(80 days)
Not Found
N/A
No
The summary describes a root canal filling material with antibacterial properties and does not mention any AI or ML components.
Yes
The device is used to promote healing effects and help prevent bacterial contamination, which are therapeutic actions.
No
This device is described as an "Antibacterial Gutta Percha" used for "final filling of prepared root canals" to "promote healing effects and to help prevent bacterial contamination," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states "Antibacterial Gutta Percha," which is a physical material used in root canal procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is "Antibacterial Gutta Percha" and its intended use is for "final filling of prepared root canals in adult or decidious teeth". This is a material used within the body during a dental procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used in a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.
Product codes
EKM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals in adult or decidious teeth
Indicated Patient Age Range
adult or decidious
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3850 Gutta percha.
(a)
Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three heads or faces, representing the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kyle H. Sibinovic, Ph.D. Agent Dr. Howard Martin, P.A. C/O Shaldra, Incorporated 7613 Carteret Road Bethesda, Maryland 20817
JUL 21 1997
Re : K971641 Antibacterial Gutta Percha Trade Name: Regulatory Class: I Product Code: EKM May 1, 1997 Dated: Received: May 2, 1997
Dear Dr. Sibinovic:
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. प्र 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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Page 2 - Dr. Sibinovic
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 findinq 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 diaqnostic 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
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.fda.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 Radioloqical Health
Enclosure
2
510 (k) Number (if known): K971641
Device Name: Antibacterial Gutta Percha
Indications for Use: For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Olf) Division of Dental, and General Hosal 510(k) Number
Prescription Use ﻟﺴﺎ (Per 21 CFR801 109)
C
Over-The-Counter Use (Optional Fomat 1-2-96)
OR