(239 days)
No
The summary describes a dental implant system made of zirconia and PEEK. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical and biological testing, not data analysis or prediction.
No.
Explanation: A therapeutic device aims to treat or cure a disease or condition. This device is an implant for replacing missing teeth, which is a restorative or prosthetic function, not a therapeutic one. It provides a structural replacement rather than acting as a treatment.
No
This device is a dental implant system used to replace missing teeth, essentially a prosthetic device. Its intended use is for surgical implantation and attachment of prosthodontic appliances, not for diagnosing conditions.
No
The device description clearly states it is a dental implant system including physical components like implants, abutments, and gingiva formers made of materials like zirconia and PEEK. It also details sterilization methods and mechanical performance testing of these physical components.
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 from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a dental implant system, including implants, abutments, and screws. These are physical components for surgical placement.
- Lack of IVD Characteristics: The text does not mention any components, processes, or intended uses related to testing biological samples (blood, urine, tissue, etc.) outside of the body.
Therefore, the Z5-BL dental implant system is a medical device, but it does not fit the definition of 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 subject device includes dental implants provided in one body diameter of 3.6 mm in lengths of 8 mm, 10 mm. The subject device also includes a gingiva former, straight abutments for single-unit cemented restorations, and a 15° angled abutment also for single-unit cemented restorations.
The subject device is compatible with components cleared previously in K190243, including a healing cap, straight abutments for multi-unit cemented restorations, Locator-type abutments for retention of overdentures, and occlusal (abutment) screws.
The subject device dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The subject device abutments are manufactured from Y-TZP zirconia conforming to ISO 13356, or from polyetheretherketone (PEEK).
The subject device implants 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 (referenced from K132881) and ISO 17665-1 (referenced from K120793);
sterile product shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from K132881);
bacterial endotoxin testing for subject devices provided sterile (Limulus Amebocyte Lysate (LAL) test according to USP 40-NF 35 , referenced from K190243);
biocompatibility of the yttria-stabilized zirconia (Y-TZP) conforming to ISO 13356 used to manufacture the subject device dental implants and abutments (referenced from identical material used for dental implants and abutments cleared in K190243);
biocompatibility endosseous threaded surface of the subject device implants (referenced from identical Al2O3 grit blasted and laser modified surface applied to the dental implants cleared in K190243);
biocompatibility of the PEEK material according to ISO 10993-5, ISO 10993-12, ISO 10993-10, ISO 19003-11. ISO 10993-18, and USP Class VI testing according to USP 37-NF32 (referenced from K190243);
static compression and compression fatigue testing according to ISO 14801 of the subject device zirconia implants and zirconia abutments, with both zirconia and titanium alloy abutment screws;
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 (referenced from K190243);
assessment of wear particles associated with the Ti-6A1-4V alloy abutment screw used with 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) (referenced from K190243).
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)
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.
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October 14, 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: K200386
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: September 11, 2020 Received: September 14, 2020
Dear Kevin Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
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 Ouality Center for Devices and Radiological Health
Enclosure
2
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) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K200386
Z5-BL
Z-Systems AG
September 11, 2020
kthomas@paxmed.com flarson@paxmed.com
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:
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Z5-BL |
|---|---|
| Common Name | Dental implant |
| Regulation Number | 21 CFR 872.3640 |
|---|---|
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental |
|---|---|
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, |
| ENT and Dental Devices) | |
| Reviewing Division | Division of Health Technology 1 B (Dental Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device: K190243, Z5-BL, Z-Systems AG Reference Devices: K132881, Z5c, Z-Systems AG K131701, Z5mlb and Z5mlc, Z-Systems AG K120793, Z-Look3 Evo SLM, Z-Systems AG
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 subject device includes dental implants provided in one body diameter of 3.6 mm in lengths of 8 mm, 10 mm. The subject device also includes a gingiva former, straight abutments for single-unit cemented restorations, and a 15° angled abutment also for single-unit cemented restorations.
The subject device is compatible with components cleared previously in K190243, including a healing cap, straight abutments for multi-unit cemented restorations, Locator-type abutments for retention of overdentures, and occlusal (abutment) screws.
The subject device dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The subject device abutments are manufactured from Y-TZP zirconia conforming to ISO 13356, or from polyetheretherketone (PEEK).
The subject device implants 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 (referenced from K132881) and ISO 17665-1 (referenced from K120793);
sterile product shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from K132881);
bacterial endotoxin testing for subject devices provided sterile (Limulus Amebocyte Lysate (LAL) test according to USP 40-NF 35 , referenced from K190243);
biocompatibility of the yttria-stabilized zirconia (Y-TZP) conforming to ISO 13356 used to manufacture the subject device dental implants and abutments (referenced from identical material used for dental implants and abutments cleared in K190243);
biocompatibility endosseous threaded surface of the subject device implants (referenced from identical Al2O3 grit blasted and laser modified surface applied to the dental implants cleared in K190243);
biocompatibility of the PEEK material according to ISO 10993-5, ISO 10993-12, ISO 10993-10, ISO 19003-11. ISO 10993-18, and USP Class VI testing according to USP 37-NF32 (referenced from K190243);
static compression and compression fatigue testing according to ISO 14801 of the subject device zirconia implants and zirconia abutments, with both zirconia and titanium alloy abutment screws;
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
5
according to ISO 14801, including microscopic examination of the abutment screws and internal threads of the implant bodies (referenced from K190243);
assessment of wear particles associated with the Ti-6A1-4V alloy abutment screw used with 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) (referenced from K190243).
