REMIN PRO

K101104 · Voco GmbH · EJR · Oct 21, 2010 · Dental

Device Facts

• Record ID: K101104
• Device Name: REMIN PRO
• Applicant: Voco GmbH
• Product Code: EJR · Dental
• Decision Date: Oct 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

VOCO Paste is intended to be used after professional tooth whitening, professional tooth cleaning and for prevention and control of hypersensitivities.

Device Story

VOCO Paste is a dental polishing and desensitizing agent. Applied by dental professionals in a clinical setting following professional tooth whitening or cleaning procedures. Functions as an abrasive polishing agent to clean tooth surfaces and as a desensitizing treatment to manage hypersensitivity. Benefits patient by providing post-procedural care and reducing sensitivity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oral cavity abrasive polishing agent; paste formulation; intended for professional dental application.

Indications for Use

Indicated for use following professional tooth whitening or cleaning, and for the prevention and control of tooth hypersensitivity in patients requiring professional dental care.

Regulatory Classification

Identification

An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

Submission Summary (Full Text)

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Public Health Service

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

Mr. M. Th. Plaumann Managing Board VOCO GMBH Anton-Flettner-Strasse 1-3 Cuxhaven Germany D-27472

## OCT 2 1 2010

Re: K101104

Trade/Device Name: VOCO Paste Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: 1 Product Code: EJR Dated: September 27, 2010 Received: September 29, 2010

Dear Mr. Plaumann;

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. Plaumann

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/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 vours.

Arem J. Soto

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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## Indications for Use Statement

| 510(k) Number: | K 101104 | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------|
| Device Name: | VOCO Paste | OCT 21 2010 |
| Indications for Use: | | |
| VOCO Paste is intended to be used after professional tooth whitening, professional tooth cleaning and for prevention and control of hypersensitivities. | | |
| Prescription Use | X | |
| OR | | |
| Over-The-Counter Use | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Pueno

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________