PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE

K983731 · Pall Medical · EIA · Dec 21, 1998 · Dental

Device Facts

• Record ID: K983731
• Device Name: PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
• Applicant: Pall Medical
• Product Code: EIA · Dental
• Decision Date: Dec 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retro: it existing dental waterlines.

Device Story

System reduces bacterial contaminants, endotoxins, and particulates in dental unit waterlines; consists of reusable filter housings and disposable filter elements. Designed as point-of-use retrofit for existing dental waterlines. Operates via physical filtration of water flowing through dental unit lines. Used in dental clinical settings; installed by dental staff. Benefits patient by providing cleaner water during dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Point-of-use filtration system; consists of reusable filter housings and disposable filter elements. Mechanical filtration principle. No electronic components, software, or energy source.

Indications for Use

Indicated for the reduction of bacteriological contaminants, endotoxins, and waterborne particulate matter in dental unit waterlines. Intended for use as a point-of-use filtration system retrofitted to existing dental waterlines.

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.

Submission Summary (Full Text)

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DEC 2 1 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert A. Dickstein, Ph.D. Senior Vice President Global Regulatory Affairs and Quality Assurance PALL Medical 2200 Northern Boulevard East Hills, New York 11548-1289

Re : K983731 Pall Dental Filtration System with Inline Trade Name: Handpiece Housing and Filter Membrane Requlatory Class: I LZA Product Code: Dated: October 21, 1998 Received: October 22, 1998

Dear Dr. Dickstein:

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 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). 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 reqistration, 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 Title 21, Parts 800 to 895. Federal Requlations, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Dickstein

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours.

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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510(k) Number (if known): 983731

Device Name: Pall Medical's Dental Unit Waterline Filtration System with

Inline Handpiece Housing and Filtration Membrane

Indications For Use:

Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retro: it existing dental waterlines.

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Concurrence of (DRH, Office of Device Evaluation (ODE)

510(k) Number .

Prescription Use *_/ Or Over-The Counter-Use _*
(Per 21 CFR 80...109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983731