(30 days)
K 972892
Not Found
No
The summary describes a dental filling material and does not mention any AI or ML components or functionalities.
No.
The device description states that CAVIT® LC is a tooth shade resin material intended to restore carious lesions or structural defects in teeth, which is a restorative function, not a therapeutic one. The intended use also describes temporary fillings and management, which are restorative or protective, not aimed at treating a disease or condition.
No
Explanation: The "Intended Use/Indications for Use" section and the "Device Description" clearly state that CAVIT® LC is a "tooth shade resin material" for "temporary fillings," "temporary management of inlay and onlay preparations," "temporary closure of implant screw holes," and "relining of temporary pre-made crowns and bridges." These are all restorative or reparative functions, not diagnostic ones. There is no mention of the device being used to identify, detect, or monitor a medical condition or disease.
No
The device description explicitly states it is a "tooth shade resin material" composed of methacrylates, which is a physical substance used for dental restoration, 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 temporary dental fillings and related procedures. This involves direct application to the patient's teeth, not the testing of samples in vitro (outside the body).
- Device Description: The device is described as a tooth shade resin material intended to restore defects in teeth. This aligns with a dental restorative material, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens, such as blood, urine, or tissue, from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely different.
N/A
Intended Use / Indications for Use
Temporary fillings
Temporary management of inlay and onlay preparations
Temporary closure of implant screw holes
Relining of temporary pre-made crowns and bridges
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
CAVIT® LC is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
To support the safety of the new formulation, biocompatibility testing was conducted which showed that CAVIT® LC has no harmful potential. The effectiveness is established by laboratory testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 972892
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
4/23/99
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
II.
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Coce, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country | Germany |
| Establishment Registration Number: | 9611385 |
| Contact | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-7001395 |
| Fax: | 011-49-8152-7001869 |
| Andreas_Petermann@ESPE.de | |
| Date: | March 22, 1999 |
Name of Dev ce
| Proprietary Name: | CAVIT® LC |
|---|---|
| Classification Name: | Tooth shade resin material |
| Common Name: | Temporary light cured filling material |
Predicate Device
CAVIT®-LC (old formula) by ESPE ....... K 972892
Description for the Premarket Notification
CAVIT® LC is classified as a tooth shade resin material (21 C.F.R. § 872.3690) becaus it is a device composed of methacrylates intended to restore carious lesions o · structural defects in teeth.
CAVIT® LC is similar in intended use and substantially equivalent to ESPE's previously 510(k)-cleared temporary filling material CAVIT®-LC (old formula) which was never c n the market because it was determined by consultant dentists to have very insuffic ent material characteristics. The consultants complained about too high rigidity of the uncured material which made it almost impossible to fill it into the cavity.
Image /page/0/Picture/12 description: The image shows the text "510(k) Cavit ESPE". The text is arranged in a stacked format, with "510(k) Cavit" on top and "ESPE" below. There is a logo to the left of the text. The logo is a tree inside of a square.
1
The now Cavin® LC is a further development based on the experience with the old CAVT -LC. The composition has changed, especially the monomer system was exchanced, which results in more advantageous material and handling characteristics.
To support the safety of the new formulation, biocompatibility testing was conducted which showed that CAVIT® LC has no harmful potential. The effectiveness is establis ned by laboratory testing.
Image /page/1/Picture/2 description: The image shows the text "510(k) CAVIT LC: ESPE:". The text is arranged in a vertical stack, with "510(k) CAVIT LC:" at the top and "ESPE:" at the bottom. There is a logo to the left of the text. The text is in a bold, sans-serif font.
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 a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1999
Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany
Re: K990982 Trade Name: Cavit LC Regulatory Class: II Product Code: EBF March 22, 1999 Dated: March 24, 1999 Received:
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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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
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 requlation (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 requlation 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.qov/cdrh/dsma/dsmamajn.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
K 990982
STATEMENT OF INDICATIONS FOR USE
Device Name:
CAVIT® LC
Indications for use:
Temporary fillings
Temporary management of inlay and onlay preparations
Temporary closure of implant screw holes
Relining of temporary pre-made crowns and bridges
Susan Rumm
(Division Sign-Off) (Division Sigil-On)
Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription use: 区
Over-the counter use □