As a Universal Self-Etching Adhesive System, ACE BOND SE, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates.

ACE BOND SE is used for:

1. Direct restorations (composite, amalgam)
1. All indirect restorations (composite, metal, porcelain)
1. Desensitization of crown preparations prior to impression making/provisionalization
1. Composite core build-ups
1. Composite to metal/set amalgam (direct veneering)
1. Root desensitization
1. New amalgam to existing amalgam
1. Repairs (composite-to-composite, composite-to-porcelain)

Device Description

ACE BOND SE is a light-cured all-in-one bending agent that combines etching, priming and bonding into one single step. ACE BOND SE is an ethanol/water-based, two-component, single step adhesive system.

AI/ML Overview

This submission pertains to a dental adhesive device, ACE BOND SE. The information provided is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device rather than strictly defining acceptance criteria through a formal study with statistical targets for performance.

Here's an analysis based on the provided text, focusing on how the device "meets acceptance criteria" in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission where substantial equivalence is claimed through comparison to a predicate device, the "acceptance criteria" are implicitly that the new device performs similarly enough to the predicate device in relevant aspects, and that any differences do not raise new questions of safety or effectiveness. The study presented here is a comparative analysis rather than a performance target.

Property	Acceptance Criteria (Implied by Predicate - ALL-IN-ONE)	Reported Device Performance (ACE BOND SE)
Intended Use	Self-Etching, Single Step Dental Adhesive	Self-Etching, Single Step Dental Adhesive
Chemical Composition	Light-cure, unfilled, multifunctional methacrylate-based resin.	Light-cure, unfilled, multifunctional methacrylate-based resin.
Mechanical/Physical Properties	Medium viscosity, light pink colored dental etching, priming, and bonding agent.	Low viscosity, pink colored dental etching, priming, and bonding agent.
Toxicity	Non-toxic (implied by predicate device clearance)	Non-toxic (explicitly stated)

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a numerical sample size for the tests conducted to demonstrate equivalence for ACE BOND SE.
The text states: "Side by side comparisons of ACE BOND SE to the device ALL-IN-ONE clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device." and "ACE BOND SE was tested for oral toxicity and was found to be non-toxic."

Test Set Sample Size: Not specified.
Data Provenance: Not explicitly stated, but assumed to be from in vitro laboratory testing given the nature of a dental adhesive and the properties compared (chemical composition, physical properties, toxicity). Details like country of origin or whether the tests were retrospective/prospective are not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is generally not applicable to a 510(k) submission for a dental adhesive where substantial equivalence is demonstrated through comparative material properties and toxicity testing. The "ground truth" here is defined by the established properties and safety profile of the predicate device (ALL-IN-ONE) and the laboratory standards for chemical/physical testing and toxicity assessment. There isn't a "ground truth" established by experts in the sense of clinical image interpretation or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. The comparisons are based on objective material property measurements and toxicity testing, not on subjective assessments requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a dental adhesive, and its performance is evaluated through material science and toxicology, not by human reader interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a material (dental adhesive), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Material Science Data: Objective measurements of chemical composition, viscosity, and color.
Toxicity Testing: Laboratory results demonstrating non-toxicity.
Predicate Device Profile: The established safety and effectiveness profile of the ALL-IN-ONE adhesive, which serves as the benchmark for equivalence.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning algorithms. This submission is for a physical dental adhesive, not an AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

Summary

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Ko63780

Page 6-1

Section 6 SPECIAL 510 (k) SUMMARY

Applicant:	Bisco, Inc.1100 W. Irving Park RoadSchaumburg IL, 60193	JAN 1 9 2007
Contact Person:	Benjamin Lichtenwalne-Tel: 847-534-6146Fax: 847-534-6111
Date Prepared:	December 20, 2006
Trade Name:	ACE BOND SE
Common Name:	Dental Adhesive
Classification/Name:	Resin Tooth Bonding Agent Class II per 21 CFR 872.3200

Description of Applicant Device:

Intended uses of Applicant Device:

The principle uses of the ACE BOND SE adhesive is to etch, prime, and bond for direct and indirect restorations involving dentin, enamel, light-cure, and dual-cure composites. amalgam/metals, porcelain, and core build-ups. ACE BOND SE can also be used for desensitization of tooth structures such as hyper ensitive dentin/enamel and exposed root surfaces.

Predicate Devices:

ALL-IN-ONE from Bisco, Inc, cleared under K 50647 dated April 20, 2006.

Significant Performance Characteristics:

ALL-IN-ONE to ACE BOND SE

Property	ALL-IN-ONE	ACE BOND SE
Intended use	Self -Etching, Single Step DentalAdhesive	Self-Etching, Single StepDental Adhesive
Chemical composition	Light-cure, unfilled,multifunctional methacrylatebased resin.	Light-cure, unfilled.multifunctional methacrylatebased resin.
Mechanical /physicalproperties	Medium viscosity, light pinkcolored dental etching, priming,and bonding agent.	Low viscosity, pink coloreddental etching, priming, andbonding agent.

Side by side comparisons of ACE BOND SE to the device ALL-IN-ONE clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. ACE BOND SE was tested for oral toxicity and was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of ACE BOND SE.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES, USA

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. Benjamin Lichtenwalner Regulatory Affairs Manager Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

JAN 1 9 2007

Re: K063780

Trade/Device Name: ACE BOND SE Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 20, 2006 Received: December 26, 2006

Dear Mr. Lichtenwalner:

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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 – Mr. Lichtenwalner

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syrite H. Michael PhD.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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06378V 510 (k) Number (if known): / 1

Device Name: ACE BOND SE

Indications for Use:

As a Universal Self-Etching Adhesive System, ACE BOND SE, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates.

ACE BOND SE is used for:

1. Direct restorations (composite, amalgam)
1. All indirect restorations (composite, metal, porcelain)
1. Desensitization of crown preparations prior to impression making/provisionalization
1. Composite core build-ups
1. Composite to metal/set amalgam (direct veneering)
1. Root desensitization
1. New amalgam to existing amalgam
1. Repairs (composite-to-composite, composite-to-porcelain)

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)

Suan Runner

(Division Spr-0.
Division of A
Lateral Hospital,
Infection Conces

510(k) Number: K063780

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.