PULPDENT CAVITY PREPARATION III

K994180 · Pulpdent Corp. · LBH · Mar 2, 2000 · Dental

Device Facts

• Record ID: K994180
• Device Name: PULPDENT CAVITY PREPARATION III
• Applicant: Pulpdent Corp.
• Product Code: LBH · Dental
• Decision Date: Mar 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2

Intended Use

Pulpdent Cavity Preparation III 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 Preparations III, a solution of glutaraldehyde and water, 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. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.

Device Story

Pulpdent Cavity Preparation III is a liquid solution containing glutaraldehyde, water, and sodium fluoride. Used by dental professionals in clinical settings during tooth preparation for various restorations (veneers, inlays, crowns, onlays, amalgam, composite). Applied to tooth structure to clean and moisten surfaces, facilitating bonding with adhesives requiring moisture and sealing dentin tubules. Cleansing action intended to reduce microleakage sensitivity. Sodium fluoride included for solution stability; no therapeutic claims made for fluoride content.

Clinical Evidence

No clinical data provided; relies on literature references suggesting cleansing steps reduce microleakage sensitivity.

Technological Characteristics

Chemical solution consisting of glutaraldehyde, water, and sodium fluoride. Formulated for topical application to tooth structure. No electronic, software, or mechanical components.

Indications for Use

Indicated for dental professionals preparing teeth for veneers, inlays, crowns, onlays, amalgam, and composite resin restorations; cleans and moistens tooth structure to facilitate bonding and seal 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2000

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

Re: K994180 Pulpdent Cavity Preparation III Trade Name: Regulatory 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, 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, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 -- Mr. Berk

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 deberibed in your sieth, promalence 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 diaqnostic 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 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

510 (k) Number (if known)

K 994480

PULPDENT CAVITY PREPARATION III Device Name

Indications for Use:

Pulpdent Cavity Preparation III 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 Preparations III, a solution of glutaraldehyde and water, 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. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution. 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

Sinem Rimmer

· Sign Off) of Dental, Infection Contro eneral Hospital Devices 10(k) Number_10994181