ACE BOND SE

K063780 · Bisco, Inc. · KLE · Jan 19, 2007 · Dental

Device Facts

• Record ID: K063780
• Device Name: ACE BOND SE
• Applicant: Bisco, Inc.
• Product Code: KLE · Dental
• Decision Date: Jan 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

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 Story

ACE BOND SE is a light-cured, two-component, ethanol/water-based, single-step dental adhesive system. It functions as a self-etching agent that simultaneously etches, primes, and bonds to tooth structures and various dental substrates. Used by dental professionals in clinical settings, the adhesive is applied to prepared tooth surfaces or restorative materials to facilitate bonding for direct and indirect restorations, core build-ups, and desensitization. The low-viscosity, pink-colored resin is cured via light activation. By integrating etching and bonding into one step, the device simplifies the restorative workflow, potentially reducing procedure time and improving clinical efficiency for the practitioner.

Clinical Evidence

Bench testing only. Oral toxicity testing was performed, confirming the device is non-toxic. No clinical data provided.

Technological Characteristics

Light-cured, unfilled, multifunctional methacrylate-based resin. Ethanol/water-based, two-component, single-step system. Low viscosity. Formulated for self-etching, priming, and bonding. No specific ASTM standards or software components described.

Indications for Use

Indicated for dental patients requiring etching, priming, and bonding for direct/indirect restorations (composite, amalgam, metal, porcelain), composite core build-ups, tooth desensitization (dentin/enamel/root surfaces), and dental repairs.

Regulatory Classification

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.

Predicate Devices

• ALL-IN-ONE (K060647)

Submission Summary (Full Text)

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Ko63780

Page 6-1

# Section 6 SPECIAL 510 (k) SUMMARY

| Applicant: | Bisco, Inc.<br>1100 W. Irving Park Road<br>Schaumburg IL, 60193 | JAN 1 9 2007 |
|----------------------|------------------------------------------------------------------|--------------|
| Contact Person: | Benjamin Lichtenwalne-<br>Tel: [phone]<br>Fax: [phone] | |
| 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

| Property | ALL-IN-ONE | ACE BOND SE |
|------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended use | Self -Etching, Single Step Dental<br>Adhesive | Self-Etching, Single Step<br>Dental Adhesive |
| Chemical composition | Light-cure, unfilled,<br>multifunctional methacrylate<br>based resin. | Light-cure, unfilled.<br>multifunctional methacrylate<br>based resin. |
| Mechanical /physical<br>properties | Medium viscosity, light pink<br>colored dental etching, priming,<br>and bonding agent. | Low viscosity, pink colored<br>dental etching, priming, and<br>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.

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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 [phone]. 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 [phone] or [phone] 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)
- 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)

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