(81 days)
RC-PREP Pre-1976 Device
Not Found
No
The summary describes a chemical and mechanical cleansing agent for root canals, with no mention of AI or ML capabilities.
No
The device is described as assisting in the chemical and mechanical cleansing of the root canal during endodontic therapy, facilitating the removal of pulp tissue and debris. While it is used in a medical procedure, its primary function is material removal and cleansing rather than directly treating, curing, mitigating, or preventing disease, which is the definition of a therapeutic device. It acts as an aid in a therapeutic procedure.
No
Explanation: The device is described as being used for the "chemical and mechanical cleansing of the root canal preparation" and for facilitating "removal of vital pulp tissue and necrotic pulp tissue." This indicates a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly describes a chemical and mechanical cleansing agent (Oxy Glide™) used in endodontic therapy, which is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is used for the "chemical and mechanical cleansing of the root canal preparation during endodontic therapy." It is a tool used within the body (specifically, the root canal) to facilitate the removal of tissue and debris.
- No Sample Analysis: The device does not analyze a sample taken from the body to provide diagnostic information. Its function is purely mechanical and chemical cleansing within the root canal.
Therefore, based on the provided information, this device falls under the category of a dental device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Oxy Glide™ is used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.
Product codes
KJJ
Device Description
Oxy Glide™ 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 urea peroxide. This action allows for the pulp tissue, dentinal shavings, and debris to float out.
The physical properties of Oxy Glide™ and the predicate device are similar, i. e., viscosity, appearance, color, and odor.
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
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)
Not Found
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 Pre-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
Not Found
N/A
0
NOV 1 9 1999
510(k) Summary
Super Glide. Incorporated
Name & Address:
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Super Glide. Inc. 225 Colchester Avenue Burlinaton. VT 05401 PH: 1-800-655-1777 Fax: 1-802-864-0201 FDA Reg. No. 1223133
CONTACT: Victor L. Ratkus, D.D.S.
DATE PREPARED: August 30, 1999
TRADE OR PROPRIETARY NAME: Oxy Glide™
CLASSIFICATION NAME: Root Canal Cleanser / Lubricant
PREDICATE DEVICE: RC-PREP Pre-1976 Device
DEVICE DESCRIPTION: Oxy Glide™ 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 urea peroxide. This action allows for the pulp tissue, dentinal shavings, and debris to float out.
The physical properties of Oxy Glide™ and the predicate device are similar, i. e., viscosity, appearance, color, and odor.
The intended use of Oxy Glide™ and the predicate device are the same, i.e., the cleansing and preparation of the root canal.
INTENDED USE: Oxy Glide™ is used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.
TECHNOLOGICAL CHARACTERISTICS: The active ingredient in Oxy Glide™ and other components have been used in predicate medical devices and/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 same active ingredient, 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 Oxy Glide™ does not require additional biocompatibility testing and that Oxy Glide™ is safe for the intended uses.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, which are connected to three curved shapes resembling hands or supporting elements.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 9 1999
Victor L. Ratkus, D.D.S. President Super Glide, Inc. 227 Colchester Avenue Burlington, Vermont 05401
K992919 Re :
Oxy Glide™ Root Canal Cleanser and Trade Name: Lubricant Unclassified Regulatory Class: Product Code: KJJ August 30, 1999 Dated: Received: August 30, 1999
Dear Dr. Ratkus:
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 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 (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. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any
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Page 2 - Dr. Ratkus
obligation you might have under sections 531 through 542 of the Act for devices under 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 finding 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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 R. Wutkowski
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: _______________________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ___V
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Remme
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .