(15 days)
RC-PREP - Prc-1976 Device
Not Found
No
The device description and performance studies focus on the chemical properties and effectiveness of a dentin chelating agent, with no mention of AI or ML technologies.
Yes
No
Explanation: The device description and intended use indicate that File-Eze is a dentin chelating agent used to aid in the instrumentation and debridement of root canals during a procedure. It is a treatment agent, not a device used to provide a diagnosis. Performance studies also evaluate its effectiveness in removing the dentin smear layer and its biocompatibility, not its diagnostic accuracy.
No
The device description clearly states that File-Eze is a chemical solution (19% EDTA dentin chelating agent) and not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in instrumentation and debridement of root canals." This is a therapeutic and procedural use within the body (in vivo), not a diagnostic test performed on samples outside the body (in vitro).
- Device Description: File-Eze is a chemical agent used directly within the root canal. IVDs are typically reagents, kits, or instruments used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Anatomical Site: The anatomical site is "root canals," which are part of the human body. IVDs are used to analyze samples taken from the body.
- Performance Studies: The performance studies described focus on the effectiveness of smear layer removal and biocompatibility, which are relevant to a device used in a medical procedure, not a diagnostic test.
In summary, File-Eze is a dental device used during a root canal procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Use File-Eze to aid in instrumentation and debridement of root canals.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
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)
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.
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.
RC-PREP - Prc-1976 Device
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
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.
2
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
3
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)