Z5-TL
Device Facts
| Record ID | K201712 |
|---|---|
| Device Name | Z5-TL |
| Applicant | Z-Systems AG |
| Product Code | DZE · Dental |
| Decision Date | Dec 1, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
Indications for Use
Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.
Device Story
Z5-TL is a root-form, endosseous threaded dental implant system for tissue-level placement. Implants are manufactured from Y-TZP zirconia (ISO 13356) with grit-blasted and laser-modified surfaces. System includes PEEK gingiva formers and temporary abutments, plus zirconia abutments (straight/15° angled) for single/multi-unit cemented restorations or overdenture retention. Used by dental clinicians in clinical settings for functional/esthetic rehabilitation of edentulous maxilla/mandible. Implants are plasma gas sterilized; other components require end-user moist heat sterilization. Device integrates with previously cleared components (K190243) including healing caps, Locator-type abutments, and zirconia/Ti-6Al-4V alloy screws. Clinical benefit is tooth replacement for patients with metal allergies.
Clinical Evidence
No clinical data included. Substantial equivalence supported by bench testing: ISO 14801 static compression and compression fatigue testing; abutment screw loosening/removal torque testing; wear particle assessment (SEM/EDX) of Ti-6Al-4V screws; biocompatibility testing (ISO 10993, USP Class VI); and sterilization/shelf-life validation.
Technological Characteristics
Materials: Y-TZP zirconia (ISO 13356), PEEK, Ti-6Al-4V alloy (ASTM F136). Design: Root-form, endosseous threaded, tissue-level. Diameters: 4mm, 5mm. Lengths: 8mm, 10mm, 12mm. Sterilization: Plasma gas (implants), moist heat (other components). Connectivity: Mechanical threaded connection with hexagonal indexing.
Indications for Use
Indicated for patients requiring dental implants in the upper or lower jaw for prosthodontic appliance attachment to replace missing teeth; suitable for patients with metal allergies and associated chronic diseases; intended for delayed 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
Reference Devices
Submission Summary (Full Text)
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December 1, 2020
Z-Systems AG % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K201712
Trade/Device Name: Z5-TL Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 3, 2020 Received: November 4, 2020
Dear Kevin Thomas:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K201712
Device Name
Z5-TL
Indications for Use (Describe)
Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 5px;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span style="padding-left: 20px;"> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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### 510(k) Summary
### Z5-TL
#### Z-Systems AG
November 20, 2020
#### ADMINISTRATIVE INFORMATION
| Manufacturer Name | Z-Systems AG<br>Werkhofstrasse 5<br>CH-4702 Oensingen<br>Switzerland<br>Telephone +41 62 388 69 69 |
|---------------------------|----------------------------------------------------------------------------------------------------|
| Official Contact | Rubino DiGirolamo, CEO |
| Representative/Consultant | Kevin A. Thomas, PhD |
| Representative/Consultant | Kevin A. Thomas, PhD |
| | Floyd G. Larson, MS, MBA |
| | PaxMed International, LLC |
| | 12264 El Camino Real, Suite 400 |
| | San Diego, CA 92130 |
| | Telephone +1 858-792-1235 |
| | Fax +1 858-792-1236 |
| | Email kthomas@paxmed.com<br>flarson@paxmed.com |
#### DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Z5-TL |
|------------------------|---------------------------------------------------------------------------------------------|
| Common Name | Dental implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Health Technology 1 B (Dental Devices) |
#### PREDICATE DEVICE INFORMATION
Primary Predicate Device: K190243, Z5-BL, Z-Systems AG Reference Devices: K132881, Z5c, Z-Systems AG K063286, OSSEOTITE® Dental Implants, Implant Innovations, Incorporated K072642, BIOMET 3i Dental Abutments and Restorative Components, BIOMET 3i, Incorporated
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#### INDICATIONS FOR USE STATEMENT
Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.
# SUBJECT DEVICE DESCRIPTION
Z5-TL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for tissue level placement. The dental implants are provided in two endosseous body diameters (4 mm and 5 mm) and each diameter is provided in three endosseous lengths (8 mm, 10 mm, and 12 mm). The corresponding platform diameters are: 4.8 mm platform diameter for 4 mm body diameter, and 6 mm platform diameter for 5 mm body diameter. The dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The system also includes gingiva formers and a temporary abutment manufactured from polyetheretherketone (PEEK). Zirconia abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, zirconia Locator-type abutments are provided in straight and 15° angled designs.
The subject device is compatible with the following components cleared in K190243: a healing cap manufactured from PEEK; Locator-type abutments manufactured from zirconia; and occlusal (abutment) screws manufactured from zirconia and from Ti-6Al-4V alloy conforming to ASTM F136.
The subject device implants are provided sterilized by plasma gas. All other subject device components are to be sterilized by the end user by moist heat (steam).
## PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 14937 and ISO 17665-1 (referenced from K132881); sterile product shelf life testing according to ISO 11607-1, ISO 11607-2. ASTM F1886/F1886M, and ASTM D3078 (referenced from K132881); biocompatibility of the PEEK material according to ISO 10993-3. ISO 10993-12, ISO 10993-10, ISO 19003-11, ISO 10993-18, and USP Class VI testing according to USP 37-NF32 <88> (referenced from K190243); static compression and compression fatigue testing of the subject device zirconia implants and zirconia abutments according to ISO 14801; assessment of abutment screw loosening and abutment screw removal torque testing (according to ISO 18130) after insertion to the torque recommended in the subject device labeling, and after dynamic testing according to ISO 14801. including microscopic examination of the abutment screws and internal threads of the implant bodies, and comparison to the reference devices K063286 and K072642; and data leveraged from K190243 that included an assessment of wear particles associated with the subject device Ti-6A1-V alloy abutment screw used with the subject device zirconia implant bodies and zirconia abutments after dynamic testing according to ISO 14801, including examination by light microscopy and scanning electron microscopy with energy dispersive X-ray analysis (SEM / EDX), and comparison to all-titanium constructs of the reference devices K063286 and K072642.
No clinical data were included in this submission.
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#### EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the additional predicate device listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device. the primary predicate device, and the additional predicate device.
The subject device is substantially equivalent in intended use to the primary predicate K190243, and to the reference device K132881. All are intended for use in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. In addition, all are intended for a delayed loading treatment protocol.
Except for the names of the devices, the Indications for Use Statement (IFUS) for the subject device is identical to that of the primary predicate device K190243 and to the additional predicate device K132881. Minor differences in the exact wording of the IFUS do not impact substantial equivalence.
The primary predicate device K190243 is for support of substantial equivalence of the subject device dental implant design. The subject device dental implants and the primary predicate device K190243 implants have an identical internal abutment interface design, including the same hexagonal indexing and threaded connection. The primary predicate device K190243 also is for substantial equivalence in terms of similar designs and identical material for the subject device temporary abutment and gingiva formers components manufactured from polyetheretherketone (PEEK), and the subject device Locatortype abutments manufactured from zirconia. The primary predicate device K190243 also is for support of substantial equivalence in terms of previously-cleared components that are compatible with the subject device, including the healing cap, the Locator-type abutments, and the abutment screws.
The additional predicate device K132881 is for support of substantial equivalence of the subject device tissue level implant design. The subject device dental implants cleared in the additional predicate device K132881 have the same implant body diameters, the same implant platform diameters, the same thread design, and the same endosseous threaded lengths.
The subject device implants and abutments are manufactured from yttria-stabilized zirconia (Y-TZP) conforming to ISO 13356. Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP), using the identical material and processing used for zirconia components cleared in the predicate devices K190243 and K132881. The subject device dental implants also have an identical endosseous threaded surface (grit-blasted and laser modified) as the implants cleared in the predicate devices K190243 and K132881. The subject device PEEK temporary abutment and PEEK gingiva formers are manufactured using the identical material and processes as PEEK components cleared in the primary predicate K 190243.
The additional predicate device K132881 also is for support of substantial equivalence of the subject device in terms of sterilization and shelf life (and referenced in K190243). The subject device dental implants are provided to the end user sterilized by plasma gas. The subject device implants use the same packaging and have the same sterile barrier shelf life as the sterile components cleared in K132881 (and referenced in K190243). The processes to monitor, control, and test for bacterial endotoxins for the subject device are the same as K190243.
All other subject device components (zirconia abutments. PEEK gingiya former, and PEEK temporary abutment) are to be sterilized by the end-user. The moist heat sterilization cycles recommended in the labeling have been validated in a prior Z-Systems AG submission (K120793), and the subject device components do not represent a new worst-case for sterilization. Dimensional analysis was conducted for
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both methods of sterilization to verify that the subject device does not introduce a new worst case. The sterilization process is the same used for the primary predicate K190243.
Mechanical performance testing of the subject device dental implants and abutments was performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. The fatigue limit data demonstrated that the subject device constructs have sufficient strength for their intended use.
Minor differences in the designs, dimensions, or sizes among the subject device, the primary predicate device, and the additional predicate device do not affect substantial equivalence. These minor differences do not impact safety or effectiveness because these differences are related to the specific designs features and system components and these differences are mitigated by the mechanical performance testing.
