Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is intended for use as a root canal sealer to be used in conjunction with gutta percha or silver endodontic points.

Device Description

Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material.

AI/ML Overview

This document describes a 510(k) submission for a modified root canal sealer, not an AI/ML powered device. Therefore, a table of acceptance criteria and reported device performance and other AI/ML specific information cannot be extracted from the document. The document describes changes to a root canal sealer formulation and provides evidence of substantial equivalence to a predicate device.

However, I can provide a summary of the provided information regarding the modified Sealapex Root Canal Sealer to address the intent of understanding the device's validation.

Device: Kerr Modified Sealapex Root Canal Sealer

Purpose of Submission: To gain market clearance for an updated formulation of Sealapex Root Canal Sealer with two modifications:

Substitution of poly(methylene methyl salicylate) resin with Neopentyl glycol disalicylate/trimethylol propane trisalicylate (NPG-TMP salicylate) resin to remove formaldehyde from the manufacturing process.
Addition of bismuth trioxide to increase radiopacity by fifty percent.

Study Type: This is a 510(k) submission for a medical device (root canal sealer), demonstrating substantial equivalence, not a study of an AI/ML system. The "studies" mentioned are related to the chemical and biological properties of the material.

Acceptance Criteria and Device Performance (Based on the provided text):

Since this is not an AI/ML device, the typical acceptance criteria for AI/ML performance metrics (e.g., AUC, sensitivity, specificity) are not applicable. Instead, the "acceptance criteria" can be inferred from the regulatory requirements for substantial equivalence and the performance standards for dental root canal sealing materials.

Acceptance Criterion (Inferred from regulatory context)	Reported Device Performance (Summary from document)
Material Safety/Biocompatibility	Demonstrated in extensive animal histopathology studies. NPG-TMP salicylate resin previously successfully and safely used in Kerr's Life Cavity Base/Liner (K961708), based on extensive animal histopathology studies showing biocompatibility and ability to stimulate hard tissue formation. Bismuth trioxide is a commonly used radiopaquing agent in other FDA-marketed root canal sealers (e.g., Procosol, Grossman's Sealer, Wach's Paste, Diaket, AH-26).
Material Efficacy/Performance	Demonstrated by comparison testing against predicate devices to the requirements of ISO International Standard 6876 for Dental root canal sealing materials. (Specific results are not in this excerpt but are mentioned as being elsewhere in the submission).
Radiopacity	Increased by fifty percent due to the addition of bismuth trioxide. (The document notes EH-26 has 60% by weight bismuth trioxide).
Working Time	Original formulation had a previous 510(k) (K944480) for minor formulation changes to extend working time. The current submission's changes do not appear to alter this aspect, but rather focus on safety of synthesis and radiopacity.
Substantial Equivalence	FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (AUG 15 1997 letter).

1. Sample sized used for the test set and the data provenance:

Test Set Sample Size: Not specified in the provided text. The "test set" here refers to the materials and animals used in the histopathology studies and the samples used for ISO 6876 testing.
Data Provenance: The animal histopathology studies are internal ("Copies of reports of these studies are included elsewhere in this submission"). Comparison testing to ISO 6876 is also internal. Country of origin is thus likely the USA where Kerr is based, but not explicitly stated. These were prospective studies designed to evaluate the new formulation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not explicitly stated. For animal histopathology, typically veterinary pathologists would interpret the tissue samples. For ISO standard testing, laboratory personnel and potentially experts in dental material science would perform and interpret the tests.
Qualifications: Not specified, but implied to be appropriately qualified professionals for histopathology and dental material testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not specified for this type of device submission. Adjudication methods are typically used in clinical trials for endpoint determination or in image interpretation studies.

4. 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/ML device, so no MRMC study or AI assistance is relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

For Safety: Histopathology (evidence of biocompatibility, tissue response, hard tissue formation).
For Efficacy/Performance: Results from objective laboratory tests conforming to ISO International Standard 6876 for Dental root canal sealing materials (e.g., flow, film thickness, working time, setting time, solubility, dimensional stability, radiopacity).
For Substantial Equivalence: Comparison of material properties and biological performance to legally marketed predicate devices that meet FDA requirements.

