(79 days)
Not Found
No
The summary describes a resin-based varnish and does not mention any AI or ML components or functionalities.
Yes
The device is used for "professional treatment of dental hypersensitivity," indicating a therapeutic purpose to alleviate symptoms.
No
The device description states it 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." This describes a treatment, not a diagnostic process.
No
The device is a resin-based varnish, which is a physical substance applied to teeth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the professional treatment of dental hypersensitivity by applying a varnish to enamel or dentin. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces that it's a varnish applied to enamel or dentin.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
76 LBH
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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510(k) Number: K100503