(30 days)
Not Found
No
The summary describes a dental adhesive system and its physical/mechanical properties, with no mention of AI or ML.
No
The device, All-Bond 3, is an ethanol-based dental adhesive system used for various dental restorations and desensitizing/sealing tooth structure. Its primary function is to bond dental materials to tooth structure, which is a structural and restorative function rather than a therapeutic one (i.e., treating or preventing disease).
No
The device, All-Bond 3, is described as an "ethanol based dual-cured adhesive system" intended for restorations, repairs, and desensitizing tooth structure. Its principle uses and device description classify it as a therapeutic and restorative dental material, not a diagnostic tool.
No
The device description clearly states it is an "ethanol based dual-cured adhesive system," which is a chemical substance, not software. The performance studies also focus on physical/mechanical properties, further indicating it is a material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (direct and indirect restorations, intra-oral repair, desensitizing/sealing of tooth structure) are all procedures performed directly on the patient's tooth structure. IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description of All-Bond 3 as an "ethanol based dual-cured adhesive system" is consistent with a dental bonding agent used in restorative procedures, not a diagnostic test.
- Anatomical Site: The anatomical site is "tooth structure," which is where the device is applied directly, not where a specimen is collected for analysis.
The information provided clearly indicates that All-Bond 3 is a dental material used for bonding and sealing tooth structure during restorative procedures, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 .
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
All-Bond 3 is an ethanol based dual-cured adhesive system that is compatible with all dental materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure
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)
The 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 Property
| Comparison | 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
2
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.
3
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
4
| 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