(253 days)
Not Found
Not Found
No
The 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) relate to a sealant for dental applications.
No
The device is used to seal dentinal tubules and aid in bonding resin fillings, which are restorative and preventative functions, not therapeutic.
No
The intended use describes the device as sealing dentinal tubules and aiding in wetting for better bonding of resin fillings and cements. These are therapeutic or preparatory functions, not diagnostic ones that identify, characterize, or monitor a disease or condition.
No
The 510(k) summary describes a material (HEMASEAL & CIDE) used to seal dentinal tubules, which is a physical substance, not software.
Based on the provided information, it is highly unlikely that HEMASEAL & CIDE is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to seal dentinal tubules and aid in bonding for dental fillings and cements. This is a direct application to a patient's anatomical structure (teeth) for a therapeutic or restorative purpose.
- Anatomical Site: The anatomical site is "dentinal tubules in cavity preparations or sensitive root surfaces," which are parts of the human body.
- 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
- Being used in a laboratory setting
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. HEMASEAL & CIDE's function is to physically interact with and modify a part of the tooth structure.
Therefore, based on the provided information, HEMASEAL & CIDE appears to be a dental device used for restorative or therapeutic purposes, not an IVD.
N/A
Intended Use / Indications for Use
HEMASEAL & CIDE is to be used to seal dentinal tubules in cavity preparations or sensitive root surfaces. It also aids in wetting for tubules to provide a better bond for resin fillings and cements.
Product codes
GBN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentinal tubules, root surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles or figures, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1999
Joseph J. Pelerin, D.D.S. Advantage Dental Products, Inc. P.O. Box 415 Lake Orion, MI 48361
Re: K990779 HemaSeal & Cide Trade Name: Regulatory Class: II ГВН Product Code: Dated: September 23, 1999 September 28, 1999 Received:
Dear Dr. Pelerin:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
1
Page 2 - Dr. Pelerin
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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (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.fdag.gov/cdrh/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
2
| T.WC |
|---|
| ------ |
| K990779 | |
|---|---|
| 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | |
| HEMASEAL & CIDE | |
| Device Name:__________________________________________________________________________________________________________________________________________________________________ | |
Indications For Use:
HEMASEAL & CIDE is to be used to seal dentinal tubules in cavity preparations or sensitive root surfaces. It also aids in wetting for tubules to provide a better bond for resin fillings and cements.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use v (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Nunn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5 1 O(k) Number _ 人