DENTAL STERLIZATION TRAY/CASSETTE

K983223 · Brasseler USA I, L.P. · FRG · Jan 14, 1999 · General Hospital

Device Facts

• Record ID: K983223
• Device Name: DENTAL STERLIZATION TRAY/CASSETTE
• Applicant: Brasseler USA I, L.P.
• Product Code: FRG · General Hospital
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Indications for Use

This is intended to enclose dental instruments that are to be sterilized by health care professionals.

Device Story

Device is a surgical/dental sterilization tray/cassette. Used in clinical settings by dental professionals to hold instruments during sterilization cycles. Protects instruments during transport and processing. Facilitates organization and sterilization of dental tools.

Clinical Evidence

bench testing only

Technological Characteristics

Sterilization tray/cassette for dental instruments. Product code FRG. Class II device.

Indications for Use

Indicated for use by health care professionals to enclose dental instruments during the sterilization process.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

Brassler USA® C/O Ms. Courtney S. Paradice 1679 Kellog Springs Drive Atlanta, Georgia 30338

Re : K983223 Dental Sterilization Tray/Cassette Trade Name: Regulatory Class: II Product Code: FRG October 30, 1998 Dated: Received: November 9, 1998

Dear Ms. Paradice:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beccron six ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . market the device reflicancy (for the indications for device is subscanciary ore) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment date or the nassified in accordance with the devices that have been roofood, Drug, and Cosmetic the esperal provisions of the reactar rood, asubject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the Act increase requeed 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 be subject to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ rederal Regulation, and determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 - Ms. Paradice

through 542 of the Act for devices under the Electronic Chrough J42 Of the not is provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Inis recei wire arrowk) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device assubsite 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compreation 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 obtained from cho rumber [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Ulatowski I'ima A. 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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Page of

510(k) Number (if known): K983223:

Device Name: Surgical / dental sterilization tray

Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Office of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Neuse 1. Melle fer Rius.

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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K983223