(75 days)
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No
The summary describes dental abutments, which are physical components, and there is no mention of software, algorithms, or any terms related to AI/ML.
No
The device, PDQ and PDQ-Ti abutments, is a part of a dental prosthesis and forms the substructure for a restored prosthesis. While it is used in a medical context, it does not directly treat or diagnose a disease or condition; rather, it is a restorative component.
No
The device is described as an abutment, a component of a dental prosthesis, which forms a substructure for restoration. Its intended use is to be seated on a dental implant, not to diagnose a condition.
No
The 510(k) summary describes physical dental abutments, which are hardware components, 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 abutments as components of a dental prosthesis, designed to be seated on dental implants. This is a structural and mechanical function within the body.
- Device Description: The description simply identifies the device as "PDQ and PDQ-Ti Abutments," which are physical components.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body).
IVDs are used to perform tests on biological samples to provide diagnostic information. This device is a physical component used in dental restoration.
N/A
Intended Use / Indications for Use
PDQ and PDQ-Ti abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
Product codes
DZE
Device Description
PDQ and PDQ-Ti Abutments
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by curved lines, suggesting a sense of unity and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 1999
Ms. Barbara J. Lewandowski Regulatory Affairs Specialist Vident, Incorporated 3150 East Birch Street P.O. Box 2340 Brea, California 92822-2340
Re : K990367 PDQ and PDQ-Ti Abutments Trade Name: Requlatory Class: III Product Code: DZE February 3, 1999 Dated: February 5, 1999 Received:
Dear Ms. Lewandowski:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug 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: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Ms. Lewandowski
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene organis on entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowsk Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 (k) Number (if known):
Device Name: PDQ and PDQ-Ti Abutments
PDQ and PDQ-Ti abutments are designed for use with Indications for Use: commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
Division Sign-Off) Division of Devel. Interest. and General Hospital De 510(k) Number __
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices
510(k) Number
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The Counter Use