(30 days)
Not Found
No
The summary describes a dental sealant material with fluoride release, focusing on its physical properties and intended use for sealing pits and fissures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is used for preventive sealing to protect teeth, not to treat an existing medical condition or disease.
No
The device is a sealant used for preventive sealing of pits and fissures, which is a treatment or preventive measure, not a diagnostic one.
No
The device description clearly states it is a "light curing pit and fissure sealant containing releasable fluoride," 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 "preventive sealing of pits and fissures in the primary and secondary dentition." This is a direct application to the patient's teeth for a preventative measure.
- Device Description: The description details a "light curing pit and fissure sealant" that is applied to the teeth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a dental sealant.
N/A
Intended Use / Indications for Use
Used for preventive sealing of pits and fissures in the primary and secondary dentition.
Product codes
EBC, EBF
Device Description
DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is a light curing pit and fissure sealant containing releasable fluoride offers an additional protection of the sealed pits and fissures.
The physical properties of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT meet ISO Standard 6874.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pits and fissures in the primary and secondary dentition
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)
The results of Ames testing on the main components were negative.
We believe that biocompatibility studies with the final formulation are not necessary, due to the prior use of all components in DENTSPLY legally marketed devices.
Therefore, we believe that the prior use of the components of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT in legally marketed devices, the similarity in composition to the predicate device, the performance data, and the results of Ames and previous biocompatibility testing support the safety and effectiveness of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT for the indicated uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982564 Delton® FS Direct Delivery System, K982395 Dyract® Flow Restorative
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
510(k) SUMMARY
NAME & ADDRESS:
DENTSPLY International
0 West College Avenue ork. PA 17405-0872 171845.7511 17,854,2343
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
DATE PREPARED:
TRADE OR PROPRIETARY NAME: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT
872.3765 CLASSIFICATION NAME: Pit and fissure sealant and conditioner
K982564 Delton® FS Direct Delivery System PREDICATE DEVICES: K982395 Dyract® Flow Restorative
DEVICE DESCRIPTION: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is a light curing pit and fissure sealant containing releasable fluoride offers an additional protection of the sealed pits and fissures.
The physical properties of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT meet ISO Standard 6874.
INTENDED USE: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is used for preventive sealing of pits and fissures in the primary and secondary dentition.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT have been used in legally marketed devices.
The results of Ames testing on the main components were negative.
We believe that biocompatibility studies with the final formulation are not necessary, due to the prior use of all components in DENTSPLY legally marketed devices.
Therefore, we believe that the prior use of the components of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT in legally marketed devices, the similarity in composition to the predicate device, the performance data, and the results of Ames and previous biocompatibility testing support the safety and effectiveness of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Requlatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 17405-0872 York, Pennsylvania
K992516 Re: Dyract® Seal Composer Pit & Fissure Sealant Trade Name: Regulatory Class: II EBC and EBF Product Code: Dated: July 27, 1999 Received: July 28, 1999
Dear Mr. Lehn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Lehn
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Device Name: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT
Used for preventive sealing of pits and fissures in the primary and secondary dentition.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Ryan
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.
000007