SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

K023232 · Smartpractice · EFS · Dec 11, 2002 · Dental

Device Facts

• Record ID: K023232
• Device Name: SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
• Applicant: Smartpractice
• Product Code: EFS · Dental
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6510
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.

Device Story

SplatrFree Swangle 360 is a disposable prophy angle used by dental professionals during prophylaxis treatments. Device attaches to standard dental handpieces to facilitate polishing of tooth surfaces. Single-use design minimizes cross-contamination risks. Operates via mechanical rotation provided by the dental handpiece. Output is the physical polishing action on patient teeth. Benefits include improved hygiene and efficiency in clinical dental settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable dental prophy angle; mechanical rotation; compatible with standard dental handpieces; single-use plastic construction.

Indications for Use

Indicated for use during dental prophylaxis treatment to polish tooth surfaces in patients.

Regulatory Classification

Identification

An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 1

Ms. Kim Sullivan VP of Regulatory and Research Smart Practice 3400 East McDowell Road Phoenix, Arizona 85008-7899

Re: K023232

Trade/Device Name: SplatrFree Swangle 360 Disposable Prophy Angle Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFS Dated: September 23, 2002 Received: September 27, 2002

Dear Ms. Sullivan:

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.

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Page 2 - Ms. sullivan

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). 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.

Petru Carinte for

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Statement of Indications for Use

The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient. .

Susan Rinn

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

510(k) Number. K023232