(86 days)
No
The document describes a physical dental implant device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a dental implant designed to replace missing teeth and attach dentures, which directly addresses a health condition (edentulism) and is intended to restore function, making it a therapeutic device.
No
Explanation: The device described is an implant designed for surgical implantation to replace missing teeth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical implant made from yttria-stabilized zirconia, designed for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the implants are designed for "surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth." This describes a surgical procedure and a medical device used within the body, not a test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of the implants (one-piece, root-form, threaded, made from zirconia) and their purpose in supporting dentures. This aligns with a medical device for implantation, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the Zsmlb and Z
N/A
Intended Use / Indications for Use
Zsmlb:
Z mlb implants are 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.
Z
§ 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
Z5mlb and Z5mlc
510(k) Summary
Z-Systems AG
Z5mlb and Z5mlc
June 10, 2013
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Z-Systems AG
Bittertenstrasse 15
702 Oensingen
Switzerland |
|---------------------------|---------------------------------------------------------------------|
| Telephone: | +41 62 388 6969 |
| Fax: | +41 62 388 6970 |
| Official Contact | Thomas Hug, Ph.D. |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH |
| | 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: lschulz@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Z5mlb and Z5mlc |
|---|---|
| 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 |
SEP 0 5 2013
1
INTENDED USE
Zsmlb:
Z mlb implants are 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.