(115 days)
The indications of use of DREAMBOND are:
- all direct restorations
- all indirect restorations
- intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
- desensitizing/sealing of tooth structure
- protective varnish for glass ionomer fillings
- priming of enamel for orthodontic use
Bisco's DREAMBOND is a single-component dental bonding agent that combines etching, priming and bonding all in one bottle. DREAMBOND is an ethanol/water-based dental adhesive which bonds to dentin and to cut and uncut enamel. As a universal adhesive, DREAMBOND has been designed to work with light-cured, self-cured and dual-cured composite materials. DREAMBOND can be used for the bonding of both direct and indirect restorations. DREAMBOND may be used with or without phosphoric acid etchant.
The provided 510(k) summary for DREAMBOND is for a Resin Tooth Bonding Agent and not a medical imaging device or an AI-powered diagnostic tool. Therefore, the questions regarding acceptance criteria, study methodologies, and performance metrics for AI/ML-based devices are not directly applicable to this submission.
However, I can extract the relevant information regarding the device's performance based on the provided text, aligning the spirit of the questions to what is available.
Device: DREAMBOND (Resin Tooth Bonding Agent)
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list "acceptance criteria" for performance in a tabular format as would be expected for a diagnostic device. Instead, it demonstrates substantial equivalence to predicate devices through comparisons of chemical composition and physical/mechanical properties. The overall acceptance criterion is "substantial equivalence" to the predicate devices.
| Feature / Property | Predicate Device (ACE Bond SE K063780) | DREAMBOND (Reported Performance) | Basis for Performance Claim |
|---|---|---|---|
| Chemical Composition | (Demonstrated Equivalence) | ||
| Light-cured | X | X | Comparison |
| Unfilled, multifunctional methacrylate resin | X | X | Comparison |
| Ethanol and water based adhesive | X | X | Comparison |
| Two component adhesive | X | DREAMBOND is single-component | |
| Single component adhesive | X | DREAMBOND is single-component | |
| Physical / Mechanical Property | (Demonstrated Equivalence) | ||
| Low viscosity | X | X | Comparison |
| Self-etching dental adhesive | X | X | Comparison |
| Total-etch dental adhesive | X | DREAMBOND feature | |
| Biocompatibility | Not explicitly listed for predicate | No mortality or toxicity observed | Oral Toxicity in Mice |
Overall Conclusion regarding performance (from submission): "The information provided in this 510(k) of DREAMBOND compared to ACE Bond SE demonstrates that DREAMBOND performs as well as or better than the predicate." And "DREAMBOND is safe for its intended use."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text for physical/mechanical testing. For biocompatibility, it mentions "Oral Toxicity in Mice," but the number of mice is not stated.
- Data Provenance: The testing was conducted "in the lab using ISO, ADA/ANSI, and Bisco Inc. QA/QC and R&D test protocols." This implies internal laboratory testing, likely based in Schaumburg, IL, USA. The data is retrospective in the sense that it's laboratory test results rather than clinical trial outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a dental bonding agent, and its performance (e.g., bond strength, viscosity) is measured through objective physical and chemical tests, not through expert interpretation of images or clinical assessments that require "ground truth" and expert consensus in the context of diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the reasons stated in point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This is not an AI/ML-based diagnostic device or a device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an AI/ML device. The "standalone" performance would refer to the physical and mechanical properties of the bonding agent itself, which were tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established by the results of standardized physical, chemical, and biological tests (e.g., ISO, ADA/ANSI standards for bond strength, viscosity, biocompatibility). It is based on objective laboratory measurements rather than clinical ground truth obtained from human experts or pathology.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable. This is not an AI/ML device.
{0}------------------------------------------------
NOV 1 7 2011
l
Image /page/0/Picture/2 description: The image shows the logo for BISCO. The logo consists of the letters "B," "I," "S," "C," and "O" inside of hexagons. Below the logo is the text "Bringing Science to the Art of Dentistry."
