SONIC AIR MM1500 + (MID), MODEL 50400014

K081268 · Micro-Mega Societe Anonyme · ELC · Aug 10, 2009 · Dental

Device Facts

• Record ID: K081268
• Device Name: SONIC AIR MM1500 + (MID), MODEL 50400014
• Applicant: Micro-Mega Societe Anonyme
• Product Code: ELC · Dental
• Decision Date: Aug 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endodontics canal preparation - canal cleaning

Device Story

The Sonic Air MM 1500+ (MID) is an ultrasonic scaler used in endodontic procedures. It functions by delivering ultrasonic energy to specialized tips to facilitate the cleaning and preparation of root canals. The device is operated by dental professionals in a clinical setting. By providing mechanical action within the canal, it assists in the removal of debris and the shaping of the canal space, supporting effective endodontic treatment and patient oral health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic scaler; operates via ultrasonic energy transmission to dental tips; intended for endodontic applications; classified under 21 CFR 872.4850 (Product Code ELC).

Indications for Use

Indicated for endodontic canal preparation and cleaning in patients requiring root canal therapy.

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/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of a stylized eagle with its wings spread.

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

Ms. Isabelle Bourg Ouality Director and Regulatory Affairs Manager MICRO-MEGA S.A. 5-12 Rue Du Tunnel-BP 1353 25006 Besancon Cedex FRANCE

AUG 1 0 2009

Re: K081268

Trade/Device Name: Sonic Air MM 1500+ (MID) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: July 29, 2009 Received: August 5, 2009

Dear Ms, Bourg:

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 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- Ms. Bourg

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/ucm115809.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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

## Indications for Use

## 510(k) Number (if known): K081268

Device Name: MICRO-MEGA S.A. Sonic Air MM 1500+ (MID)

Indications for use: Endodontics

canal preparation -

canal cleaning

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DON NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kevin Mulley for MSR

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

Page 1 of 1

510(k) Number: K081268