← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K091735

# DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT (K091735)

_S & C Polymer GmbH · EMA · Sep 25, 2009 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K091735

## Device Facts

- **Applicant:** S & C Polymer GmbH
- **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md)
- **Decision Date:** Sep 25, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Intended Use

DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges inlays or onlays; as well as for trial cementing of permanent restorations; DC Provi Cem Implant: Intended for cementing of semi-permanent implants; all cements can also be used as temporary filling materials

## Device Story

Provi Cem Esthetic is a dental cement system comprising three variants: DC Provi Cem Esthetic, DC Provi Cem Esthetic Multi F, and DC Provi Cem Implant. These materials are used by dental professionals in clinical settings to secure temporary restorations (crowns, bridges, inlays, onlays), trial-cement permanent restorations, or secure semi-permanent implants. The products also function as temporary filling materials. The device is applied manually by the clinician to the restoration or implant interface. It provides mechanical retention and sealing for the restoration or implant during the temporary or trial period, facilitating subsequent removal or permanent placement as required by the clinical treatment plan.

## Clinical Evidence

No clinical data provided; substantial equivalence is based on device description and intended use comparisons to the predicate.

## Technological Characteristics

Dental cement system (Product Code: EMA; Regulation: 21 CFR 872.3275). The system consists of three chemical formulations (DC Provi Cem Esthetic, DC Provi Cem Esthetic Multi F, and DC Provi Cem Implant) designed for temporary or semi-permanent dental fixation.

## Regulatory 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.

## Predicate Devices

- Tempbond Clear ([K982590](/device/K982590.md))

## Submission Summary (Full Text)

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#### 12. Summary of Safety and Effectiveness

## SEP 2 5 2009

#### Submitter

Name of company: S&C Polymer Silicon- und Composite Spezialitaeten GmbH Address: Robert-Bosch-Strasse 5, D-25335 Elmshorn (Germany) Phone: 0049 4121 483 0 Fax: 0049 4121 483 184 Contact Person: Dr. Christian Boettcher Date of preparation: June 2009

## Device Name:

Trade name: Provi Cem Esthetic

Common Name: Provi Cem Esthetic (consisting of DC Provi Cem Esthetic, DC Provi Cem Esthetic Multi F and DC Provi Cem Implant)

Classification Name: Cement Dental, per 21CFR § 872.3275

### Devices for which Substantial Equivalence is Claimed:

Tempbond Clear, K982590

#### Device description and Intended Use of the device:

Provi Cem Esthetic consist of three different cements:

DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations;

DC Provi Cem Implant: Intended for cementing of semi-permanent implants;

All cements can also be used as temporary filling materials

#### Substantial Equivalence:

Provi Cem Esthetic is substantially equivalent to other legally marketed devices in the United States. The Cements marketed by S&C Polymer Silicon- und Compositen Spezialitaeten GmbH function in a manner similar to and is intended for the same use as the products marketed by Sybron Dental Specialities, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars above its head, all enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

# SEP 2 5 2009

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

Dr. Christian Boettcher Official Correspondent S& C Polymer GmbH Robert-Bosch -Strasse 5 Elmshorn, Germany D-25335

K091735 Re:

> Trade/Device Name: Provi Cem Esthetic (DC PROVI Cem Esthetic, DC Provi Cem . Esthetic Multi F, and DC Provi Cem Implant)

Regulation Number: 21 CFR 872,3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: September 11, 2009 Received: September 15, 2009

Dear Dr. Boettcher:

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.

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## Page 2- Dr. Boettcher

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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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# 10. Statement of Indication for Use

510(k) Number (if known):

Device Name:

Indications for Use:

Provi Cem Esthetic (consisting of three different cements):

DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F:

Intended for cementing temporary restorations such as crowns, bridges inlays or onlays; as well as for trial cementing of permanent restorations;

DC Provi Cem Implant:

Intended for cementing of semi-permanent implants;

all cements can also be used as temporary filling materials

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Haley for MSR

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

10(k) Number: K0911735

Prescription Use:

or

Over-The-Counter Use

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K091735](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K091735)

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