DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER

K033044 · American Green Dent. Mfg, Inc. · ELC · Dec 21, 2004 · Dental

Device Facts

• Record ID: K033044
• Device Name: DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
• Applicant: American Green Dent. Mfg, Inc.
• Product Code: ELC · Dental
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.

Device Story

Dream Cleans "S" Scaler and Compact "S" Scaler are handheld ultrasonic dental instruments. Devices utilize ultrasonic vibration to remove supragingival and subgingival calculus, stains, and perform root planing. Operated by dental professionals in clinical settings. Output is mechanical vibration at the scaler tip for physical removal of dental deposits. Benefits include efficient cleaning and periodontal maintenance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Handheld ultrasonic dental scaler. Operates via ultrasonic energy for calculus removal. Class II device (21 CFR 872.4850).

Indications for Use

Indicated for removal of supragingival and subgingival calculus and stains from teeth, and for periodontal scaling and root planing in dental patients.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three abstract shapes resembling human figures or stylized waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2004

Mr. Andrew Rowe Ouality Assurance Manager American Green Dent. Manufacturing, Incorporated 3432 E 14th Street Los Angeles, California 90023

Re: K033044

Trade/Device Name: Dream Cleans "S" Scaler and Compact "S" Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 25, 2004 Received: October 28, 2004

Dear Mr. Rowe:

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 premarket 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 - Mr. Rowe

Please be advised that FDA's issuance of a substantial equivalence determination does not I teast that FDA has made a determination that your device complies with other requirements moun that I Dr mas muss statutes and regulations administered by other Federal agencies. or the Fret of any a with all the Act's requirements, including, but not limited to: registration r ou intelst compty wart 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 et read on 1) , systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in one of 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) rins leter witification. The FDA finding of substantial equivalence of your device to a premainer retirement --------------------------------------------------------------------------------------------------------------------------------------------------------your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), ' If you desire specific acroof 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 from the may obtain 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,

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

{2}------------------------------------------------

K033044

## Indications for Use

510(k) Number (if known): K033044

Device Name: Dream Cleans "S" Scaler and Dream Compact "S" Scaler

Indications For Use: The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Sunabunner

Civision Sian-Off) Jivision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K083044