(35 days)
Not Found
Not Found
No
The provided text describes a dental sealer and delivery system, focusing on its physical properties and delivery method. There is no mention of AI, ML, image processing, or any other computational technology that would suggest the use of AI/ML.
Yes
The device, EndoSeal, is a sealer delivered to dental canals, which indicates its use in treating dental conditions. Therapeutic devices are used to treat or alleviate disease or injury.
No
The text describes a dental sealer (EndoSeal) and its delivery system, used for filling root canals. There is no mention of the device being used to identify or diagnose a condition.
No
The description focuses on a dental sealer and delivery system, which are physical 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 a material (EndoSeal) and a delivery system (Endo-Eze, SpaTwist) for use within dental canals. This is a therapeutic or procedural device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Anatomical Site: The anatomical site is "canals (dental)", which aligns with a dental procedure, not an in vitro diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of EndoSeal and its delivery system does not fit this definition.
N/A
Intended Use / Indications for Use
EndoSeal is easily delivered to the canals with the Endo-Eze 31 gauge tip. When mixed and delivered with the SpaTwist System, the sealer can be placed directly, to the bottom of the roct and is-filled from the borcom up, eliminating air entrapment. Using Spalvist with the Endo-Ene 31 gauge tip or capillary tip eliminates the need for gutta percha points.
Product codes
KIF
Device Description
Endo-Seal
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chester McCoy Regulatory Affairs & Quality Assurance Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
JUN 2 6 1997
- K971899 Re : Endo-Seal Trade Name: Regulatory Class: II Product Code: KIF Dated: May 12, 1997 Received: May 22, 1997
Dear Mr. McCoy:
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 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 requirement, as set forth in the Quality System Requlation (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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. McCoy
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 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 Radiological Health
Enclosure
2
1971899 5 10(k) Number (if known):
EndoSea1 Device Namc:
Indications For Usc:
EndoSeal is easily delivered to the canals with the Endo-Eze 31 gauge tip. When mixed and delivered with the SpaTwist System, the sealer can be placed directly, to the bottom of the roct and is-filled from the borcom up, eliminating air entrapment. Using Spalvist with the Endo-Ene 31 gauge tip or capillary tip eliminates the need for gutta percha points.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODB)
Susan Lunorr
(Division Sign-Off) (Division of Dental, Infectio and General Hospita 510(k) Number
Prescription Use (Por 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
Image /page/2/Picture/13 description: The image shows a black circle with several white spots scattered throughout. The spots vary in size and shape, with some appearing as small dots and others as slightly larger, irregular shapes. The overall impression is that of a dark, textured surface with scattered light reflecting off of it.
ರ