(267 days)
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No
The provided text describes dental implants and their intended use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The sections related to AI/ML training and testing data are explicitly marked as "Not Found".
No
The device, implants, are used to support dental prostheses, which restores function (e.g., chewing) and aesthetics. While they improve quality of life, they do not treat or cure a disease or condition in a therapeutic sense.
No
The "Intended Use / Indications for Use" states that the implants are "intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures." This describes a therapeutic or reconstructive function, not a diagnostic one.
No
The 510(k) summary describes dental implants, which are physical medical 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 clearly states that the implants are for "surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures." This describes a surgical procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The device described here does not involve testing samples.
Therefore, this device falls under the category of a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A.B. Dental Devices' implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Two-piece implants - I1, I2, I2b & I5:
Two-stage implants - I2, I2b & I5 implants:
One-stage implants -- I1
One piece implants - I6, I7
Implants for immediate loading when good primary stability is achieved and with appropriate occlusal loading - I2, I2b, I5, I6 & I7.
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
maxillary and/or mandibular arch
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three wavy lines extending from the head, all in black. This figure is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The text is also in black, and the overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2006
A.B. Dental Devices, Limited C/O Mr. Benny Arazy Arazy Group Mitzpe Aviv, Industrial Park 13 M.P. Misgav 20187 Israel
Re: K051719
Trade/Device Name: A.B. Dental Devices Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: February 18, 2006 Received: February 23, 2006
Dear Mr. Arazy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roved 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 (1 Nr.), it hay be colled 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
Page 2 - Mr. Benny Arazy
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be actived that 22 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of ally I ederal the Act's requirements, including, but not limited to: registration r ou into compry with and 807); labeling (21 CFR Part 801); good manufacturing practice and itsung (21 ce read 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 This letter will and will and 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), rt you don't 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 maj overall 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,
Snyite y. Michael Davis
Chíu Lin, Ph.D. Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K051719
Device Name: Dental Implants
Indications for Use:
A.B. Dental Devices' implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Two-piece implants - I1, I2, I2b & I5: Two-stage implants - 12, 12b & 15 implants:
Onc-stage implants -- 11
One piece implants - 16, 17
Implants for immediate loading when good primary stability is achieved and with appropriate occlusal loading - 12, 12b, 15, 16 & 17.
Over-The-Counter Use Use -Prescription — AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
. ..
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___
Center for Devices and Radiological Health / CDRH
Super Phazer
Division Engineering
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K651719 |
|---|---|
| ---------------- | --------- |