(66 days)
Not Found
No
The device description and intended use clearly describe a chemical-based varnish for treating dental hypersensitivity, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for the "professional treatment of dental hypersensitivity" by occluding dentinal tubules and filling enamel lesions, which is a therapeutic action.
No
The device is described as a resin-based varnish applied for the professional treatment of dental hypersensitivity by occluding dentinal tubules. Its function is therapeutic (treatment), not diagnostic (identifying a condition).
No
The device description clearly states it is a "resin-based varnish" which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that Activ Varnish is applied to enamel or dentin, which are parts of the patient's body, not specimens taken from the body for examination.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. While Activ Varnish is used for treatment (dental hypersensitivity), it does so by a physical/chemical action on the tooth structure, not by analyzing a biological sample to provide diagnostic or monitoring information.
The description aligns with a therapeutic dental device applied directly to the patient's teeth.
N/A
Intended Use / Indications for Use
Activ Varnish is a resin-based varnish, containing 17% Xylitol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions.
Product codes
76LBH
Device Description
Activ Varnish is a resin-based varnish, containing 17% Xyliol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions. Activ Vamish is available in unit-dose and bulk packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel or dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional treatment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K093620, K080249, K880741, K945794, K101104
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
R11294
EXHIBIT 2
DEC - 9 2011
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
DEVICE
.
Trade Name: Activ Varnish Class: Il
Telephone: 617-926-6666 617-926-6262 Fax: ken@pulpdent.com
Classification Name: Cavity Varnish FDA Product Code: 76LBH, 21 CFR Part 872.3260
PREDICATE DEVICES:
Pulpdent Fluoride Varnish Ultradent Flor-Opal Vamish White 3M Vanish 5% NaF White Vamish Colgate Duraphat Voco ReminPro
DESCRIPTION AND INTENDED USE:
Activ Vamish is a resin-based varnish, containing 17% Xyliol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions. Activ Vamish is available in unit-dose and bulk packaging.
COMPARISON WITH PREDICATE PRODUCTS:
Activ Varnish is substantially equivalent in design, composition, performance, and intended use to the predicate products:
| Product | 510(k) Number | Description | Intended Use | Composition |
|---|---|---|---|---|
| Pulpdent Activ Varnish | Resin-based fluoride | |||
| varnish | To treat tooth | |||
| hypersensitivity | Resin, Ethyl alcohol, Xylitol, | |||
| Sodium fluoride, Calcium and | ||||
| Phosphate salts, Flavorant. | ||||
| Pulpdent Fluoride Varnish | K093620 | Resin-based fluoride | ||
| varnish | To treat tooth | |||
| hypersensitivity | Rosin, Ethyl lactate FCC, Sodium | |||
| fluoride, Flavorant | ||||
| Ultradent | ||||
| Flor-Opal Varnish White | K080249 | 5% sodium fluoride in a | ||
| resin carrier | To treat tooth | |||
| hypersensitivity | Natural resin, Alcohol, Xylitol | |||
| 3M Vanish | ||||
| 5% NaF White Varnish | K880741 | Resin-based fluoride | ||
| varnish | To treat tooth | |||
| hypersensitivity | Rosin ester, n-Hexane, Ethyl | |||
| alcohol, Sodium fluoride, | ||||
| Thickener, Flavor and Color | ||||
| Colgate Duraphat | K945794 | Rosin-based fluoride | ||
| varnish | To treat tooth | |||
| hypersensitivity. | Rosin, Ethyl alcohol, Sodium | |||
| fluoride, Water, Flavorant | ||||
| Voco ReminPro | K101104 | Hydroxyapatite and | ||
| fluoride paste | Prevention and | |||
| control of | ||||
| hypersensitivity | Calcium phosphate, Sodium | |||
| fluoride, Xylitol |
SAFETY AND EFFECTIVENESS:
Activ Vamish 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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, Masachussets 02472
Re: K112946
Trade/Device Name: Pulpdent Activ Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: September 29, 2011 Received: October 6, 2011
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.
DEC - 9 2011
2
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 /ucm11.5809.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,
Anthony V. Amato
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 (if known): K | | 2 946
Device Name: Pulpdent Activ Varnish
Indications For Use:
Activ Varnish is a resin-based varnish, containing 17% Xylitol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions.
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)
Susan Kuener
(Division Sign-Off) (Division of Anesthesiology. General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K112946