(44 days)
Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.
The provided K073117 document is a 510(k) summary for a "DENTIN DESENSITIZER AGENT." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.
It does not contain information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria using a test set, ground truth, or expert review in the way that would typically be described for a diagnostic AI or imaging device.
Therefore, I cannot populate the requested table and detailed study information as the document does not provide this type of data.
Here's why and what information is present:
- Type of Device: The DENTIN DESENSITIZER AGENT is a chemical agent for treating tooth sensitivity, not a software algorithm, an AI device, or an imaging modality.
- Approval Pathway: This is a 510(k) submission, which means the device is being approved based on "substantial equivalence" to legally marketed predicate devices, not necessarily on demonstrating new performance metrics against a defined acceptance criterion via a clinical study with a control group and robust statistical analysis for novel claims.
- Focus of the Submission: The submission highlights:
- Components: All components have been used in legally marketed devices or found safe for dental use.
- Biocompatibility Testing: The device passed agar overlay cytotoxicity, intracutaneous irritation, and systemic toxicity tests. This demonstrates safety, but not clinical effectiveness in terms of reducing sensitivity in a quantifiable manner against specific criteria.
- Predicate Devices: The device is compared to Gluma Desensitizer (K962812) and Quell Desensitizer (K010957). The implication is that since these predicates are accepted for treating dentinal hypersensitivity, and the new device shares similar characteristics and has passed safety tests, it is also safe and effective for the same indication.
Conclusion:
Based on the provided text, there is no information to fill in the requested table and answer questions 1-9 regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, ground truth, adjudication methods, or MRMC studies. These details are typically found in submissions for devices that make novel performance claims or rely on AI/software for diagnostic or interpretive functions, which is not the case for this chemical desensitizer.
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510(k) SUMMARY
DEC 1 9 2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | November 1, 2007 |
| TRADE OR PROPRIETARY NAME: | DENTIN DESENSITIZER AGENT |
| CLASSIFICATION NAME: | Resin Tooth Bonding Agent 872.3200 |
| PREDICATE DEVICES: | Gluma DesensitizerK962812Quell DesensitizerK010957 |
DEVICE DESCRIPTION: The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.
The DENTIN DESENSITIZER AGENT is intended for treating and INTENDED USE: preventing dentinal hypersensitivity. The Agent can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in DENTIN DESENSITIZER AGENT have been used in legally marketed devices and/or were found safe for dental use. The DENTIN DESENSITIZER AGENT has been evaluated and passed biocompatibility testing for agar overlay cytotoxicity, intracutaneous irritation, and systemic toxicity.
We believe that the prior use of the components of DENTIN DESENSITIZER AGENT in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of DENTIN DESENSITIZER AGENT for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
DEC 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K073117
Trade/Device Name: Dentin Desensitizer Agent Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: November 1, 2007 Received: November 5, 2007
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K073117
Device Name:
DENTIN DESENSITIZER AGENT
Indications for Use:
Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Rumpe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K672117
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§ 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.