SCI-PHARM DFV VARNISH

K982915 · Scientific Pharmaceuticals, Inc. · LBH · Feb 12, 1999 · Dental

Device Facts

• Record ID: K982915
• Device Name: SCI-PHARM DFV VARNISH
• Applicant: Scientific Pharmaceuticals, Inc.
• Product Code: LBH · Dental
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements

Device Story

Sci-Pharm DFV Varnish is a dental cavity varnish consisting of a viscous liquid containing Sodium Fluoride, Colophony resin, and an ethyl alcohol/water solvent. Applied as a thin layer to tooth dentin, the solvent evaporates, leaving a resin film with suspended fluoride. Used by dental professionals in clinical settings to treat tooth sensitivity and provide caries protection under restorations. The device functions via physical barrier formation and fluoride delivery. It is designed for faster curing and reduced initial irritation compared to traditional varnishes by utilizing an azeotropic solvent mixture.

Clinical Evidence

Bench testing only. Equivalence established through comparative chemical and physical analysis including IR spectrophotometry, pyrolysis, viscosity measurements, refractive index measurements, and dry residue determination against predicate devices.

Technological Characteristics

Cavity varnish; viscous liquid. Composition: 71.25% ethyl alcohol, 20% colophony, 5% sodium fluoride, 3.75% water. Solvent system: 95:5 ethyl alcohol/water azeotrope. Principle: solvent evaporation leaves a resin film with suspended fluoride. Professional use only.

Indications for Use

Indicated for patients requiring temporary reduction of tooth sensitivity due to exposed dentin or cementum, reduction of post-operative sensitivity, and caries prevention under restoratives and cements.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• Duraphat (Colgate-Palmolive)
• Durafluor (PharmaScience)

Submission Summary (Full Text)

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## SCIENTIFIC PHARMACEUTICALS, INC.

3221 Producer Way • Pomona, California USA 91768 PHONE: [phone] • Outside California [phone] • FAX: [phone] E-MAIL: [e-mail] · WEBSITE: http://www.scipharm.com

.chemistry working for medicine and dentistry

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- Dr. Jan A. Orlowski (1) Submitted by: Scientific Pharmaceuticals, Inc. 3221 Producer Way Pomona, California 91768 phone: [phone]
Date Prepared: August 18, 1998

- (2) Device Trade Name: Sci-Pham DFV Vamish Dental Varnish Device Common Name: Device Classification Name: Cavity Vamish
- Sci-Pharm DFV Vamish is substantially equivalent to Duraphat by Colgate-Palmolive and (3) Durafluor by PharmaScience (as shown in the table in Point 4 below).

## (4) Chemical Composition

| Ingredient | Sci-Pharm DFV Varnish | Colgate Duraphat |
|-----------------|-----------------------|------------------|
| Ethyl Alcohol | 71.25% | 75% |
| Colophony | 20% | 20% |
| Sodium Fluoride | 5% | 5% |
| Water | 3.75% | <1% |

## Device Function

The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.

- (5) The use of varnishes similar or virtually identical to Sci-Pharm DFV Varnish is accepted worldwide for three major functions:
- temporary reduction of sensitivity of teeth where dentin or cementum is exposed l
- I reduction of post-operative sensitivity
- 트 caries prevention under restoratives and cements
- The technological characteristics (i.e., chemical composition and device function) of Sci-(6) Pharm DFV Varnish are similar to that of cavity varnishes which have been in widespread use for many decades. It is virtually identical to varnishes currently commercially available (Duraphat by Colgate-Palmolive and Durafluor by PharmaScience), the only difference being that it incorporates an azeotrope of ethyl alcohol and water (95:5 ratio) as solvent instead of pure ethyl alcohol, in order to achieve faster cure and reduced potential of initial irritation of very sensitive teeth.
- In order to determine substantial equivalence of Sci-Pharm DFV Varnish to Duraphat and (7) Durafluor, the identity and concentration of solvents (carriers), resin, and fluoride salt comprising Duraphat and Durafluor versus those comprising Sci-Pharm DFV Varnish were determined and confirmed by tests including: IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, and dry residue determination.

Manufacturers of Medical Devices, Fine Chemicals, and Pharmaceuticals

**FLUOROSE.**

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Dr. Jan A. Orlowski Scientific Pharmaceuticals, Incorporated 3221 Producer Way Pomona, California 91768

Re: K982915 Sci-Pharm DFV Varnish Trade Name: Regulatory Class: II Product Code: IBH November 25, 1998 Dated: Received: December 1, 1998

## Dear Dr. Orlowski

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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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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Paqe 2 - Dr. Orlowski

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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K982915 510(k) NUMBER (if KNOWN) :

_SCI-PHARM DFV VARNISH DEVICE NAME:

INDICATIONS FOR USE:

For use as a varnish on sensitive teeth over exposed
ed the formism becamerary restoratives and cements For use as a varnish on sensitive ticen ond cements
dentin and under temporary restoratives and cements dentin and under temporary rebebrating of Concern.

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

FOR PROFESSIONAL USE ONLY *None of the above:

Shon Turner

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