A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE

K032757 · A-Dec, Inc. · EIA · Dec 10, 2003 · Dental

Device Facts

• Record ID: K032757
• Device Name: A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
• Applicant: A-Dec, Inc.
• Product Code: EIA · Dental
• Decision Date: Dec 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The A-dec Self-Contained Water System is intended for use in providing water to the dental syringe, various handpiece devices, and cuspidor cup-fill. The system allows for flushing and waterline maintenance to help prevent contamination and maintain clean dental unit waterlines.

Device Story

A-dec Self-Contained Water System (0.7L and 2L bottles) provides water to dental unit components including syringes, handpieces, and cuspidor cup-fills. System replaces municipal water supply to dental units; allows for independent water source management. Used in dental clinics by dental professionals. Enables flushing and maintenance of dental unit waterlines to reduce microbial contamination. Benefits patient by providing controlled water quality for dental procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Self-contained water delivery system consisting of 0.7L or 2L bottles and associated plumbing/valving for integration into dental units. Mechanical fluid delivery system; no electronic or software components.

Indications for Use

Indicated for use in dental settings to provide water to dental syringes, handpieces, and cuspidor cup-fills, and to facilitate waterline flushing and maintenance to prevent contamination.

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2003

Mr. Tom Louisell Regulatory Affairs Scientist A-dec, Incorporated 2601 Crestview Drive Newburg, Oregon 97132

Re: K032757

Trade/Device Name: A-dec Self-Contained Water System, Model 0.7L Bottle and 2 L Bottle Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: September 03, 2003 Received: September 11, 2003

Dear Mr. Louisell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a preemarket approval application (PMA). 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 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 (PMA), it may be subject to such additional controls. Existing major regulations offecting your device can be found in the Code of Federal Regulations, Title 21, Parts 8015 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Tom Louisell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Charles

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):K032757

Device Name: _ A-dec Self-Contained Water System, Model 0.7 Liter Bottle & 2 Liter Bottle

Indications For Use: The A-dec Self-Contained Water System is intended for use in manations For of one the providing water to the dental syringe, various handpiece general devices, and cuspidor cup-fill. The system allows for flushing and waterline anointenance to help prevent contamination and maintain clean dental unit waterlines.

ﺐ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russe

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
K032757

510(k) Number