(78 days)
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No
The summary describes a chemical desensitizer for dental use and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML medical devices.
No
The device is used to seal dentinal tubules and as a wetting agent, which are preparatory steps in dental procedures rather than direct treatment of a disease or condition.
No
The device is used to seal dentinal tubules or as a wetting agent, which are treatment or preparation functions, not diagnostic functions.
No
The 510(k) summary describes a chemical substance (Prime-Dent® Hema Desensitizer) used by dentists, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to seal dentinal tubules and act as a wetting agent within the mouth during dental procedures. This is a direct application to the patient's tissues.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
The Prime-Dent® Hema Desensitizer is a dental material used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also used as a wetting agent prior to bonding resin fillings and composites.
Product codes
LBH
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
tooth / dentinal tubules / root surfaces
Indicated Patient Age Range
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Intended User / Care Setting
Dentists
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
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2002
Mr. Rolando Marasigan Vice President of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618
Re: K013970
Trade/Device Name: Prime-Dent Hema Desensitizer Regulation Number: 872.3260 Regulation Name: Sealant Regulatory Class: II Product Code: LBH Dated: November 28, 2001 Received: December 3, 2001
Dear :
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.
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.
1
Page 2 - Mr. Marasigan
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth Prime-Dent® Hema Desensitizer is used or Delitise to other Desensitizer is also
cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also cavity preparation of sensitive root surfaces. I stillings and composites.
used as a wetting agent prior to bonding resin fillings and composites.
Susan Rungen
(Sivision Sign-Off) ുംഗ്ലോസ Sign-Off)
അമ്മ of Dental, Infection Control, ാന ന് Dental, Devices
Coneral Hospital Devices a mber ----