(15 days)
Use File-Eze to aid in instrumentation and debridement of root canals.
File-Eze is a 19% EDTA dentin chelating agent in an aqueous, water-soluble solution with a lubricating base. File-Eze is irrigated and rinsed from canal as with other root canal preparations; ChlorCid and ChlorCid V (more viscous) sodium hypochlorite solution works well for this. Also, a slight effervescent cleansing action occurs when ChiorCid contacts residual File-Eze which helps remove extraneous material from canal.
This is a pre-amendment device, therefore no clinical study was required to prove substantial equivalence. The device leverages a predicate device to prove safety and effectiveness.
Acceptance Criteria and Device Performance Table:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar effectiveness in removing dentin smear layer compared to predicate device | File-Eze found similar in effectiveness to RC Prep in removing dentin smear layer (SEM study). |
| Not cytotoxic | File-Eze found not cytotoxic (Agar Diffusion Method). |
| Same intended use as predicate device | "Use File-Eze to aid in instrumentation and debridement of root canals." - Same as predicate. |
| Similar physical properties to predicate device (viscosity, appearance, color, odor) | "The physical properties of File-Eze and the predicate device are similar, i.e. viscosity, appearance, color, and odor." |
| Same active ingredient as predicate device | "File-Eze and the predicate device have the same active ingredient..." |
Study Information:
-
Sample size for the test set and data provenance:
- Dentin Smear Layer Removal Study: Not specified.
- Biocompatibility (Cytotoxicity) Study: Not specified.
- Data Provenance: Not specified, but generally, such studies for regulatory submissions are conducted in a controlled lab setting, usually in the country of origin of the manufacturer (USA, in this case). Retrospective or prospective nature is not explicitly mentioned but typically these are prospective lab studies.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The studies mentioned (SEM and Agar Diffusion) are laboratory-based and do not typically involve human experts for "ground truth" in the way clinical studies do. The measurements would be objective laboratory readings.
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Adjudication method for the test set: Not applicable for these types of laboratory studies.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No, this was not mentioned. This type of study is more common for diagnostic imaging AI devices, not for dental materials like this product.
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Standalone (algorithm only without human-in-the-loop performance) study: Yes, implicitly. The two studies mentioned (SEM and Agar Diffusion) are standalone laboratory evaluations of the material's properties and performance, not involving human interpretation in a clinical context.
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Type of ground truth used:
- Dentin Smear Layer Removal Study: The "ground truth" would be the objective visual assessment of smear layer removal via Scanning Electron Microscopy (SEM) images, comparing the efficacy of File-Eze to the predicate device.
- Biocompatibility (Cytotoxicity) Study: The "ground truth" would be the observed cellular response (or lack thereof) to the material using the Agar Diffusion Method, likely assessed against established cytotoxicity standards or controls.
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Sample size for the training set: Not applicable. This device is a chemical dental material, not an AI/ML algorithm that requires a training set. The "training" for such a product involves formulation and testing iterations by the manufacturer.
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How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
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L 060335
FEB 2 4 2006
510K SUMMARY
SUBMITTED BY: ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UTAH 84095
CONTACT PERSON: Tammy Lavery RA Senior Manager Phone: 1-801-553-4323
DATE PREPARED: 12-05-05 TRADE NAME: File-Eze COMMON NAME: Root Canal Cleanser CLASSIFICATION: Unclassified PREDICATE DEVICE: RC-PREP - Prc-1976 Device
DEVICE DESCRIPTION: File-Eze is a 19% EDTA dentin chelating agent in an aqueous, water-soluble solution with a lubricating base. File-Eze is irrigated and rinsed from canal as with other root canal preparations; ChlorCid and ChlorCid V (more viscous) sodium hypochlorite solution works well for this. Also, a slight effervescent cleansing action occurs when ChiorCid contacts residual File-Eze which helps remove extraneous material from canal.
INTENDED USE: Use File-Eze to aid in instrumentation and debridement of root canals.
The intended use of File-Eze and the predicate device, RC-Prep are the same, i.e. the cleansing and preparation of the root canal.
The physical properties of File-Eze and the predicate device are similar, i.e. viscosity, appearance, color, and odor.
TECHNOLOGICAL CHARACTERISTICS: File-Eze and the predicate device have the same active ingredient and the same intended use,
We believe that File-Eze is similar to RC Prep and because of the long established safe and efficacious use of the predicate device in the same intended use, the same active ingredient, the short duration of contact within the oral cavity, and the thorough removal of the product from the canal space, that File-Eze is safe and effective for the intended use. Additionally, the results of the following two studies further demonstrate the safety and effectiveness of File Eze for its intended use:
A study was done utilizing SEM`s comparing the removal of the dentin smear layer in root canal systems, the results show that File-Eze is similar in effectiveness compared to RC Prep. A biocompatibility study was done to evaluate cytotoxicity of File-Eze using the Agar Diffusion Method. The results of this study show that File-Eze is not cytotoxic.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
FEB 2 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K060335
Trade/Device Name: File-Eze Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 05, 2005 Received: February 09, 2006
Dear Ms. Lavery:
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.
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Page 2 - Ms. Tammy Lavery
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issualice of a substition of the requirements of the Act or
that FDA has made a determination that your device complies . You must comply with that FDA has made a delectimation that your devices. You must comply with any Federal statures and regulations administered by outding (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Pa all the Act's requirements, including, but not immed in see forth in the quality
labeling (21 CFR Part 801); good manufacturer and security of the colunt rediction labeling (21 CFR Part 801), good manufacturing prosolicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic pro systems (QS) regulation (21-54-12-12-12-12-21-21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgii maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, pe prematket notification. The FDA Inding of substantial equice 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), please If you desire specific advice for your ac not the regulation of the regulation entitled, a contact the Office of Comphance at (210) 276 or over 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Riginian of Small "Misoranding of Terence to promation on the Act from the Division of Small
general information on your responsibilities under the Act from the 1990 for general information on your responsionnes and its toll-free number (800) 638-2041 or and index think Manufacturers, International and Colisal.http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chas S. Liem, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: File-Eze
Indications for use:
Use File-Eze to aid in instrumentation and debridement of root canals.
Prescription Use:_ X (Pcr 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use:_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N/A