(58 days)
Temporary fillings for inlay and onlay preparations .
Temporary fillings of cavities ●
Temporary filling of implant sites ●
Relining of prefabricated temporary crowns and bridges .
light-curing temporary filling material, tradenamed Cavit®-LC
The provided text describes a 510(k) premarket notification for a dental material, Cavit®-LC, and references comparative testing. However, it does not include detailed information regarding acceptance criteria or the specific study that proves the device meets those criteria in a format that would allow me to fill out all the requested fields for a typical AI/software device evaluation.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Fermit-N and Clip®) by comparing physical and technical characteristics, and reporting on biocompatibility tests (cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization).
Here's an attempt to extract the relevant information based on the provided text, with many fields being marked as "Not Applicable" or "Not Provided" due to the nature of the submission (a dental material, not an AI/software device):
Acceptance Criteria and Device Performance
This section is difficult to fully populate with numerical acceptance criteria and reported performance from the provided text, as the submission focuses on substantial equivalence to predicate devices rather than specific performance metrics against predefined thresholds. The "tests undertaken" are primarily biocompatibility tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Similar principal ingredient composition to predicate device (Fermit-N) | Cavit®-LC and Fermit-N have similar principal ingredient composition. |
| Intended Use | Similar intended uses as predicate devices (Fermit-N, Clip®) | Cavit®-LC has similar intended uses to Fermit-N and Clip®. |
| Physical/Technical Characteristics | Comparative characteristics to predicate devices | Physical and technical characteristics of Cavit™-LC have been compared to those of Fermit-N and Clip. (Specific results not detailed) |
| Biocompatibility | Acceptable results for standard biocompatibility tests | Cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization tests undertaken on Cavit®-LC. (Specific results not detailed, but implied to be acceptable for 510(k) clearance) |
Notes on Acceptance Criteria: For a 510(k) submission for a material, the "acceptance criteria" are generally that the new device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, is as safe and effective, and has similar technological characteristics. The comparison of physical and technical characteristics and biocompatibility tests serve to demonstrate this equivalence, rather than meeting specific numerical performance thresholds for an AI algorithm.
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of cases or patients. The tests mentioned (biocompatibility, physical/technical characteristics) would involve material samples or in vitro/animal models.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were "undertaken on the final Cavit®-LC product."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information is relevant for AI/software devices requiring expert review for ground truth establishment. For a dental filling material, ground truth would be established through material testing standards and biocompatibility guidelines.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this pertains to expert review of diagnostic findings for AI/software, not material science or biocompatibility testing.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a material science product, not an AI-assisted diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a material science product. The performance of the material is assessed directly, not via an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Standardized in vitro tests (e.g., cytotoxicity, Ames) and in vivo animal studies (skin irritation, eye irritation, acute oral toxicity, sensitization) with defined endpoints and acceptance criteria from regulatory guidelines.
- For physical/technical characteristics: Material science testing methods and standards.
- For substantial equivalence: Comparison to the established characteristics and performance of predicate devices.
-
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of a dental material submission demonstrating substantial equivalence through physical and biocompatibility testing.
-
How the ground truth for the training set was established:
- Not Applicable. See above.
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II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for tooth shade resin material, tradenamed Cavit®-LC. Cavit®-LC is a light-curing temporary filling material indicated for the following uses: (1) temporary fillings for inlay and onlay preparations; (2) temporary fillings in cavities; (3) temporary fillings of implant sites; and (4) relining of prefabricated temporary crowns and bridges.
ESPE is claiming substantial equivalence to the previously cleared temporary filling materials Fermit-N Light-Curing Temporary Filling Material (K934978) and Clip® (K926418). Cavit®LC, Fermit-N, and Clip® have similar intended uses and Cavit®-LC and Fermit-N have similar principal ingredient composition. To support substantial equivalence to predicate products, the physical and technical characteristics of Cavit™-LC have been compared to those of Fermit-N and Clip. 8 In addition, certain tests have been undertaken on the final Cavit®-LC product, including cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization.
ESPE's 510(k) has been submitted on August 4, 1997, by Dr. Barbara Wagner-Schuh at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 2 1997
Dr. Barbara Wagner-Schuh Regulatory Affairs ESPE GMBH & Company KG AM Griesberg 2 Seefeld, OBB Germany
K972892 Re : Cavit-LC Trade Name: Regulatory Class: II Product Code: EBF Dated: August 4, 1997 Received: Auqust 5, 1997
Dear Dr. Waqner-Schuh:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ಗಳ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Wagner-Schuh
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 beqin 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) 594-4618. 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" (21 CFR 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/dsmamain.html".
Sincerely Yours,
Timo ühv 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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STATEMENT OF INDICATIONS FOR USE
Device Name: Cavit®-LC
Indications for use:
- Temporary fillings for inlay and onlay preparations .
- Temporary fillings of cavities ●
- Temporary filling of implant sites ●
- Relining of prefabricated temporary crowns and bridges .
Sueen Ruarrez
(Division Sign-Off) Division of Dental, Infection Control. Didision of Dental, Info
and General Hospital Deneral Deneral Deneral
510(k) Number 510(k) Number .
Prescription Use X_ OR 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.