(75 days)
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.
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 provided text describes a 510(k) premarket notification for a dental device, DELTON® FS DIRECT DELIVERY SYSTEM, and focuses on its substantial equivalence to a predicate device. This type of submission generally does not include detailed acceptance criteria or a comprehensive study report with quantitative performance metrics as would be found in a De Novo or PMA submission.
However, based on the text, we can infer the primary "acceptance criterion" and the "study" that supports it:
Primary Acceptance Criterion: The physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent to or better than those of DELTON® Plus Pit & Fissure Sealant (the predicate device).
Study Proving Acceptance: The submission states: "The physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant." This implies a comparison study was conducted to demonstrate this equivalence or superiority.
Here's a breakdown based on your requested information, with limitations due to the nature of the provided document:
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A table of acceptance criteria and the reported device performance
Acceptance Criterion Reported Device Performance Physical properties equivalent or better than predicate device Physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant. Nearly equivalent composition to predicate device Nearly equivalent composition. Safety and effectiveness for indicated uses Supported by prior use of components in predicate, nearly equivalent composition, and performance data. -
Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified, but implied to be from internal testing or comparison against established properties of the predicate device. The document does not indicate country of origin or whether it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable to this type of submission. The "ground truth" here is the established physical properties of a dental sealant, likely measured in a lab, rather than expert interpretation of clinical data.
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Adjudication method for the test set
- Not applicable. This is not a study involving human readers or clinical interpretation requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a dental sealant, not an AI-powered diagnostic tool. MRMC studies are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical dental material, not an algorithm.
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The type of ground truth used
- Laboratory measurements of physical properties: The "ground truth" for the comparison is the established physical properties of the predicate device (DELTON® Plus Pit & Fissure Sealant) and the newly measured physical properties of DELTON® FS PIT & FISSURE SEALANT.
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The sample size for the training set
- Not applicable. This is not a machine learning model.
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How the ground truth for the training set was established
- Not applicable. This is not a machine learning model.
Summary of the "Study":
The "study" referenced in the 510(k) summary is a comparative analysis of the physical properties of the new device (DELTON® FS PIT & FISSURE SEALANT) against its predicate device (DELTON® Plus Pit & Fissure Sealant). The applicant states that the new device's properties are "equivalent or better." Additionally, the submission relies on the "nearly equivalent composition" to the predicate device and the fact that "all of the components found in DELTON® FS PIT & FISSURE SEALANT have been used in the predicate dental device" to argue for its safety and effectiveness without requiring extensive new clinical testing or toxicity testing beyond what was already established for the predicate. This approach is standard for demonstrating substantial equivalence in many 510(k) submissions for similar devices.
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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.
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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.
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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 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
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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
§ 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.