(283 days)
Not Found
Not Found
No
The 510(k) summary describes a temporary dental cement and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The intended use states "TEMPORARY CEMENT FOR DENTAL USE ONLY," which is a material used in a therapeutic context (dental restorations) but the device itself is a material, not a therapeutic device designed to treat a medical condition or ailment.
No
Explanation: The device is a "TEMPORARY CEMENT FOR DENTAL USE ONLY," which indicates it is a therapeutic or restorative material, not a device used to diagnose a condition.
No
The 510(k) summary describes a "TEMPORARY CEMENT FOR DENTAL USE ONLY," which is a physical material, not software. The lack of information about software, image processing, AI, or data sets further confirms it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "TEMPORARY CEMENT FOR DENTAL USE ONLY." This clearly indicates a direct application within the mouth for dental procedures, not for testing samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVDs are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This temporary dental cement does not fit that description.
N/A
Intended Use / Indications for Use
TEMPORARY CEMENT FOR DENTAL USE ONLY.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
PROVI CEMENT
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
DENTAL
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a human form, with three curved lines suggesting a person's head, body, and legs. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1668
Dr. Jurgen Engelbrecht S&C Polymer GmbH Offenauer Weq 19 S-25335 Bokholt-Hanredder DEUTSCHLAND
Re : K973201 Trade Name: Provi Cement Requlatory Class: II Product Code: EMA May 20, 1998 Dated: Received: May 26, 1998
Dear Dr. Engelbrecht:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895: Asubstantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
1
Page 2 - Dr. Engelbrecht
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/dsmamaip.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
2
:
| 510(k) Number (if known): | K973201 | Page | of |
|---|---|---|---|
| Device Name: | PROVI CEMENT | ||
| Indications For Use: | TEMPORARY CEMENT | ||
| FOR DENTAL USE ONLY. |
S & C Polymer
Silicon- und Composite
Spezialitäten GmbH
Offenauer Weg 19
D-25335 Bokholt-Hanredder
Telefon 04121 / 86 19
Telefax 04121 / 8 72 21
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K973201 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |
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