Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Device Description

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The dental implants are provided in body diameters of 4 mm and 5 mm, and each diameter is provided in 8, 10, and 12 mm lengths. The dental implants are manufactured from Y - TZP zirconia conforming to ISO 13356. The system also includes a healing cap, gingiva formers, and a temporary abutment manufactured from polyetheretherketone (PEEK). Zircoma 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. Occlusal (abutment) screws are provided in Ti-6Al-4V alloy conforming to ASTM F136 and in zirconia.

The subject device implants and Healing Cap are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

AI/ML Overview

The provided text is a 510(k) summary for the Z5-BL dental implant. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data. However, it does not contain information about acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, or MRMC studies).

The document explicitly states: "No clinical data were included in this submission." This means there is no performance data related to human-in-the-loop studies, standalone AI performance, or any studies that would involve establishing ground truth from expert consensus or pathology for evaluating AI model performance.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria from the provided text, as it describes a traditional medical device submission for dental implants, not an AI/ML-driven device.

To answer your specific questions in the context of an AI/ML device, I would need a different type of document that describes performance data related to an AI/ML algorithm.

Summary

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January 3, 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: K190243

Trade/Device Name: Z5-BL Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 3, 2019 Received: December 4, 2019

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 (QS) 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,

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K190243

Device Name

Z5-BL

Indications for Use (Describe)

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

K190243

Z5-BL

Z-Systems AG

January 2, 2020

ADMINISTRATIVE INFORMATION

Manufacturer Name	Z-Systems AG
	Werkhofstrasse 5
	CH-4702 Oensingen
	Switzerland
	Telephone: +41 62 388 69 69
Official Contact	Rubino DiGirolamo, CEO

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-BL
Common Name	Dental implant

Regulation Number Regulation Name Regulatory Class Product Code

21 CFR 872.3640 Endosseous dental implant Class II DZE

Classification Panel Reviewing Branch

Dental Products Panel Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate Device: K132881, Z5c, Z-Systems AG

Reference Devices:

K131701, Z5mlb and Z5mlc, Z-Systems AG
K153509, GPS® Angled Abutment, Implant Direct Sybron Manufacturing, LLC
K121131, Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants, Straumann USA
K172668, W Zirconia Implants, TAV Medical Ltd.
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

SUBJECT DEVICE DESCRIPTION

The subject device implants and Healing Cap are provided sterilized by plasma gas. All other 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-16. and ASTM D3078-02 (referenced from K132881); bacterial endotoxin testing according to USP 40-NF 35 <85>; biocompatibility testing of the PEEK material according to ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), ISO 19003-11 (acute systemic toxicity and subacute/subchronic systemic toxicity), ISO 10993-18 (extraction of organic substances), and USP Class VI testing according to USP 37-NF32 <88>; confirmatory biocompatibility testing of the final finished PEEK and Ti-6A1-4V alloy devices according to ISO 10993-5 and ISO 10993-12; static compression and compression fatigue testing of the subject device zirconia implants, zirconia abutments, zirconia abutment screws, and Ti-6A1-4V alloy abutment screws 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 assessment of wear particles associated with the subject device Ti-6Al-4V 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-4titanium constructs of the reference devices K063286 and K072642.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.

The subject device is substantially equivalent in intended use to the primary predicate K132881, and to the reference devices K131701, K153509, K121131, and K172668. All are intended for use in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.

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The subject device and the predicate device K132881 are made of identical materials, have the identical endosseous threaded surface (grit-blasted and laser modified), and have the same implant body diameters, implant platform diameters, and implant lengths. The subject device and the predicate device K132881 also include straight and angled abutments for cement-retained, single-unit and multi-unit restorations. Differences between subject device and the predicate device K132881 include: the fixation of the abutments to the implant (screws for subject device, cement for K132881); the subject device includes indexed abutments (K132881 includes only non-indexed abutments); and the subject device includes Locator-type abutments for attachment of overdentures. None of these minor design differences impact safety or effectiveness or change the intended use of the device.

The reference device K131701 is for support of substantial equivalence of the subject device straight (0°) Locator-type abutment design. The subject device and the reference device K131701 also are made of identical materials (implants and abutments), and have the identical endosseous threaded surface (gritblaster and laser modified). Similarly, the reference device K153509 is for support of substantial equivalence of the subject device 15° angled Locator-type abutment design.

The reference device K121131 is for support of substantial equivalence of the subject device implants indicated for bone level placement. The previously cleared Z-Systems AG dental implants (K13281 and K131701) are indicated for tissue level placement.

The reference device K172668 is for support of substantial equivalence of the subject device use of a titanium alloy abutment screw with a zirconia dental implant fixture.

The reference devices K063286 and K072641 are for support of substantial equivalence of screw removal torque and wear particle analysis following dynamic mechanical testing.

