BisBlock is an aqueous solution of oxalic acid in a semi-gel formulation. It is designed to be used on dentin etched with a phosphoric acid etchant prior to restoration of exposed dentin. It forms calcium oxalate crystals with dentin or bonds to the dentin. The crystals occlude the dentinal tubules opened with the etchant, which results in desensitization of natural dentition. The occlusion does not affect the following restoration.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (BisBlock) and does not involve AI/ML. Therefore, many of the requested categories are not applicable. The submission is for a dentin desensitizing agent, and the evaluation focuses on its substantial equivalence to a predicate device based on intended use, chemical composition, and physical properties, rather than performance metrics from a study involving AI.

Here's a breakdown of the provided information, addressing what is applicable and indicating what is not:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (BisBlock)
Intended Use: Dentin Desensitizer	Intended Use: Dentin Desensitizer
Chemical Composition: Oxalate solution	Chemical Composite: Oxalate solution
Mechanical/Physical Properties: Forms crystals (calcium oxalate) occluding dentinal tubules.	Mechanical/Physical Properties: Blue semi-gel liquid that forms crystals (calcium oxalate) occluding dentinal tubules.
Biocompatibility: Non-toxic	Biocompatibility: Found to be non-toxic

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a physical medical device (dental material), not an AI/ML device that generates performance data from a test set. The evaluation is based on comparison to an existing predicate device and non-clinical testing for biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. No ground truth was established by experts for a test set in the context of an AI/ML device. The "ground truth" for this device would be its physical/chemical properties and efficacy as a desensitizer, demonstrated through laboratory tests and comparison to a predicate, not expert labeling of data.

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

Not Applicable. No adjudication method for a test set was mentioned, as it's not an AI/ML device study.

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. No MRMC study was conducted or mentioned because this is not an AI/ML device.

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

Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For biocompatibility: The ground truth was based on established biocompatibility testing standards (the specific tests are not detailed but the result "non-toxic" is reported).
For substantial equivalence: The ground truth was the characteristics and performance of the predicate device (Super Seal), which the applicant device aimed to match in terms of intended use, chemical composition, and mechanism of action.

8. The sample size for the training set

Not Applicable. No training set was used, as this is not an AI/ML device.

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

Not Applicable. No training set ground truth was established.

Summary

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033521

510 (k) submission for BisBlock BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193

CONFIDENTIAL

Page 5-1

JAN 1 6 2004

Section 5 510 (k) SUMMARY

Bisco, Inc. Applicant: 1100 W. Irving Park Road Schaumburg IL, 60193 Contact Person: Benjamin Lichtenwalner Tel: 847-534-6146 Fax: 847-534-6111 Date Prepared: November 7, 2003

BisBlock Trade Name: Oxalate Dentin Desensitizing Agent Common Name: Classification/Name: Cavity Liner, Calcium Hydroxide Class II per 21 CFR 872.3250

Description of Applicant Device:

Intended uses of Applicant Device:

BisBlock is a dentin desensitizing agent that is indicated for application prior to restoration of exposed dentin or when root surfaces are exposed. Its physical properties are similar to the predicate device and uses are identical.

Predicate Device: Super Seal from Phoenix Dental, Inc., cleared under K983477 dated 12/22/1998

	BisBlock	Super Seal
Intended use	Dentin Desensitizer	Dentin Desensitizer
Chemical composite	Oxalate solution	Oxalate solution
Mechanical/physicalproperties	Blue semi-gel liquid that formscrystals (calcium oxalate)occluding dentinal tubules.	Clear low viscosity liquid that formscrystals (calcium oxalate) occludingdentinal tubules.

Significant Performance Characteristics:

Side by side comparisons of BisBlock to the predicate device Super Seal from Phoenix Dental, Inc. clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. BisBlock was tested for biocompatibility and it was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BisBlock.

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Re: K033521

Trade/Device Name: Bisblock Regulation Number: 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Il Product Code: EJK Dated: November 7, 2003 Received: November 10, 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 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.

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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 vour 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,

Charles

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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Indications for Use

510(k) Number (if known): K033521

Device Name: BisBlock

Indications For Use:

BisBlock forms oxalate crystals which occlude the dentin tubules resulting in a reduction of sensitivity of teeth by applying:

1. Prior to temporization (placement of provisional restorations).
1. Prior to permanent cementation of indirect restorations.
1. Prior to placement of direct restorations.
1. When root surfaces are exposed.

AND/OR Prescription Use √_ (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)

Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K033521

Page 1 of 1

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.