Z7 Zirconia Implant System
Device Facts
| Record ID | K221488 |
|---|---|
| Device Name | Z7 Zirconia Implant System |
| Applicant | Z7, LLC |
| Product Code | DZE · Dental |
| Decision Date | Jun 26, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Z7 Zirconia Implant System is intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.
Device Story
Z7 Zirconia Implant System consists of yttria-stabilized tetragonal zirconia (Y-TZP) endosseous dental implants and PEEK prosthetic components (healing caps, temporary abutments). Implants feature integrated abutments (monotype) and are manufactured via ceramic injection molding (CIM) with structured macro/micro surface topography. Used in dental clinics by clinicians for surgical placement into alveolar bone to support artificial teeth. Implants are provided sterile (Ethylene Oxide); PEEK components are non-sterile and require end-user steam sterilization. Device provides mechanical support for prosthetic restoration; immediate loading is permitted under specific stability conditions. Benefits include restoration of chewing function and tooth replacement.
Clinical Evidence
No clinical data. Bench testing only: material performance (ISO 13356:2015), fatigue testing (ISO 14801:2016), surface morphology/chemical analysis (SEM/EDS), biocompatibility (ISO 10993-1/5), endotoxin testing (USP 85/161), and sterilization validation (ISO 11135/17665).
Technological Characteristics
Material: Y-TZP (ISO 13356:2015) for implants; PEEK (ASTM F2026-17) for prosthetic components. Manufacturing: Ceramic injection molding. Sterilization: Ethylene Oxide (implants); steam (PEEK components). Form factor: One-piece monotype with integrated abutment; diameters 3.7mm and 4.3mm. Connectivity: None.
Indications for Use
Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices and restore chewing function. Suitable for immediate loading given good primary stability and appropriate occlusal loading. Reduced diameter (3.7mm) implants restricted to central and lateral incisors.
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
- TAV Medical Ltd. W Zirconia Implants (K192053)
Reference Devices
Submission Summary (Full Text)
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Z7 LLC % Linda Braddon Chief Executive Officer Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K221488
Trade/Device Name: Z7 Zirconia Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 25, 2023 Received: May 25, 2023
Dear Linda Braddon:
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.
# Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
K221488
Device Name Z7 Zirconia Implant System
#### Indications for Use (Describe)
The Z7 Zirconia Implant System is intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the wing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;width:20px;height:20px;border:1px solid black;">☑</div> |
|----------------------------------------------|------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;width:20px;height:20px;border:1px solid black;">☐</div> |
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## K221488
| Date Prepared | June 26, 2023 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Z7, LLC<br>28 Felmley Road<br>Whitehouse Station, NJ<br>908-399-1359 |
| 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>Regulatory@SecureBME.com |
| Trade Name | Z7 Zirconia Implant System |
| Common Name | Endosseous Dental Implant |
| Code –<br>Classification | DZE, NHA<br>21 CFR 872.3640: Class II |
| Primary Predicate | K192053 TAV Medical Ltd. W Zirconia Implants |
| Reference Device | K172668 TAV Medical Ltd. W Zirconia Implants<br>K132585 Zibone Ceramic Dental Implant System |
| Device Description | The Z7 Zirconia Implant System is an integrated system of endosseous dental<br>implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7<br>Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP)<br>dental implants composed of a One Piece, monotype implant with an<br>integrated abutment. The implant is manufactured via a ceramic injection<br>molding with the macro and micro surface characteristics of the implant<br>directly structured in the mold. The implant body portion is configured to<br>extend into the bone and osseo-integrate with the alveolar bone. The neck<br>should be positioned 1.8mm above the bone. The implants come in<br>corresponding diameters of 3.7 and 4.3 mm. |
| Indications for Use<br>Statement | The Z7 Zirconia Implant System is intended for surgical placement in the<br>patient's upper and lower jaw to provide support for prosthetic devices, such<br>as artificial teeth and in order to restore the patient chewing function. The<br>implants are indicated for immediate loading when good primary stability is<br>achieved and with appropriate occlusal loading.<br><br>The Ø3.7mm reduced diameter implants are recommended for central and<br>lateral incisors only. |
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#### Comparison of Indications for Use
| Subject Device<br>Z7 Zirconia Implant System | Primary Predicate Device<br>TAV Medical's W Zirconia Implants<br>K192053 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended for surgical placement in the patient's<br>upper and lower jaw to provide support for<br>prosthetic devices, such as artificial teeth and in<br>order to restore the patient chewing function.<br>The implants are indicated for immediate<br>loading when good primary stability is achieved<br>and with appropriate occlusal loading. | Intended for surgical placement in the patient's<br>upper and lower jaw to provide support for<br>prosthetic devices, such as artificial teeth and in<br>order to restore the patient chewing function.<br>The implants are indicated for immediate<br>loading when good primary stability is achieved<br>and with appropriate occlusal loading |
| The $ø$ 3.7 mm reduced diameter implants are<br>recommended for central and lateral incisors<br>only. | The $ø$ 3.6 mm reduced diameter implants are<br>recommended for central and lateral incisors<br>only. |
There are no significant differences between the subject and predicate device indications for use. The minor differences in wording to align with the provided sizes of the subject device do not change the intended use for demonstration of substantial equivalence.
