(246 days)
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No
The provided 510(k) summary describes a dental implant and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML device submissions.
No
The device, a dental implant, is intended as a support structure for a dental prosthesis to replace missing teeth, which is a restorative function, not a therapeutic one. It treats edentulism by replacing missing teeth, but it doesn't cure a disease or alleviate a condition in the way a therapeutic device would.
No
Explanation: The device, PerioSeal® dental implant, is described as an artificial root structure for replacement of teeth and support for dental prostheses. Its intended use is surgical implantation for treatment of edentulism. There is no mention of it being used to identify, monitor, or assess health conditions or diseases.
No
The device description is not found, but the intended use clearly describes a physical dental implant, which is a hardware device.
Based on the provided information, the PerioSeal® dental implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a surgically implanted dental implant to support a dental prosthesis. This is a medical device used in vivo (within the body) for structural support.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological or pathological state. The PerioSeal® dental implant does not perform this function.
- Device Description, Image Processing, AI/ML, Input Imaging Modality: The lack of information in these sections further supports that it's not an IVD, as IVDs often involve analysis of samples, potentially with imaging or AI.
- Anatomical Site: The device is implanted in the mandible or maxilla, which is an in vivo application.
Therefore, the PerioSeal® dental implant is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PerioSeal® dental implant is intended to be surgically implanted into the edentulous areas of the mandible or maxilla to serve as support for a dental prosthesis. This device is intended for the treatment of edentulism in the totally or partially edentulous population, but limited to those individuals who are suitable candidates for the surgical and prosthetic procedures. The PerioSeal® dental implant is intended for use in the mandible or maxilla as an artificial root structure for replacement of a single tooth or as an abutment for retention of bridgework or dentures of various configurations.
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
mandible or maxilla
Indicated Patient Age Range
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Intended User / Care Setting
licensed dentist of physician.
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/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Donald P. Callan, DDS ·Perioseal 10319 West Markham; Suite 300 " Little Rock, Arkansas 72205
K965032 Re: The Perioseal Dental Implant Trade Name: Regulatory Class: III Product Code: DZE Dated: May 20, 1997 Received: May 23, 1997
AUG 20 1997
Dear Dr. Callan:
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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਿ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA aspoing 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) 594-4618. 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 ene regaracion cheroids" (21 CFR 807.97). Other general 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;
Aliltrust
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page of
K965032 510(k) Number (if known):
0
PerioSeal ® Dental Implant Device Name:
Indications For Use:
Indications for use: The PerioSeal® dental implant is intended to be surgically implanted into the edentulous areas of the mandible or maxilla to serve as support for a dental prosthesis. This device is intended for the treatment of edentulism in the totally or partially edentulous population, but limited to those individuals who are suitable candidates for the surgical and prosthetic procedures. The PerioSeal® dental implant is intended for use in the mandible or maxilla as an artificial root structure for replacement of a single tooth or as an abutment for retention of bridgework or dentures of various configurations. This device is intended for sale to or use on the order of a licensed dentist of physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Gerald Shippps |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Optional Format 1-2-96) |