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 is a table 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 K190243, and to the reference devices K132881 and K131701. All are intended for use in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The subject device and the primary predicate device K190243 are made of identical materials (implants and abutments). The subject device dental implants and the primary predicate device K190243 dental implants have an identical endosseous threaded surface (grit-blasted and laser modified), have the same internal implant connection features, and the same implant lengths. The subject device and the primary predicate device K190243 also include straight and angled abutments for cement-retained, single-unit restorations. Differences between subject device and the primary predicate device K190243 include the implant diameter (subject device 3.6 mm) and implant platform diameter (subject device also 3.6 mm). None of these minor design differences impact safety or effectiveness or change the intended use of the device.
The reference device K132881 is for support of substantial equivalence of the subject device in terms of sterilization and shelf life (also referenced in K190243). The subject device dental implants are provided to the end user sterilized by plasma gas. 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 (referenced in K190243). The processes to monitor, control, and test for bacterial endotoxins for the subject device are the same as K190243.
The reference device K131701 is for support of substantial equivalence of the subject device in terms of the smaller dental implant body diameter and corresponding implant platform diameter (both 3.6 mm). The subject device dental implants and the reference device K131701 dental implants also are made of identical materials, and have the identical endosseous threaded surface (grit-blaster and laser modified).
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.
6
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 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.
7
Table of Substantial Equivalence
| Comparison | Subject Device | Primary Predicate | Reference Device | Reference Device |
|---|---|---|---|---|
| Indications for Use Statement | K200386 | |||
| Z5-BL | ||||
| Z-Systems AG |
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. | K190243
Z5-BL
Z-Systems AG
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. | K132881
Z5c
Z-Systems AG
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 with
metal allergies and the chronic diseases resulting from
them. Z5c implants are intended for delayed loading. | K131701
Z5mlb and Z5mlc
Z-Systems AG
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. |
| 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 |
| Reason for Predicate/
Reference Device | Not applicable | IFU Statement; implant design, material, surface;
abutment design | Reference for sterilization and shelf life | Reference for implant diameter (3.6 mm) |
| Product Codes | DZE, NHA | DZE, NHA | DZE, NHA | DZE |
| Components | Implants, abutments | Implants, abutments,
abutment screws | Implants, abutments
(abutment cemented to implant) | One-piece implants |
| Implant Designs | | | | |
| Implant Diameter, mm | 3.6 | 4.0, 5.0 | 4.0, 5.0 | 3.6, 4.0 |
| Implant Endosseous Length, mm | 8, 10, 12 | 8, 10, 12 | 8, 10, 12 | 8, 10 |
| Platform diameter, mm | 3.6 | 4.0, 5.0 | 4.0, 5.0 | Not applicable |
| Implant Material | Y-TZP | Y-TZP | Y-TZP | Y-TZP |
| Implant Surface | Grit-blasted and laser modified | Grit-blasted and laser modified | Grit-blasted and laser modified | Grit-blasted and laser modified |
| Abutment Designs | | | | |
| Features | Subject device
Indexed, straight and angled
Previously cleared compatible
Non-indexed straight;
Indexed and Non-indexed Locator-type | 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 |
| Prosthesis Attachment | Subject device
Cement-retained
Previously cleared compatible
Cement-retained;
Locator-type attachment | Cement-retained;
Locator-type attachment | Cement-retained | Ball-type attachment;
Locator-type attachment |
| Restoration | Single-unit; Multi-unit | Single-unit; Multi-unit | Single-unit; Multi-unit | Multi-unit |
| Comparison | Subject Device | Primary Predicate | Reference Device | Reference Device |
| | K200386
Z5-BL
Z-Systems AG | K190243
Z5-BL
Z-Systems AG | K132881
Z5c
Z-Systems AG | K131701
Z5mlb and Z5mlc
Z-Systems AG |
| Prosthetic platform diameter, mm | Subject device
3.8 mm – 4.3 mm
Previously cleared compatible
4.5 mm | 4.5 mm – 6.5 mm | 3.6 mm | Not applicable |
| Abutment angle | Straight (0°), 15° | Straight (0°), 15° | Straight (0°), 15° | Straight (0°) |
| Abutment material | Y-TZP | Y-TZP | Y-TZP | Y-TZP |
| Abutment Screw Material | Previously cleared compatible
Y-TZP
Ti-6Al-4V alloy | Y-TZP
Ti-6Al-4V alloy | Not applicable | Not applicable |
| Sterilization Status/Method | | | | |
| Implants | Sterile / plasma gas | Sterile / plasma gas | Sterile / plasma gas | Sterile / plasma gas |
| Abutments | Non-sterile / moist heat (steam) | Healing Cap: Sterile / plasma gas
All other:
Non-sterile / moist heat (steam) | Non-sterile / Dry heat | Not applicable |
| Other Components | Not applicable | Non-sterile / moist heat (steam) | Non-sterile / moist heat (steam) | Not applicable |
8
510(k) Summary
Page 6 of 6