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

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.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the "All-Bond Universal w/BAC" dental adhesive.

Here's the information requested, extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

Physical / Mechanical Property	Acceptance Criteria (Implied by Equivalence to Predicates or ISO Standard)	Reported Device Performance (All-Bond Universal w/BAC)
Bond Strength	Equivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)	Equivalent to the primary and reference predicate.
Moisture Tolerance	Equivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)	Equivalent to the primary and reference predicate.
Film Thickness	Meets requirements of ISO 4049:2009 (Predicate values: DREAMBOND: 2.6µm, Peak Universal Bond: 17.0µm)	Meets the requirements of ISO 4049:2009 for Film Thickness. (Reported value: 3.4µm, shown in a separate table implying it meets the standard and is comparable to predicates).
Water Sorption / Solubility	Equivalent to primary predicate (DREAMBOND) based on ADA/ANSI Specification No. 27	Equivalent to the primary predicate.
Immediate Bond Strength	Equivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)	Equivalent to the primary and reference predicate.
Bond Strength Durability	Performance comparable to or better than predicates (Reference predicate showed 23% reduction, Primary predicate showed 27% reduction)	Showed a 4% increase in bond strength on completion of the test.
Solvent Evaporation	Equivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)	Equivalent to the primary and reference predicate.
pH	Equivalent to primary predicate (DREAMBOND)	Equivalent to the primary predicate.
Biocompatibility	Not toxic (Implied standard based on ISO 7405:2008 and ISO 10993-1)	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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- For Biocompatibility, an "Oral Toxicity Study" used 10 rats.
- For other physical/mechanical properties (Bond Strength, Moisture Tolerance, Film Thickness, Water Sorption / Solubility, Immediate Bond Strength, Bond Strength Durability, Solvent Evaporation, pH), specific sample sizes are not explicitly stated in the provided text. The testing is described as occurring for "All-Bond Universal w/BAC".
Data Provenance: The text does not explicitly state the country of origin or whether the studies were retrospective or prospective. It is implied these are laboratory-based studies conducted by or for the manufacturer (Bisco, Inc. in Schaumburg, IL, USA) for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The studies described are physical/mechanical property tests and biocompatibility tests, not studies requiring expert interpretation (like medical imaging). Therefore, there were no human experts establishing "ground truth" in the diagnostic sense. The "ground truth" is established by the standardized testing methodologies (e.g., ISO, ADA/ANSI standards) and measurements of physical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not applicable here as the studies are laboratory-based physical and mechanical property tests and animal biocompatibility studies, not studies requiring human adjudication of subjective data. Therefore, none was used.

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

No MRMC comparative effectiveness study was done. This device is a dental adhesive, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a dental adhesive, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance demonstrated is the standalone performance of the material itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the dental adhesive is based on standardized laboratory testing methods (e.g., modified ISO 29022:2013 for bond strength, ISO 4049:2009 for film thickness, ADA/ANSI Specification No. 27 for water sorption/solubility, and ISO 7405:2008 and ISO 10993-1 for biocompatibility). For biocompatibility, it was specifically an "Oral Toxicity Study" with animal models.

8. The sample size for the training set

There is no training set mentioned or implied, as this is a physical product (dental adhesive), not a machine learning model.

9. How the ground truth for the training set was established

As there is no training set, this question is not applicable.

Summary

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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.

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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

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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)

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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:

1. all direct restorations
1. 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)
1. desensitizing/sealing of tooth structure
1. protective varnish for glass ionomer fillings
1. priming of enamel for orthodontic use

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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™ UniversalBond bonds to thefollowing materials:• Dentin andenamel• Porcelain• Metal• Composite
2.	all indirect restorations	8. all indirect restorations
3.	intra-oral repairs (i.e.repair of any fixed dentalprosthesis containingzirconia, alumina, metals,glass ceramics, toothstructure, and composites)	9. intra-oral repairs (i.e.repair of any fixed dentalprosthesis containingzirconia, alumina, metals,glass ceramics, toothstructure, and composites)
4.	desensitizing/sealing oftooth structure	10. desensitizing/sealing oftooth structure
5.	protective varnish for glassionomer fillings	11. protective varnish for glassionomer fillings
6.	priming of enamel fororthodontic use	12. priming of enamel fororthodontic use

Description of Applicant Device:

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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 UniversalBond (K100752)	All-Bond Universalw/BAC
Method of polymerization	Light Cured	Light Cured	Light Cured
Resin composition	Unfilled, multifunctionalmethacrylate resin	Filled, multifunctionalmethacrylate resin	Unfilled, multifunctionalmethacrylate resin
Solvent	Ethanol based	Ethanol based	Ethanol based
Method of application	Single componentadhesive	Multi-component,primer required	Single componentadhesive
Bond Enhancer	Not applicable	Chlorohexidine	BenzalkoniumChloride

Physical / Mechanical PropertyComparison	DREAMBOND(K112118)	Peak Universal Bond(K100752)	All-Bond Universalw/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.

Regulation Number and Section

§ 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.