← Product Code [LBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH) · K100503 # PULPDENT COPAL VARNISH WITH FLUORIDE (K100503) _Pulpdent Corporation · LBH · May 12, 2010 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH/K100503 ## Device Facts - **Applicant:** Pulpdent Corporation - **Product Code:** [LBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH.md) - **Decision Date:** May 12, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3260 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use Pulpdent Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film. ## Device Story Resin-based varnish for professional dental use; applied to enamel or dentin by dental professionals. Functions by occluding dentinal tubules with an adherent film to treat dental hypersensitivity. No complex inputs, processing, or outputs; manual application only. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on comparison to legally marketed predicate devices with a history of successful use. ## Technological Characteristics Resin-based varnish containing alpha copal, denatured ethanol, fluoride mineral source, water, and flavorant. Applied as a liquid film to enamel or dentin. No energy source, software, or electronic components. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - DVF Varnish, Scientific Pharmaceuticals ([K982915](/device/K982915.md)) - Copalite, Cooley & Cooley - Duraphat, Colgate Oral Pharmaceuticals ([K945794](/device/K945794.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K100503 MAY 1 2 2010 . - * -- . ## EXHIBIT 2 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA May 11, 2010 Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 ken@pulpdent.com DEVICE: Trade Name: Copal Varnish with Fluoride Classification Name: Cavity Varnish Class: Il FDA Product Code: 76 LBH, 21 CFR Part 872.3260 #### PREDICATE DEVICES: DVF Varnish, Scientific Pharmaceuticals Copalite, Cooley & Cooley Duraphat, Colgate Oral Pharmaceuticals #### DESCRIPTION AND INTENDED USE: Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film. #### COMPARISON WITH PREDICATE PRODUCTS: Copal Varnish with Fluoride is substantially equivalent in design, composition, performance, and intended use to the predicate products listed above. | Product | 510(k) Number | Description | Intended Use | Composition | |----------------------------------------------|---------------|------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------| | Pulpdent
Copal Varnish with
Fluoride | K100503 | Copal-based fluoride
varnish | To treat tooth
hypersensitivity | Alpha copal
Denatured ethanol
Fluoride mineral source
Water
Flavorant | | Scientific
Pharmaceuticals
DVF Varnish | K982915 | Colophony-based
varnish with fluoride | To treat tooth
hypersensitivity | Ethyl alcohol
Colophony
Sodium fluoride
Water | | Cooley & Cooley
Copalite | ------ | Copal-based varnish | To treat tooth
hypersensitivity. | Copal
Ethyl ether anhydrous
Chloroform | | Colgate
Duraphat | K945794 | Rosin-based fluoride
varnish | To treat tooth
hypersensitivity. | Rosin
Ethyl alcohol
Sodium fluoride
Water
Flavorant | ## SAFETY AND EFFECTIVENESS: Copal Varnish with Fluoride is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products list have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems. {1}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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 Watertown, Massachusetts 02472 # MAY 1 2 2010 Re: K100503 Trade/Device Name: Pulpdent Copal Varnish with Flouride Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 16, 2010 Received: February 23, 2010 Dear Mr. Kenneth J. 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. {2}------------------------------------------------ # Page 2-- Mr. Kenneth J. 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/Resourcesfor You/Industry/default.htm. Sincerely yours. h 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 {3}------------------------------------------------ # Indications for Use 510(k) Number: K 100503 Pulpdent Copal Varnish with Fluoride Device Name: ## Indications For Use: Pulpdent Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) 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) Kei. iMuly for. M.S.R (Division Sign-Off) Division of Anesthesional General Hospital Infection Control, Dentai Devices Page 1 of 1 510(k) Number: K100503 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH/K100503](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH/K100503) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com