BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE

K993255 · Coltene/Whaledent, Inc. · FRG · Dec 6, 1999 · General Hospital

Device Facts

• Record ID: K993255
• Device Name: BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
• Applicant: Coltene/Whaledent, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Indications for Use

The BioSonic UC-70 Sterilizable Instrument Cassette (The Cassette) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments in a 132°C gravity cycle for 12 minutes.

Device Story

BioSonic UC-70 Sterilizable Instrument Cassette is a container designed to hold dental/medical instruments during ultrasonic cleaning and subsequent steam sterilization (autoclaving). Used in dental or medical clinical settings; operated by dental/medical staff. The cassette facilitates the processing of contaminated instruments through a 132°C gravity steam cycle for 12 minutes. By securing instruments within the cassette, the device streamlines the cleaning and sterilization workflow, ensuring instruments are processed safely and efficiently, thereby reducing the risk of cross-contamination and protecting both patients and healthcare providers.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterilizable instrument cassette designed for ultrasonic cleaning and steam sterilization (autoclaving). Compatible with 132°C gravity steam cycles. Materials and construction are intended to withstand repeated ultrasonic and thermal processing.

Indications for Use

Indicated for the ultrasonic cleaning and steam sterilization of contaminated dental and medical instruments.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

Mr. H. J. Vogelstein Official Correspondent Coltene/Whaledent®, Inc. 750 Corporate Drive Mahwah, New Jersey 07430

K993255 Re : Trade Name: BioSonic UC-70 Sterilizable Instrument Cassette II Requlatory Class: Product Code: FRG Dated: September 24, 1999 Received: September 28, 1999

Dear Mr. Vogelstein:

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 be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Vogelstein

obligation you might have under sections 531 through 542 of obligation you might have ander bestronic Product Radiation the Act for devices and ther Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis recei will arrow your our on one fication. The FDA described in your six in puivalence of your device to a legally Finding of Subbeancial Squaresults in a classification for your marketed predicate device your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regulacion (ir devices), please contact the Office of VILID draghobere at [phone]. Additionally, for questions on compriance as (od advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercrow, MacFR 807.97). Other general information on your responsibilities under the Act may be information on your iddings of Small Manufacturers Assistance obcarned from che bivir [phone] or [phone] or at at its coll free namber (o:t)/www.fda.gov/cdrh/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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/27/1999 16:37 12015292118 10/27/89 2301 480 3002 14:01

510(k) Number (if known):

## K993255

BioSonic UC-70 Sterilizable Device Name: Instrument Cassette

Indications For Use:

The BioSonic UC-70 Sterilizable Instrument Cassette (The Cassette) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments in a 132°C gravity cycle for 12 minutes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)

Olin S. Lim

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