Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.

Device Description

Pulpdent CAVITY CLEANSER PLUS combines all the features of Pulpdent CAVITY CLEANSER with the addition of sodium fluoride.

AI/ML Overview

This document is a 510(k) Premarket Notification for PULPDENT Cavity Cleanser and PULPDENT Cavity Cleanser Plus. It is a regulatory submission to the FDA, asserting substantial equivalence to existing predicate devices, rather than a study designed to establish acceptance criteria or device performance in the typical sense of a clinical trial or algorithm validation.

Therefore, the requested information pertaining to acceptance criteria, specific performance metrics, sample sizes for testing/training sets, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as these concepts are not applicable to this type of regulatory submission.

This document focuses on:

Device Name: Pulpdent Cavity Cleanser and Pulpdent Cavity Cleanser Plus
Predicate Devices: Ultradent UltraCid and UltraCid F, Ultradent Concepsis, Dental Therapeutics AB Tubulicid Plus, Tubulicid Blue Label, Tubulicid Red Label
Description and Intended Use: To cleanse and moisten cavity preparations prior to sealing dentin tubules or placing an adhesive that bonds to damp tooth structure. Can be used under veneers, inlays, crowns, onlays, amalgams, and composite resins. The "Plus" version includes sodium fluoride.
Comparison with Predicate Products: Stated to be "substantially equivalent in composition and intended use to the predicate products."
Safety and Effectiveness: Stated that "The materials that make up these products are accepted by the Council on Dental Therapeutics and have been used safely in dental products for decades." References are provided in Exhibit 8 (not included in the provided text).

The FDA's response (MAR 19 1998) confirms that they "reviewed your Section 510(k) notification... 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." This is a regulatory finding, not a performance study.

Summary

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510 k Premarket Notification

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EXHIBIT 2

MAR 1 9 1998

RESPONSE TO SMDA OF 1990

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown. MA 02272-0780 USA TELEPHONE: (617) 926-6666 (617) 926-6262 FAX:

PULPDENT Cavity Cleanser and DEVICE NAME: PULPDENT Cavity Cleanser Plus

Ultradent UltraCid and UltraCid F PREDICATE DEVICES: Ultradent Concepsis Dental Therapeutics AB Tubulicid Plus Tubulicid Blue Label Tubulicid Red Label

DESCRIPTION AND INTENDED USE:

Pullodent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.

Pulpdent CAVITY CLEANSER PLUS combines all the features of Pulpdent CAVITY CLEANSER with the addition of sodium fluoride.

COMPARISON WITH PREDICATE PRODUCTS: Pulpdent CAVITY CLEANSER and CAVITY CLEANSER PLUS are substantially equivalent in composition and intended use to the predicate products. Please see Exhibit 4 for the entire comparison.

SAFETY AND EFFECTIVENESS: The materials that make up these products are accepted by the Council on Dental Therapeutics and have been used safely in dental products for decades. Please see Exhibit 8 for the complete references,

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1998

Mr. Kenneth J. Berk ·Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02272

Re : K974202 Pulpdent Cavity Cleanser, Pulpdent Cavity Trade Name: Cleanser Plus Regulatory Class: III Product Code: ГВН Dated: January 29, 1998 Received: February 3, 1998

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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulations, Title 21, Parts 800 to-895. A ------substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (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 section 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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Page 2 - Mr. Berk

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy Be advised that under Section 519(e) of the Act as enclosed). amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

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 regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address

"http://www.fda.gov/cdrh/dsma/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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510(k) Number (if known): _ K 974202__________________________________________________________________________________________________________________________________________

CAVITY CLEANSER Device Name: PULPDENT

Indications I-or Usc:

DESCRIPTION AND INTENDED USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEDI

Concurrence of CORH, Office of Device Evaluation (ODE)

	Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K974262

Prescription Use		Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
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.(b)
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.