(104 days)
Not Found
No
The device is a chemical solution for cleaning and disinfecting root canals, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "dual-action device that cleanses and disinfects the root canal system" and "removes the smear layer and killing bacteria after endodontic instrumentation," which are therapeutic functions.
No
The device is an irrigating solution used to cleanse and disinfect the root canal system, not to diagnose a medical condition.
No
The device description clearly states it is a "premixed dual-action device" which is a chemical solution, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to cleanse and disinfect the root canal system after endodontic instrumentation. This is a direct treatment/procedure application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the direct application within the root canal system for cleaning and disinfecting.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing information for diagnosis.
- Performance Studies: The studies mentioned are non-clinical in vitro and ex vivo studies demonstrating efficacy and biocompatibility, which are typical for devices used in procedures, not diagnostic tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used within the body for a therapeutic/procedural purpose.
N/A
Intended Use / Indications for Use
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation.
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)
Non-Clinical Performance Data.
The efficacy and biocompatibility of QMix™ 2in1 Endodontic Irrigating Solution was demonstrated via non-clinical in vitro and ex vivo studies.
Clinical Performance Data.
No clinical studies were conducted on this device.
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.
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
FEB 1 4 2011
Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letters are tightly spaced, and the overall appearance is clean and modern. The image is likely a logo or branding element for a company named DENTSPLY.
SECTION 5. 510(k) SUMMARY
for
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street ork. PA 17405-0872 717) 845-7511 (voice) 717) 849-4343 (fax) ww.dentsply.com
QMix™ 2in1 Endodontic Irrigating Solution
-
- Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
01 February 2011 Date Prepared:
-
- Device Name:
- Proprietary Name: .
QMix™ 2in1 Endodontic Irrigating Solution
- Cleanser, Root Canal
- CFR Number: .
Classification Name:
N/A Unclassified
- Device Class: . Product Code: KJJ .
-
- Predicate Device: BioPure MTAD Root Canal Cleanser, DENTSPLY International, K053167
- Description of Device: 4.
.
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation.
- റ് Indications for Use: QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.
- Description of Safety and Substantial Equivalence: Q. Technological Characteristics.
All of the components found in QMix™ 2in1 Endodontic Irrigating Solution have been used in legally marketed devices and were found safe for dental use. We believe that prior use of components in legally marketed devices, the performance and biocompatibility data provided support the safety and effectiveness of QMix™ 2in1 Endodontic Irrigating Solution for the indicated uses.
1
Non-Clinical Performance Data.
The efficacy and biocompatibility of QMix™ 2in1 Endodontic Irrigating Solution was demonstrated via non-clinical in vitro and ex vivo studies.
Clinical Performance Data.
No clinical studies were conducted on this device.
Conclusion as to Substantial Equivalence
QMix™ 2in1 Endodontic Irrigating Solution, to be manufactured by DENTSPL Y International, is substantially equivalent to the currently cleared and marketed BioPure MTAD root canal cleanser.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. To the right of the circle is a stylized symbol that resembles three abstract human figures or waves, stacked vertically.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405
FFB 1 4 201
Re: K103244
Trade/Device Name: QMix" 2in1 Endodontic Irrigating Solution Regulatory Class: Unclassified Product Code: KJJ Dated: February 1, 2011 Received: February 2, 2011
Dear Ms. Lewis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Ms. Lewis
Enclosure
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
N for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K103244
Device Name: QMix™ 2in1 Endodontic Irrigating Solution
Indications for Use:
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Buenger
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102241