(24 days)
Not Found
No
The summary describes a chemical cleanser and does not mention any computational or data-driven components.
No.
The primary function of this device is to clean and disinfect the root canal, which is a preparatory step for treatment rather than a direct therapeutic intervention. Its intent is to aid in the chemical cleaning of the canal and remove bacteria, which falls under the category of a dental accessory or disinfectant.
No
Explanation: The device is a root canal cleanser used for chemical cleaning and disinfection, not for diagnosing a condition or disease.
No
The device description clearly states it is a "two-part liquid and powder product," indicating it is a chemical substance, 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 to "chemically clean the canal and disinfect the root canal system after endodontic instrumentation." This describes a treatment or procedure performed directly on the patient's body (specifically, within the root canal).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description of the product as a "two-part liquid and powder product" that "cleanses the root canal, removes the smear layer, and kills the bacteria in an instrumented root canal" further reinforces its use within the body during a dental procedure.
Therefore, BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a medical device used in a clinical setting for treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.
Product codes
KJJ
Device Description
BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a two-part liquid and powder product. Part A is the liquid and Part B is the powder. The mixed solution cleanses the root canal, removes the smear layer, and kills the bacteria in an instrumented root canal without harming the tooth structure or soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal system
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DEC 8 2005
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | December 5, 2005 |
| TRADE OR PROPRIETARY NAME: | BIOPURE™ MTAD™ ROOT CANAL CLEANSER |
| CLASSIFICATION NAME: | Root canal cleanser, Unclassified |
| PREDICATE DEVICES: | EndoPure™ Root Canal Cleanser, K032361 |
DEVICE DESCRIPTION:
BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a two-part liquid and powder product. Part A is the liquid and Part B is the powder. The mixed solution cleanses the root canal, removes the smear layer, and kills the bacteria in an instrumented root canal without harming the tooth structure or soft tissue.
INTENDED USE:
BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in BIOPURE™ MTAD™ ROOT CANAL CLEANSER have been used in legally marketed devices or were found safe for dental use. We believe that the prior use of components in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of BIOPURE™ MTAD™ ROOT CANAL CLEANSER for the indicated uses.
BIOPURE™ MTAD™ ROOT CANAL CLEANSER Premarket Notification
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 8 2005
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K053167
K055107
Trade/Device Name: BioPure™ MTAD™ Root Canal Cleanser Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: November 09, 2005 Received: November 14, 2005
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass bated in 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 nure occh footable in a mot 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 connells provized on the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be may or store 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. Helen Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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 premated 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Juliette Y. Mcclain-Owens
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
14053167
510(K) Number (if known):
BIOPURE™ MTAD™ ROOT CANAL CLEANSER Device Name:
Indications for Use:
BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.
Prescription Use _ X ___ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDEDI
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ake Russe
sion of Anesthesinlo General Hospital. Solion Control, Dental Device
Number. K53167
יין א