PROCEM

K984248 · Espe Dental AG · EMA · Jan 8, 1999 · Dental

Device Facts

• Record ID: K984248
• Device Name: PROCEM
• Applicant: Espe Dental AG
• Product Code: EMA · Dental
• Decision Date: Jan 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Provisional dental cement for the temporary fixation of: - temporary crowns and bridges - temporary inlays and onlays - definite restorations

Device Story

PROCEM® is a eugenol-free dental cement used for the temporary fixation of crowns, bridges, inlays, and onlays. It is intended for use by dental professionals in a clinical setting. The device functions as a bonding agent to secure temporary or definite restorations during the provisional phase of dental treatment. It is formulated to be chemically similar to existing eugenol-free dental cements, with biocompatibility testing performed to account for a new component. The product is applied by the clinician to the restoration, which is then seated in the patient's mouth to provide temporary retention.

Clinical Evidence

Biocompatibility testing data provided to support the safety of the new component in the formulation. No clinical performance data or human trials reported.

Technological Characteristics

Eugenol-free dental cement. Classified as dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275).

Indications for Use

Indicated for temporary fixation of temporary crowns, bridges, inlays, onlays, and definite restorations in dental patients.

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.

Predicate Devices

• FREEGENOL® by GC (K842994)
• SCUTABOND® by ESPE (K771451)
• PROTEMP® GARANT by ESPE (K950203)
• DIMENSION® PENTA H by ESPE (K960547)
• CAVIT® G by ESPE (Preamendment Device)

Submission Summary (Full Text)

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II.

K984248

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# Submitter

| Name: | ESPE Dental AG |
|-----------------|-------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Contact: | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-700395 |
| Fax: | 011-49-8152-700869 |
| E-mail: | [e-mail] |
| Date: | 11/16/1998 |

### Name of Device

| Proprietary Name: | PROCEM® |
|----------------------|------------------|
| Classification Name: | Cement, Dental |
| Common Name: | Temporary Cement |

# Predicate Devices

| FREEGENOL® by GC | K842994 |
|----------------------------|---------------------|
| SCUTABOND® by ESPE | K771451 |
| PROTEMP® GARANT by ESPE | K950203 |
| DIMENSION® PENTA H by ESPE | K960547 |
| CAVIT® G by ESPE | Preamendment Device |

## Description for the Premarket Notification

PROCEM® is classified as a dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275) because it is a eugenol-free dental cement intended to be used for temporary fixations of crowns, bridges, inlays, and onlays.

PROCEM® is substantially equivalent in intended use and function to the predicate device FREEGENOL®. Concerning the chemical composition PROCEM® is con-

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sisting of the same ingredients as the above mentioned predicate devices. PROCEM® also contains a new component, for that reason biocompatibility testing data is provided.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 8 1999

Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany

K984248 Re : Trade Name: Procem® Requlatory Class: II Product Code: EMA Dated: November 16, 1998 Received: November 27, 1998

Dear Dr. Petermann:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug . Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K984248

# statement of Indications for use

Device Name:

PROCEM®

Indications for use:

Provisional dental cement for the temporary fixation of:

- temporary crowns and bridges
- temporary inlays and onlays
- definite restorations

Suom Rumm

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription use: 网

Over-the counter use □