(101 days)
Analytic Endodontics., Quantec-E Irrigation System
Not Found
No
The description focuses on a fluid delivery system with a peristaltic pump and lacks any mention of AI, ML, or related concepts.
No
The device provides irrigation during dental procedures, which is a supportive function rather than directly treating a disease or condition.
No
The device is described as a 'fluid delivery unit' used for 'irrigation' during dental procedures. Its function is to provide fluid, not to diagnose conditions or capture diagnostic information.
No
The device description explicitly states it is an AC-powered, self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs, and tubing, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation while using dental handpieces. This is a functional support system for a dental procedure, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a fluid delivery system for irrigation during dental procedures. It doesn't mention any analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological specimen. There is no mention of providing diagnostic information.
The device is clearly intended for use during a dental procedure to facilitate the procedure itself, not to diagnose or monitor a patient's condition based on in vitro analysis.
N/A
Intended Use / Indications for Use
The intended use of the Quantec-E Irrigation System 2 is to provide irrigation while using the dental handpieces attached to Quantec-E Endo System.
The Quantec-E Irrigation System 2 is an AC-powered, self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System.
Product codes
EIA
Device Description
The device is an AC-powered, self-contained, fluid delivery unit consisting of a pump console, two irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System. The unit attaches to the Quantec-E Endo System via the accessory port located on the rear panel of the unit. The unit has a positive displacement peristaltic design to prevent fluid retraction which could result in patient cross-contamination. To operate the Quantec-E Endo System 2 without irrigation, the Power Switch on the Quantec-E Irrigation System 2 console is turned to the "O" position. When irrigation is desired, the switch is turned to "I". The irrigation tip assemblies supplied with the Quantec-E Irrigation System 2 is autoclavable.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Analytic Endodontics., Quantec-E Irrigation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
8 1999
Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, sans-serif font at the top. Below that, "DENTAL SPECIALTIES, INC." is printed in a smaller, sans-serif font.
192195
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: June 1999
Device Name:
- Trade Name Quantec-E Irrigation System 2 ●
- Common Name Fluid Delivery Unit .
- Classification Name Dental Operative Unit and Accessories, per 21 CFR § . 872.6640
Devices for Which Substantial Equivalence is Claimed:
- Analytic Endodontics., Quantec-E Irrigation System .
Device Description:
The device is an AC-powered, self-contained, fluid delivery unit consisting of a pump console, two irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System. The unit attaches to the Quantec-E Endo System via the accessory port located on the rear panel of the unit. The unit has a positive displacement peristaltic design to prevent fluid retraction which could result in patient cross-contamination. To operate the Quantec-E Endo System 2 without irrigation, the Power Switch on the Quantec-E Irrigation System 2 console is turned to the "O" position. When irrigation is desired, the switch is turned to "I". The irrigation tip assemblies supplied with the Quantec-E Irrigation System 2 is autoclavable.
Intended Use of the Device:
The intended use of the Quantec-E Irrigation System 2 is to provide irrigation while using the dental handpieces attached to Quantec-E Endo System.
Image /page/0/Picture/18 description: The image shows a recycling symbol next to the words "Printed on Recycled Paper." The recycling symbol is a circular arrow made up of three arrows chasing each other. The text is in a small, simple font and is right-aligned to the recycling symbol. The image is likely used to indicate that the paper used for printing is made from recycled materials.
1
Substantial Equivalence:
The Quantec-E Irrigation System 2 is substantially equivalent to several other legally marketed devices in the United States. The modified version of the Quantec-E Irrigation System functions in a manner similar to and is intended for the same use as the original version of the Quantec-E Irrigation System designed by Analytic Endodontics.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0CT 8 1999
Ms. Colleen Boswell Manager, Regulatory Affairs Sybron Dental Specialties, Inc. Sybron Dental Special Ties, Inc. 1717 W. Collins Avenue 92867 Orange, California
K992195 Re : Trade Name: Quantec-E Irrigation ·System 2 Regulatory Class: I Product Code: EIA September 24, 1999 Dated: September 28, 1999 Received:
Dear Ms. Boswell:
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 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 Existing major be subject to such additional controls. 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
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Page 2 - Ms. Boswell
the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 requlation (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,
Season Runner
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
.. t'agc ⊥ of ⊥
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K992195 |
| Device Name: | Quantec-E Irrigation System 2 |
Indications For Usc:
The Quantec-E Irrigation System 2 is an AC-powered, self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruaser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number . GARY
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)