DELTON FS DIRECT DELIVERY SYSTEM

K982564 · Dentsply Intl. · EBC · Oct 6, 1998 · Dental

Device Facts

• Record ID: K982564
• Device Name: DELTON FS DIRECT DELIVERY SYSTEM
• Applicant: Dentsply Intl.
• Product Code: EBC · Dental
• Decision Date: Oct 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

The Delton FS Direct Delivery System is a dental device used by clinicians to seal pits and fissures on the occlusal surfaces of caries-susceptible posterior teeth. The system consists of a radiopaque, light-cured, resinous sealant material dispensed via an individually filled cartridge inserted into an applicator handle. The procedure involves applying the sealant to acid-etched tooth surfaces to prevent the ingress of oral fluids, food, and debris. The device is intended for use in a clinical setting to provide a physical barrier against dental caries.

Clinical Evidence

No clinical data provided; substantial equivalence is based on composition, physical property comparisons, and prior use of components in legally marketed predicate devices.

Technological Characteristics

Radiopaque, light-cured, resinous pit and fissure sealant. Delivered via cartridge and applicator handle system. Includes acid-etch gel component. Composition is nearly equivalent to predicate device.

Indications for Use

Indicated for preventive sealing of pits and fissures in primary and secondary dentition in combination with acid-etch technique.

Regulatory Classification

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.

Predicate Devices

• DELTON® Plus Direct Delivery System (K951296)

Reference Devices

• Delton® Etchant Gel (K942031)

Submission Summary (Full Text)

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K982564

DENTSPLY

## 510(k) SUMMARY

NAME & ADDRESS:

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171 845-7511 x [phone]

000013

OCT 6 1998

P. J. Lehn Telefax [phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

K982564

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