(14 days)
RC Prep Pre-1976 Device
Not Found
No
The description focuses on the chemical and mechanical properties of a gel used in root canal procedures and makes no mention of AI or ML.
Yes
The device is used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy, facilitating the removal of pulp tissue and debris, which are therapeutic actions to treat a condition (endodontic issues).
No
The device description indicates it is used for cleansing and removal of tissue and debris during endodontic therapy, which is a treatment function, not a diagnostic one.
No
The device description clearly describes a physical gel used in endodontic procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "chemical and mechanical cleansing of the root canal preparation during endodontic therapy." This is a procedure performed on the patient's tooth, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description details how the gel works within the root canal to remove tissue and debris. It doesn't mention analyzing any biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
The device is a therapeutic and procedural aid used directly in the treatment of a patient's tooth.
N/A
Intended Use / Indications for Use
RCT GEL™ is used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.
Product codes
EIC
Device Description
RCT GEL™ allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. It is designed to be used with endodontic irrigation with sodium hypochlorite solutions. Oxygen bubbling occurs through the release of oxygen from the carbamide peroxide. This action allows for pulp tissue, dentinal shavings and debris to float out.
The physical properties of RCT GEL™ and the predicate device are similar, i.e., pH values, viscosity, appearance, color, and odor,
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
RC Prep Pre-1976 Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
JUN 30 1997
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
| CONTACT: | P. Jeffery Lehn |
|---|---|
| DATE PREPARED: | June 12, 1997 |
| TRADE OR PROPRIETARY NAME: | RCT GEL™ |
| CLASSIFICATION NAME: | Dental Instrument 872.4565 |
| PREDICATE DEVICE: | RC Prep Pre-1976 Device |
DEVICE DESCRIPTION: RCT GEL™ allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. It is designed to be used with endodontic irrigation with sodium hypochlorite solutions. Oxygen bubbling occurs through the release of oxygen from the carbamide peroxide. This action allows for pulp tissue, dentinal shavings and debris to float out.
The physical properties of RCT GEL™ and the predicate device are similar, i.e., pH values, viscosity, appearance, color, and odor,
INTENDED USE: RCT GEL™ is used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.
TECHNOLOGICAL CHARACTERISTICS: All components in RCT GEL™ have been used in predicate medical devices or have been found safe for dental use.
We believe that, due to the long established safe and efficacious use of the predicate device in the same intended use, the identical concentrations of active ingredients, the short duration of contact within the oral cavity, and the decomposition and thorough removal of the product from the canal space, the use of RCT GEL™ does not require additional biocompatibility testing and that the GEL is safe and effective for the intended uses.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the left side of the image. To the right of the text is a stylized symbol that resembles an abstract human form or a caduceus, a symbol often associated with medicine and healthcare. The words "USA" are written at the top right of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 1997
Mr. P. Jeffery Lehn 'Director, Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
K972234 Re: RCT Gel™ Root Canal Therapy Gel Trade Name: Requlatory Class: I Product Code: EIC Dated: June 12, 1997 Received: June 16, 1997
Dear Mr. Lehn:
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, Druq, 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. ರ್ಗ 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Lehn
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
KO 72830
Device Name:
{
RCT GEL™ ROOT THERAPY GEL
Indications for Use:
Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.
oncurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ SHARGA
000007