(148 days)
No
The device description and performance studies focus on the chemical and physical properties of a dental bonding agent, with no mention of AI or ML.
No
The device is a dental bonding agent and adhesive used for direct and indirect restorations and repairs, not for treating any specific disease or condition. Its purpose is mechanical bonding, not therapeutic action.
No
This device is a dental bonding agent used for restorations and repairs, not for diagnosing conditions.
No
The device description clearly indicates it is a light-cured single-component dental bonding agent, which is a physical material, not software. The performance studies also focus on physical and chemical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct application within the mouth for dental procedures (restorations, repairs, desensitizing, sealing, priming, protective varnish). These are therapeutic and restorative applications, not diagnostic ones.
- Device Description: The description details a dental bonding agent used to adhere materials to tooth structure. This is a material used in treatment, not for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) to provide information about a patient's health status or diagnose a disease.
- Performance Studies: The performance studies focus on physical and mechanical properties relevant to its function as a dental adhesive (bond strength, film thickness, water sorption, etc.) and biocompatibility, not on diagnostic accuracy or performance.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) for therapeutic and restorative dental procedures.
N/A
Intended Use / Indications for Use
ALL-BOND UNIVERSAL w/BAC adhesive is used for:
-
- all direct restorations
-
- all indirect restorations
- intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, 3. metals, glass ceramics, tooth structure, and composites)
-
- desensitizing/sealing of tooth structure
-
- protective varnish for glass ionomer fillings
-
- priming of enamel for orthodontic use
Product codes
KLE
Device Description
BISCO's ALL-BOND UNIVERSAL w/BAC is a light-cured single-component dental bonding agent that combines etching, priming, and bonding with benzalkonium chloride (BAC) in one bottle. ALL-BOND UNIVERSAL w/BAC is an ethanol/water-based dental adhesive which bonds to dentin and cut and un-cut enamel. ALL-BOND UNIVERSAL w/BAC has been designed to be fully compatible with light-cured and dual-cured composite materials. ALL-BOND UNIVERSAL w/BAC can be used for the bonding of both direct and indirect restorations. ALL-BOND UNIVERSAL w/BAC may be used with or without phosphoric acid etchant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, enamel, fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites.
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
The following physical/mechanical properties of All-Bond Universal w/BAC were tested:
- Bond Strength (Modified ISO 29022:2013): All-Bond Universal w/BAC is equivalent to the primary and reference predicate.
- Moisture Tolerance (Modified ISO 29022:2013): All-Bond Universal w/BAC is equivalent to the primary and reference predicate.
- Film Thickness (ISO 4049:2009): All-Bond Universal w/BAC meets the requirements of ISO 4049:2009 for Film Thickness.
- Water Sorption / Solubility (ADA/ANSI Specification No. 27): All-Bond Universal w/BAC is equivalent to the primary predicate.
- Immediate Bond Strength (Modified ISO 29022:2013): All-Bond Universal w/BAC is equivalent to the primary and reference predicate.
- Bond Strength Durability: Reference predicate showed a 23% reduction in bond strength, primary predicate showed a 27% reduction in bond strength, and All-Bond Universal w/BAC showed a 4% increase in bond strength on completion of the test.
- Solvent Evaporation: All-Bond Universal w/BAC is equivalent to the primary and reference predicate.
- pH: All-Bond Universal w/BAC is equivalent to the primary predicate.
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the biocompatibility of All-Bond Universal w/BAC. It is concluded from the evaluation and the results of the Oral Toxicity Study (10 rats, 7 days) that All-Bond Universal w/BAC was not toxic in this test.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Bisco, Inc. Ryan Hobson Regulatory Affairs Product Registration Coordinator 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K161051
Trade/Device Name: All-Bond Universal w/ BAC Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 8, 2016 Received: August 10, 2016
Dear Ryan Hobson:
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.
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161051
Device Name All-Bond Unviersal w/BAC
Indications for Use (Describe)
-
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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the alphanumeric string "K161051" in a bold, sans-serif font. The string appears to be a code or identifier. The characters are uniformly sized and spaced, making the string easily readable. The background is plain and white.
