(62 days)
Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.
Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)
Acceptance Criteria and Device Performance for Dentinal Tubuli Seal:
Based on the provided documents, it is not possible to extract specific quantitative acceptance criteria or detailed study results for the Dentinal Tubuli Seal. The documents are a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence in terms of indications for use, technological characteristics, and safety and effectiveness, rather than meeting specific pre-defined quantitative performance metrics in a new clinical study.
Therefore, the following sections will indicate "Not Applicable" or "Not Provided" where the requested information is not present in the given FDA letter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Indications for Use | Sealing cavities before restorations; Barrier against irritants from cements/restorative materials; Reduces penetration of oral fluids at restoration-tooth interface into dentin; Minimizes postoperative sensitivity when applied to dentinal surfaces under new restorations. | Device is recognized as substantially equivalent for these indications for use. Specific performance metrics are not detailed in this document. |
| Technological Characteristics | (Implied: Similar to predicate device) | (Implied: Similar to predicate device) |
| Safety and Effectiveness | (Implied: Equivalent to predicate device) | (Implied: Equivalent to predicate device) |
| Quantitative Performance | Not specified in the provided document. | Not specified in the provided document. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided in the document. 510(k) clearance often relies on existing data from the predicate device and potentially product specifications rather than a new standalone clinical test set.
- Data Provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided in the document.
- Qualifications of Experts: Not provided in the document.
4. Adjudication method for the test set:
- Adjudication Method: Not provided in the document.
5. 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:
- MRMC Study: Not applicable. This device is a cavity varnish, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical product (cavity varnish), not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: Not explicitly stated. For a 510(k) submission of a cavity varnish, ground truth would typically be established based on accepted dental practices, material science principles, and existing clinical data or performance data of the predicate device, rather than patient outcomes or pathology from a new study.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a physical product, and the concept of a "training set" as understood in machine learning/AI does not apply.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. The concept of a "training set" does not apply to this device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra Gillaspy Official Correspondent Medental International 1246 Clear Creek Road Evergreen, Colorado 80439
DEC 1 6 1997
K973919 Re : Cavity Varnish (Intermediary Varnish and Trade Name: Dentinal Tubuli Seal) Requlatory Class: II Product Code: LBH October 7, 1997 Dated: October 15, 1997 Received:
Dear Ms. Gillaspy:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Gillaspy
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 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot Ulatowsk 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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MEDENTAL INTERNATIONAL 1246 Clear Creek Road Evergreen, CO 80439 Establishment # 1723973
510(k) Number:
Not Yet Assigned K973919
Device Name:
Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)
Indications for Usc:
Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.
Susan Runnes
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number . KA-
Prescription Use Yu
s
Over the Counter Use No
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.