7. The sample size for the training set:

Not applicable for this type of device. The term "training set" is used for AI/ML models. For this device, the "training" can be considered the cumulative knowledge and testing from prior formulations and predicate devices, as well as the newly conducted studies.

8. How the ground truth for the training set was established:

Not applicable for this type of device.

Summary

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510 ( k ) Summary

Statement of Safety an Effectiveness

Kerr Modified Sealapex Root Canal Sealer

BACKGROUND

Sealapex is a root canal sealing material which has been used successfully by the dental profession since 1984. The original Sealapex formulation received market clearance from the Food and Drug Administration in July of 1984 ( 510 ( k ) Reference Number K841910 ).Another 510 ( k ) application was submitted in September, 1994 for minor formulation changes to extend the working time ( 510 ( k ) Reference Number K944480 ). This submission addresses two anticipated formulation modifications which will, when implemented, make the manufacturing process for synthesizing one of the polymeric resins safer to the employees, and increase the radiopacity by fifty per cent.

Current Sealapex formulations utilize Poly(methylene methyl salicylate) resin in the catalyst paste component. It is synthesized in-house using formaldehyde as one of the reactants. Formaldehyde is considered to be carcinogenic and presents a serious hazard in the workplace. If Neopentyl glycol disalicylate/ trimethylol propane trisalicylate ( NPG-TMP salicylate ) resin is substituted for the current resin, the use of formaldehyde is eliminated. The second modification consists of the addition of bismuth trioxide to the catalyst component to increase the radiopacity of the mixed sealant.

Modified Sealapex

The two formulation changes described above do not alter the safety and efficacy of the product to the extent that the new formulation is not significantly equivalent to products currently on the market and under the jurisdiction of FDA. This is demonstrated below:

Change Number 1: Substitution of poly(methylene methyl salicylate) resin with NPG-TMP Salicylate resin. NPG-TMP Salicylate has been used successfully and safely since 1996 in Kerr's Life Cavity Base/Liner ( 510 ( k ) Reference Number K961708 ). And, in fact, that resin change was made for exactly the same reasons described in this submission and was based on extensive animal histopathology studies which demonstrated both the biocompatibility of the resin and the ability of the calcium hydroxide ingredient to stimulate the formation of hard tissue both in the periapical area and along the canal walls as well.

Change Number 2: The addition of bismuth trioxide to increase the radiopacity of the set sealant. Bismuth trioxide has been used previously in root canal sealers. Procosol. Grossman's Sealer, Wach's Paste, Diaket and AH-26 all use bismuth compounds as radiopaquing agents. In the case of AH-26, it has 60 % by weight bismuth trioxide All of these products are currently on the market under the jurisdiction of FDA.

A table of comparative ingredient lists for the modified Sealapex formulation along with predicate device compositions, where known is included elsewhere in this submission in order to contrast and compare the various devices.

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Safety

The safety of the modified Sealapex formulation has been demonstrated in extensive animal histopathology studies. Copies of reports of these studies are included elsewhere in this submission.

Efficacy

The effectiveness of the modified Sealapex formulation has been demonstrated by comparison testing of several predicate devices to the requirements of ISO International Standard 6876 for Dental root canal sealing materials. A copy of this standard as well as a table of comparative results can be found elsewhere in this submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 1997

Mr. William R. Pike Regulatory Affairs Specialist Sybron Dental Specialities, Incorporated 2717 W. Collins Avenue -Orange, California 92667

Re: K972369 Trade Name: Sealapex Regulatory Class: II Product Code: KIF June 6, 1997 Dated: Received: June 25, 1997

Dear Mr. Pike:

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, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಥ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Pike

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 focument 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) 594-4618. 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/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 :

Device Name : Kerr Modified Sealapex Root Canal Sealer

Indications For Use : Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is intended for use as a root canal sealer to be used in conjunction with gutta percha or silver endodontic points.

Susan Runsey

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ Jeg 72369

Prescription Use
(Per 21 CFR 801.109)

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.