The subject device dental implants and Healing Cap are provided sterilized by plasma gas, identical to the sterilization process for K132881 and K131701. The subject device components that are provided sterile use the same packaging and have the same sterile barrier shelf life as the sterile components cleared in K132881.

Mechanical performance testing of the subject device was performed according to ISO 14801 Dentistry -Implants – Dynamic fatigue test for endosseous dental implants. The fatigue limit data demonstrated that constructs of the device have sufficient strength for their intended use.

Minor differences in the designs, dimensions, sizes, or materials among the subject device, the primary predicate device, and the reference devices 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 are mitigated by the mechanical performance testing.

CONCLUSION

The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, and reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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Substantial Equivalence – Indications for Use Statement

Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device	Reference Device
Z5-BL	K132881Z5c	K131701Z5mlb and Z5mlc	K153509GPS® Angled Abutment	K121131Straumann Bone Level Ø4.1 mm andØ4.8 mm Regular Connection (RC)Roxolid Dental Implants	K172668W Zirconia Implants
Z-Systems AG	Z-Systems AG	Z-Systems AG	Implant Direct Sybron Manufacturing, LLC	Straumann USA	TAV Medical Ltd.
Z5-BL implants are designed for surgicalimplantation into the upper and lower jaw for theattachment of prosthodontic appliances to replacemissing teeth. Z5-BL implants are suitable forpatients with metal allergies and the chronicdiseases resulting from them. Z5-BL implants areintended for delayed loading.	Z5c implants are designed for surgical implantationinto the upper and lower jaw for the attachment ofprosthodontic appliances to replace missing teeth.Z5c implant system is also suitable for patients wimetal allergies and the chronic diseases resultingfrom them. Z5c implants are intended for delayedloading.	Z5mlb:Z5mlb implants arc designed for surgicalimplantation into the edentulous upper and lowerjaw for the attachment of dentures to replacemissing teeth. Z5mlb implant system is alsosuitable for patients with metal allergies and thechronic diseases resulting from them.Z5mlc:Z5mlc implants are designed for surgicalimplantation into the edentulous upper and lowerjaw for the attachment of dentures to replacemissing teeth. Z5mlc implant system is also suitablefor patients with metal allergies and the chronicdiseases resulting from them.	GPS® Angled Abutments are designed to be used insupport of a dental implant(s) to provide support forprosthetic restorations in a partially or completelyedentulous patient. These abutments are designed toonly receive a fabricated multi-unit bridge oroverdenture. Abutments are intended for use in themandible or maxilla. Implants can be indicated forimmediate loading when good primary stability hasbeen achieved and with appropriate occlusalloading.Compatibility:• Legacy System: Prosthetically compatible withZimmer Dental Tapered Screw-Vent system3.5mm platform implants (3.7mmD, 4.1mmD,8mm-16mm Length), 4.5mm platform implants(4.7mmD, 8mm-16mm Length), and 5.7mmplatform implants (6.0mmD, 8mm-16mmLength).• SwishTapered System: Prosthetically compatiblewith Straumann Standard and Standard Plussystem RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platformimplants (4.8mmD, 6mm-12mm Length).• SwishPlus System: Prosthetically compatiblewith Straumann Standard and Standard Plussystem RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length) and WN platformimplants (4.8mmD, 6mm-12mm Length).• SwishActive Implants: SwishActive implants areprosthetically compatible with InterActive 3.0and 3.4mm abutments and Nobel Biocare conicalconnection NobelActive™ NP (Narrow Platform– 3.0mm diameter) and NobelActive™ RP(Regular Platform – 3.4mm diameter) titaniumabutments. InterActive 3.0 and 3.4mm abutmentsare prosthetically compatible with Nobel Biocareconical connection NobelActive™ NP (NarrowPlatform - 3.0mm diameter) and NobelActiveTMRP (Regular Platform -3.4mm diameter) (3.5-5.0mmD, 8.5-18mm Length).InterActive System: InterActive implants areprosthetically compatible with InterActive 3.0and 3.4mm abutments and Nobel Biocare conicalconnection Nobel Active™ NP (NarrowPlatform-3.0mm diameter) and NobelActive™RP (Regular Platform - 3.4mm diameter)titanium abutments. InterActive 3.0 and 3.4mmabutments are prosthetically compatible withNobel Biocare conical connection NobelActive™NP (Narrow Platform - 3.0mm diameter) andNobelActive™ RP (Regular Platform – 3.4mmdiameter) (3.5-5.0mmD, 8.5-18mmLength)implants.	Straumann® dental implants are suitable for thetreatment of oral endosteal implantation in theupper and lower jaw and for the functional andesthetic oral rehabilitation of edentulous andpartially dentate patients (unless specificindications and limitations are present, as statedbelow). Straumann® dental implants can also beused for immediate or early implantationfollowing extraction or loss of natural teeth.Implants can be placed with immediate functionon single-tooth and/or multiple tooth applicationswhen good primary stability is achieved and withappropriate occlusal loading, to restore chewingfunction. The prosthetic restorations used aresingle crowns, bridges and partial or full dentures,which are connected to the implants by thecorresponding elements (abutments). Whenplacing implants in the posterior region, werecommend using only large diameter implants. Incases of fully edentulous patients, 4 or moreimplants must be used in immediately loadedcases.	TAV Medical's W Zirconia Implants are intendedfor surgical placement in the patient's upper andlower jaw to provide support for prosthetic devicessuch as artificial teeth and in order to restore thepatient chewing function. The implants areindicated for immediate loading when good primarystability is achieved and with appropriate occlusalloading.
	Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device	Reference Device
Comparison	Z5-BL	K132881Z5c	K131701Z5mlb and Z5mlc	K153509GPS® Angled Abutment	K121131Straumann Bone Level Ø4.1 mm andØ4.8 mm Regular Connection (RC)Roxolid Dental Implants	K172668W Zirconia Implants
	Z-Systems AG	Z-Systems AG	Z-Systems AG	Implant Direct Sybron Manufacturing,LLC	Straumann USA	TAV Medical Ltd.
Intended Use	Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible	Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible
Reason for Predicate/Reference Device	Not applicable	IFU Statement; implant design, material,surface; abutment design	Overdenture abutment design	Overdenture abutment design	Bone level implant	Ti-6Al-4V alloy abutment screw used witha zirconia implant fixture
Product Codes	DZE, NHA	DZE, NHA	DZE	NHA	DZE	DZE, NHA
Features	Implants, abutments,abutment screws	Implants, abutments(abutment cemented to implant)	One-piece implants	Abutments	Implants	Implants (standard and one-piece),abutments, abutment screws
Implant Designs
Implant Diameter, mm	4.0, 5.0	4.0, 5.0	3.6, 4.0	Not applicable	4.1, 4.8	4.1, 4.8
Implant Endosseous Length, mm	8, 10, 12	8, 10, 12	8, 10	Not applicable	8, 10, 12, 14	8, 10, 12
Platform diameter, mm	4.0, 5.0	4.0, 5.0	Not applicable	Not applicable	RC (4.1 mm)	4.8, 6.0
Implant Material	Y-TZP	Y-TZP	Y-TZP	Not applicable	TiZr alloy	Y-TZP
Implant Surface	Grit-blasted and laser modified	Grit-blasted and laser modified	Grit-blasted and laser modified	Not applicable	SLActive	Micro and macro roughened

