(331 days)
No
The summary describes a dental implant system and its components, focusing on materials, dimensions, sterilization, and mechanical testing. There is no mention of AI, ML, image processing, or any software-based analysis that would suggest the use of these technologies.
No
This device is a dental implant system designed to replace missing teeth and attach prosthodontic appliances. While it serves a medical purpose, it primarily performs a structural and restorative function rather than directly treating a disease or condition in a therapeutic manner.
No
Explanation: The device is a dental implant system designed to replace missing teeth, not to diagnose a condition or disease.
No
The device description clearly outlines physical components such as dental implants, healing caps, gingiva formers, temporary abutments, and abutment screws, all made from various materials like zirconia, PEEK, and Ti-6Al-4V alloy. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical implantation into the jaw to replace missing teeth and attach prosthodontic appliances. This is a surgical/implantable device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a dental implant system, including implants, healing caps, abutments, and screws. These are all components for surgical implantation and restoration, not for in vitro testing.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
- Using reagents or calibrators
Therefore, the Z5-BL dental implant system is a medical device intended for surgical implantation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE, NHA
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ; 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 ; 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K131701, K153509, K121131, K172668, K063286, K072642
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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.
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 (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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Z5-BL
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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
4
INDICATIONS FOR USE STATEMENT
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.
SUBJECT 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).
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 ; 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 ; 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.
5
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.
6
Substantial Equivalence – Indications for Use Statement
| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|---|
| Z5-BL | K132881 | |||||
| Z5c | K131701 | |||||
| Z5mlb and Z5mlc | K153509 | |||||
| GPS® Angled Abutment | K121131 | |||||
| Straumann Bone Level Ø4.1 mm and | ||||||
| Ø4.8 mm Regular Connection (RC) | ||||||
| Roxolid Dental Implants | K172668 | |||||
| W 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 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. | Z5c implants are designed for surgical implantation | |||||
| into the upper and lower jaw for the attachment of | ||||||
| prosthodontic appliances to replace missing teeth. | ||||||
| Z5c implant system is also suitable for patients wi | ||||||
| metal allergies and the chronic diseases resulting | ||||||
| from them. Z5c implants are intended for delayed | ||||||
| loading. | Z5mlb: | |||||
| Z5mlb implants arc designed for surgical | ||||||
| implantation into the edentulous upper and lower | ||||||
| jaw for the attachment of dentures to replace | ||||||
| missing teeth. Z5mlb implant system is also | ||||||
| suitable for patients with metal allergies and the | ||||||
| chronic diseases resulting from them. | ||||||
| Z5mlc: | ||||||
| Z5mlc implants are designed for surgical | ||||||
| implantation into the edentulous upper and lower | ||||||
| jaw for the attachment of dentures to replace | ||||||
| missing teeth. Z5mlc implant system is also suitable | ||||||
| for patients with metal allergies and the chronic | ||||||
| diseases resulting from them. | GPS® Angled Abutments are designed to be used in | |||||
| support of a dental implant(s) to provide support for | ||||||
| prosthetic restorations in a partially or completely | ||||||
| edentulous patient. These abutments are designed to | ||||||
| only receive a fabricated multi-unit bridge or | ||||||
| overdenture. Abutments are intended for use in the | ||||||
| mandible or maxilla. Implants can be indicated for | ||||||