Image /page/3/Picture/1 description: The image shows the BISCO logo. The logo consists of a series of connected hexagons in red, white, and blue. Below the hexagons is the word "BISCO" in a sans-serif font, with the top half of the letters in gray and the bottom half in black.
510 (k) SUMMARY
Applicant:
Bisco. Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Rvan Hobson RA Product Registration Coordinator Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Tel: 847-534-6143 Fax: 847-534-6143
Date Prepared:
8 September 2016
Trade Name: Common Name: Product Code: Classification/Name:
All-Bond Universal w/BAC Light Curable Dental Adhesive w/BAC KLE Resin Tooth Bonding Agent Class II per 21 CFR 872.3200
Predicate Devices:
Primary Predicate:
DREAMBOND by Bisco, Inc. K112118, Agent, Tooth Bonding Resin - KLE
Reference Predicate:
PEAK UNIVERSAL BOND (Light Cure Resin Adhesive and Chlorhexidine), by Ultradent, K100752, Agent, Tooth Bonding Resin - KLE
Indications for Use:
ALL-BOND UNIVERSAL w/BAC adhesive is used for:
-
- all direct restorations
-
- all indirect restorations
- intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, 3. metals, glass ceramics, tooth structure, and composites)
-
- desensitizing/sealing of tooth structure
-
- protective varnish for glass ionomer fillings
-
- priming of enamel for orthodontic use
4
Image /page/4/Picture/0 description: The image shows the BISCO logo, which consists of three hexagons in red and blue, followed by the word "BISCO" in gray and black. The text "510 (k) SUMMARY (continued)" is located to the right of the logo. The background of the image features a pattern of light blue hexagons.
The indications for use of AII-Bond Universal w/BAC are the same as those for its predicates and are summarized in the table below:
| | DREAMBOND
(K112118) | All-Bond Universal w/BAC | Peak Universal Bond
(K100752) |
|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 1. | all direct restorations | 7. all direct restorations | Peak™ Universal
Bond bonds to the
following materials:
• Dentin and
enamel
• Porcelain
• Metal
• Composite |
| 2. | all indirect restorations | 8. all indirect restorations | |
| 3. | intra-oral repairs (i.e.
repair of any fixed dental
prosthesis containing
zirconia, alumina, metals,
glass ceramics, tooth
structure, and composites) | 9. intra-oral repairs (i.e.
repair of any fixed dental
prosthesis containing
zirconia, alumina, metals,
glass ceramics, tooth
structure, and composites) | |
| 4. | desensitizing/sealing of
tooth structure | 10. desensitizing/sealing of
tooth structure | |
| 5. | protective varnish for glass
ionomer fillings | 11. protective varnish for glass
ionomer fillings | |
| 6. | priming of enamel for
orthodontic use | 12. priming of enamel for
orthodontic use | |
Description of Applicant Device:
BISCO's ALL-BOND UNIVERSAL w/BAC is a light-cured single-component dental bonding agent that combines etching, priming, and bonding with benzalkonium chloride (BAC) in one bottle. ALL-BOND UNIVERSAL w/BAC is an ethanol/water-based dental adhesive which bonds to dentin and cut and un-cut enamel. ALL-BOND UNIVERSAL w/BAC has been designed to be fully compatible with light-cured and dual-cured composite materials. ALL-BOND UNIVERSAL w/BAC can be used for the bonding of both direct and indirect restorations. ALL-BOND UNIVERSAL w/BAC may be used with or without phosphoric acid etchant.
5
Image /page/5/Picture/0 description: The image shows the BISCO company logo. The logo consists of five hexagons arranged in a row, with the two outer hexagons being red and the three inner hexagons being blue. Below the hexagons is the word "BISCO" in gray, with a gradient effect that makes the bottom of the letters darker than the top.
