← Product Code [EJK](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK) · K033521 # BISBLOCK (K033521) _Bisco, Inc. · EJK · Jan 16, 2004 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K033521 ## Device Facts - **Applicant:** Bisco, Inc. - **Product Code:** [EJK](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK.md) - **Decision Date:** Jan 16, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3250 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## 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). 2. Prior to permanent cementation of indirect restorations. 3. Prior to placement of direct restorations. 4. When root surfaces are exposed. ## Device Story BisBlock is an aqueous oxalic acid solution in a semi-gel formulation used by dental professionals. Applied to etched dentin, it reacts to form calcium oxalate crystals that occlude dentinal tubules, reducing tooth sensitivity. The device is used in clinical dental settings prior to restorative procedures or for exposed root surfaces. It does not interfere with subsequent restorative materials. Benefits include patient comfort through desensitization. ## Clinical Evidence Bench testing only. Biocompatibility testing performed; device found to be non-toxic. No clinical trials conducted. ## Technological Characteristics Aqueous oxalic acid solution in a blue semi-gel formulation. Functions via chemical reaction with dentin to form calcium oxalate crystals. Standalone dental material; no energy source or software. ## Regulatory 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. ## Predicate Devices - Super Seal ([K983477](/device/K983477.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: 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. #### 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/physical
properties | Blue semi-gel liquid that forms
crystals (calcium oxalate)
occluding dentinal tubules. | Clear low viscosity liquid that forms
crystals (calcium oxalate) occluding
dentinal 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ 0 3 3 521 # 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). - 2. Prior to permanent cementation of indirect restorations. - 3. Prior to placement of direct restorations. - 4. 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K033521](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K033521) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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