| Characteristic | Subject Device<br>Z7 Zirconia Implant<br>System | Primary Predicate<br>Device<br>TAV Medical's W<br>Zirconia Implants<br>K192053 | Reference Device<br>TAV Medical's W<br>Zirconia Implants<br>K172668 |
|-----------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Purpose of Device | Subject Device | Same Indications | Similar One-Piece<br>Sizes as Subject<br>Device |
| Device Classification | Class II | Class II | Class II |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA |
| Material | Yttria-stabilized<br>zirconia (Y-TZP) per<br>ISO 13356:2015 | Yttria-stabilized<br>zirconia (Y-TZP) per<br>ISO 13356:2015 | Yttria-stabilized<br>zirconia (Y-TZP) per<br>ISO 13356:2015 |
| Surface Topography | Macro and Micro<br>Roughness | Macro and Micro<br>Roughness | Macro and Micro<br>Roughness |
| Description | Endosseous dental<br>implant | Endosseous dental<br>implant | Endosseous dental<br>implant |
| Design | One-Piece Ceramic<br>Implants | One-Piece Ceramic<br>Implants | One-Piece Ceramic<br>Implants |
| | N/A | Two-Piece Ceramic<br>Implants | Two-Piece Ceramic<br>Implants |
| Diameter | Z7 One-Piece:<br>3.7mm, 4.3mm | TAV W One-Piece:<br>3.6mm | TAV W One-Piece:<br>4.1mm, 4.8mm |
#### Comparison of Technological Characteristics - Implants
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| Characteristic | Subject Device<br>Z7 Zirconia Implant<br>System | Primary Predicate<br>Device<br>TAV Medical's W<br>Zirconia Implants<br>K192053 | Reference Device<br>TAV Medical's W<br>Zirconia Implants<br>K172668 |
|-----------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | N/A | TAV W Two-Piece:<br>4.1mm, 4.8mm | TAV W Two-Piece:<br>4.1mm, 4.8mm |
| Length | Z7 One-Piece: 10mm,<br>13mm | TAV W One-Piece:<br>8mm, 10mm, 12mm,<br>14mm | TAV W One-Piece:<br>8mm, 10mm, 12mm,<br>14mm |
| | N/A | TAV W Two Piece:<br>8mm, 10mm, 12mm,<br>14mm | TAV W Two Piece:<br>8mm, 10mm, 12mm,<br>14mm |
| Manufacturing<br>Technology | CIM: Ceramic<br>injection molding | CIM: Ceramic<br>injection molding | CIM: Ceramic<br>injection molding |
| Sterilization Method | Ethylene Oxide | Gamma irradiation | Gamma irradiation |
| Intended Use<br>Environment | Dental clinic setting | Dental clinic setting | Dental clinic setting |
| Abutments | Straight | TAV W One-Piece:<br>Straight | TAV W One-Piece:<br>Straight |
| | N/A | TAV W Two-Piece:<br>Straight and Angled | TAV W Two-Piece:<br>Straight and Angled |
| Biocompatibility | Implant device with<br>permanent (>30 days)<br>contact with tissue /<br>bone / dentin | Implant device with<br>permanent (>30 days)<br>contact with tissue /<br>bone / dentin | Implant device with<br>permanent (>30 days)<br>contact with tissue /<br>bone / dentin |
| Shelf-Life | 5 years | Not stated in 510(k)<br>Summary | 1 year |
#### Comparison of Technological Characteristics – PEEK Healing Caps
| Characteristic | Subject Device<br>MABB<br>Z7 Zirconia Implant<br>System | Primary Predicate<br>Device<br>TAV Medical's W<br>Zirconia Implants<br>K192053 | Reference Device<br>TAV Medical's W<br>Zirconia Implants<br>K172668 |
|--------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Classification Product<br>Code | DZE, NHA | DZE, NHA | DZE, NHA |
| Product Name | PEEK Healing Cap | PEEK Healing Cap<br>for W One Piece<br>Zirconia Implant | PEEK Healing Cap for<br>W One Piece<br>Zirconia Implant |
| Product Description | Protect the implant<br>during the healing<br>phase up to 180 days. | Protect the implant<br>during the healing<br>phase up to 180 days. | Protect the implant<br>during the healing<br>phase up to 180 days. |
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| Characteristic | Subject Device<br>MABB<br>Z7 Zirconia Implant<br>System | Primary Predicate<br>Device<br>TAV Medical's W<br>Zirconia Implants<br>K192053 | Reference Device<br>TAV Medical's W<br>Zirconia Implants<br>K172668 |
|----------------|---------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Material | PEEK per ASTM<br>F2026-17 | PEEK | PEEK |
| Diameter (mm) | 3.7, 4.3 | 3.6, 4.1, 4.8 | 4.1, 4.8 |
| Height (mm) | 5 | 5 | 5 |
