PULPDENT CAVITY PREPARATION IV

K013411 · Pulpdent Corp. · LBH · Dec 12, 2001 · Dental

Device Facts

• Record ID: K013411
• Device Name: PULPDENT CAVITY PREPARATION IV
• Applicant: Pulpdent Corp.
• Product Code: LBH · Dental
• Decision Date: Dec 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpdent Cavity Preparation IV 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 IV, 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. No claim as to the antimicrobial effect of chlorhexidine gluconate.

Device Story

Pulpdent Cavity Preparation IV is an aqueous solution of chlorhexidine gluconate used by dental professionals in clinical settings. The solution is applied to tooth structures during the preparation phase for various dental restorations (veneers, inlays, crowns, onlays, amalgam, and composite resins). The device functions by cleaning and moistening the tooth surface, which facilitates bonding with adhesives requiring moist surfaces and aids in sealing dentin tubules. This process is intended to reduce micro-leakage sensitivity in teeth undergoing restorative treatment. The device is applied directly by the clinician as part of the standard restorative workflow.

Clinical Evidence

No clinical data provided. The safety and effectiveness are supported by the long-term historical use of the constituent materials in dentistry and their classification as Class II dental devices.

Technological Characteristics

Aqueous solution of chlorhexidine gluconate. Classified as a cavity varnish under 21 CFR 872.3260. Product code LBH.

Indications for Use

Indicated for use by dental professionals during the preparation of teeth for veneers, inlays, crowns, onlays, amalgam, and composite resin restorations to clean and moisten tooth structure 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.

Predicate Devices

• Pulpdent Cavity Preparation II
• Ultradent: Consepsis
• BISCO Cavity Cleanser

Submission Summary (Full Text)

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PULPDENT CORPORATION

510 k Premarket Notification Pulpdent Cavity Preparation IV

## EXHIBIT 4

RESPONSE TO SMDA OF 1990

DEC 1 2 2001

9

# SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

617-926-6666 Telephone: [phone] Fax:

DEVICE NAME:

PULPDENT Cavity Preparation IV

## PREDICATE DEVICES:

Pulpdent Cavity Preparation II Ultradent: Consepsis BISCO Cavity Cleanser

# DESCRIPTION AND INTENDED USE:

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

restorations.
Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidire majot surfaces Pulpdent Cavity Preparation TV, "an aquodo ovith adhesives that require moist surfaces.
and moistens tooth structure to facilitate bonding with adhesives that this and molstens toom structure to laumate of laings. Recent studies have suggested this this It can also be used prior to sealing dontin tubers. Treeth undergoing treatment of cleansing step Teddes Thilor loakers sentimicrobial effect of chlorhexidine gluconate.

# COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent Cavity Preparations are substantially equivalent in composition and intended Pulpdent Cavity Preparations are Gabotantian) Squrantialy Squarantire comparison.
use to the predicate products listed above. Please see Exhibit 5 for the entire compariso

#### SAFETY AND EFFECTIVENESS:

The materials that make up these products are accepted by the Council on Dental The materials that make up those products for decades. In addition, the Therapedits and have been used ballery in dones proval as Class II Dental Devices under CFR 872.3260.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2001

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P. O. Box 780 Watertown, Massachusetts 02471-0780

Re: K013411

Trade/Device Name: Pulpdent Cavity Preparation Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 9, 2001 Received: October 15, 20001

Dear Mr. Berk:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 970(2) proceed.
referenced above and have determined the device is substantially equivalent (for the referenced above and have decembered to legally marketed predicate devices marketed in indications for use stated in the ensiesary to enginent date of the Medical Device interstate collinetee prior to may 20, 1978, as a secondance with the provisions of Amendments, or to de vices that nave oose (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmene 110 (110) ................................................................................................................................ apploval application (1 Nirry) - 1 The general controls provisions of the Act include controls provisions of the Fict - First Jisting of devices, good manufacturing practice, requirements for aid prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classinod (500 a0010) in the subject to such and the major regulations affecting (FMA), it may of subject to sach adding the end Regulations, Title 21, Parts 800 to 898. In your device can be found in the South nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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### Page 2 - Mr. Berk

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally receitar statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements, including, but not limited to pressio You must comply with an this Free Free Free 21 CFR Part 801); good manufacturing practice and if in the (21 CFR I att 607), laceling (21 CFR Pat 820); and if requirents as set form in the quality of exceller (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to begin manoching your substantial equivalence of your device to 510(K) premarket nourceation. 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 II you desire specific advice for your for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 609-4613. Additionally, for questions on the promotion and Office of Comphance at [phone] contact the Office of Compliance at [phone]. advertising or your a ...
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutication (ZTCI K Part 007.97). Oaks golds Manufacturers, International and the Act may be obtained from the Brumber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

[Signature]

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATIONS FOR USE STATEMENT

KU13411

510 (k) Number (if known)

#### PULPDENT CAVITY PREPARATION IV Device Name

Indications for Use:

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

Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. These molsteris toom Straotars to taoling dentin tubules. Recent studies have suggested that products our alle be acouces micro leakage sensitivity in teeth undergoing treatment or this "olounting" otop" (ourses no claim as to the antimicrobial effect of chlorhexidine gluconate.

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