(77 days)
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Not Found
No
The summary describes a dental sealant and does not mention any AI or ML capabilities.
No.
The device is a light-activated dental sealant and surface glaze used for sealing pits and fissures and for denture/orthodontic retention, which are preventative or supportive functions, not therapeutic.
No
The device is a sealant/surface glaze, not a tool for diagnosing medical conditions.
No
The device description clearly indicates a physical product ("light-activated dental sealant") and its application to anatomical sites ("anterior and posterior teeth; denture and orthodontic retention systems"). There is no mention of software as the primary or sole component.
Based on the provided information, the Bosworth Seal is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a dental sealant for sealing pits and fissures of teeth, a surface glaze for dentures, and for orthodontic retention systems. These are all applications performed directly on or in the patient's mouth, or on dental prosthetics.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The Bosworth Seal's function is to physically seal and glaze surfaces, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Bosworth Seal is a light-activated dental sealant for sealing pits and fissures of anterior and posterior teeth.
The Bosworth Seal is a surface glaze and is used for denture and temporary crown and bridge fabrication systems.
Product codes
EBC
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
anterior and posterior teeth, denture, temporary crown and bridge
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three heads or faces, represented by curved lines.
Public Health Service
JUL 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Re: K051224
Trade/Device Name: Bosworth Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: May 6, 2005 Received: May 24, 2005
Dear Ms. Goldstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufavituring 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 (1 Nr.), I har ob daily 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 - Ms. Goldstein
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I Dri 3 issualled on that your device complies with other requirements mean that IDA nas made a dotening and regulations administered by other Federal agencies. of the Act of ally I ederal states and regurements, including, but not limited to: registration 1 ou must comply with an the rise ing (21 CFR Part 801); good manufacturing practice and ilsung (21 CFR Part 007), laceling (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality ijon 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) This letter will anow you to begal mailoring of substantial equivalence of your device to a premarket notification. The PDF Intellig on 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), If you desire specific advice for your de 100 at 100 miles of 15. Also, please note the regulation in 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Diviser (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suzette y. Michael Davis
Chiu Lin, Ph.D. 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: K05/224
Device Name: Bosworth Seat
INDICATIONS FOR USE:
Bosworth Seal is a light-activated dental sealant for sealing pits and Bosworth Ocal is a light a light and posterior teeth.
The Bosworth Seal is a surface glaze and is used for denture and The Bosworth Seat 15 a Surface gration systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use OR Prescription Use (Optional Format 1/2/96) (Per 21 CFR 801.109) CONFIDENTIAL (Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number.