HERMES BOND 2

K043043 · 3M Espe AG Dental Products · KLE · Jan 10, 2005 · Dental

Device Facts

• Record ID: K043043
• Device Name: HERMES BOND 2
• Applicant: 3M Espe AG Dental Products
• Product Code: KLE · Dental
• Decision Date: Jan 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Bonding between dentin/enamel and silorane based composite filling materials Bonding between dentin/enamel and methacrylate based composite filling materials Bonding mediator for fissure sealing

Device Story

Hermes Bond 2 is a resin tooth bonding agent applied to the interior of prepared tooth cavities to improve restorative material retention. It eliminates the need for a separate etching step, reducing application errors and post-operative sensitivity while saving chair time. The device is used by dentists in clinical settings. It is based on methacrylate chemistry and optimized for compatibility with both methacrylate and silorane-based composites. Available in single-dose applicators or a two-vial version, it functions as a bonding mediator for fissure sealing. The device is applied by the clinician to the tooth structure prior to composite placement, facilitating a secure bond between the tooth and the restorative material.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through biocompatibility testing and bench performance data comparing bond strength to predicate devices.

Technological Characteristics

Resin tooth bonding agent; methacrylate-based chemistry; optimized for silorane and methacrylate composite compatibility. Form factor: single-dose applicators or two-vial liquid system. No electronic components or software.

Indications for Use

Indicated for bonding dentin/enamel to silorane-based or methacrylate-based composite filling materials and as a bonding mediator for fissure sealing in dental patients.

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

• Adper Prompt L-Pop by 3M ESPE (K020946)
• RelyX Unicem by 3M ESPE (K020256)
• Protemp 3 Garant by 3M (K033022)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitter

| Company: | 3M ESPE AG |
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| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann,<br>Senior Specialist Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | November 2, 2004 |
| Name of Device | |
| Proprietary Name: | Hermes Bond 2 |
| Classification Name: | Resin tooth bonding agent |
| Common Name: | Dental Adhesive |
| Predicate Devices | |
| Adper Prompt L-Pop by 3M ESPE | K 020946 |
| RelyX Unicem by 3M ESPE | K 020256 |
| Protemp 3 Garant by 3M | K 033022 |

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Description for the Premarket Notification

Hermes Bond 2 is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.320(1) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restorative material.

Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Hermes Bond 2 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. Being based on methacrylate chemistry itself, Hermes Bond 2 is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond 2 which has especially becu optimized for this purpose. In fact, the bond strength obtained for Hermes/Hermes Bond 2 is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites.

Hermes Bond 2 is also intended to be used as a bonding mediator for fissure sealing as is Adper Prompt L-Pop.

Like Adper Prompt L-Pop, Hermes Bond 2 will be available in single dose applicators and in a two-vial version.

To provide evidence for safety biocompatibility testing was carried out. The results show that Hermes Bond 2 is a safe device.

The comparison for chemistry, performance data and indications for use shows that Hermes Bond 2 is substantially equivalent to the predicate devices.

In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 2 are completely met.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

JAN I 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY

Re: K043043

Trade/Device Name: Hermes Bond 2 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 02, 2004 Received: December 08, 2004

Dear Dr. Petermann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your because on the device is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that provision with 20, 1970, the encounters with the provisions of the Federal Food, Drug, and Cosmetic have occh reciassified in accordines with a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mailier the act include requirements for annual registration, listing of devices, good controls provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to such additions, 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. Andreas Petermann

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/dsma/dsmamain.html

Sincerely yours,

Ole

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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## Indications for Use

510(k) Number (if known): K043043

Device Name: Hermes Bond 2

Indications For Use:

Bonding between dentin/enamel and silorane based composite filling materials

Bonding between dentin/enamel and methacrylate based composite filling materials

Bonding mediator for fissure sealing

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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)

Swpa Rummer

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental De

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