Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core build-ups)
Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina)
Bonding Resin or Primer for Substrates
Desensitization/Sealing of Tooth
Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)

Device Description

All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (<5 µm). All-Bond Universal SC has a chemical formulation that allows the adhesive to be used in either self-etch or total-etch mode, based on the clinical situation and dentist preference. All-Bond Universal SC is compatible with light-cured, self-cured, dual-cured resin composite and cement base materials for direct and indirect procedures without any additional activators.

AI/ML Overview

The provided text is a 510(k) summary for a dental adhesive, "All-Bond Universal SC," indicating its substantial equivalence to a predicate device, "ACE Bond SE." The summary focuses on chemical composition, physical/mechanical properties, and biocompatibility rather than clinical performance based on a test set and ground truth in the way one might expect for an AI/CADe device. Therefore, many of the requested categories about acceptance criteria, study design for a test set, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as it describes a traditional dental adhesive, not a diagnostic or AI-powered medical device.

However, I can extract the information that is present and indicate where the requested information is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (All-Bond Universal SC)
Light-Cured	X (Present)	X (Present)
Auto-Polymerizing	X (Present)	X (Present)
Unfilled, multifunctional methacrylate resin	X (Present)	X (Present)
Ethanol based	X (Present)	X (Present)
Two component adhesive	X (Present)	X (Present)
Color Changes from pink to clear after cure	X (Present)	--- (Not Present)
Solvent Based Formulation (solvent>40% by weight)	X (Present)	X (Present)
Self-Etching Dental Adhesive	X (Present)	X (Present)
Total-Etching Dental Adhesive	X (Present)	X (Present)
Film Thickness	Modified technique from ISO 4049	`<5 µm` (Stated as low film thickness)
Shear Bond Strength	(Not explicitly stated, compared via R&D protocols)	Tested via R&D protocols (results not quantified)
Microleakage	(Not explicitly stated, compared via R&D protocols)	Tested via R&D protocols (results not quantified)
Biocompatibility	ISO 7405:2008 standards	"Not toxic in this test" (Oral Toxicity Study)

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is described as "R&D testing protocols" conducted in the lab. These protocols were used to determine shear bond strength, microleakage, and film thickness (using a modified technique from ISO 4049). An evaluation of biocompatibility was conducted using ISO 7405:2008 and an Oral Toxicity Study (10 rats, 14 days). The conclusion is based on "Side by side comparisons" demonstrating substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set:
- For physical/mechanical properties (shear bond strength, microleakage, film thickness): Not explicitly stated. The document mentions "R&D testing protocols" but does not quantify the number of samples or tests.
- For Biocompatibility: 10 rats were used for the Oral Toxicity Study.
Data Provenance: The studies were conducted in the lab by BISCO, Inc. (location: Schaumburg, IL, USA). The studies are retrospective regarding their submission date, as the tests were performed prior to filing the 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device and study. The "ground truth" for a dental adhesive focuses on its physical, chemical, and biological properties, which are measured using established scientific/engineering methods and standards (e.g., ISO standards, R&D protocols), not typically through expert consensus readings of images or clinical cases.

4. Adjudication method for the test set:

This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic studies, not for the analytical testing of material properties.

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 information is not applicable. This is not an AI/CADe device, and therefore, no MRMC study was performed as described.

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

This information is not applicable. This is not an AI/CADe device.

7. The type of ground truth used:

The "ground truth" for the performance claims relies on:
- Measurements against industry standards/protocols: For film thickness (modified ISO 4049) and biocompatibility (ISO 7405:2008).
- Results from R&D testing protocols: For shear bond strength and microleakage.
- Direct chemical and physical comparisons to a legally marketed predicate device.

8. The sample size for the training set:

This information is not applicable. This is not an AI/CADe device, and therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable. As there is no training set for an AI model, there is no ground truth established for such a purpose.

Summary

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Image /page/0/Picture/0 description: The image shows the word "BISCO" in bold, sans-serif font. Above the word is a geometric design consisting of several interconnected, three-dimensional shapes that resemble stylized honeycombs or crystals. The overall impression is that of a logo or brand mark, possibly for a company or product named BISCO.

