. The implant body, thread design and self-tapping feature of the Z5m(t) are substantially equivalent to the design of the reference device Legacy3 implant cleared

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510(k) Summary K150021

in K131097. Z5m(t) is different from the reference devices in that it is a one piece implant and abutment, where the reference devices are a two-piece implant and abutment configuration.

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

#### CONCLUSION

Overall, the subject device has the following similarities to the predicate and reference 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.

The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.