(127 days)
Not Found
Not Found
No
The summary describes a root canal obturation material and does not mention any AI or ML capabilities.
Yes
EndoREZ is used for permanent obturation of root canals, which is a medical treatment.
No
The device, EndoREZ, is described as a material for permanent obturation (filling) of root canals, which is a therapeutic rather than a diagnostic function.
No
The description clearly states the device is a material (EndoREZ) used for obturation, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent obturation of root canals of the secondary dentition." This describes a procedure performed on the patient's body (specifically, within their teeth), not a test performed on a sample taken from the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is a material used in a dental procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
EndoREZ is used for permanent obturation of root canals of the secondary dentition with or without obturation points. It is easily delivered to the canal with a small Endo-Eze tip. When mixed and delivered, it eliminates or minimizes air entrapment.
Product codes
KIF
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
Root canals of the secondary dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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 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 resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1999
Mr. Scott E. Moore Regulatory Affairs Manager Ultradent Products, Inc. 505 West 10200 South South Jordan, Utah 84095
K992097 Re : Trade Name: EndoRez Root Canal Sealer Regulatory Class: II Product Code: KIF September 21, 1999 Dated: Received: September 28, 1999
Dear Mr. Moore:
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. ਸ 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 requlation may result in requlatory 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 - Ms. Moore
obligation you might have under sections 531 through 542 of obligation you magne mark 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 described in your Slovky picmazio of your device to a legally
finding of substantial equivalence of alsacification for your Finding of Subscancial equirastission a classification for your marketed predicate device bur 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 regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreance at (50) devertising 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 CRR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obcarned from one (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
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Page_1_of_1
510(k) Number (if known):
EndoREZ UDMA Root Canal Sealer Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
EndoREZ is used for permanent obturation of root canals of the secondary dentition with or without EndoREZ is used for permation of toot canals with a small Endo-Eze tip. When mixed and the and of obturation points. It is easily delivered to the unal ment, eliminating or minimizing air entrapment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices, 510(k) Number .