(23 days)
No
The summary describes a dental sealant with a fluorescent dye for visualization, not AI/ML technology. There are no mentions of AI, ML, image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is a pit and fissure sealant, which is used for preventive sealing of teeth, not for treating a disease or condition.
No
The device is a pit and fissure sealant used for preventive sealing of teeth, not for diagnosing a medical condition.
No
The device description clearly states it is a pit and fissure sealant containing a dye, indicating it is a physical substance, not software.
Based on the provided information, the DELTON® Illuminating Pit and Fissure Sealant 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. This is a direct treatment or preventative measure applied to the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The description details a sealant material with a fluorescent dye to aid in visual inspection during application. It doesn't describe a test or assay to detect a condition or substance in a sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a specific analyte
- Providing diagnostic information about a disease or condition
The device is a dental material used for a preventative procedure.
N/A
Intended Use / Indications for Use
DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive sealing of pits and fissures in children and adults in primary and secondary dentition in combination with the acid-etch technique.
Product codes
EBC
Device Description
The DELTON® Illuminating Pit & Fissure Sealant is a pit and fissure sealant containing releasable fluoride. The DELTON® Illuminating Sealant contains a dye that is not visible in ordinary light but fluoresces a blue-white upon exposure to UVA light. Fluorescence provides contrast with natural dentition for margin inspection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pits and fissures in primary and secondary dentition (teeth).
Indicated Patient Age Range
Children and adults
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
DELTON® F Pit & Fissure Sealant (K951296)
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
MAY 11 2005
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | April 15, 2005 |
| TRADE OR PROPRIETARY NAME: | DELTON ® Illuminating Pit & Fissure Sealant |
| CLASSIFICATION NAME: | Pit and fissure sealant and conditioner 872.3765 |
| PREDICATE DEVICES: | DELTON® F Pit & Fissure Sealant (K951296) |
DEVICE DESCRIPTION:
The DELTON® Illuminating Pit & Fissure Sealant is a pit and fissure sealant containing releasable The DECTONS mains a dye that is not visible in ordinary light but fluoresces a blue-white upon exposure to UVA light. Fluorescence provides contrast with natural dentition for margin inspection.
INTENDED USE:
DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive sealing of pits and DELT ON® Inummanding in and secondary dentition in combination with the acid-etch technique.
TECHNOLOGICAL CHARACTERISTICS:
There are no changes in use proposed and fundamental technology, light-cured acrylate chemistry, is unchanged.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in all capital letters. The text is arranged in a circular fashion around the eagle.
MAY 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DENTSPLY International Ms. Helen Lewis Director Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K050959
Trade/Device Name: DELTON Illuminating Pit & Fissure Sealant Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: April 15, 2005 Received: April 18, 2005
Dear Ms. Lewis:
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 the Fouchar I Jour, Drag, Inag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or 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 (1 Writ), It they of bacyses in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earred fourther announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 1 Da determination that your device complies with other requirements mean that 1 Dr. I has muse statutes and regulations administered by other Federal agencies. of the Act of ally I out the Act's requirements, including, but not limited to: registration I ou inust comply with are and many (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 807), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in alle qt 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) I mis letter will anon your over substantial equivalence of your device to a premarket notified.com - 110 evice 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), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 ovents 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,
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
3
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): 056959
DELTON® Illuminating Pit & Fissure Sealant Device Name:
Indications for Use:
DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive scaling of pits . . DELTON® Illuminating Pit and Pissure Scalair 15 mailed with the acid-etch technique.
Advertising Claims:
-
- Pit and fissure sealant
-
- Contains releasable fluoride
-
- Fluoresces upon exposure to UVA light
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runnels
. Triston Sign-Off) ് Sision of Anesthesiology, General Hospital, Intection Control, Dental Devices
Number: K050959