TOTAL ETCH BONDING AGENT

K063444 · Dmg USA, Inc. · KLE · Mar 20, 2007 · Dental

Device Facts

• Record ID: K063444
• Device Name: TOTAL ETCH BONDING AGENT
• Applicant: Dmg USA, Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Total-Etch Dualbond is indicated for: - Bonding resin-based materials (especially dual-cure composite / compomer . materials) to tooth structure (dentin and enamel) - Treatment of hypersensitive teeth . Total-Etch Bond is indicated for: - Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel) - Treatment of hypersensitive teeth .

Device Story

Total Etch Bonding Agent consists of two dental adhesive formulations: Total-Etch Dualbond (for dual-cured materials) and Total-Etch Bond (for light-cured materials). Used by dental professionals in clinical settings to bond resin-based composites or compomers to tooth structure (dentin and enamel) and to treat tooth hypersensitivity. Device functions as a chemical bonding agent applied to prepared tooth surfaces to facilitate adhesion of restorative materials. No automated processing or software components involved.

Clinical Evidence

Bench testing only. Safety and performance established via chemical composition analysis and physical performance testing.

Technological Characteristics

Dental bonding agent; chemical formulation for dual-cure or light-cure resin bonding. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring dental restorative procedures involving bonding of resin-based materials (composite or compomer) to dentin and enamel, or treatment of hypersensitive teeth.

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

• Excite DSC (K003293)
• Optibond Solo Plus (Dual-cure) (Unknown)
• All Bond 2 (K910628)
• Scotchbond MP Plus (K942493)
• Contax bonding agent (K041960)

Submission Summary (Full Text)

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# 510(k) Summary

| Trade Name: | Total Etch Bonding Agent (Total-Etch Bond & Total-<br>Etch Dual-Bond) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DMG USA, Inc.<br>23 Frank Mossberg Drive<br>Attleboro, MA 02703<br>Registration # not yet assigned<br>Owner/Operator No. 9005969 |
| Device Generic Name: | Dental Bonding Agent |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |

# Product Description:

The Total Etch Bonding Agent consists of two dental bonding agent formulations for use in dual- and light-cured bonding procedures:

Total-Etch Bonding Agent for Dual-Cured Resin-Based Materials (Total-Etch Dualbond) Total-Etch Bonding Agent for Light-Cured Resin-Based Materials (Total-Etch Bond)

# Indications for Use:

Total-Etch Dualbond is indicated for

- Bonding resin-based materials (especially dual cure composite, compomer . materials) to tooth structure (dentin and enamel)
- . Treatment of hypersensitive teeth

Total-Etch Bond is indicated for

- Bonding resin-based materials (especially light cure composite, compomer . materials) to tooth structure (dentin and enamel)
- . Treatment of hypersensitive teeth

#### Predicate Devices:

The components of the proposed Post and Core Kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:

| Product Name | Predicates |
|--------------------------------|--------------------------------------|
| Excite DSC | K003293 (Ivoclar North America Inc.) |
| Optibond Solo Plus (Dual-cure) | Unknown (Kerr Mfg. Co.) |
| All Bond 2 | K910628 (Bisco) |
| Scotchbond MP Plus | K942493 (3M Espe) |

# Total-Etch Dualbond:

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### Total-Etch Bond:

| Product Name | Predicate |
|---------------------------------------------------------------------------------|---------------------|
| Contax bonding agent contained in<br>the DMG Composite / Compomer<br>Repair Kit | K041960 (DMG - USA) |

## Safety and Performance:

This submission contains safety and performance information (chemical composition and physical performance data) sufficient to establish substantial equivalence in comparison to the devices listed above.

#### Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Total Etch Bond has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432

MAR 2 0 2007

Re: K063444

Trade/Device Name: Total Etch Bonding Agent (Total Etch Bond & Total Etch Dual Bond) Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 01, 2007 Received: March 07, 2007

Dear Ms. Papineau:

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.

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 – Ms. Pamela Papineau

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" (21 CFR 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,

Clair S. Lizio, Ph.D.

Chiu S. Lin. PhD 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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Page _ 1 of

510(k) Number (if known): K063444

Device Name: Total Etch Bonding Agent (Total Etch Bond & Total Etch Dual Bond)

Indications for Use:

Total-Etch Dualbond is indicated for:

- Bonding resin-based materials (especially dual-cure composite / compomer . materials) to tooth structure (dentin and enamel)
- Treatment of hypersensitive teeth .

Total-Etch Bond is indicated for:

- Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel)
- Treatment of hypersensitive teeth .

Prescription Use × (Per 21 CFR 801 Subpart D) OR

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sunor Teare

f Arkansas Building, General Hospital,
Infection Control, Clean Devices

July 26

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