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.

AI/ML Overview

This looks like a 510(k) premarket notification for a dental cement called PROCEM®. The document indicates that this is a traditional medical device, not an AI/ML medical device. Therefore, a study demonstrating AI/ML performance metrics such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies would not be relevant or present in this type of submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, function, and chemical composition (with biocompatibility data provided for a new component).

Therefore, I cannot provide the requested information as it is not applicable to this submission.

Summary

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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:	Andreas_Petermann@ESPE.de
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 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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Page 2 - Dr. Petermann

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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 □

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.