PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE

K994181 · Pulpdent Corp. · LBH · Feb 29, 2000 · Dental

Device Facts

• Record ID: K994181
• Device Name: PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
• Applicant: Pulpdent Corp.
• Product Code: LBH · Dental
• Decision Date: Feb 29, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2

Intended Use

Pulpdent Cavity Preparation II is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation II. an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate. Pulpdent Cavity Preparation II with Fluoride combines all the features of Pulpdent Cavity Preparation II with the addition of sodium fluoride as a stabilizer. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.

Device Story

Pulpdent Cavity Preparation II is an aqueous solution containing chlorhexidine gluconate; a version with sodium fluoride as a stabilizer is also available. Used by dental professionals in clinical settings during tooth preparation for various restorations (veneers, inlays, crowns, onlays, amalgam, composite). The solution cleans and moistens tooth structure to facilitate bonding with adhesives requiring moist surfaces and to seal dentin tubules. Application is intended to reduce micro-leakage sensitivity. No antimicrobial or therapeutic claims are made for the active ingredients.

Clinical Evidence

No clinical data provided; device relies on established use of chlorhexidine gluconate in dental procedures.

Technological Characteristics

Aqueous solution containing chlorhexidine gluconate; version with sodium fluoride stabilizer. Chemical-based dental preparation agent.

Indications for Use

Indicated for dental professionals to clean and moisten tooth structure during preparation for veneers, inlays, crowns, onlays, amalgam, and composite resin restorations; facilitates bonding with adhesives requiring moist surfaces and used prior to sealing dentin tubules.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 9 2000

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re : K994181 Pulpdent Cavity Preparation II Trade Name: Requlatory Class: II Product Code: LBH Dated: December 7, 1999 Received: December 10, 1999

Dear Mr. Berk:

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 registration, 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 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 Manufacturinq Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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

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Page 2 - Mr. Berk

Please note: this response to your the Federal Register. 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.

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 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,

Patricia Cucentiffor

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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## INDICATIONS FOR USE STATEMENT

19994181

510 (k) Number (if known)

## Device Name: PULPDENT CAVITY PREPARATION II

Indications for Use:

Pulpdent Cavity Preparation II is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations.

Pulpdent Cavity Preparation II. an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate.

Pulpdent Cavity Preparation II with Fluoride combines all the features of Pulpdent Cavity Preparation II with the addition of sodium fluoride as a stabilizer. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.

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

Susan Rumm

(Division Sign-Off Division of Dental. Infection Con and General Hospital Devic 510(k) Number