(206 days)
No
The summary describes a physical dental implant and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is designed for surgical implantation to replace missing teeth and is suitable for patients with metal allergies, indicating a therapeutic purpose to treat or alleviate a medical condition.
No
The device is an implant designed to replace missing teeth, which is a therapeutic function, not a diagnostic one. Its purpose is to physically replace missing teeth and attach prosthodontic appliances.
No
The device description clearly states it is a physical implant made from yttria-stabilized zirconia (Y-TZP) and describes its physical characteristics and dimensions. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for surgical implantation into the jaw for the attachment of prosthodontic appliances to replace missing teeth. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant made of zirconia, designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.
Product codes
DZE
Device Description
Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.
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 testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 14937 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process: software validation: and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants.
- Sterilization parameters have been validated to an SAL of 10.
- No new biocompatibility testing has been performed, as the materials and manufacturing methods used for the subject device are identical to those used for the predicate device.
- The subject device does not represent a new worst case in mechanical testing.
- No clinical data were included in this submission.
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
Z-systems Ag c/o Ms. Linda Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K150021
Trade/Device Name: Z5m(t) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 29, 2015 Received: July 1, 2015
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Tina
Kiang-S
for 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150021
Device Name
Z5m(t)
Indications for Use (Describe)
Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.
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)
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3
510(k) Summary
Z-Systems AG
Z5m(t)
July 23, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Z-Systems AG | ||
|---|---|---|---|
| Bittertenstrasse 15 | |||
| CH-4702 Oensingen | |||
| Switzerland | |||
| Telephone | +41 62 388 69 69 | ||
| Fax | +41 62 388 69 70 | ||
| Official Contact | Thomas Hug, PhD | ||
| 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 | ||
| lschulz@paxmed.com | |||
| kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Z5m(t) |
|---|---|
| Common Name | Dental Implant |
| Classification Name | Implant, endosseous, root-form |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
4
INDICATIONS FOR USE
Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.
PREDICATE AND REFERENCE DEVICES
Z-Systems AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Z5m(t) is substantially equivalent in indications and design principles to the following legally marketed devices:
Primary Predicate Z-Systems AG, Z-Look3 Evo SLM, K120793 Reference Devices Z-Systems AG, Z5c, K132881; and Implant Direct Sybron Manufacturing LLC, Legacy3 6 mm Length Implants, K131097.
DEVICE DESCRIPTION
Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 14937 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process: software validation: and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants.
- Sterilization parameters have been validated to an SAL of 10 . ·
- . No new biocompatibility testing has been performed, as the materials and manufacturing methods used for the subject device are identical to those used for the predicate device.
- The subject device does not represent a new worst case in mechanical testing. •
- No clinical data were included in this submission.
5
| | Subject Device | Primary Predicate
Device | Reference Devices | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Z-Systems AG | Z-Systems AG | Z-Systems AG | Implant Direct Sybron
Manufacturing LLC |
| | Z5m(t) | Z-Look3 Evo SLM | Z5c | Legacy3 6 mm Length
Implants |
| | | K120793 | K132881 | K131097 |
| Indications
for Use | Z5m(t) implants are
designed for surgical
implantation into the
upper and lower jaw for
the attachment of
prosthodontic appliances
to replace missing teeth.
The Z5m(t) implant
system is also suitable for
patients with metal
allergies and the chronic
diseases resulting from
them. | Z-Look3 Evo SLM
implants are designed for
surgical implantation into
the upper and lower jaw
for the attachment of
prosthodontic appliances
to replace missing teeth.
The Z-Look3 Evo SLM
implant system is also
suitable for patients with
metal allergies and the
chronic diseases resulting
from them. | 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. | Lcgacy3 6mm Length
consists of two-piece
implants for one-stage or
two-stage surgical
procedures. These
implants are intended for
use in partially and fully
edentulous upper and
lower jaws in support of
single or multiple-unit
restorations and terminal
or intermediate abutment
support for fixed
bridgework. Implants can
be indicated for
immediate loading when
good primary stability has
been achieved and with
appropriate occlusal
loading. |
| Design | One-piece,
implant/abutment | One-piece,
implant/abutment | Two-piece,
implant/abutment | Two-piece,
implant/abutment |
| Implant
Diameter, mm | 4.0, 5.0 | 3.6, 4.0, 5.0 | 4.0, 5.0 | 3.7, 4.2, 4.7, 5.2, 5.7, 7.0 |
| Implant
Length, mm | 8, 10, 12 | 8, 10, 11.5, 13 | 8, 10, 12 | 6 |
| Material | | | | |
| Implant,
Abutment | Y-TZP
Laser treated surface | Y-TZP
Laser treated surface | Y-TZP
Laser treated surface | Titanium |
This submission expands the Z-System Implant line to include a tapered version of the Z5m (previously named Z-Look3 Evo SLM) originally cleared in K120793. The modification includes a tapered implant body, a double thread design and a self-tapping apex. The primary predicate has a straight body and a single thread design. Both the subject device and the predicate device have the same abutment portion of the one-piece implant.
Z5m(t) diameters and lengths are the same as the reference device Z5c implant diameters and lengths cleared in K132881. The implant body, thread design and self-tapping feature of the Z5m(t) are substantially equivalent to the design of the reference device Legacy3 implant cleared
6
510(k) Summary K150021
in K131097. Z5m(t) is different from the reference devices in that it is a one piece implant and abutment, where the reference devices are a two-piece implant and abutment configuration.
The subject device and the predicate and reference devices have intended use, the same technological characteristics, and encompass the same range of physical dimensions and characteristics, including implant diameter, length, and surface treatment.
CONCLUSION
Overall, the subject device has the following similarities to the predicate and reference 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.
The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.