QUANTEC-E IRRIGATION SYSTEM 2

K992195 · Sybron Dental Specialties, Inc. · EIA · Oct 8, 1999 · Dental

Device Facts

• Record ID: K992195
• Device Name: QUANTEC-E IRRIGATION SYSTEM 2
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EIA · Dental
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Quantec-E Irrigation System 2 is an AC-powered, self-contained fluid delivery unit; consists of pump console, irrigation reservoirs, and tubing. Designed to attach to Quantec-E Endo System via rear accessory port. Operates via positive displacement peristaltic pump to prevent fluid retraction and potential patient cross-contamination. Controlled by simple power switch (on/off). Used in dental clinical settings by dental professionals. Provides irrigation to dental handpieces during endodontic procedures. Autoclavable irrigation tip assemblies included. Benefits include controlled fluid delivery and reduced risk of cross-contamination during endodontic treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered fluid delivery unit; positive displacement peristaltic pump design; includes pump console, reservoirs, and tubing. Irrigation tip assemblies are autoclavable. Standalone device designed for integration with Quantec-E Endo System.

Indications for Use

Indicated for use in dentistry to provide irrigation during procedures utilizing the Quantec-E Endo System dental handpieces.

Regulatory Classification

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.

Predicate Devices

• Quantec-E Irrigation System (Analytic Endodontics)

Submission Summary (Full Text)

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8 1999

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# 192195

## Section III - 510(k) Summary of Safety and Effectiveness

### Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - 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.

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#### 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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.. t'agc ⊥ of ⊥

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------------|
| 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)