(107 days)
Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.
Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.
This 510(k) premarket notification for Pulpdent Fluoride Varnish does not contain a study that establishes acceptance criteria and then demonstrates the device meets those criteria through performance testing.
Instead, the submission relies on the concept of substantial equivalence to predicate devices that have been on the market for an extended period with a history of safe and effective use.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable to this specific submission.
Here's an breakdown of the available information based on your request, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable.
This submission does not define specific acceptance criteria (e.g., a required percentage reduction in hypersensitivity, or a specific level of remineralization) for Pulpdent Fluoride Varnish, nor does it present device performance data against such criteria.
The basis for regulatory clearance is "substantial equivalence" to predicate devices, implying that its performance is expected to be similar to devices already found safe and effective. The submission states: "Pulpdent Fluoride Varnish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable.
No specific test set or associated sample size is described for this device's performance evaluation. The safety and effectiveness claim is based on the long-term market history of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable.
No specific ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set
Not Applicable.
No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not Applicable.
No MRMC comparative effectiveness study was performed or referenced for this device. The device is a physical product (fluoride varnish), not an AI or imaging diagnostic tool where such studies are typically relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable.
This is a physical medical device (fluoride varnish), not an algorithm or software. Standalone performance as typically understood in AI/software evaluations is not relevant here.
7. The Type of Ground Truth Used
Indirect Ground Truth: Clinical history of predicate devices.
The "ground truth" for the claim of safety and effectiveness is the established safety and effectiveness profile of the predicate devices, which have been "on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems." This relies on real-world clinical outcomes over an extended period.
8. The Sample Size for the Training Set
Not Applicable.
No "training set" in the context of algorithm development is relevant to this physical device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
No training set or associated ground truth establishment is relevant to this physical device.
Summary of the K093620 Submission Strategy:
The manufacturer, Pulpdent Corporation, opted for a 510(k) Premarket Notification based on substantial equivalence. This pathway allows devices to be cleared for market if they are shown to be as safe and effective as a legally marketed predicate device. In this case, the safety and effectiveness of Pulpdent Fluoride Varnish is primarily supported by:
- Comparison to Predicate Products: Pulpdent Fluoride Varnish is stated to be "substantially equivalent in design, composition, performance, intended use, safety and effectiveness" to several fluoride varnishes already on the market (e.g., Scientific Pharmaceuticals Sci-Pharm Desensitizing Varnish, Ultradent Flor-Opal Varnish White, 3M Vanish 5% NaF White Varnish, Colgate Duraphat).
- Long-term Market History of Predicates: The predicate products have a history of "more than 15 years" of successful use by dental professionals "with no serious safety or effectiveness problems."
- Compositional Similarity: The device is formulated with materials "that have been used in the dental industry for many years without incident."
- Literature References: A list of 16 scientific articles related to the safety and effectiveness of fluoride varnishes in general is provided, further supporting the understanding of the class of devices. These references likely contribute to the general understanding of fluoride varnish efficacy in treating dental hypersensitivity and promoting remineralization, implicitly supporting the claim for the new device as well.
This approach bypasses the need for new clinical trials or detailed performance studies for the specific device if substantial equivalence can be adequately demonstrated.
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510 k Premarket Notification
Pulpdent Fluoride Varnish
EXHIBIT 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA MAR 1 0 2010
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
617-926-6666 Telephone: 617-926-6262 Fax: ken@pulpdent.com
DEVICE:
Trade Name: Pulpdent Fluoride Varnish Classification Name: Cavity Varnish Class: Il FDA Product Code: 76 LBH, 21 CFR Part 872.3260
PREDICATE DEVICES:
Scientific Pharmaceuticals Sci-Pharm Desensitizing Varnish Scientific Pharmaceuticals Sci-Pharm DFV Varnish Ultradent Flor-Opal Varnish White 3M Vanish 5% NaF White Varnish Colgate Duraphat
DESCRIPTION AND INTENDED USE:
Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solyents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent Fluoride Varnish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3260.
SAFETY AND EFFECTIVENESS:
Pulpdent Pulpdent Fluoride Varnish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems. Pulpdent Fluoride Varnish is formulated without solvents and from materials that have been used in the dental industry for many years without incident.
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PULPDENT CORPORATION
Kog 3620
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510 k Premarket Notification
Pulpdent Fluoride Varnish
REFERENCES: Safety and Effectiveness of Fluoride Varnish
- Ambjerg D. Use of professionally administered fluoride among Danish children. Acta Odontol 1. Scand 1992;50:289-93.
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- Beltran-Aquilar ED. Fluoride varnishes. A review of their clinical use, cariostatic mechanism, efficacy and safety. Am Dent Assoc. 2000;131(5):589-96.
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- Clark DC. A review of fluoride varnishes: an alternative topical fluoride treatment. Community Dent Oral Epidemiol 1982; 10:117-23.
- de Bruyn H, Arends J. Fluoride varnishes a review. J Biol Buccale 1987;15:71-82. 4.
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- Flanigan PJ, et al. Coating thickness influences fluoride release from white fluoride varnish. 2008 IADR abstract.
- Gaffar A. Treating hypersensitivity with fluoride varnish. Compend Contin Educ Dent. 1999;20(1 6. Suppl):27-33.
- Hoang-Dao BT, et al. Clinical efficiency of a natural resin fluoride varnish (Shellac F) in reducing 7. dentin hypersensitivity. J Oral Rehabil 2009;36(2):124-31.
- Hoang-Dao BT, et al. Evaluation of a natural resin-based new material (Shellac F) as a potential 8. desensitizing agent. Dent Mater. 2008 Jul;24(7):1001-7.
- Koch G, et al. Kinetics of fluorine in deciduous enamel after application of fluoride containing 9. varnish (Duraphat). I. Update, distribution and release. Swed Dent J 1982;6;39-44.
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- Olusile AO, et al. Short-term clinical evaluation of four desensitizing agents. J Contemp Dent Pract 2008;9(1):22-9.
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- Ozen T. et al. Dentin hypersensitivity: a randomized clinical companison of three different agents in a short-term treatment period. Oper Dent 2009;34(4):392-8.
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- Ritter AV, et al. Treating cervical dentin hypersensitivity with fluoride varnish: a randomized clinical study. J Am Dent Assoc 2006;137(7):1013-20.
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- Seppa L. Effects of sodium fluoride solution and a varnish with different fluoride concentrations on enamel remineralization in vitro. Scand J Dent Res 1988;96:304-9.
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- Seppa L. Studies of fluoride varnishes in Finland. Proc Finn Dent Soc 1991;87:541-7.
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- Stamm JW. Fluoride uptake from topical sodium fluoride varnish measured by an in vivo enamel biopsy. J Can Dent Assoc 1974;40:501-2.
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- van Eck AA, et al. Effect of annual application of polyurethane lacquer containing silane-fluoride. Community Dent Oral Epidemiol 1984; 12:1221-2.
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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 features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
MAR 1 0 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P.O. Box 780 Watertown, Massachusetts 02471-0780
Re: K093620
Trade/Device Name: Pulpdent Fluoride Varnish Regulation Number: 21CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 23, 2010 Received: February 24, 2010
Dear Mr. Berk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Berk
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801).. please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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
510(k) Number (if known): K093620
Device Name: Pulpdent Fluoride Varnish
Indications For Use:
Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding rentinal tubules and by promoting an environment conducive to remineralization.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz DDS for Dr. K.P. Mulry
(Division Sign-Off) D vision of Anesthesiology, General Hospital maction Control, Dental Devices
Page 1 of 1
.10(k) Number: K093620
§ 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.