(425 days)
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No
The provided text describes a physical dental implant and its intended use, contraindications, and physical characteristics. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is a dental implant intended for oral rehabilitation and restoration, which directly treats the condition of edentulousness or partial edentulousness.
No
The provided text describes a dental implant used for rehabilitation, not for diagnosing conditions or diseases. It focuses on the functional and aesthetic restoration of edentulous patients.
No
The device description clearly states it is a physical dental implant, which is a hardware component.
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. These tests are performed outside of the body.
- Z-Look3 Dental Implant Function: The description clearly states that the Z-Look3 Dental Implant is an endosseous dental implant. This means it is a device surgically placed inside the body (specifically, the jawbone) to support dental prosthetics.
- Intended Use: The intended use is for the functional and aesthetic oral rehabilitation of patients, which is a surgical and restorative procedure, not a diagnostic test performed on a sample.
The information provided describes a surgically implanted medical device, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z -Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies.
Contraindications for the Z-Look3 Dental Implant 0 3.25 mm:
- Restoration of posterior teeth in the upper or lower jaw ।
- Single-tooth restoration of canines and central incisors in the upper jaw .
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Z-Look3 Dental Implant is a one-piece, self tapping, threaded, root form endosseous dental implant. Z-Look3 Dental Implants are offered in three diameters (3.25 mm, 4.0 mm, 5.0 mm) and four lengths (10 mm, 11.5 mm, 13.0 mm, 14.0 mm).
Material
All Z-Look3 implants are produced from ZrO2 TZP/TZP-A Bio HIP bioceramics, also referred to as yttria-stabilized tetragonal zirconia polycrystal (Y-TZP), conforming to ISO 13356 Implants for surgery - Ceramic materials based on Yttria-stabilized tetragonal zirconia (Y-TZP). This material has been in use for 20 years in the production of hip joint prostheses. It has a fine grain size and offers the best mechanical properties among structural ceramics.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper and lower jaw
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Z-Look3 Dental Implant System
K062542 510(k) Summary - REVISED
007 2 9 2007
Z-Systems AG Z-Look3 Dental Implant System
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Z-Systems AG
Bittertenstrasse 15
CH-4702 Oensingen
Switzerland
Telephone 41 62 3886969
FAX 41 62 3886970 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Franz Berghänel |
| Representative/Consultant: | Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA 92130
Telephone (858) 792-1235
FAX (858) 792-1236 |
| DEVICE NAME | |
| Classification Names: | Implant, Endosseous, Root-Form |
| Trade/Proprietary Name: | Z-Look3 Dental Implant System |
Dental implants Common Name
ESTABLISHMENT REGISTRATION NUMBER
Z-Systems AG has submitted an Establishment Registration to FDA. The Establishment Registration number and the owner/operator number for Z-Systems AG are pending.
DEVICE CLASSIFICATION
FDA has classified endosseous dental implants as Class II devices (21 CFR 872.3640 according to revision 69 FR 26307, May 12, 2004). The product code for "Implant, Dental, Root-Form" is DZE. Endosseous dental implants are reviewed by the Dental Devices Branch.
1
510(k) Summary
INTENDED USE
Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z -Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies.
Contraindications for the Z-Look3 Dental Implant 0 3.25 mm:
- Restoration of posterior teeth in the upper or lower jaw ।
- Single-tooth restoration of canines and central incisors in the upper jaw .
DEVICE DESCRIPTION
The Z-Look3 Dental Implant is a one-piece, self tapping, threaded, root form endosseous dental implant. Z-Look3 Dental Implants are offered in three diameters (3.25 mm, 4.0 mm, 5.0 mm) and four lengths (10 mm, 11.5 mm, 13.0 mm, 14.0 mm).
Material
All Z-Look3 implants are produced from ZrO2 TZP/TZP-A Bio HIP bioceramics, also referred to as yttria-stabilized tetragonal zirconia polycrystal (Y-TZP), conforming to ISO 13356 Implants for surgery - Ceramic materials based on Yttria-stabilized tetragonal zirconia (Y-TZP). This material has been in use for 20 years in the production of hip joint prostheses. It has a fine grain size and offers the best mechanical properties among structural ceramics.
EQUIVALENCE TO MARKETED DEVICE
Z-Systems AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Z-Look3 Dental Implant System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined serpents around a staff. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Z-Systems AG C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
OCT 2 9 2007
Re: K062542
Trade/Device Name: Z-Look3 Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 8, 2007 Received: October 9, 2007
Dear Mr. Larson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Larson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Neil R. Ogden
Chiu Lin, Ph.D. Jov Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use - REVISED
510(k) Number (if known): K062542
Device Name: Z-Look3 Dental Implant System
Indications for Use:
Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z-Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies.
Contraindications for the Z-Look3 Dental Implant Ø 3.25 mm:
- Restoration of posterior teeth in the upper or lower jaw -
- Single-tooth restoration of canines and central incisors in the upper jaw -
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)
Sual Funne
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: TCS10252