R7

K130834 · Cefla S.C. · ELC · Oct 8, 2013 · Dental

Device Facts

• Record ID: K130834
• Device Name: R7
• Applicant: Cefla S.C.
• Product Code: ELC · Dental
• Decision Date: Oct 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2

Intended Use

The R7 Dental System and accessories are in general dental applications by providing the dental practitioner a user interface to control operation of the dental charted dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control common and normal patient treatment procedures, including use of an ultrasonic scaler, performed in the dental operatory.

Device Story

R7 Dental System serves as a centralized control interface for dental operatory equipment. Device manages delivery of air, water, vacuum, and electricity to connected dental instruments, including ultrasonic scalers. Operated by dental practitioners in clinical settings to facilitate routine patient treatment procedures. System provides intuitive control over integrated dental devices, streamlining workflow during standard dental care.

Clinical Evidence

No clinical data provided; device is a dental operatory control system.

Technological Characteristics

System acts as a utility distribution and control interface for dental operatory equipment. Delivers air, water, vacuum, and electrical power. Classified as an ultrasonic scaler accessory (21 CFR 872.4850).

Indications for Use

Indicated for use by dental practitioners in general dental applications to control dental devices and deliver air, water, vacuum, and electricity during normal patient treatment procedures, including ultrasonic scaling, in a dental operatory setting.

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)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

October 8, 2013

CEFLA s.c. C/O Mr. Claude Berthoin President Thema USA/Denterprise International. Incorporated 110 E. Granada Boulevard, Suite 209 ORMOND BEACH FL 32176

Re: K130834

Trade/Device Name: R7 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC, EIA Dated: September 3, 2013 Received: September 9, 2013

## Dear Mr. Berthoin:

We have reviewed vour 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. Berthoin

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary S-Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K130834

## R7 Dental System

#### Indications for Use (Describe)

Device Name

The R7 Dental System and accessories are in general dental applications by providing the dental practitioner a user interface to control operation of the dental charted dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control common and normal patient treatment procedures, including use of an ultrasonic scaler, performed in the dental operatory.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

# Please do not write below this line - continue on a separate page if needed.

CONTRACTOR PORTER OF THE FOR FDALUSE ONLY FOR FOR MILLER SELLER SELLER SELLERS FOR FOR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/2/Picture/14 description: The image shows the name "Andrew I. Steen" in bold, black font. Below the name, the date "2013.10.08" and time "14:00" are printed in a similar font. There is also a stamp on the right side of the image.