.510 (k) SUMMARY
| Applicant: | Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contact Person: | Michelle Schiltz-Taing Tel: 847-534-6146 Fax: 847-534-6146 | ||||||||||||||
| Date Prepared: | 08 November 2011 | ||||||||||||||
| Device Name: | Trade Name:DREAMBONDCommon Name:Adhesive for Both Self and Total Etch TechniquesProduct Code:KLEClassification Name:Resin tooth bonding AgentRegulation Number:21 CFR 872.3200Classification:IIClassification Panel:Dental | Trade Name: | DREAMBOND | Common Name: | Adhesive for Both Self and Total Etch Techniques | Product Code: | KLE | Classification Name: | Resin tooth bonding Agent | Regulation Number: | 21 CFR 872.3200 | Classification: | II | Classification Panel: | Dental |
| Trade Name: | DREAMBOND | ||||||||||||||
| Common Name: | Adhesive for Both Self and Total Etch Techniques | ||||||||||||||
| Product Code: | KLE | ||||||||||||||
| Classification Name: | Resin tooth bonding Agent | ||||||||||||||
| Regulation Number: | 21 CFR 872.3200 | ||||||||||||||
| Classification: | II | ||||||||||||||
| Classification Panel: | Dental |
Predicate Device:
DREAMBOND is substantially equivalent to Ace Bond SE from Bisco, Inc. Schaumburg IL (K063780) and to Adhesive EXL-759 from 3M ESPE AG Seefeld, Bavaria (K110302).
Indications for Use:
The indications of use of DREAMBOND are:
-
- all direct restorations
- all indirect restorations 2.
- intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, 3. glass ceramics, tooth structure and composites)
-
- desensitizing/sealing of tooth structure
-
- protective varnish for glass ionomer fillings
- priming of enamel for orthodontic use 6.
Description of Applicant Device:
Bisco's DREAMBOND is a single-component dental bonding agent that combines etching, priming and bonding all in one bottle. DREAMBOND is an ethanol/water-based dental adhesive which bonds to dentin and to cut and uncut enamel. As a universal adhesive, DREAMBOND has been designed to work with light-cured, self-cured and dual-cured composite materials. DREAMBOND can be used for the bonding of both direct and indirect restorations. DREAMBOND may be used with or without phosphoric acid etchant. .
An ISO 13485 Certified Company
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 supply company. The logo consists of the letters "B I S C O" arranged in a hexagonal pattern. Below the logo is the text "Bringing Science to the Art of Dentistry."
Technological Characteristics
The chemical components of DREAMBOND are based upon industry standard monomer chemistry and are found in legally marketed predicate device ACE Bond SE (K063780). A comparison of the chemical composition of DREAMBOND to the predicate device is provided.
| Chemical Composition | ACE Bond SE(K063780) | DREAMBOND |
|---|---|---|
| Light-cured | X | X |
| Unfilled, multifunctional methacrylate resin | X | X |
| Ethanol and water based adhesive | X | X |
| Two component adhesive | X | |
| Single component adhesive | X |
Performance Data:
They physical/mechanical properties of DREAMBOND were tested in the lab using ISO, ADA/ANSI, and Bisco Inc. QA/QC and R&D test protocols. The information provided in this 510(k) of DREAMBOND compared to ACE Bond SE demonstrates that DREAMBOND performs as well as or better than the predicate. A comparison of the physical and mechanical properties to the predicate device is included.
| Physical / Mechanical PropertyComparison | ACE Bond SE(K063780) | DREAMBOND |
|---|---|---|
| Low viscosity | X | X |
| Self-etching dental adhesive | X | X |
| Total-etch dental adhesive | X |
Biocompatibility:
A biocompatibility evaluation was conducted to determine the safety of DREAMBOND using Oral Toxicity in Mice. No mortality or toxicity was observed for the tested time period. The conclusion of the safety evaluation and subsequent oral toxicity testing is that DREAMBOND is safe for its intended use.
Conclusion:
The information provided in this 510(k) submission demonstrates that DREAMBOND is substantially equivalent to the predicate devices Ace Bond SE (K063780) and to Adhesive EXL-759 (K110302) 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 logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
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
NOV 1 7 2011
Re: K112118
Trade/Device Name: DREAMBOND Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 8, 2011 Received: November 9, 2011
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 (OS) 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/ ucm 1 15809.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.
Nh for
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): ___________________________________________________________________________________________________________________________________________________
Device Name: __DREAMBOND
Indications for Use:
The indications of use of DREAMBOND are:
-
- all direct restorations
-
- all indirect restorations
-
- intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
- desensitizing/sealing of tooth structure র্ব
- protective varnish for glass ionomer fillings 5.
- priming of enamel for orthodontic use 6.
Prescription Use √ (Part 21 CFR 801 Subpart D) AND/OR
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 Ruse
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112118
§ 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.