(87 days)
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Not Found
No
The summary describes a dental sealant based on methacrylate resin chemistry and focuses on bench test performance metrics like bond strength and cure time. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device is a pit and fissure sealant, used to prevent dental caries, not to treat a disease or condition.
No
Explanation: The device is a pit and fissure sealant, which is a dental material used for prevention. Its "Intended Use / Indications for Use" clearly states it is a "Pit and fissure sealant," and the "Device Description" elaborates on it being a "single part, light curing, pit and fissure sealant" made from methacrylate resin chemistry. None of the provided information suggests it is used for identifying, detecting, or monitoring a disease or condition.
No
The device description explicitly states it is a "single part, light curing, pit and fissure sealant" based on "methacrylate resin chemistry," indicating 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 "Pit and fissure sealant." This describes a material applied to teeth to prevent cavities, which is a therapeutic or preventative dental procedure, not a diagnostic test performed on samples from the body.
- Device Description: The description states it's a "single part, light curing, pit and fissure sealant" based on "methacrylate resin chemistry." This aligns with the composition of dental materials used for sealing teeth.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition. The performance studies focus on physical properties relevant to a dental sealant (bond strength, cure time, etc.).
Therefore, the device described is a dental sealant, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 3M™ Clinpro™ Sealant can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.
Pit and fissure sealant .
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
3M™ Clinpro™ Sealant is a single part, light curing, pit and fissure sealant. This device, as well as the predicate device, are based on methacrylate resin chemistry.
3M™ Clinpro™ Sealant and the predicate device have similar technological characteristics as indicated by their methacrylate resin chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include Shear Bond Strength, Ambient Light Sensitivity, Cure Time, Depth of Cure, and Uncured Film Thickness.
The 3M™ Clinpro™ Sealant also meets ISO 6874-1988 "Dental resin-based pit and fissure sealants".
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The 3M™ Clinpro™ Sealant and the predicate device have similar technological characteristics as indicated by their methacrylate resin chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include Shear Bond Strength, Ambient Light Sensitivity, Cure Time, Depth of Cure, and Uncured Film Thickness.
Based on the conclusions drawn from the safety analysis conducted on this device and the results of the bench testing, 3M™ Clinpro™ Sealant is safe, effective and performs as well, or better, than the predicate device mentioned above.
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.
3M™ Concise™ Light Cure White Sealant
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
§ 872.3765 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
8 1999
OCT
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Name: | Lael J. Pickett
Regulatory Affairs Specialist |
|----------------------|-------------------------------------------------------------------------------------------|
| Address: | 3M Dental Products Laboratory
3M Center, Building 260-2B-12
St. Paul, MN 55144-1000 |
| Telephone: | 612-733-3594 |
| Fax: | 612-736-0990 |
| Trade Name: | 3MTM ClinproTM Sealant |
| Common Names: | Dental sealant, pit and fissure sealant. |
| Classification Name: | 21 CFR § 872.3765 Pit and fissure sealant, Class II |
| Predicate Devices: | 3MTM ConciseTM Light Cure White Sealant, 3M |
3M™ Clinpro™ Sealant is a single part, light curing, pit and fissure sealant. This device, as well as the predicate device, are based on methacrylate resin chemistry.
The 3M™ Clinpro™ Sealant can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.
3M™ Clinpro™ Sealant and the predicate device have similar technological characteristics as indicated by their methacrylate resin chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include Shear Bond Strength, Ambient Light Sensitivity, Cure Time, Depth of Cure, and Uncured Film Thickness.
The 3M™ Clinpro™ Sealant also meets ISO 6874-1988 "Dental resin-based pit and fissure sealants".
Based on the conclusions drawn from the safety analysis conducted on this device and the results of the bench testing, 3M™ Clinpro™ Sealant is safe, effective and performs as well, or better, than the predicate device mentioned above.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form the shape of a snake wrapped around a staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 0CT
Ms. Lael J. Pickett Regulatory Affairs Specialist 3M Company Dental Products Division 3M Center, Building 260-2B-12 St. Paul, Minnesota 55144-1000
Re: K992326
3M™ Clinpro™ Sealant Trade Name: Regulatory Class: II Product Code: EBC July 7, 1999 Dated: Received: July 12, 1999
Dear Ms. Pickett:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 requlation 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
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Page 2 - Ms. Pickett
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.
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,
Susan Ransom
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Device Name:_3M™ Clinpro™ Sealant
Indications For Use: This device is indicated for:
Pit and fissure sealant .
(Please DO NOT WRITE BELOW THIS LINE - Continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Pamilo. D. Second for Juson finning Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________