(188 days)
The indication for use of Seal Block PRO is to relieve sensitive teeth. Seal Block PRO is used to relieve sensitive teeth by blocking the pain caused by: Hot, Cold, Sweet, Acidic, Dental whitening agents. Seal Block PRO can also be used to relieve sensitivity: 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.
Seal Block relieves sensitive teeth by blocking the pain caused by: heat, cold, sweets, acidic foods and drinks, dental whitening agents.
Seal Block is applied using an applicator to the sensitive tooth/teeth. It forms calcium oxalate crystals that occlude dentinal tubules resulting in desensitization of natural dentition.
The provided 510(k) summary for K123653, "Seal Block Tooth Desensitizer," states that the device's substantial equivalence to predicate devices (BisBlock, Super Seal, and Super Seal Tooth Desensitizer) is based on "Technological Characteristics" and "Performance Data" which primarily involve in vitro testing and chemical composition comparison. It does not describe acceptance criteria in the typical sense of quantitative performance metrics from a clinical study, nor a comparative effectiveness study involving human readers.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the form of specific thresholds (e.g., sensitivity > X%, specificity > Y%) for clinical performance, as one might find for diagnostic AI devices. Instead, the device's performance is demonstrated through comparison to predicate devices and in vitro R&D testing. The acceptance is based on demonstrating substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Chemical Composition Equivalence | Seal Block (Pro and OTC) has "Oxalate Solution" and is "Water Based," matching predicates. |
| Physical/Mechanical Property Equivalence (e.g., viscosity, SEM comparison) | Seal Block has "Low viscosity" and "SEM Comparison" data matches predicates where available. |
| Dentin Permeability Reduction (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| Shear Bond Strength (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| pH (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| Biocompatibility | Evaluation conducted; concluded safe based on evaluation and ADA Oral Toxicity Study (10 rats, 14 days). |
| Safety and Efficacy (Overall Conclusion) | Concluded to be safe and efficacious based on substantial equivalence to predicates and provided data. |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size:
- For physical/mechanical properties and dentin permeability, shear bond strength, and pH, the sample sizes for these in vitro R&D tests are not specified in the document.
- For biocompatibility, an "ADA Oral Toxicity Study" was conducted on 10 rats.
- Data Provenance: The R&D testing was conducted "in the lab," implying an in-house (Bisco, Inc.) development and testing environment. The ADA Oral Toxicity Study would likely have been conducted in a specialized laboratory for animal testing. The document does not specify a country of origin beyond "U.S.A." for Bisco, Inc. All data appears to be prospective in nature, as it was generated specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable, as no human expert-driven ground truth was established for a test set in the context of device performance as described. The device's performance is assessed through in vitro and animal studies, not by human interpretation.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no test set requiring human adjudication for diagnostic or interpretive performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a desensitizer, not an interpretive AI diagnostic tool.
- Effect Size of AI Assistance: Not applicable.
6. Standalone Performance Study
- Standalone Study: Yes, performance data on "Seal Block" was generated through in vitro R&D testing (dentin permeability reduction, shear bond strength, pH) and an animal study (biocompatibility on 10 rats). This represents the algorithm-only performance for the device's stated function (blocking pain by occluding dentinal tubules). There is no "human-in-the-loop" component described for the device's direct function.
7. Type of Ground Truth Used
- Ground Truth Type:
- For chemical composition and physical/mechanical properties, the ground truth is established by chemical analysis and physical measurements (e.g., rheology for viscosity, microscopy for SEM).
- For dentin permeability, shear bond strength, and pH, the ground truth is established by laboratory measurements taken under R&D protocols.
- For biocompatibility, the ground truth is based on the results of the "ADA Oral Toxicity Study" in rats, which measures biological responses to the device material.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is based on its chemical formulation and physical properties, tested directly in lab settings and animal models.
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/1 description: The image shows the word "BISCO" in a bold, sans-serif font. Above the word, there are four geometric shapes that appear to be connected. The shapes are arranged in a row, and they have a three-dimensional appearance. The image is black and white, and the text and shapes are clearly visible.
JUN 0 3 2013
510 (k) SUMMARY
Applicant:
Contact Person:
Date Prepared: Trade Name: Common Name: Product Code: Classification/Name:
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Michelle Schiltz-Taing Tel: 847-534-6146 Fax: 847-534-6146 24 April 2013 Seal Block Tooth Desensitizer LBH Varnish, Cavity Class Il per 21 CFR 872.3260
Predicate Devices:
Seal Block is substantially equivalent to:
BisBlock by Bisco, Inc. Schaumburg IL K033521 Super Seal by Phoenix Dental, Inc. Fenton, MI K983477 Super Seal Tooth Desensitizer by Phoenix Dental, Inc. Fenton, MI K120109
Indications for Use Seal Block PRO Version:
The indication for use of Seal Block PRO is to relieve sensitive teeth.
Seal Block PRO is used to relieve sensitive teeth by blocking the pain caused by:
- . Hot
- . Cold
- Sweet .
