(42 days)
Not Found
No
The summary describes a dental cement and does not mention any AI or ML capabilities.
No
The device is a temporary dental cement used for fixation, which does not fit the definition of a therapeutic device designed for treating or healing medical conditions.
No
Explanation: The device is described as a "provisional dental cement for the temporary fixation of temporary crowns and bridges, temporary inlays and onlays, definite restorations." Its classification as "dental cement" and intended use for fixation indicate it is a therapeutic or restorative device, not one used for diagnosis.
No
The device description clearly identifies PROCEM® as a dental cement, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary fixation of dental restorations (crowns, bridges, inlays, onlays). This is a direct application within the mouth for a physical purpose.
- Device Description: It is described as a dental cement, which is a material used in dentistry for bonding or filling.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) for a restorative purpose.
N/A
Intended Use / Indications for Use
Provisional dental cement for the temporary fixation of:
- temporary crowns and bridges
- temporary inlays and onlays
- definite restorations
Product codes
EMA
Device Description
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 consisting of the same ingredients as the above mentioned predicate devices. PROCEM® also contains a new component, for that reason biocompatibility testing data is provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K842994, K771451, K950203, K960547
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
II.
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 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-
1
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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2
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
3
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
4
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 □