Provicol QM Plus

K161630 · Voco GmbH · EMB · Sep 15, 2016 · Dental

Device Facts

• Record ID: K161630
• Device Name: Provicol QM Plus
• Applicant: Voco GmbH
• Product Code: EMB · Dental
• Decision Date: Sep 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Provicol QM Plus is intended for use as: - Temporary cementation of provisional restorations (crowns, bridges, inlays and onlays) - Temporary cementation of definitive restorations (crowns, bridges, inlays and onlays)

Device Story

Provicol QM Plus is a dental cement used by dental professionals for the temporary cementation of both provisional and definitive dental restorations, including crowns, bridges, inlays, and onlays. The device functions as a luting agent to secure these restorations in the patient's mouth during the temporary phase or prior to final cementation. It is applied by a dentist or dental professional in a clinical setting. The product provides temporary adhesion, allowing for the later removal of the restoration if necessary. It benefits the patient by ensuring the stability of temporary or definitive restorations during the treatment process.

Clinical Evidence

bench testing only

Technological Characteristics

Dental cement classified under 21 CFR 872.3275 (Product Code: EMB).

Indications for Use

Indicated for temporary cementation of provisional or definitive dental restorations including crowns, bridges, inlays, and onlays.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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

September 15, 2016

VOCO GmbH T. Gerkensmeier Regulatory Affairs Anton-flettner-str. 1-3 Cuxhaven, 27472 GERMANY

Re: K161630

Trade/Device Name: Provicol QM Plus Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class I Product Code: EMB Dated: June 20, 2016 Received: June 22, 2016

Dear T. Gerkensmeier:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno, DDS, MA

Tina Kiang, Ph.D. Acting 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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## Indications for Use Statement

510(k) Number:

Device Name: ______Provicol QM Plus _____

Indications for Use:

Provicol QM Plus is intended for use as:

- · Temporary cementation of provisional restorations (crowns, bridges, inlays and onlays)
- . Temporary cementation of definitive restorations (crowns, bridges, inlays and onlays)

Prescription Use __X___ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)