(217 days)
Not Found
Not Found
No
The summary describes a dental coating material and desensitizer, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is described as a desensitizer to relieve dentin hypersensitivity, indicating a direct therapeutic action on the tooth.
No
The device is described as a "tooth surface coating material as well as desensitizer to relieve dentin hypersensitivity." Its function is therapeutic (coating, desensitizing), not diagnostic (identifying or characterizing a disease or condition).
No
The device is described as a "light-cured two-component mixing type, tooth surface coating material as well as desensitizer," which clearly indicates it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "tooth surface coating material as well as desensitizer to relieve dentin hypersensitivity." This describes a device that is applied directly to the tooth surface for a therapeutic purpose (relieving sensitivity).
- IVD Definition: In vitro diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
This device does not involve the examination of specimens from the human body in vitro. It is a material applied directly to the body.
N/A
Intended Use / Indications for Use
PRG BARRIER COAT, is a light-cured two-component mixing type, tooth surface coating material as well as desensitizer to relieve dentin hypersensitivity.
Product codes
LBH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tooth surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2013
Mr. David-P .- Morais -Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive SAN MARCOS CA 92078
Re: K122908
Trade/Device Name: PRG BARRIER COAT Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: April 10, 2013 Received: April 11, 2013
Dear Mr. Morais:
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.
1
Page 2 - Mr. Morais
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 vours.
Digitally signed by Mary S. Runner -S
ON: C=US, OU.S. Government,
Ou HHS, ou FDA, ou People,
Susan Runner, DOSMA Man Sumner
DU
0.9.2342.19200300.100.1.1-130008795
0
Date: 2013.04.26 12:39:29-04'00'
Anthony D. Watson, B.S., M.S., M.B.A. Director
. Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K122908
Device Name: PRG BARRIER COAT
_Indications_For_Use: --------
PRG BARRIER COAT, is a light-cured two-component mixing type, tooth sufface coating material as well as desensitizer to relieve dentin hypersensitivity.
Prescription Use (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)
Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government, ou=HHS,
Susan Runner, DDS,MA ou=FDA, ou=People, cn=Mary S. Runner -
5,0.9.2342.19200300.100.1.1=1300087950
Date: 2013.04.26 14:42:54 -04′00′ IX
Shofu Dental Corporation PRG BARRIER COAT 510(k) Premarket Notification
(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number:_K(229)