(84 days)
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No
The document describes a dental sealant and does not mention any AI or ML components or functionalities.
No.
The device is a sealant used to prevent dental caries, which is a preventive measure rather than a therapeutic treatment for an existing condition.
No
The device is described as a "dental sealant for sealing pits and fissures," which is a treatment or preventive measure, not a diagnostic one. There is no mention of it being used to detect, identify, or assess a condition.
No
The device description clearly states it is a "light-activated dental sealant," which is a physical material applied to teeth, 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 of this device is to seal pits and fissures in teeth, which is a direct application to the body, not an examination of a specimen taken from the body.
- The description focuses on a dental sealant. The device description clearly states it's a "light-activated dental sealant." This is a material applied to teeth for a therapeutic or preventative purpose, not a diagnostic test.
The information provided describes a dental material used for a preventative dental procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Pit & Fissure Sealant with Fluoride is available in clear, opaque and tintcd shades, when different shades are indicated for use.
Product codes
EBC
Device Description
Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Pit & Fissure Sealant with Fluoride is available in clear, opaque and tintcd shades, when different shades are indicated for use.
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
primary or permanent posterior teeth
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 4 2003
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076-3999
Re: K031811
Trade/Device Name: Pit & Fissure Sealant with Fluoride Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant Regulatory Class: II Product Code: EBC Dated: June 9, 2003 Received: June 19, 2003
Dear Ms. Goldstein:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Ms. Goldstein
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runov
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(K) Number: K031811
Device Name: Pit & Fissure Sealant with Fluoride
INDICATIONS FOR USE:
Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.
The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades, when differen! shades are indicated for use.
Kevin Mulvey for MCR
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031811
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEI:DED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-the-Counter Use (Optional Format 1/2/96)