(82 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 sealant for preventive sealing and lining, which are prophylactic and restorative uses, not explicitly therapeutic.
No
Explanation: The device is a sealant for preventive sealing of pits and fissures, which is a treatment or preventive measure, not a diagnostic one.
No
The intended use describes a sealant material, which is a physical substance applied to teeth, indicating it is a hardware device, 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 for the preventive sealing of pits and fissures in teeth and as a sealant/lining under amalgam restorations. This is a direct application to the patient's body for a therapeutic or preventative purpose.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve the analysis of any such specimens.
Therefore, the Premier Self-Etching Enamel Sealant is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.
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
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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
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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 a black and white drawing of three birds flying in formation. The birds are stylized with simple lines, giving them a modern and abstract look. The birds are flying in the same direction, with their wings slightly curved upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OLT = 4 2006
Mr. Vince Di Alessandro Regulatory Manager Premier Dental Products. Company 1710 Romano Drive Plymouth Meeting. Pennsylvania 19462
Re: K061997
Trade/Device Name: Premier Self-Etching Enamel Scalant Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: Il Product Code: EBC Dated: July 13, 2006 Received: July 14, 2006
Dear Mr. Alessandro:
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.
1
Page 2 – Mr. Alessandro
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 clectronic 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 vour 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
C. Lin, Ph.D.
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
2
STATEMENT OF INDICATIONS FOR USE
| 510(k) Number (If known): | () 06 K161647 |
|---|---|
| --------------------------- | ----------------- |
Device Name: Premier Self-Etching Enamel Sealant
- Indications for use: Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mellon for USSR
lesthesiology, General Hospital,
Number: K061997