For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: Intracanal Medicament, Apexification, Periapical Lesions, Root Resorption, Temporary Root Filling, Perforations, Underdeveloped pulpless teeth.

Device Description

DIAPEX is a yellow radiopaque calcium hydroxide paste with iodoform, used as a root canal filling material. It is packaged as a 2 gm syringe. Intraoral application uses enclosed disposable intracanal tips.

AI/ML Overview

This document is a 510(k) summary for the medical device "DIAPEX," a calcium/iodoform root canal treatment paste. The purpose of this summary is to demonstrate that DIAPEX is substantially equivalent to a legally marketed predicate device, Vitapex Pre-loaded dental syringe (K973667).

The document does not contain information regarding a study with specific acceptance criteria and detailed device performance metrics in the format requested. Instead, it relies on demonstrating substantial equivalence to a predicate device through a comparison of intended use, chemical composition, and mechanical/physical properties.

Therefore, many of the requested sections below cannot be populated from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The submission focuses on substantial equivalence rather than performance against pre-defined acceptance criteria from a specific study. The "reported device performance" is implied to be equivalent to the predicate device's performance.

Criterion Type	Acceptance Criterion	Reported Device Performance
Intended Use	Equivalent to predicate device (Root Canal Filling Material)	DIAPEX is a Root Canal Filling Material
Chemical Composition	Equivalent to predicate device (Calcium Hydroxide / Iodoform Paste)	DIAPEX is a Calcium Hydroxide / Iodoform Paste
Mechanical/Physical Properties	Equivalent to predicate device (Yellow Radiopaque Paste)	DIAPEX is a Yellow Radiopaque Paste

2. Sample size used for the test set and the data provenance

Not applicable. No specific test set or study with performance data is presented. The substantial equivalence argument relies on direct comparison of characteristics.

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

Not applicable. Ground truth for a test set is not established as no performance study is described.

4. Adjudication method for the test set

Not applicable. No test set adjudication method is described.

5. 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 device is a treatment paste, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a treatment paste, not an algorithm.

7. The type of ground truth used

Not applicable. No performance study requiring a specific type of ground truth is described. The "ground truth" for substantial equivalence is the characteristics and intended use of the predicate device.

8. The sample size for the training set

Not applicable. No training set is relevant for a medical paste device submission based on substantial equivalence.

9. How the ground truth for the training set was established

Not applicable. No training set is relevant for a medical paste device submission.

Summary

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ONE DENTIAL

Section 5

JAN 1 6 2004

Pagc 5-1

510 (k) SUMMARY

1. Applicant:	Bisco, Inc1100 West Irving Park RoadSchaumburg, IL 60193
Contact Person:	Benjamin LichtenwalnerPh. 847-534-6146Fax 847-534-6111
Prepared Date:	November 12, 2003

1. Device Trade Name: DIAPEX Common/Usual Name: Calcium/Iodoform Root Canal Treatment Paste Class II per 21 CFR 872.3820 Rood Canal Filling Resin Classification/Name:
1. Predicate Device: Vitapex Pre-loaded dental syringe from Neo Dental Chemical Products, cleared under K973667 dated 11/6/1997.

4. Description of Application Device:

5. Intended Uses of Applicant Device:

DIAPEX is used to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. DIAPEX is used to promote healing effects and to help prevent bacterial contamination of the canal, as the two main ingredicnts improve the induction effect for hard tissue induction and deposition. DIAPEX can also be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. The use of DIAPEX in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha is also indicated.

TechnologicalCharacteristic	Vitapex	DIAPEX
Intended use	Root Canal Filling Material	Root Canal Filling Material
Chemicalcomposition	Calcium Hydroxide / Iodoform Paste	Calcium Hydroxide / Iodoform Paste
Mechanical/Physical properties	Yellow Radiopaque Paste	Yellow Radiopaque Paste

6. Technological Characteristics:

Side by side comparisons of DIAPEX to the predicate device Vitapex Pre-loaded dental syringe from Neo Dental Chemical Products clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. It is concluded that the information supplied in this submission has proven the safety and efficacy of DIAPEX.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2004

Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road, Schaumburg, Illinois 60193

Rc: K033585

Trade/Device Name: DIAPEX Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: November 12, 2003 Received: November 13, 2003

Dear Mr. Lichtenwalner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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.

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Page 2 -Mr. Lichtenwalner

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. 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Ours

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko33585

Indications for Use

510(k) Number (if known): K033585

Device Name: DIAPEX

Indications For Use:

For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform 1. and the induction effect of these two ingredients.
1. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition.
ဒေ To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete.
For use in the treatment of infected root canals, or following pulpectorny, or for the apexedenesis ব or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

These indications include application in:

1. Intracanal Medicament
Apexification 2.
Periapical Lesions నే
Root Resorption বা
Temporary Root Filling 5.
1. Perforations
1. Underdeveloped pulpless teeth

Prescription Use ✓ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Burns

Division of Anesthesiology, General Hospital,

510(k) Number: K033353

Page 1 of

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.