- . Acidic
- . Dental whitening agents
Seal Block PRO can also be used to relieve sensitivity:
- 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. .
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-60C Fax: 847-891-5049 www.bisco.com
.
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Image /page/1/Picture/0 description: The image shows the word "BISCO" in a stylized font, with the top half of the letters outlined and the bottom half filled in with black. Above the word, there is a row of four geometric shapes that resemble cubes or hexagons, arranged in a slightly staggered pattern. The shapes are also black and white, with some having vertical lines.
510 (k) SUMMARY (continued)
Indications for Use Seal Block OTC Version:
Seal Block relieves sensitive teeth by blocking the pain caused by: heat, cold, sweets, acidic foods and drinks, dental whitening agents.
Description of Applicant Device:
Seal Block is applied using an applicator to the sensitive tooth/teeth. It forms calcium oxalate crystals that occlude dentinal tubules resulting in desensitization of natural dentition.
Technological Characteristics:
All components of Seal Block are based upon industry standard chemistry and are found in the legally marketed predicate devices Super Seal (K983477 and K120109) and BisBlock (K033521). Comparisons of the chemical composition of Seal Block to the predicates are provided in the following table:
| ChemicalComposition | Super SealK983477 | Super Seal ToothDesensitizerK120109 | BisBlockK033521 | Seal BlockPro and OTC |
|---|---|---|---|---|
| Oxalate Solution | X | X | X | X |
| Water Based | X | X | X | X |
Performance Data:
The physical/mechanical properties of Seal Block were tested in the lab using R&D testing protocols to determine dentin permeability reduction, shear bond strength, and pH. The information provided in this 510(k) for Seal Block compared to the predicates demonstrates that it is effective for its indications of use. A comparison of the physical/mechanical properties are included below:
| Physical / MechanicalProperty Comparison | Super SealK983477 | Super SealToothDesensitizerK120109 | BisBlockK033521 | Seal Block |
|---|---|---|---|---|
| Low viscosity | X | X | X | X |
| SEM Comparison | X | X | X |
BISCO, Inc. 1100 W. Irving Park Road - -Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-600 Fax: 847-891-5049 www.bisco.com
An ISO 13485 Certified Company
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Image /page/2/Picture/0 description: The image shows the word "BISCO" in a stylized font, with a geometric pattern above it. The letters of the word are partially filled in with black, creating a contrast with the white outlines. The geometric pattern consists of interconnected shapes, some of which are filled with black while others are white, creating a visually interesting design element above the word.
510 (k) SUMMARY (continued)
Biocompatibility:
An evaluation of biocompatibility was conducted to determine the safety of Seal Block. It is concluded from the safety evaluation and the results of the ADA Oral Toxicity Study (10 rats, 14 days) that Seal Block is safe for its intended uses.
Conclusion:
Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to the other legally marketed devices. It is concluded that the information supplied in this submission has proven the safety and efficacy of these products.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
800-247-3368 or 847-534-600 Fax: 847-891-5049 www.bisco.com
An ISO 13485 Certified Company
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2013
Ms. Michelle Schiltz-Taing Bisco, Incorporated 1100 West Irving Park Road SCHAUMBURG IL 60193
Re: K123653
Trade/Device Name: Seal Block OTC, Seal Block Pro Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: April 24, 2013 Received: May 9, 2013
Dear Ms. Schiltz-Taing:
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. F.ood., Drug. and Cosmetic Act (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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{4}------------------------------------------------
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Suzan Ruaner, DDS, MA
Digitally signed by Mary S. Runner -5
DN: c=US, o=U.S. Government; ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner
0.9.2342.19200300.100.1.1=1300087950
Date: 2013.06.03:14:24:10 -04'00'
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known): _ K123653
Device Name: _ Seal Block Pro
Indications for Use:
The indication for use of Seal Block PRO is to relieve sensitive teeth.
Seal Block PRO is used to relieve sensitive teeth by blocking the pain caused by:
- Hot .
- . Cold
- Sweet .
- Acidic .
- Dental whitening agents .
Seal Block PRO can also be used to relieve sensitivity:
- 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 P (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)
Digitally signed by Mary S. Runner -S
DN: C=US, o=US. Government,
ou-HHS, ou FDA, ou=People,
Susan Runner, DDS,MA cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=1300087
950
Date: 2013.06.03 14:24:48-04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K123653
{6}------------------------------------------------
510 (k) Number (if known): _ Kl23653
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Seal Block relieves sensitive teeth by blocking the pain caused by: heat, cold, sweets, acidic foods and drinks, dental whitening agents
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
510(k) Number:
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 Runner, DDSBIA
(Division Sign-Off)
Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People, cn=Mary
S. Runner -S
0.9.2342.19200300.100.1.1=130008795
Date: 2013.06.03 14:25:11 -04'00'
Division of Anestheslology, General Hospital Infection Control, Dental Devices
KI23653
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.