(30 days)
Temporary fillings; Temporary management of inlay and onlay preparations; Temporary closure of implant screw holes; Relining of temporary pre-made crowns and bridges
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.
The provided 510(k) summary for CAVIT® LC is for a temporary light-cured filling material, which is a medical device and not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as typically applied to AI/ML software (e.g., performance metrics like sensitivity, specificity, AUC) does not directly apply here.
Instead, the submission focuses on biocompatibility and material effectiveness for a physical product. The "acceptance criteria" in this context would be related to meeting regulatory standards for material safety and performance for a medical device.
Therefore, many of the requested points regarding AI/ML clinical studies will not be present in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No harmful potential (based on regulatory standards for dental materials). | "biocompatibility testing was conducted which showed that CAVIT® LC has no harmful potential." |
| Effectiveness/Material Characteristics | More advantageous material and handling characteristics compared to the predicate device (CAVIT®-LC old formula), addressing issues of rigidity. | "The effectiveness is established by laboratory testing." (Specific metrics are not provided in this summary but would have been in the full submission). "composition has changed, especially the monomer system was exchanced, which results in more advantageous material and handling characteristics." |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable to AI/ML software. The testing was laboratory-based for material properties and biocompatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable to AI/ML software. However, the document mentions: "clinical testing to verify efficacy and material characteristics of the new formulation. This product was shown to exhibit advantages in some indications compared to the predicate device and other devices." This suggests some form of clinical evaluation, but details like the number or qualifications of clinicians are not provided in this summary. The old formula's issues were identified by "consultant dentists."
4. Adjudication Method for the Test Set:
- Not applicable to AI/ML software. The evaluation of material properties would involve standardized laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- Not applicable to AI/ML software. This is a physical, not an AI, device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- Not applicable to AI/ML software.
7. The Type of Ground Truth Used:
- For Biocompatibility: likely established through standardized biological tests (e.g., cytotoxicity, sensitization, irritation) as per ISO 10993 series or similar standards for dental materials.
- For Effectiveness/Material Characteristics: established through physical and mechanical property laboratory tests (e.g., setting time, strength, wear resistance, handling properties) as per relevant ISO standards for temporary restorative materials.
8. The Sample Size for the Training Set:
- Not applicable. This refers to a physical product, not an AI model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This refers to a physical product, not an AI model.
Summary relevant to AI/ML questions:
This submission is for a traditional medical device (temporary dental filling material), not an AI/ML-powered device. Therefore, the detailed AI/ML-specific study design elements (such as test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or training set details) are entirely irrelevant to this submission and are not present in the provided text. The "study" mentioned is laboratory testing for biocompatibility and material effectiveness.
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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.
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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.
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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 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
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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 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
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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 □
§ 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.