#### CONCLUSION
The subject device, the primary predicate device, and the additional predicate device have the same intended use, have similar technological characteristics, and are made of identical materials. The subject device, the primary predicate, and additional predicate device encompass the same range of physical dimensions, are packaged in the same materials, and are sterilized using the same methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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# Table of Substantial Equivalence
| | Subject Device | Primary Predicate | Additional Predicate Device |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Z5-TL<br>Z-Systems AG | K190243<br>Z5-BL<br>Z-Systems AG | K132881<br>Z5c<br>Z-Systems AG |
| Indications for Use Statement | Z5-TL implants are designed for surgical implantation into the upper and lower<br>jaw for the attachment of prosthodontic appliances to replace missing teeth.<br>Z5-TL implants are suitable for patients with metal allergies and the chronic<br>diseases resulting from them.<br>Z5-TL implants are intended for delayed loading. | Z5-BL implants are designed for surgical implantation into the upper and lower<br>jaw for the attachment of prosthodontic appliances to replace missing teeth.<br>Z5-BL implants are suitable for patients with metal allergies and the chronic<br>diseases resulting from them.<br>Z5-BL implants are intended for delayed loading. | Z5c implants are designed for surgical implantation into the upper and lower<br>jaw for the attachment of prosthodontic appliances to replace missing teeth.<br>Z5c implant system is also suitable for patients with metal allergies and the<br>chronic diseases resulting from them.<br>Z5c implants are intended for delayed loading. |
| Intended Use | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulous maxilla and mandible |
| Reason for Predicate Device | Not applicable | IFU Statement; implant design, material, surface; abutment design,<br>materials, sterilization | Implant design; sterilization and shelf life |
| Product Codes | DZE, NHA | DZE, NHA | DZE, NHA |
| Components | Implants, abutments | Implants, abutments, abutment screws | Implants, abutments<br>(the abutment is cemented to the implant) |
| Implant Designs | | | |
| Implant Diameter, mm | 4.0, 5.0 | 4.0, 5.0 | 4.0, 5.0 |
| Implant Platform diameter, mm | 4.8, 6.0 | 4.8, 6.0 | 4.8, 6.0 |
| Implant Endosseous Length, mm | 8, 10, 12 | 8, 10, 12 | 8, 10, 12 |
| Implant Material | Y-TZP, ISO 13356 | Y-TZP, ISO 13356 | Y-TZP, ISO 13356 |
| Implant Surface | Grit-blasted and laser modified | Grit-blasted and laser modified | Grit-blasted and laser modified |
| Abutment / Prosthetic Component<br>Designs | | | |
| Features | Subject device<br>Indexed, straight and angled (15°)<br>Indexed Locator-type, angled (15°)<br>Non-indexed Locator-type, straight | Indexed, straight and angled (15°)<br>Non-indexed straight<br>Indexed Locator-type, angled (15°)<br>Non-indexed Locator-type, straight | Non-indexed straight<br>Non-indexed angled (15°) |
| | Previously cleared compatible<br>Indexed Locator-type, angled (15°)<br>Non-indexed Locator-type, straight | | |
| Prosthesis Attachment | Subject device<br>Cement-retained<br>Locator-type attachment | Cement-retained<br>Locator-type attachment | Cement-retained |
| | Previously cleared compatible<br>Cement-retained<br>Locator-type attachment | | |
| Restoration | Single-unit; Multi-unit | Single-unit; Multi-unit | Single-unit; Multi-unit |
| Prosthetic platform diameter, or<br>Coronal diameter | Subject device<br>3.6 - 6.6 mm | 4.5 - 6.5 mm | 3.6 mm |
| | Previously cleared compatible<br>4.4 mm | | |
| | Subject Device | Primary Predicate | |
| | Z5-TL<br>Z-Systems AG | K190243<br>Z5-BL<br>Z-Systems AG | |
| Abutment angle | Straight (0°), 15° | Straight (0°), 15° | Straight (0°), 15° |
| Abutment material | Y-TZP, ISO 13356 | Y-TZP, ISO 13356 | Y-TZP, ISO 13356 |
| Abutment screw material | Previously cleared compatible screws<br>Y-TZP, ISO 13356<br>Ti-6Al-4V alloy, ASTM F136 | Y-TZP, ISO 13356<br>Ti-6Al-4V alloy, ASTM F136 | Not applicable |
| Sterilization Status/Method | | | |
| Implants | Provided sterile to end user / plasma gas sterilized | Provided sterile to end user / plasma gas sterilized | Provided sterile to end user / plasma gas sterilized |
| Abutments and Prosthetic Components | Previously cleared compatible<br>Healing Cap: Provided sterile to end user / plasma gas sterilized<br>Abutment screws: Provided non-sterile to end user / moist heat (steam)<br>sterilization required | Healing Cap: Provided sterile to end user / plasma gas sterilized | Provided sterile to end user / plasma gas sterilized |
| | All other subject device abutments and prosthetic components:<br>Provided non-sterile to end user / moist heat (steam) sterilization required | All other:<br>Provided non-sterile to end user / moist heat (steam) sterilization required | |
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# Additional Predicate Device
K132881
Z-Systems AG
t (0°), 15°
, ISO 13356
olicable (the abutment is cemented to the implant)
ed sterile to end user / plasma gas sterilized
ed non-sterile to end user / dry heat sterilization required
