(127 days)
Not Found
Not Found
No
The summary describes a dental sealant, a material-based device, and contains no mention of software, image processing, AI, or ML.
No.
The device is a sealant for teeth, which is a preventive measure rather than a therapeutic treatment for a disease or condition.
No
This device is a sealant used for filling fissures in teeth, which is a treatment rather than a diagnostic function.
No
The device is described as a "BisGMA based light cured resin," which 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 to seal and fill fissures in teeth. This is a direct treatment applied to the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: While the description is "Not Found," the intended use clearly indicates a dental material applied directly to the tooth.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological samples.
IVDs are devices used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This dental sealant does not fit that description.
N/A
Intended Use / Indications for Use
SeLECT Defense Dental Pit and Fissure Sealant is a BisGMA based light cured resin for the sealing of deciduous teeth and the filling of fissures in primary tooth structure.
Product codes
EBC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
deciduous teeth, primary tooth
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes extending from its back, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jill Davis ClassOne Orthodontics, Incorporated 5064 50th Street Lubbock, Texas 79414
FEB - 4 2010
Re: K093059
Trade/Device Names: SeLECT Defense Dental Pit and Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: January 21, 2010 Received: January 25, 2010
Dear Ms. Davis:
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
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,
Nh far
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
2
510(k) Number (if known):
Device Name: SeLECT Defense Dental Pit and Fissure Sealant
Indications for Use: SeLECT Defense Dental Pit and Fissure Sealant is a BisGMA based light cured resin for the sealing of deciduous teeth and the filling of fissures in primary tooth structure. . . . . . . . .
Indications for Use
| Prescription Use X
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use N/A
(Part 21 CFR 801 Subpart C) |
| --------------------------------------------------- | -------- | --------------------------------------------------------- |
|---|
| Division Sign-Off) | Re. M. |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation(ODE) | MSR |
Division of Anesthesiology, General Hospital Page 2.1
Infection Control, Dental Devices
| 10(k) Number: | K093059 |
|---|---|
| --------------- | --------- |