| immediate loading when good primary stability has | ||||||
| been achieved and with appropriate occlusal | ||||||
| loading. | ||||||
| Compatibility: | ||||||
| • Legacy System: Prosthetically compatible with | ||||||
| Zimmer Dental Tapered Screw-Vent system | ||||||
| 3.5mm platform implants (3.7mmD, 4.1mmD, | ||||||
| 8mm-16mm Length), 4.5mm platform implants | ||||||
| (4.7mmD, 8mm-16mm Length), and 5.7mm | ||||||
| platform implants (6.0mmD, 8mm-16mm | ||||||
| Length). | ||||||
| • SwishTapered System: Prosthetically compatible | ||||||
| with Straumann Standard and Standard Plus | ||||||
| system RN platform implants (3.3mmD- | ||||||
| 4.8mmD, 6mm-16mm Length) and WN platform | ||||||
| implants (4.8mmD, 6mm-12mm Length). | ||||||
| • SwishPlus System: Prosthetically compatible | ||||||
| with Straumann Standard and Standard Plus | ||||||
| system RN platform implants (3.3mmD- | ||||||
| 4.8mmD, 6mm-16mm Length) and WN platform | ||||||
| implants (4.8mmD, 6mm-12mm Length). | ||||||
| • SwishActive Implants: SwishActive implants are | ||||||
| prosthetically compatible with InterActive 3.0 | ||||||
| and 3.4mm abutments and Nobel Biocare conical | ||||||
| connection NobelActive™ NP (Narrow Platform | ||||||
| – 3.0mm diameter) and NobelActive™ RP | ||||||
| (Regular Platform – 3.4mm diameter) titanium | ||||||
| abutments. InterActive 3.0 and 3.4mm abutments | ||||||
| are prosthetically compatible with Nobel Biocare | ||||||
| conical connection NobelActive™ NP (Narrow | ||||||
| Platform - 3.0mm diameter) and NobelActiveTM | ||||||
| RP (Regular Platform -3.4mm diameter) (3.5- | ||||||
| 5.0mmD, 8.5-18mm Length). | ||||||
| InterActive System: InterActive implants are | ||||||
| prosthetically compatible with InterActive 3.0 | ||||||
| and 3.4mm abutments and Nobel Biocare conical | ||||||
| connection Nobel Active™ NP (Narrow | ||||||
| Platform-3.0mm diameter) and NobelActive™ | ||||||
| RP (Regular Platform - 3.4mm diameter) | ||||||
| titanium abutments. InterActive 3.0 and 3.4mm | ||||||
| abutments are prosthetically compatible with | ||||||
| Nobel Biocare conical connection NobelActive™ | ||||||
| NP (Narrow Platform - 3.0mm diameter) and | ||||||
| NobelActive™ RP (Regular Platform – 3.4mm | ||||||
| diameter) (3.5-5.0mmD, 8.5-18mmLength) | ||||||
| implants. | Straumann® dental implants are suitable for the | |||||
| treatment of oral endosteal implantation in the | ||||||
| upper and lower jaw and for the functional and | ||||||
| esthetic oral rehabilitation of edentulous and | ||||||
| partially dentate patients (unless specific | ||||||
| indications and limitations are present, as stated | ||||||
| below). Straumann® dental implants can also be | ||||||
| used for immediate or early implantation | ||||||
| following extraction or loss of natural teeth. | ||||||
| Implants can be placed with immediate function | ||||||
| on single-tooth and/or multiple tooth applications | ||||||
| when good primary stability is achieved and with | ||||||
| appropriate occlusal loading, to restore chewing | ||||||
| function. The prosthetic restorations used are | ||||||
| single crowns, bridges and partial or full dentures, | ||||||
| which are connected to the implants by the | ||||||
| corresponding elements (abutments). When | ||||||
| placing implants in the posterior region, we | ||||||
| recommend using only large diameter implants. In | ||||||
| cases of fully edentulous patients, 4 or more | ||||||
| implants must be used in immediately loaded | ||||||
| cases. | TAV Medical's W Zirconia Implants are 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. | ||||||
| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | |
| Comparison | Z5-BL | K132881 | ||||
| Z5c | K131701 | |||||
| Z5mlb and Z5mlc | K153509 | |||||
| GPS® Angled Abutment | K121131 | |||||
| Straumann Bone Level Ø4.1 mm and | ||||||
| Ø4.8 mm Regular Connection (RC) | ||||||
| Roxolid Dental Implants | K172668 | |||||
| W 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 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 | 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/ | ||||||
| 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 with | ||
| a 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 straight | |||||
| Non-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-TZP | |||||
| Ti-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 gas | |||||
| All 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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