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:

26 August 2013

Trade Name: Common Name: Product Code: Classification/Name:

All-Bond Universal SC Self and Light Curable Dental Adhesive KLE Resin Tooth Bonding Agent Class II per 21 CFR 872.3200

Predicate Devices:

All-Bond Universal SC is substantially equivalent to:

ACE Bond SE by Bisco, Inc. Schaumburg IL K063780

Indications for Use:

All-Bond Universal SC adhesive is used for:

Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core . build-ups)
Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina) ◆
Bonding Resin or Primer for Substrates .
Desensitization/Sealing of Tooth .
Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)

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

K13773

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Image /page/1/Picture/0 description: The image shows the logo for BISCO. The logo consists of a series of interconnected, three-dimensional hexagonal shapes arranged in a row above the word "BISCO". The hexagonal shapes are shaded to give them a three-dimensional appearance. The word "BISCO" is written in a bold, sans-serif font.

510 (k) SUMMARY (continued)

Description of Applicant Device:

All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (<5 µm). All-Bond Universal SC has a chemical formulation that allows the adhesive to be used in either self-etch or totaletch mode, based on the clinical situation and dentist preference. All-Bond Universal SC is compatible with light-cured, self-cured, dual-cured resin composite and cement base materials for direct and indirect procedures without any additional activators.

Technological Characteristics:

All components of All-Bond Universal SC are based upon industry standard chemistry. Comparisons of the chemical composition of All-Bond Universal SC to the predicate is provided in the following table:

Chemical Composition	ACE Bond SEK063780	All-BondUniversal SC
Light-Cured	X	X
Auto-Polymerizing	X	X
Unfilled, multifunctional methacrylate resin	X	X
Ethanol based	X	X
Two component adhesive	X	X
Color Changes from pink to clear after cure	X	---

Performance Data:

The physical/mechanical properties of AII-Bond Universal SC were tested in the lab using R&D testing protocols to determine shear bond strength and microleakage. A modified technique form ISO 4049 was used to determine film thickness. The information provided in this 510(k) for All-Bond Universal SC compared to the predicate demonstrate that it is substantially equivalent for its indications for use. A comparison of the physical/mechanical properties are included below:

Physical / Mechanical Property Comparison	ACE Bond SEK063780	All-BondUniversal SC
Solvent Based Formulation (solvent>40% by weight)	X	X
Self-Etching Dental Adhesive	X	X
Total-Etching Dental Adhesive	X	X

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

An ISO: 13485 Certified Company.

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Image /page/2/Picture/0 description: The image shows the word "BISCO" in large, bold letters. Above the word, there is a geometric design composed of several interconnected, three-dimensional shapes. The shapes appear to be arranged in a row, creating a visually interesting pattern above the text.

510 (k) SUMMARY (continued)

Biocompatibility:

An evaluation of biocompatibility was conducted using ISO 7405:2008 to determine the safety of All-Bond Universal SC. It is concluded from the safety evaluation and the results of the Oral Toxicity Study (10 rats, 14 days) that All-Bond Universal SC was not toxic in this test."

Conclusion:

Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to the other legally marketed devices. It is concluded that the information supplied in this submission has demonstrated that All-Bond Universal SC is substantially equivalent to the legally marketed predicate device.

BİSCO, İnc. 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

An ISO 13485 Certified Company

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

April 11, 2014

Bisco, Incorporated Ms. Michelle Schiltz-Taing 1100 W. Irving Park Road Schaumburg, IL 60193

Re: K131734

Trade/Device Name: All-Bond Universal SC Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 3, 2014 Received: March 12, 2014

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 for about 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 may of subjoct to additions, 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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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K131734 510 (k) Number (if known):

Device Name: _ All-Bond Universal SC .........................................................................................................................................

Indications for Use:

All-Bond Universal SC adhesive is used for:

Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, . core build-ups)
Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina) .
Bonding Resin or Primer for Substrates ●
Desensitization/Sealing of Tooth �
Intraoral Repair (e.g. chipped porcelain, additions to direct restorations) �

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)

Sheena A. Green 2014.04.11 09:37:0

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.