LogoFDA 510(k) Search
K Number
K063780
Device Name
ACE BOND SE
Manufacturer
BISCO, INC.
Date Cleared
2007-01-19

(29 days)

Product Code
KLE
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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) - 2. All indirect restorations (composite, metal, porcelain) - 3. Desensitization of crown preparations prior to impression making/provisionalization - 4. Composite core build-ups - 5. Composite to metal/set amalgam (direct veneering) - 6. Root desensitization - 7. New amalgam to existing amalgam - 8. 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.
More Information

K 50647

Not Found

No
The summary describes a dental adhesive and does not mention any AI or ML components.

No.
The device is an adhesive system used for dental restorations and desensitization, not for treating or curing a disease or condition.

No

This device is an adhesive system used for various dental restorations and desensitization, not for diagnosing any condition.

No

The device description clearly indicates it is a light-cured all-in-one bonding agent, which is a chemical substance, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: ACE BOND SE is a dental adhesive used to bond materials to tooth structure and dental substrates. It is applied directly to the patient's teeth during dental procedures.
  • Intended Use: The intended uses listed are all related to dental restorations, desensitization, and repairs performed directly on the patient.
  • Device Description: The description confirms it's a light-cured bonding agent applied to the tooth.

There is no indication that this device is used to analyze samples taken from the body for diagnostic purposes. It is a therapeutic and restorative dental material.

N/A

Intended Use / Indications for Use

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.

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)

Product codes

KLE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K 50647

Reference Device(s)

Not Found

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.

0

Ko63780

Page 6-1

Section 6 SPECIAL 510 (k) SUMMARY

| Applicant: | Bisco, Inc.
1100 W. Irving Park Road
Schaumburg IL, 60193 | JAN 1 9 2007 |
|----------------------|------------------------------------------------------------------|--------------|
| Contact Person: | Benjamin Lichtenwalne-
Tel: 847-534-6146
Fax: 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:

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.

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

PropertyALL-IN-ONEACE BOND SE
Intended useSelf -Etching, Single Step Dental
AdhesiveSelf-Etching, Single Step
Dental Adhesive
Chemical compositionLight-cure, unfilled,
multifunctional methacrylate
based resin.Light-cure, unfilled.
multifunctional methacrylate
based resin.
Mechanical /physical
propertiesMedium viscosity, light pink
colored dental etching, priming,
and bonding agent.Low viscosity, pink colored
dental etching, priming, and
bonding 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.

1

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.

2

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

3

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