PULPDENT CALCIUM HYDROXIDE PREPARATION is a biocompatible polydimethylsiloxanebased root canal sealer used for the temporary and permanent filling of root canals after endodontic surgery. PULPDENT CALCIUM HYDROXIDE PREPARATION can be used on its own, in conjunction with Gutta Percha and for vital pulpdectomies in deciduous teeth.

Device Description

PULPDENT CALCIUM HYDROXIDE PREPARATION is a biocompatible polydimethylsiloxane-based root canal sealer used for the temporary and permanent filling of root canals after endodontic surgery. PULPDENT CALCIUM HYDROXIDE PREPARATION can be used on its own, in conjunction with Gutta Percha and for vital pulpectomies in deciduous teeth.

AI/ML Overview

This document is a 510(k) premarket notification for a dental device, the "PULPDENT CALCIUM HYDROXIDE PREPARATION." The review of this document confirms that it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria through testing.

Instead, this SSED (Summary of Safety and Effectiveness Data) relies on the concept of substantial equivalence to predicate devices. It states that the device is "substantially equivalent in design, composition and intended use" to existing, legally marketed predicate devices. The safety and effectiveness are supported by:

General usage of predicate products: "General usage of the predicate products over about 5 years indicates a high benefit-to-risk ratio."
Lack of reported issues with predicate devices: "There is no evidence of short-term or long-term risk or suspicion of any problems."
Existing 510(k) approvals for predicate devices: The predicate products have already received 510(k) Premarket approval.
References to clinical literature: Several references are provided, which appear to discuss the use of iodoform paste and calcium hydroxide in endodontic procedures, likely supporting the concept of using such materials, rather than directly evaluating the specific performance of this device.

Therefore, since no specific performance study was conducted for this device as part of this 510(k) submission, the requested information elements cannot be extracted from the provided text. The device's clearance is based on its similarity to already approved devices, not on new performance data demonstrating its adherence to specific acceptance criteria.

Response regarding Acceptance Criteria and Study:

The provided document, a 510(k) Summary of Safety and Effectiveness Data for the "PULPDENT CALCIUM HYDROXIDE PREPARATION," does not contain information about specific acceptance criteria or a study designed to prove the device meets these criteria.

Instead, the device's clearance is based on the principle of substantial equivalence to predicate devices. The rationale for safety and effectiveness is derived from the established history and prior approvals of those predicate devices, rather than new performance data for the subject device against defined acceptance criteria.

Therefore, the following information cannot be provided from the given document:

A table of acceptance criteria and the reported device performance: Not available.
Sample sized used for the test set and the data provenance: Not applicable, as no dedicated test set for performance evaluation of this specific device is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI/imaging device).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

EXHIBIT 2

K0227341

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PQ Box 780 Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 Email: Pulpdent(@pulpdent.com

PULPDENT CALCIUM HYDROXIDE PREPARATION DEVICE NAME:

PREDICATE DEVICES: NEO / DIADENT VITAPEX CALCIUM HYDROXIDE PASTE

ROEKO RSA RoekoSeal

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT CALCIUM HYDROXIDE PREPARATION is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

SAFETY AND EFFECTIVENESS:

General usage of the predicate products over about 5 years indicates a high benefit-to-risk ratio. See references below. There is no evidence of short-term or long-term risk or suspicion of any problems. In addition, the predicate products listed above have been given 510 (k) Premarket approval as Class II Dental Devices under CFR 872.3820. Please see Exhibit 4 for 510(k) numbers.

REFERENCES:

Thomas AM, et al. Elimination of infection in pulpectomized teeth: a short-term study using iodoform paste. J. Enodod. 1994 20(5): 233-5.

Eda S, et al. Clinico-pathological studies on the healing of periapical tissues in aged patients by root canal filling using pastes of Calcium hydroxide added iodoform. Geriodontics 1985 1:98-104.

Cohen S, Burns.R. Pathways of the Pulp. 7th Ed. 1998 Mosby.

Nurko C, Garcia-Godoy F. Evaluation of a Calcium hydroxide / iodoform paste (Vitapex) in root canal therapy for primary teeth. J. Clin Pediatr. Dent. 1999 23(4): 289-294.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left and top of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

OCT 0 7 2002

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

Re: K022734

Trade/Device Name: Pulpdent Calcium Hydroxide Preparation Regulation Number: 21 CFR 872.3820(b)(1) Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: August 12, 2002 Received: August 16, 2002

Dear Mr. Berk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 (PMA), 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 898. In addition, FDA may publish further announcements 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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

{2}------------------------------------------------

Page 2 – Mr. Kenneth J. Berk

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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

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

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

K022734

510 (k) Number (if known)

Device Name:

PULPDENT CALCIUM HYDROXIDE PREPARATION

Indications for Use:

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

Susan Runse

Division of Anesthesiology, General Hospital. Infection Control. Dental Devices

510(k) Number

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.