(399 days)
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.
The Z7 Zirconia Implant System is an integrated system of endosseous dental implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) dental implants composed of a One Piece, monotype implant with an integrated abutment. The implant is manufactured via a ceramic injection molding with the macro and micro surface characteristics of the implant directly structured in the mold. The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone. The implants come in corresponding diameters of 3.7 and 4.3 mm.
The provided text describes the Z7 Zirconia Implant System, a dental implant device, and its compliance with FDA requirements for substantial equivalence to a predicate device. However, the information you've requested regarding acceptance criteria and study details in the context of an AI/ML device is not present in this document.
The document is a 510(k) clearance letter for a medical device manufactured from Zirconia (an endosseous dental implant), not an AI/ML-driven medical device. Therefore, it does not contain information about:
- Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
- Sample size for test sets in an AI context
- Data provenance for AI training/testing
- Number/qualifications of AI ground truth experts
- Adjudication methods for AI ground truth
- MRMC studies for AI assistance
- Standalone AI algorithm performance
- Type of ground truth used for AI
- Training set sample size for AI
- Ground truth establishment for AI training
The performance testing summarized in the document (Page 7) is related to the physical and material properties of the dental implant itself:
- Material Performance Testing: Per ISO 13356:2015 for Yttria-stabilized tetragonal zirconia (Y-TZP).
- Fatigue Testing: Per ISO 14801:2016 for dynamic loading of endosseous dental implants.
- Implant Surface Roughness and Chemical Analysis Validation: Through 3D Scanning Electron Microscope (SEM) Imaging and Energy Dispersive Spectrometry (EDS Analysis).
- Biocompatibility: According to ISO 10993-1 and ISO 10993-5 (cytotoxicity).
- Endotoxin Testing: Following USP<85> and USP<161>.
- Sterilization Validation: Per ISO 11135:2014 (Ethylene Oxide) and ISO 17665 (Moist Heat) for sterility assurance level (SAL) of 10^-6.
- Shelf-Life Validation: Accelerated aging followed by real-time aging.
For these physical device tests, all results are reported as "PASS" and "Device met all predetermined acceptance criteria" or "Substantially equivalent fatigue strength to reference device."
To reiterate, this document does not contain the information you are looking for regarding AI/ML device acceptance criteria and study details.
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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)
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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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K221488
| Date Prepared | June 26, 2023 |
|---|---|
| Sponsor | Z7, LLC28 Felmley RoadWhitehouse Station, NJ908-399-1359 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com |
| Trade Name | Z7 Zirconia Implant System |
| Common Name | Endosseous Dental Implant |
| Code –Classification | DZE, NHA21 CFR 872.3640: Class II |
| Primary Predicate | K192053 TAV Medical Ltd. W Zirconia Implants |
| Reference Device | K172668 TAV Medical Ltd. W Zirconia ImplantsK132585 Zibone Ceramic Dental Implant System |
| Device Description | The Z7 Zirconia Implant System is an integrated system of endosseous dentalimplants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP)dental implants composed of a One Piece, monotype implant with anintegrated abutment. The implant is manufactured via a ceramic injectionmolding with the macro and micro surface characteristics of the implantdirectly structured in the mold. The implant body portion is configured toextend into the bone and osseo-integrate with the alveolar bone. The neckshould be positioned 1.8mm above the bone. The implants come incorresponding diameters of 3.7 and 4.3 mm. |
| Indications for UseStatement | The Z7 Zirconia Implant System is intended for surgical placement in thepatient's upper and lower jaw to provide support for prosthetic devices, suchas artificial teeth and in order to restore the patient chewing function. Theimplants are indicated for immediate loading when good primary stability isachieved and with appropriate occlusal loading.The Ø3.7mm reduced diameter implants are recommended for central andlateral incisors only. |
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Comparison of Indications for Use
| Subject DeviceZ7 Zirconia Implant System | Primary Predicate DeviceTAV Medical's W Zirconia ImplantsK192053 |
|---|---|
| Intended for surgical placement in the patient'supper and lower jaw to provide support forprosthetic devices, such as artificial teeth and inorder to restore the patient chewing function.The implants are indicated for immediateloading when good primary stability is achievedand with appropriate occlusal loading. | Intended for surgical placement in the patient'supper and lower jaw to provide support forprosthetic devices, such as artificial teeth and inorder to restore the patient chewing function.The implants are indicated for immediateloading when good primary stability is achievedand with appropriate occlusal loading |
