(30 days)
The principle uses of All Bond 3 are:
- All Direct Restorations .
- All Indirect Restorations ●
- Intra-oral Repair .
- Desensitizing/sealing of tooth structure .
All-Bond 3 is an ethanol based dual-cured adhesive system that is compatible with all dental materials.
The provided document is a 510(k) Summary for a dental adhesive, All-Bond 3. It does not present a study with specific acceptance criteria and performance results for an AI/CAD-based device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through chemical and physical property comparisons and biocompatibility testing.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, expert qualifications, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as it describes a traditional medical device, not an AI/CAD system.
However, I can extract the information relevant to its substantial equivalence claim, which serves a similar function to "acceptance criteria" in this context, and the "study" that proves it.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For traditional medical devices seeking 510(k) clearance, the "acceptance criteria" for substantial equivalence often relate to demonstrating similar technological characteristics, intended use, and performance to a legally marketed predicate device. The "reported device performance" is then the comparison showing this similarity or superiority.
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | All-Bond 3 Performance (vs. Predicate) |
|---|---|
| Intended Use | Same as predicate (direct/indirect restorations, intra-oral repair, desensitizing/sealing) |
| Indications for Use | Same as predicate (direct/indirect restorations, intra-oral repair, desensitizing/sealing) |
| Chemical Composition | Similar, methacrylate resin based, contains ethanol solvent. Differs from All-Bond 2 by not containing Acetone Solvent, but matches All-Bond XL in this regard. |
| Physical/Mechanical Properties | Performs "as well as or better than" the predicate devices (e.g., thin solutions for components, low viscosity when mixed, dental substrate priming/wetting agent, bonding agent to tooth structure). |
| Biocompatibility | Safe for its intended use, based on FDA guidelines and ISO 4049:2009. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "QA/QC or R&D test protocols" for physical/mechanical properties and "FDA guidelines and ISO 4049:2009" for biocompatibility, but no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are mentioned for the tests conducted to compare All-Bond 3 to its predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the clearance is for a dental adhesive, not an AI/CAD system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this type of device would be established through laboratory testing and validated industry standards.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD systems that assist human readers in tasks like diagnosis or detection, which is not the function of a dental adhesive.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone performance evaluation is not applicable. This is for AI algorithms, and the device is a chemical dental product. The performance evaluation was based on physical, mechanical, and biocompatibility testing.
7. The Type of Ground Truth Used
The "ground truth" for claiming substantial equivalence primarily relies on:
- Chemical composition analysis: Comparing the ingredients.
- Physical/mechanical property measurements: Standard laboratory tests (e.g., viscosity, bond strength, flow characteristics, though not all explicitly detailed here) according to QA/QC or R&D protocols.
- Biocompatibility testing: Adherence to FDA guidelines and ISO 4049:2009 standards.
8. The Sample Size for the Training Set
This information is not applicable as the device is a chemical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image shows the logo for BISCO, a dental company. The logo consists of the letters "BISCO" in a stylized font, with each letter contained within a hexagon. Below the logo is the tagline "Bringing Science to the Art of Dentistry™".
Kro2844
OCT 2 9 2010
510 (k) SUMMARY
Applicant:
Contact Person:
Michelle Schiltz-Taing Tel: 847-534-6000 Fax: 847-534-6111
27 September 2010
1100 W. Irving Park Road Schaumburg IL, 60193
Bisco, Inc.
Date Prepared:
Device Name:
Trade Name: Common Name: Product Code: Classification Name: Regulation Number: Classification: Classification Panel:
All-Bond 3 Dual-Cure Universal Adhesive System KLE Resin tooth bonding Agent Class II per 21 CFR 872.3200 II. Dental
Predicate Device:
All-Bond 3 is substantially equivalent to All-Bond XL from Bisco, Inc. Schaumburg IL (K910860).
Indications for Use:
- All Direct Restorations .
- All Indirect Restorations .
- Intra-oral Repair .
- Desensitizing/sealing of tooth structure .
Description of Applicant Device:
All-Bond 3 is an ethanol based dual-cured adhesive system that is compatible with all dental materials.
Technological Characteristics
All chemical components of All-Bond 3 are based upon industry standard monomer chemistry and are found in legally marketed predicate device All-Bond 2/All Bond XL (K910860). A comparison of the chemical composition of All-Bond 3 to the predicate device is provided in Table 1.
BISCO, Inc. . 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/1/Picture/0 description: The image shows the logo for BISCO, a dental company. The logo is made up of hexagons with the letters B, I, S, C, and O inside. Below the logo is the tagline "Bringing Science to the Art of Dentistry™".
Table 1
| Chemical Composition | All Bond 2 | All Bond XL | All-Bond 3 |
|---|---|---|---|
| Light Cure | X | X | X |
| Self Cure | X | X | X |
| Methacrylate resin based | X | X | X |
| Contains Ethanol Solvent | X | X | X |
| Contains Acetone Solvent | X |
Performance Data:
They physical/mechanical properties of All-Bond 3 were tested in the lab using either QA/QC or R&D test protocols. The information provided in this 510(k) of All-Bond 3 compared to All Bond 2/All Bond Xli demonstrated that All-Bond 3 performs as well as or better than the predicates. A comparison of the physical/mechanical properties is included in Table 2.
| 2 | ||
|---|---|---|
| Ta | able | 1 |
| Physical / Mechanical PropertyComparison | All Bond 2 | All Bond XL | All-Bond 3 |
|---|---|---|---|
| Component 1 is a thin solution | X | X | X |
| Component 2 is a thin solution | X | ||
| Component 2 is a thick solution | X | X | |
| Low Viscosity when mixed 1:1 | X | X | X |
| Dental Substrate Priming/Wetting Agent | X | X | X |
| Bonding agent to tooth structure | X | X | X |
Biocompatibility:
Biocompatibility testing was conducted to determine the safety of All-Bond 3 using FDA guidelines and ISO 4049:2009. The conclusion of the safety evaluation and subsequent biocompatibility testing is that All-Bond 3 is safe for its intended use.
Conclusion:
The information provided in this 510(k) submission demonstrates that All-Bond 3 is substantially equivalent to the predicate device All Bond XLi (K910860) in terms of intended use, indications for use, chemical composition and physical properties.
It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.
BISCO, Inc. 1100 W. Irving Park Road · Schaumburg, IL 60193 U.S.A.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/2/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 emblem consisting of three stylized lines that resemble a caduceus, a symbol often associated with medicine and healthcare. The emblem is black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
OCT 2 9 2010
Re: K102844
Trade/Device Name: All-Bond 3 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 27, 2010 Received: September 29, 2010
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 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. 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.
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Page 2- Ms. Schiltz-Taing
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Susan Runos
Anthony D. Watson, B.S., M.S., M.B.A. 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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| 510 (k) Number (if known): | K102844 |
|---|---|
| ---------------------------- | --------- |
Device Name: __ All Bond 3 ___________________________________________________________________________________________________________________________________________________
Indications for Use:
The principle uses of All Bond 3 are:
- All Direct Restorations .
- All Indirect Restorations ●
- Intra-oral Repair .
- Desensitizing/sealing of tooth structure .
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 Runne
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wision of Anesthesiology, General Hospital ection Control, Dental Devices
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0(k) Number: K162844
OCT 2 9 2010
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.