| Angle (°) | 0° (Straight) | 0° (Straight) | 0° (Straight) |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
#### Comparison of Technological Characteristics - PEEK Temporary Abutments
| Characteristic | Subject Device<br>MABB<br>Z7 Zirconia Implant<br>System | Primary Predicate<br>Device<br>TAV Medical's W<br>Zirconia Implants<br>K192053 | Reference Device<br>TAV Medical's W<br>Zirconia Implants<br>K172668 |
|--------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Classification Product<br>Code | DZE, NHA | DZE, NHA | DZE, NHA |
| Product Name | PEEK Healing Cap | PEEK Healing Cap<br>for W One Piece<br>Zirconia Implant | PEEK Healing Cap<br>for W One Piece<br>Zirconia Implant |
| Product Description | Serves as a basis for<br>temporary restoration<br>for crown. Up to 180<br>days. | Serves as a basis for<br>temporary restoration<br>for crown or bridge.<br>Up to 180 days. | Serves as a basis for<br>temporary restoration<br>for crown or bridge.<br>Up to 180 days. |
| Material | PEEK per ASTM<br>F2026-17 | PEEK | PEEK |
| Diameter (mm) | 3.7, 4.3 | 3.6, 4.1, 4.8 | 4.1, 4.8 |
| Angle (°) | 0° (Straight) | 0° (Straight) | 0° (Straight) |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
#### Technological Characteristics
There are no significant technological differences between the subject and predicate devices. Minor differences include the method of sterilization, and the exact size offerings. The subject device uses the same material as the additional predicates and all devices are manufactured using ceramic injection molding techniques. Any technological differences between the subject and predicate devices do not raise new concerns for safety or effectiveness.
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#### Non-Clinical Performance Testing Summary
| Test | Test Method Summary | Results |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Material<br>Performance<br>Testing | Per ISO 13356:2015 Implants for surgery —<br>Ceramic materials based on yttria-stabilized<br>tetragonal zirconia (Y-TZP) | PASS<br>Device met all<br>predetermined<br>acceptance criteria |
| Fatigue Testing | Per ISO 14801:2016 Dentistry — Implants —<br>Dynamic loading test for endosseous dental<br>implants | PASS<br>Substantially equivalent<br>fatigue strength to<br>reference device<br>(K132585) |
| Implant Surface<br>Roughness and<br>Chemical<br>Analysis<br>Validation | Surfaces macro and micro morphological<br>characterization through 3D Scanning Electron<br>Microscope (SEM) Imaging. Surface chemical<br>analysis through Energy Dispersive<br>Spectrometry (EDS Analysis). | PASS<br>Device met all<br>predetermined<br>acceptance criteria |
Performance testing for the subject device is summarized in the table below:
Biological evaluation of the subject device was performed according to ISO 10993-1 (cytotoxicity testing per ISO 10993-5). Endotoxin testing on the subject device or suitable test specimens was performed following USP<85> and USP<161> according to the sponsor's endotoxin sampling plan.
The implants are provided sterile to the end user via Ethylene Oxide (EO) sterilization. The applicable cycle was validated in compliance with ISO 11135:2014 "Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices" to a sterility assurance level of 10° for the worst-case configuration of the subject device. All cycle parameters were within the limits established by the protocol and residue testing yielded acceptable results for EO and ECH (ethylene chlorohydrin) per ISO 10993-7:2008 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals". The subject device non-sterile components are end-user steam sterilized. The applicable steam sterilization cycle was validated in compliance with ISO 17665 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices" and demonstrated a sterility assurance level of 10-6
Accelerated aging has been applied on the final sterile implant packaging and is being followed by real time aging to validate a five-year shelf life.
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#### Conclusions
Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.
