Not Found
No
The summary describes a dental implant system made of zirconia and focuses on its material properties, design, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is designed to replace missing teeth and is used for surgical implantation, making it a therapeutic device.
No
Explanation: The device description clearly states that Z5c implants are designed for surgical implantation to replace missing teeth and attach prosthodontic appliances. This indicates a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a two-piece, root-form, threaded implant and abutment system made from yttria-stabilized zirconia (Y-TZP), which are physical components, not software. The performance studies also focus on physical testing like compression-bending and fatigue.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgically implanted device (dental implant) used to replace missing teeth. It is a physical object placed within the body.
- Intended Use: The intended use is for surgical implantation and attachment of prosthodontic appliances. This is a therapeutic and restorative function, not a diagnostic one performed on samples outside the body.
The description clearly indicates a medical device used in vivo (within the living body) for structural support and restoration, not for diagnostic testing in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Z5c is a two-piece, root-form, threaded implant and abutment system made from yttria-stabilized zirconia (Y-TZP). The Z5c implant endosseous surface is grit blasted and laser modified. The Z5c implant and corresponding abutment are bonded together using a self-adhesive resin cement. The Z5c implant system is designed for single or multiple tooth restorations. Z5c implants are provided in two endosseous diameters (4.0 and 5.0 mm) and each diameter is provided in three lengths (8, 10, and 12 mm). Z5c abutments are provided in two designs, straight and angled 15°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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 testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing performed in a saline environment demonstrated the subject device to the predicate devices. Clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: a summary of clinical placement, loading, follow-up.data, and multiple clinical case reports. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K120793, K041661, K091904, K091920, K062277, K083496, K110640
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
510(k) Summary
Z-Systems AG
JUL 0 3 2014
Z5c K132881
June 26, 2014
Z-Systems AG Bittertenstrasse 15 CH-4702 Oensingen
Switzerland Telephone:
Thomas Hug, PhD
Fax:
Z5c
Dental Implant
ADMINISTRATIVE INFORMATION
Manufacturer Name
Official Contact
Representative/Consultant
Linda K. Schulz, BSDH, RDH Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: lschulz@paxmed.com kthomas@paxmed.com
+41 62 388 6969 +41 62 388 6970
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name Common Name
Classification Name
)
Classification Regulations Product Code
Implant, endosseous, root-form Endosseous dental implant abutment 21 CFR 872.3640, Class II DZE, NHA
Classification Panel Reviewing Branch
Dental Products Panel Dental Devices Branch
1
510(k) Summary
· INTENDED USE
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.
DEVICE DESCRIPTION
Z5c is a two-piece, root-form, threaded implant and abutment system made from yttria-stabilized zirconia (Y-TZP). The Z5c implant endosseous surface is grit blasted and laser modified. The Z5c implant and corresponding abutment are bonded together using a self-adhesive resin cement. The Z5c implant system is designed for single or multiple tooth restorations. Z5c implants are provided in two endosseous diameters (4.0 and 5.0 mm) and each diameter is provided in three lengths (8, 10, and 12 mm). Z5c abutments are provided in two designs, straight and angled 15°.
EQUIVALENCE TO MARKETED DEVICE
Z-Systems AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Z5c is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Z-Systems AG, Z-Look3 Evo SLM, K120793;
Nobel Biocare USA Inc., Nobel Biocare Endosseous Implants, K041661;
Nobel Biocare AB. Nobel Procera Zi Abutment, K091904:
Astra Tech Inc., Atlantis™ Abutment in Zirconia for Nobel Replace Implant, K091920; Atlantis Components Inc., Atlantis™ Abutment in Zirconia for Nobel Biocare Replace, K062277; Altatec GmbH, Camlog Implant System Modified Implants and Abutments, K083496; and Astra Tech Inc., Atlantis™ Abutment for Camlog Implant, K110640.
The subject device and the predicate devices have intended use and have the same technological characteristics. The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter, length, and surface treatment.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing performed in a saline environment demonstrated the subject device to the predicate devices. Clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: a summary of clinical placement, loading, follow-up.data, and multiple clinical case reports.
2
| | Z-Systems
AG
Z5c | K120793 | K041661 | K091904 | K091920 | K062277 | K083496 | K110640 |
|----------------------------|---------------------------------------|---------------------------------------|----------------------------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|
| System
Design | Two-piece,
implant/
abutment | One-piece,
implant/
abutment | Two-
piece,
implant/
abutment | Two-piece,
implant/
abutment | Two-piece,
implant/
abutment | Two-piece,
implant/
abutment | Two-piece,
implant/
abutment | Two-piece,
implant/
abutment |
| Abutment
Design | Straight,
angled | Straight | NA | Straight | Straight,
angled | Straight,
angled | Straight,
angled | Straight,
angled |
| Abutment
Diameter | 3.6 | NA | NA | 3.5 - 6.0 | 3.5 | 4.3 - 6.0 | 3.3 - 6.0 | 3.3 - 6.0 |
| Implant
Diameter,
mm | 4.0 - 5.0 | 3.6 - 5.0 | 3.5 - 6.0 | NA | NA | NA | 3.3 - 6.0 | NA |
| Implant
Length, mm | 8 - 12 | 8 - 13 | 8 - 16 | NA | NA | NA | 9 - 16 | NA |
| Material | | | | | | | | |
| Implant/
Abutment | Zirconia, | Zirconia | Titanium | Zirconia | Zirconia | Zirconia | Zirconia,
Titanium | Zirconia,
Titanium |
| Implant
Surface | Grit blasted
and laser
modified | Grit blasted
and laser
modified | TiUnite® | NA | NA | NA | Grit blasted
and acid
etched | NA |
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Overall, Z5c has the following similarities to the predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2014
Z-Systems AG C/O Ms. Linda K. Schulz, BSDH, RDH PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K132881
Trade/Device Name: Z5c Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 4, 2014 Received: June 5, 2014
Dear Ms. Schulz:
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. 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.
4
Page 2 - Ms. Schulz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Premarket Notification .
Indications for Use
K132881 510(k) Number:
Device Name: Z5c
Z.Sc 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
Sheena A. Green -S 2014.07.02 14:11:22 -04'00'