(70 days)
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's instructions, and in conjunction with the cleaner tablet ICX", the Antimicrobial AlphaSan" contained in the bottle helps to reduce microbial contamination.
A-dec Self-Contained Water System
The provided text from the FDA 510(k) summary for the A-DEC Self-Contained Water System does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The document is a clearance letter from the FDA, stating that the device is substantially equivalent to a legally marketed predicate device. It defines the indications for use of the A-DEC Self-Contained Water System but does not include any performance data, clinical study results, or the methodology for any such studies.
Therefore, I cannot provide the requested information based on the given input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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 (800) 638-2041 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: __
§ 872.6640 Dental operative unit and accessories.
(a)
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.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.