A-DEC SELF-CONTAINED WATER SYSTEM

K051657 · A-Dec, Inc. · EIA · Aug 30, 2005 · Dental

Device Facts

• Record ID: K051657
• Device Name: A-DEC SELF-CONTAINED WATER SYSTEM
• Applicant: A-Dec, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The A-dec Self-Contained Water System with Antimicrobial AlphaSan is intended for use in general dental applications by providing water to the dental syringe, various handpiece ancillary devices, and cuspidor cup-fill. When used according to manufacturer instructions, and in conjunction with the cleaner tablet, the Antimicrobial AlphaSan contained in the system is intended to reduce microbial contamination.

Device Story

A-dec Self-Contained Water System provides water to dental operatory equipment including syringes, handpieces, and cuspidor cup-fillers. System incorporates Antimicrobial AlphaSan and cleaner tablets to mitigate microbial contamination in dental unit waterlines. Used in dental clinics by dental professionals. Device functions as a fluid delivery system for dental procedures; output is treated water delivered to instruments. Benefits include reduced microbial load in dental water systems, supporting infection control protocols.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Self-contained water delivery system for dental units. Incorporates Antimicrobial AlphaSan and cleaner tablets for microbial control. Mechanical fluid delivery system. No electronic or software components described.

Indications for Use

Indicated for use in general dental applications to provide water to dental syringes, handpieces, and cuspidor cup-fillers, while utilizing Antimicrobial AlphaSan and cleaner tablets to reduce microbial contamination in the water supply.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

AUG 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom Louisell A-DEC, Incorporated 2601 Crestview Dr. Newberg, Oregon 97132-9257

Re: K051657

Trade/Device Name: A-DEC Self-Contained Water System Regulation Number: 21 CFR 872.6640 Regulation Name: Dental operative unit and accessories Regulatory Class: I Product Code: EIA Dated: June 16, 2005 Received: June 21, 2005

Dear Mr. Louisell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premainer is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manation possible in the Medical Device American be of Days. commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been reculted in assessment of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen o the general controls provisions of the Act. The You may, merceible, market the devreet, seejever to use annual registration, listing of general controls provisions of the rist 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 If your device is classified (see above) this existing major regulations affecting your device can may be subject to such additional controller 2. Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Registering your device in the Federal Register.

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Page 2 - Mr. Louisell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issumos on a succession of the requirements of the Act that FDA has made a decemination and Jointer Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act stequirements, mercesses, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors of 2 vice as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. The PDA miding of bactification 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 If you desire specific advice for your ac now its . Also, please note the regulation entitled, Contact the Office of Complance at (21 t m rt 807.97). You may obtain " Wilsbranding by reference to promance rollities under the Act from the Division of Small other general information on your responses Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sybilte H. Michie Oms.

Chiu Lin, Ph.D. 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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Page 1 of 1

510(k) Number (if known): K051657

Device Name: A-dec Self-Contained Water System

Indications for Use:

The A-dec Self-Contained Water System with Antimicrobial AlphaSan" is The A-dec Sell-Contained Vrator Cycling by providing water to the intended for use in general dental appillarly devices, and cuspidor cup-fill.
dental syringe, various handpiece ancillary devices, and cuspituredion dental synnge, vanous handpido unors instructions, and in conjunction When used according to manufacturer of the Antimicrobial AlphaSan " contained in the with the cleaner tablet ЮХ - , the Antimisterial microbial contamination.

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

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Prescription Use (Per 21 CFR 801.109) OROver-The-Counter Use (Optional Format 1-2-96)

Susan Puorro

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

510(k) Number: __