510 (k) SUMMARY (continued)
Technological Characteristics:
Comparisons of the chemical composition of ALL-BOND UNIVERSAL w/BAC to the predicates is provided in the following table:
| Chemical Composition | DREAMBOND
(K112118) | Peak Universal
Bond (K100752) | All-Bond Universal
w/BAC |
|--------------------------|-------------------------------------------------|-----------------------------------------------|-------------------------------------------------|
| Method of polymerization | Light Cured | Light Cured | Light Cured |
| Resin composition | Unfilled, multifunctional
methacrylate resin | Filled, multifunctional
methacrylate resin | Unfilled, multifunctional
methacrylate resin |
| Solvent | Ethanol based | Ethanol based | Ethanol based |
| Method of application | Single component
adhesive | Multi-component,
primer required | Single component
adhesive |
| Bond Enhancer | Not applicable | Chlorohexidine | Benzalkonium
Chloride |
| Physical / Mechanical Property
Comparison | DREAMBOND
(K112118) | Peak Universal Bond
(K100752) | All-Bond Universal
w/BAC |
|----------------------------------------------|--------------------------|----------------------------------|-----------------------------|
| Film thickness | 2.6μm | 17.0μm | 3.4μm |
| Etch Methods | Self-etch and total-etch | Self-etch and total-etch | Self-etch and total-etch |
The difference in chemical composition as compared to the DREAMBOND is the addition of Benzalkonium. Both DREAMBOND and ALL-BOND UNIVERSAL w/BAC have the same technological characteristics before the addition of Benzalkonium Chloride. All-Bond Universal w/BAC uses Benzalkonium Chloride while Peak Universal Bond (K100752) uses Chlorohexidine however; both are cationic surface-acting agents and both have a long history of use in dental medical devices. Peak Universal Bond (K100752) is a filled resin, All-Bond Universal w/BAC and DREAMBOND are both unfilled resins, the lack of filler does not affect intended use and performance data shows the materials are equivalent. All-Bond Universal w/BAC is a single component system, requiring no additional primer in self-etch mode and fewer steps in its use compared to Peak Universal Bond (K100752).
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
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Image /page/6/Picture/0 description: The image shows the BISCO company logo. The logo consists of five connected hexagons, with the two outer hexagons colored red, the middle hexagon colored blue, and the two inner hexagons colored light blue. Below the hexagons is the word "BISCO" in gray letters, with the bottom half of the letters colored black.
510 (k) SUMMARY (continued)
Performance Data:
The following physical/mechanical properties of All-Bond Universal w/BAC were tested:
| Physical / Mechanical Property | All-Bond Universal w/BAC |
|---|---|
| Bond Strength | |
| (Modified ISO 29022:2013) | All-Bond Universal w/BAC is equivalent to the primary and reference predicate. |
| Moisture Tolerance | |
| (Modified ISO 29022:2013) | All-Bond Universal w/BAC is equivalent to the primary and reference predicate. |
| Film Thickness | |
| (ISO 4049:2009) | All-Bond Universal w/BAC meets the requirements of ISO 4049:2009 for Film Thickness. |
| Water Sorption / Solubility | |
| (ADA/ANSI Specification No. 27) | All-Bond Universal w/BAC is equivalent to the primary predicate. |
| Immediate Bond Strength | |
| (Modified ISO 29022:2013) | All-Bond Universal w/BAC is equivalent to the primary and reference predicate. |
| Bond Strength Durability | Reference predicate showed a 23% reduction in bond strength, primary predicate showed a 27% reduction in bond strength, and All-Bond Universal w/BAC showed a 4% increase in bond strength on completion of the test. |
| Solvent Evaporation | All-Bond Universal w/BAC is equivalent to the primary and reference predicate. |
| pH | All-Bond Universal w/BAC is equivalent to the primary predicate. |
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the biocompatibility of All-Bond Universal w/BAC. It is concluded from the evaluation and the results of the Oral Toxicity Study (10 rats, 7 days) that All-Bond Universal w/BAC was not toxic in this test.
Conclusion:
It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that All-Bond Universal w/BAC to be substantially equivalent to the predicate devices.