(75 days)
No
The summary describes a dental sealant and delivery system, with no mention of AI or ML capabilities.
No
The device is used for preventive sealing of pits and fissures to prevent dental caries, which is a preventive measure rather than a therapeutic treatment for an existing condition.
No
The device is described as a "preventive sealing" system for pits and fissures, aimed at preventing tooth decay rather than identifying or diagnosing a condition. Its function is to apply a sealant material.
No
The device description clearly outlines physical components like a resinous material, etchant gel, cartridges, and an applicator handle, indicating it is a hardware-based medical device.
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. This is a direct treatment or preventive measure applied to the patient's body (the teeth).
- Device Description: The device is a sealant material and a delivery system for applying it to the tooth surface. This is a physical intervention on the patient.
- Lack of In Vitro Testing: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve testing any bodily specimens.
The device is a dental sealant system used for a preventive procedure directly on the patient's teeth. This falls under the category of a medical device used for treatment or prevention, not an IVD.
N/A
Intended Use / Indications for Use
The DELTON® FS DIRECT DELIVERY SYSTEM is used for preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
DELTON® FS PIT & FISSURE SEALANT is a radiopaque, light cured, resinous material designed for application to the occlusal surfaces of caries susceptible posterior teeth to seal irregularities and prevent ingress of oral fluids, food and debris.
DELTON® FS DIRECT DELIVERY SYSTEM also includes Delton® Etchant Gel, a DENTSPLY legally marketed device (K942031). The sealant is dispensed to the acid-etched tooth via an individually filled cartridge inserted into the applicator handle (Direct Delivery System).
The physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant.
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 physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
DELTON® Plus Direct Delivery System K951296
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.
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
DENTSPLY
510(k) SUMMARY
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171 845-7511 x (717) 854-2343
000013
OCT 6 1998
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
July 22, 1998 DATE PREPARED:
TRADE OR PROPRIETARY NAME DELTON® FS-DIRECT DELIVERY SYSTEM
CLASSIFICATION NAME: Pit and fissure sealant and conditioner 872.3765
PREDICATE DEVICES: DELTON® Plus Direct Delivery System K951296
DEVICE DESCRIPTION: DELTON® FS PIT & FISSURE SEALANT is a radiopaque, light cured, resinous material designed for application to the occlusal surfaces of caries susceptible posterior teeth to seal irregularities and prevent ingress of oral fluids, food and debris.
DELTON® FS DIRECT DELIVERY SYSTEM also includes Delton® Etchant Gel, a DENTSPLY legally marketed device (K942031). The sealant is dispensed to the acid-etched tooth via an individually filled cartridge inserted into the applicator handle (Direct Delivery System).
The physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant.
INTENDED USE: DELTON® FS DIRECT DELIVERY SYSTEM is used for preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.
TECHNOLOGICAL CHARACTERICS: All of the components found in DELTON® FS PIT & FISSURE SEALANT have been used in the predicate dental device. Beeause of the nearly equivalent composition, no additional toxicity testing was necessary.
We believe that the prior use of the components of DELTON® FS DIRECT DELIVERY SYSTEM in the legally marketed predicate device, the nearly equivalent composition to the predicate device. and the performance data support the safety and effectiveness of DELTON® FS DIRECT DELIVERY SYSTEM for the indicated uses.
1
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of human faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1998
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re : K982564 Trade Name: Delton® FS Director Delivery System Regulatory Class: II Product Code: EBC Dated: July 22, 1998 Received: July 23, 1998
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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. A 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 Reqister. 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.
2
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 regulation (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.fday.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
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
Device Name: DELTON®FS DIRECT DELIVERY SYSTEM
The DELTON® FS DIRECT DELIVERY SYSTEM is used for preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
510(K) Number:
OR
Over-The-Counter Use _
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .
000007