(67 days)
K 020946, K 020256, K 033022
Not Found
No
The description focuses on the chemical composition and application of a resin bonding agent, with no mention of AI or ML technologies.
No
The device is a bonding agent used in dental restorative procedures, not for treating diseases or conditions.
No
The device description clearly states its intended use is to improve the retention of restorative materials in a tooth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly indicates that Hermes Bond 2 is a physical substance (resin tooth bonding agent) intended to be applied to teeth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding dental materials to tooth structure (dentin/enamel) and as a bonding mediator for fissure sealing. This is a direct application within the body (or on a part of the body) for a therapeutic or restorative purpose.
- Device Description: The description clearly states it's a "Resin Tooth Bonding Agent" intended to be painted on the interior of a prepared cavity to improve retention of restorative material. This is a physical interaction with the tooth structure.
- Lack of In Vitro Testing: The description of performance studies mentions biocompatibility testing and comparison to predicate devices based on chemistry, performance data, and indications for use. There is no mention of testing biological samples (like blood, urine, tissue) outside of the body to diagnose a condition or provide information about a physiological state.
- Anatomical Site: The anatomical site is dentin/enamel, which is part of the human body. IVDs typically analyze samples taken from the body.
In summary, the device is a dental material used directly on the tooth for bonding purposes, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
KLE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth; dentin/enamel; fissure
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K 020946, K 020256, K 033022
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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| 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, |
| Senior Specialist Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | Andreas.Petermann@mmm.com |
| 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.
2
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 (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/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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