PRINCESS SYRINGE

K980577 · Sodexco · EIA · May 8, 1998 · Dental

Device Facts

• Record ID: K980577
• Device Name: PRINCESS SYRINGE
• Applicant: Sodexco
• Product Code: EIA · Dental
• Decision Date: May 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Princess Syringe is an air and water spray syringe assembled as a dental handpiece. It is intended to deliver air and water spray to a cavity during dental procedures.

Device Story

Princess Syringe is a dental handpiece designed to deliver air and water spray to oral cavities during dental procedures. Operated by dental professionals in a clinical setting, the device functions as a standard air/water syringe. It provides irrigation and drying capabilities to assist in dental treatments. The device is a mechanical instrument; it does not involve electronic processing, software, or automated analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical dental handpiece for air and water delivery. No electronic components, software, or energy sources described.

Indications for Use

Indicated for use as an air and water spray syringe in dental procedures to deliver air and water to a cavity.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1008 MAY

SODEXCO ·C/O Mr. Gaylen Cox President MEDICAL INNOVATIONS, Incorporated 1450 West 8040 South Sandy, Utah 84088

Re : K980577 Princess Syringe Trade Name: Requlatory Class: I Product Code: EIA Dated: February 12, 1998 February 17, 1998 Received:

Dear Mr. Cox:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Cox

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

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

Enclosure

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PAX 001-568-9239

## 510(k) for Princess Syringe

## Statement of Use

The Princess Syringe is an air and water spray syringe assembled as a dental
, and the same of the same in to ded use. It is intended to deliver The Princess Syringe is an all any watch spies of this intended to deliver
handpiece. This device has only one as of the orgal causiv during dental handpiece. I his device has only one michael as a more as a cavity during dental procedures.

SHARON RIVERA
(Division Sign-Off)

(Division of Dental, Infection Control.
and General Hospital, Infection Control, and General Hospital, Infection and General Hospital Concession of 510(k) Number_ K 9)