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 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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-TL) and does not contain information about the acceptance criteria and study design you've requested for typical AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices, primarily through non-clinical data.

Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.

Here is what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or tabulated performance data for an AI/ML device are provided in this document. The performance data discussed relates to the mechanical properties and sterilization of the dental implant itself.

2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device relying on a test set of data. The "performance data" section refers to non-clinical testing of the dental implant's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was mentioned or performed, as this is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be established by validated test methods and physical measurements according to specified ISO and ASTM standards.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Summary of relevant performance data (non-clinical, from the document):

The performance data submitted was non-clinical and aimed to demonstrate substantial equivalence of the Z5-TL dental implant device.

Sterilization Validation: According to ISO 14937 and ISO 17665-1 (referenced from predicate K132881).
Sterile Product Shelf Life Testing: According to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from predicate K132881).
Biocompatibility of 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 predicate K190243).
Static compression and compression fatigue testing: Of the zirconia implants and abutments according to ISO 14801.
Assessment of abutment screw loosening and removal torque testing: According to ISO 18130, after insertion and dynamic testing (ISO 14801), including microscopic examination, and comparison to reference devices K063286 and K072642.
Assessment of wear particles: Associated with the Ti-6A1-V alloy abutment screw used with zirconia implant bodies and abutments after dynamic testing (ISO 14801), including light microscopy and SEM/EDX, and comparison to all-titanium constructs of reference devices K063286 and K072642 (leveraged from K190243).

Conclusion on Performance: The document states that the non-clinical data demonstrated that the device has "sufficient strength for their intended use" and supports substantial equivalence to the predicate devices. No clinical data was included in the submission.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

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

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

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

Indications for Use

510(k) Number (if known)

K201712

Device Name

Z5-TL

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

EF PSC Publishing Services (301) 443-6740

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

510(k) Summary

Z5-TL

Z-Systems AG

November 20, 2020

ADMINISTRATIVE INFORMATION

Manufacturer Name	Z-Systems AGWerkhofstrasse 5CH-4702 OensingenSwitzerlandTelephone +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 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

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

INDICATIONS FOR USE STATEMENT

SUBJECT DEVICE DESCRIPTION

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.

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

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

{6}------------------------------------------------

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.

{7}------------------------------------------------

Table of Substantial Equivalence

	Subject Device	Primary Predicate	Additional Predicate Device
	Z5-TLZ-Systems AG	K190243Z5-BLZ-Systems AG	K132881Z5cZ-Systems AG
Indications for Use Statement	Z5-TL implants are designed for surgical implantation into the upper and lowerjaw for the attachment of prosthodontic appliances to replace missing teeth.Z5-TL implants are suitable for patients with metal allergies and the chronicdiseases resulting from them.Z5-TL implants are intended for delayed loading.	Z5-BL implants are designed for surgical implantation into the upper and lowerjaw for the attachment of prosthodontic appliances to replace missing teeth.Z5-BL implants are suitable for patients with metal allergies and the chronicdiseases resulting from them.Z5-BL implants are intended for delayed loading.	Z5c implants are designed for surgical implantation into the upper and lowerjaw for the attachment of prosthodontic appliances to replace missing teeth.Z5c implant system is also suitable for patients with metal allergies and thechronic diseases resulting from them.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,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(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 ComponentDesigns
Features	Subject deviceIndexed, straight and angled (15°)Indexed Locator-type, angled (15°)Non-indexed Locator-type, straight	Indexed, straight and angled (15°)Non-indexed straightIndexed Locator-type, angled (15°)Non-indexed Locator-type, straight	Non-indexed straightNon-indexed angled (15°)
	Previously cleared compatibleIndexed Locator-type, angled (15°)Non-indexed Locator-type, straight
Prosthesis Attachment	Subject deviceCement-retainedLocator-type attachment	Cement-retainedLocator-type attachment	Cement-retained
	Previously cleared compatibleCement-retainedLocator-type attachment
Restoration	Single-unit; Multi-unit	Single-unit; Multi-unit	Single-unit; Multi-unit
Prosthetic platform diameter, orCoronal diameter	Subject device3.6 - 6.6 mm	4.5 - 6.5 mm	3.6 mm
	Previously cleared compatible4.4 mm
	Subject Device	Primary Predicate
	Z5-TLZ-Systems AG	K190243Z5-BLZ-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 screwsY-TZP, ISO 13356Ti-6Al-4V alloy, ASTM F136	Y-TZP, ISO 13356Ti-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 compatibleHealing Cap: Provided sterile to end user / plasma gas sterilizedAbutment screws: Provided non-sterile to end user / moist heat (steam)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:Provided non-sterile to end user / moist heat (steam) sterilization required	All other:Provided non-sterile to end user / moist heat (steam) sterilization required

{8}------------------------------------------------

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

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.