DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE

K103157 · Angstrom Mfg., Inc. · EGS · Jan 24, 2011 · Dental

Device Facts

• Record ID: K103157
• Device Name: DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
• Applicant: Angstrom Mfg., Inc.
• Product Code: EGS · Dental
• Decision Date: Jan 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

This Device is to be used by a Dentist or A Dental Hygienist for cleaning procedures on teeth.

Device Story

Disposable Prophy Angle is a dental instrument used by dentists or dental hygienists for cleaning teeth. It is a manual or powered accessory attached to a dental handpiece. The device facilitates the application of polishing agents to tooth surfaces. It is intended for professional use in a clinical dental setting.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable dental prophy angle; mechanical accessory for dental handpieces; intended for single-use; non-sterile or sterile (as indicated by labeling); materials consistent with standard dental instrument manufacturing.

Indications for Use

Indicated for use by dentists or dental hygienists for tooth cleaning procedures.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Chris J. Carron President Angstrom Manufacturing, Incorporated 6539 U.S. Highway 61 Bloomsdale, Missouri 63627

JAN 2 4 2011

Re: K103157

Trade/Device Name: Disposable Prophy Angle Project's 020,021 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: September 30, 2010 Received: October 26, 2010

Dear Mr. Carron:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Carron

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR: Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh foc

Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/2/Picture/0 description: The image shows the logo for Angstrom Manufacturing, Inc. The logo features a stylized "A" with a circle above it, enclosed in a square. To the right of the square is the word "NGSTROM" in large, bold letters. Below "NGSTROM" is the text "MANUFACTURING, INC." in a smaller font.

## 4 Indications for Use Statement

020-10-1004_ Indications for Use - Disposable Prophy Angle.docx Page 1 of 1

September 30, 2010

## Indication for Use - Disposable Prophy Angle Project's 020,021

4103157 510(k) Number:

Device Name: Disposable Prophy Angle

Indication:

This Device is to be used by a Dentist or A Dental Hygienist for cleaning procedures on teeth.

Prescription Use: Used by dental Professional Only Over the Counter Use: No

Soren Russer

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

510(k) Number: K103157

Angstrom Manufacturing, Inc. ■ 6539 US Hwy 61 ▪ Bloomsdale MO 63627 Ph: 573-483-3773 ■ Fax: [phone] ■ E-Mail: [e-mail]