(149 days)
Not Found
Not Found
No
The summary describes chemical and material-based products for root canal procedures and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is described as a "System for cleansing, sealing and filling of root canals," which are procedures aimed at treating diseased or damaged root canals, clearly indicating a therapeutic purpose to restore health or prevent further deterioration.
No
The device is described as a system for cleansing, sealing, and filling root canals, which are therapeutic and restorative functions, not diagnostic ones.
No
The device description clearly outlines three physical products: a gel in syringes, a sealer, and a flowable filling material. These are all tangible substances and delivery mechanisms, 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 "cleansing, sealing and filling of root canals" during dental procedures. This is a therapeutic and procedural use within the body (in vivo), not for examining specimens taken from the body (in vitro) to provide diagnostic information.
- Device Description: The description details materials and forms used for direct application within the root canal.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical components or processes associated with IVD devices (reagents, calibrators, controls, analytical methods, etc.).
The device is clearly intended for use by a dentist for treating a patient's root canal, which falls under the category of a medical device used for treatment or procedural purposes, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation. DC Canal Seal SE is a simple to use self-etching dual cure sealer for conditioning of root canals and for sealing of side tubuli. DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.
Product codes
KIF
Device Description
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation. DC Canal Seal SE is a simple to use self-etching dual cure sealer for conditioning of root canals and for sealing of side tubuli. DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo 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 logo is simple and recognizable.
MAR 1 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Christian Boettcher Regulatory Compliance Officer S & C Polymer Silicon- und Composite Spezialitaten GmbH Robert-Bosch- Strasse 5 D-25335 Elmshorn GERMANY
Re: K083062
Trade/Device Name: Root Canal XR Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 23, 2009 Received: February 25, 2009
Dear Dr. Boettcher:
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.
1
Page 2 - Dr. Boettcher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Ranoc
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
9. Statement of Indication for Use
510(k) Number (if known):
Device Name:
Root Canal XR
Indications for Use: root
Concerned products:
DC Canal Seal SE:
DC Root XR:
Canal Cleaner:
System for cleansing, sealing and filling of canals consisting of 3 products:
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation.
DC Canal Seal SE is a simple to use selfetching dual cure sealer for conditioning of root canals and for sealing of side tubuli.
DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.
All directions and all labels are marked with
Caution: Federal Law restricts this device to sale by or on the order of a dentist - For dental use only
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pinover
KOS 3060
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Over-The-Counter Use
Prescription Use: _ V
or