(337 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use of dental implants.
Yes
The device, IMZ implants, is explicitly indicated for single tooth replacement, support for fixed bridgework, and overdentures, all of which are treatments for restoring dental function and structure.
No
The "Intended Use" section describes the IMZ implants as being used for replacing teeth and supporting various dental prostheses. This indicates a therapeutic or restorative purpose, not a diagnostic one.
No
The intended use describes dental implants, which are physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as implants for tooth replacement and supporting dental prostheses. This is a direct interaction with the patient's body for structural support and restoration.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on in vitro analysis.
- Using reagents or kits for testing.
IVDs are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant placed within the body.
N/A
Intended Use / Indications for Use
IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
Product codes
DZE
Device Description
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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
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the upper portion of the circle. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IMZ, GmbH C/O Robert Joel Slomoff - 9229 Cranford Drive -----Potomac, Maryland 20854
AUG - 6 1997
Re: K963521 Trade Name: IMZ Twin Plus - Cylinder Regulatory Class: III Product Code: DZE Dated: June 3, 1997 Received: June 3, 1997
Dear Mr. Slomoff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug
1
Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register... Please note: ... r this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. A. Wiatrowski
Timo hy A. Ülatowski Direttor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
2
Page__________of_
510(k) Number (if known): Pending
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
INDICATIONS
IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Sugar Kunper
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number
Prescription Use (Per 21 CFR 801.109) ામ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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