HERMES BOND 3

K071260 · 3M Espe AG Dental Products · KLE · Jul 17, 2007 · Dental

Device Facts

• Record ID: K071260
• Device Name: HERMES BOND 3
• Applicant: 3M Espe AG Dental Products
• Product Code: KLE · Dental
• Decision Date: Jul 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Bonding between dentin/enamel and 3M ESPE silorane (or oxirane) based composites

Device Story

Hermes Bond 3 is a resin tooth bonding agent applied to the interior of prepared tooth cavities to improve retention of restorative materials. The device consists of a two-vial system: a primer and a link (bond). It is designed to bond dentin and enamel specifically to silorane or oxirane-based composites. By eliminating the need for a separate etching step, the device simplifies the bonding procedure, reduces application errors, minimizes post-operative sensitivity, and saves chair time for the dentist. It is intended for professional use by dentists in a clinical setting.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through biocompatibility testing and performance data comparisons.

Technological Characteristics

Two-vial resin bonding agent (primer and link). Formulated for compatibility with silorane/oxirane-based composites. Classified as a resin tooth bonding agent (21 CFR 872.3200).

Indications for Use

Indicated for bonding dentin and enamel to silorane or oxirane-based dental composites.

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

• Hermes Bond 2 by 3M ESPE
• Adper Prompt L-Pop by 3M ESPE
• RelyX Unicem by 3M ESPE
• ESPE Sil by 3M ESPE
• Sinfony by 3M ESPE

Submission Summary (Full Text)

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K071260

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitter

JUL 1 7 2007

| Company: | 3M ESPE AG |
|-----------------------------------|------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann,<br>Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | May 02, 2007 |

### Name of Device

| Proprietary Name: | Hermes Bond 3 |
|----------------------|---------------------------|
| Classification Name: | Resin tooth bonding agent |
| Common Name: | Dental Adhesive |

#### Predicate Devices

| Hermes Bond 2 by 3M ESPE | |
|-------------------------------|--|
| Adper Prompt L-Pop by 3M ESPE | |
| RelyX Unicem by 3M ESPE | |
| ESPE Sil by 3M ESPE | |
| Sinfony by 3M ESPE | |

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#### Description for the Premarket Notification

Hermes Bond 3 is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.

Hermes Bond 3 offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Hermes Bond 3 is intended to provide bonding between dentin/enamel and silorane (or oxirane) based composites. This is ensured by the formulation of Hermes Bond 3 which has especially been optimized for this purpose.

Hermes Bond 3 will be available in a two-vial version, one containing the Hermes Bond 3 Primer and one containing the Hermes Bond 3 Link (Bond).

To provide evidence for safety biocompatibility testing was carried out. The results show that Hermes Bond 3 is a safe device.

The comparison for chemistry, performance data and indications for use shows that Hermes Bond 3 is substantially equivalent to the predicate devices.

In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 3 are completely met.

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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 outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz Seefeld, Bavaria, GERMANY D-82229

JUL 17 2007

Re: K071260

Trade/Device Name: Hermes Bond 3 Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 2, 2007 Received: May 7, 2007

Dear Dr. Soegiarto:

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 - Dr. Soegiarto

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 vours,

Carl Lin, Ph.D.

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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# Indications for Use

Hermes Bond 3

510(k) Number (if known):

Device Name:

Indications For Use:

Bonding between dentin/enamel and 3M ESPE silorane (or oxirane) based composites

Prescription Use
(Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
"10(k) Number: K071260
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