| The $ø$ 3.7 mm reduced diameter implants arerecommended for central and lateral incisorsonly. | The $ø$ 3.6 mm reduced diameter implants arerecommended for central and lateral incisorsonly. |
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 DeviceZ7 Zirconia ImplantSystem | Primary PredicateDeviceTAV Medical's WZirconia ImplantsK192053 | Reference DeviceTAV Medical's WZirconia ImplantsK172668 |
|---|---|---|---|
| Purpose of Device | Subject Device | Same Indications | Similar One-PieceSizes as SubjectDevice |
| Device Classification | Class II | Class II | Class II |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA |
| Material | Yttria-stabilizedzirconia (Y-TZP) perISO 13356:2015 | Yttria-stabilizedzirconia (Y-TZP) perISO 13356:2015 | Yttria-stabilizedzirconia (Y-TZP) perISO 13356:2015 |
| Surface Topography | Macro and MicroRoughness | Macro and MicroRoughness | Macro and MicroRoughness |
| Description | Endosseous dentalimplant | Endosseous dentalimplant | Endosseous dentalimplant |
| Design | One-Piece CeramicImplants | One-Piece CeramicImplants | One-Piece CeramicImplants |
| N/A | Two-Piece CeramicImplants | Two-Piece CeramicImplants | |
| Diameter | Z7 One-Piece:3.7mm, 4.3mm | TAV W One-Piece:3.6mm | TAV W One-Piece:4.1mm, 4.8mm |
Comparison of Technological Characteristics - Implants
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| Characteristic | Subject DeviceZ7 Zirconia ImplantSystem | Primary PredicateDeviceTAV Medical's WZirconia ImplantsK192053 | Reference DeviceTAV Medical's WZirconia ImplantsK172668 |
|---|---|---|---|
| N/A | TAV W Two-Piece:4.1mm, 4.8mm | TAV W Two-Piece:4.1mm, 4.8mm | |
| Length | Z7 One-Piece: 10mm,13mm | TAV W One-Piece:8mm, 10mm, 12mm,14mm | TAV W One-Piece:8mm, 10mm, 12mm,14mm |
| N/A | TAV W Two Piece:8mm, 10mm, 12mm,14mm | TAV W Two Piece:8mm, 10mm, 12mm,14mm | |
| ManufacturingTechnology | CIM: Ceramicinjection molding | CIM: Ceramicinjection molding | CIM: Ceramicinjection molding |
| Sterilization Method | Ethylene Oxide | Gamma irradiation | Gamma irradiation |
| Intended UseEnvironment | Dental clinic setting | Dental clinic setting | Dental clinic setting |
| Abutments | Straight | TAV W One-Piece:Straight | TAV W One-Piece:Straight |
| N/A | TAV W Two-Piece:Straight and Angled | TAV W Two-Piece:Straight and Angled | |
| Biocompatibility | Implant device withpermanent (>30 days)contact with tissue /bone / dentin | Implant device withpermanent (>30 days)contact with tissue /bone / dentin | Implant device withpermanent (>30 days)contact with tissue /bone / dentin |
| Shelf-Life | 5 years | Not stated in 510(k)Summary | 1 year |
Comparison of Technological Characteristics – PEEK Healing Caps
| Characteristic | Subject DeviceMABBZ7 Zirconia ImplantSystem | Primary PredicateDeviceTAV Medical's WZirconia ImplantsK192053 | Reference DeviceTAV Medical's WZirconia ImplantsK172668 |
|---|---|---|---|
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Classification ProductCode | DZE, NHA | DZE, NHA | DZE, NHA |
| Product Name | PEEK Healing Cap | PEEK Healing Capfor W One PieceZirconia Implant | PEEK Healing Cap forW One PieceZirconia Implant |
| Product Description | Protect the implantduring the healingphase up to 180 days. | Protect the implantduring the healingphase up to 180 days. | Protect the implantduring the healingphase up to 180 days. |
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| Characteristic | Subject DeviceMABBZ7 Zirconia ImplantSystem | Primary PredicateDeviceTAV Medical's WZirconia ImplantsK192053 | Reference DeviceTAV Medical's WZirconia ImplantsK172668 |
|---|---|---|---|
| Material | PEEK per ASTMF2026-17 | 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 DeviceMABBZ7 Zirconia ImplantSystem | Primary PredicateDeviceTAV Medical's WZirconia ImplantsK192053 | Reference DeviceTAV Medical's WZirconia ImplantsK172668 |
|---|---|---|---|
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Classification ProductCode | DZE, NHA | DZE, NHA | DZE, NHA |
| Product Name | PEEK Healing Cap | PEEK Healing Capfor W One PieceZirconia Implant | PEEK Healing Capfor W One PieceZirconia Implant |
| Product Description | Serves as a basis fortemporary restorationfor crown. Up to 180days. | Serves as a basis fortemporary restorationfor crown or bridge.Up to 180 days. | Serves as a basis fortemporary restorationfor crown or bridge.Up to 180 days. |
| Material | PEEK per ASTMF2026-17 | 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 |
|---|---|---|
| MaterialPerformanceTesting | Per ISO 13356:2015 Implants for surgery —Ceramic materials based on yttria-stabilizedtetragonal zirconia (Y-TZP) | PASSDevice met allpredeterminedacceptance criteria |
| Fatigue Testing | Per ISO 14801:2016 Dentistry — Implants —Dynamic loading test for endosseous dentalimplants | PASSSubstantially equivalentfatigue strength toreference device(K132585) |
| Implant SurfaceRoughness andChemicalAnalysisValidation | Surfaces macro and micro morphologicalcharacterization through 3D Scanning ElectronMicroscope (SEM) Imaging. Surface chemicalanalysis through Energy DispersiveSpectrometry (EDS Analysis). | PASSDevice met allpredeterminedacceptance 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.
§ 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.