Abutment Designs	Indexed straight and angled;Non-indexed straight;Indexed and Non-indexed Locator-type	Non-indexed straightNon-indexed angled 15°	Ball-type attachment;Locator-type attachment	Locator-type	Not provided in 510(k) Summary	Various; specifics not provided in 510(k)Summary
Prosthesis Attachment	Cement-retained;Locator-type attachment	Cement-retained	Ball-type attachment;Locator-type attachment	Locator-type	Not provided in 510(k) Summary	Not provided in 510(k) Summary
Restoration	Single-unit; Multi-unit	Single-unit; Multi-unit	Multi-unit	Multi-unit	Single-unit; Multi-unit	Single-unit; Multi-unit
Prosthetic platform diameter, mm	4.5 mm - 6.5 mm	3.6 mm	Not applicable	Locator-type	Not provided in 510(k) Summary	4.8
Abutment angle	Straight (0°), 15°	Straight (0°), 15°	Straight (0°)	15°, 30°	Not provided in 510(k) Summary	Straight (0°), 5°, 10°, 15°
Abutment material	Y-TZP	Y-TZP	Y-TZP	Titanium alloy with TiN coating	Not provided in 510(k) Summary	Ti-6Al-4V alloy

Abutment Screw Material	Y-TZPTi-6Al-4V alloy	Not applicable	Not applicable	Not applicable	Not provided in 510(k) Summary	Ti-6Al-4V alloy

Sterilization Status/Method
Implants	Sterile / plasma gas	Sterile / plasma gas	Sterile / plasma gas	Not applicable	Not provided in 510(k) Summary	Sterile / gamma irradiation
Abutments	Healing Cap: Sterile / plasma gasAll other:Non-sterile / moist heat (steam)	Non-sterile / Dry heat	Not applicable	Non-sterile / moist heat (steam)	Not applicable	Non-sterile / moist heat (steam)
Other Components	Non-sterile / moist heat (steam)	Non-sterile / moist heat (steam)	Not applicable	Non-sterile / moist heat (steam)	Not applicable	Non-sterile / moist heat (steam)

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Substantial Equivalence – Technological Characteristics

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.