DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT

K991909 · Dentsply Intl. · EBC · Aug 20, 1999 · Dental

Device Facts

• Record ID: K991909
• Device Name: DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
• Applicant: Dentsply Intl.
• Product Code: EBC · Dental
• Decision Date: Aug 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT is used for preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.

Device Story

DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT is a visible light-cured, radiopaque, resinous material. It is applied to occlusal surfaces of caries-susceptible posterior teeth to seal irregularities and prevent ingress of oral fluids, food, and debris. The device is used in a clinical setting by dental professionals. It is dispensed via an individually filled cartridge inserted into an applicator handle (Direct Delivery System) onto acid-etched tooth surfaces. The sealant provides a physical barrier to prevent dental caries.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and comparison of physical properties to predicate devices.

Technological Characteristics

Visible light-cured, radiopaque, resinous material. Delivered via cartridge and applicator handle. Components are identical to those used in previously cleared predicate dental devices.

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 Pit & Fissure Sealant (K951296)
• DELTON® FS Direct Delivery System (K982564)

Reference Devices

• DELTON® Etchant Gel (K942031)

Submission Summary (Full Text)

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AUG 20 1999

## 510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

#### DENTSPLY International

K99 1988

570 West College Avenue P.O. Box 872 York, PA 17405-0872 17 845-7511 717 854-2343

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

June 3, 1999 DATE PREPARED:

DELTON® FS WITH FLUORIDE PIT & FISSURE TRADE OR PROPRIETARY NAME: SEALANT 872.3765 CLASSIFICATION NAME: Pit and fissure sealant and conditioner

K951296 DELTON® Plus Pit & Fissure Sealant PREDICATE DEVICES: K982564 DELTON® FS Direct Delivery System

DEVICE DESCRIPTION: DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT is a visible light-cured, radiopaque, 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 WITH FLUORIDE PIT & FISSURE SEALANT 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 WITH FLUORIDE PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant and DELTON® FS Direct Delivery System.

INTENDED USE: DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT is used for preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT have been used in the predicate dental devices. Because of the nearly equivalent composition, no additional toxicity testing was necessary.

We believe that the prior use of the components of DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT in the legally marketed predicate devices, the nearly equivalent composition to the predicate devices, and the performance data support the safety and effectiveness of DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT for the indicated uses.

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Public Health Service

Image /page/1/Picture/11 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract, flowing shapes that resemble human profiles or birds in flight.

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AUG 20 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

K991909 Re : DELTON® FS With Fluoride Pit & Fissure Trade Name: Sealant Regulatory Class: II Product Code: EBC Dated: June 3, 1999 June 7, 1999 Received:

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 The general controls provisions of the Act 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 (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.

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Page 2 - Mr. Lehn

this response to your premarket notification Please note: 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.

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 requlation (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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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)

510(K) Number:

K991909

# Device Name: DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT

DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT 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

✓

OR

Over-The-Counter Use_

Susan Runge

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

0000000