(46 days)
Bonding between dentin/enamel and silorane based composite filling materials Bonding between dentin/enamel and methacrylate based composite filling materials
Hermes Bond 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 a restorative material. Like Adper Prompt L-Pop, 3M ESPF's well-known and well-established resin bonding agent, Hermes Bond offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible crrors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itsclf, Hermes Bond is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond which has especially been optimized for this purpose. The acidic methacrylates provide efficient etching of the dental hard tissue and initiation of the polymerization of the siloranc-based composite (e.g. "Hermes")at the interface with the adhesive. The blend of co-monomers allows at the same time formation of a uniform adhesive film on dentin and enamel, and additional chemical crosslinking between OHfunctionalized methacrylates and siloranes.
The provided document is a 510(k) summary for a dental adhesive, "Hermes Bond." It discusses the device's characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain the information required to answer the specific questions about acceptance criteria and a study proving device performance as it pertains to AI/algorithm performance.
The document describes a traditional medical device (a dental bonding agent) and its regulatory clearance process, which focuses on demonstrating substantial equivalence to existing devices through chemistry, performance data (like bond strength), and indications for use. It does not mention any AI component, algorithms, or studies involving human readers, ground truth establishment, or training/test sets for AI models.
Therefore, I cannot extract the requested information from the provided text. The questions posed ("Acceptance criteria and the study that proves the device meets the acceptance criteria," including details like "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for the training set") are typically relevant for evaluating AI/machine learning medical devices, which this document does not describe.
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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,Manager U.S. Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | Andreas.Petermann@mmm.com |
Name of Device
| Proprietary Name: | Hermes Bond |
|---|---|
| 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 ESPE.......................K 033022 |
| 3M ESPE HAUR by 3M ESPE.......................K 010781 |
Description for the Premarket Notification
Hermes Bond 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 a restorative material.
Like Adper Prompt L-Pop, 3M ESPF's well-known and well-established resin bonding agent, Hermes Bond offers the advantages of a simplified bonding procedure, eliminating
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the need for a separate etching step. Thus it reduces both possible crrors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time.
Being based on methacrylate chemistry itsclf, Hermes Bond is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond which has especially been optimized for this purpose. The acidic methacrylates provide efficient etching of the dental hard tissue and initiation of the polymerization of the siloranc-based composite (e.g. "Hermes")at the interface with the adhesive. The blend of co-monomers allows at the same time formation of a uniform adhesive film on dentin and enamel, and additional chemical crosslinking between OHfunctionalized methacrylates and siloranes.
In fact, the bond strength obtained for Hermes/Hermes Bond is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites.
The comparison for chemistry, performance data and indications for use shows that Hermes Bond is substantially equivalent to the predicate devices.
In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 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 and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 2004
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY
Re: K033974
Trade/Device Name: Hermes Bond Regulation Number: 21 CFR 872.200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EMA Dated: December 18, 2003 Received: December 22, 2003
Dear Dr. Petermann:
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 indicee use stated in the enclosure) to legally marketed predicate devices marketed in interstanding to 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 Cometic Act (Act) that do not require approval of a premarket approval application (PMA). You cossi, therefore, market the device, subject to the general controls provisions of the Act. Troumeral controls provisions of the Act include requirements for annual registration, listing of eeencer, 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 artify it 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. 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Chiu S. Lin, PhD
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):
| Device Name: | Hermes Bond |
|---|---|
| Indications For Use: | Bonding between dentin/enamel and silorane basedcomposite filling materials |
| Bonding between dentin/enamel and methacrylatebased composite filling materials |
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)
Susan Burns
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K063374
§ 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.