(70 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the solution and its interaction with dentin, with no mention of AI or ML technologies.
Yes
The device is described as forming oxalate crystals which occlude dentin tubules to reduce sensitivity of teeth, thereby treating a condition.
No
Explanation: The device is a desensitizing agent that occludes dentinal tubules to reduce tooth sensitivity. It is a treatment device, not a diagnostic one.
No
The device description clearly states that BisBlock is an "aqueous solution of oxalic acid in a semi-gel formulation," indicating it is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a treatment applied directly to the patient's teeth to reduce sensitivity. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description explains how the product works by forming crystals to occlude dentinal tubules. This is a physical/chemical interaction with the patient's tissue, not an analysis of a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
BisBlock forms oxalate crystals which occlude the dentin tubules resulting in a reduction of sensitivity of teeth by applying:
-
- Prior to temporization (placement of provisional restorations).
-
- Prior to permanent cementation of indirect restorations.
-
- Prior to placement of direct restorations.
-
- When root surfaces are exposed.
Product codes
EJK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, dentinal tubules, root surfaces, teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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:
-
- Prior to temporization (placement of provisional restorations).
-
- Prior to permanent cementation of indirect restorations.
-
- Prior to placement of direct restorations.
-
- 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
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