(71 days)
Bonding between dentin/enamel and 3M ESPE silorane (or oxirane) based composites
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).
The provided text describes a 510(k) premarket notification for a dental adhesive named "Hermes Bond 3." It is a regulatory document focused on establishing substantial equivalence to predicate devices, rather than a detailed study report on device performance based on acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It makes a qualitative statement about meeting safety and effectiveness requirements. The "performance" described is in the context of the device's function and advantages.
| Acceptance Criteria (Not explicitly stated as such) | Reported Device Performance (Qualitative descriptions) |
|---|---|
| Safety: Biocompatibility | Results of biocompatibility testing show that Hermes Bond 3 is a safe device. |
| Effectiveness/Functionality: improved retention of restorative materials | Intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. |
| Effectiveness/Functionality: bonding between dentin/enamel and silorane (or oxirane) based composites | 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. |
| Advantages over previous methods: Simplified bonding procedure, reduced application errors, reduced post-operative sensitivity, saved chair time | 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. |
| Substantial Equivalence: Chemistry, performance data, indications for use compare to predicate devices | The comparison for chemistry, performance data and indications for use shows that Hermes Bond 3 is substantially equivalent to the predicate devices (Hermes Bond 2, Adper Prompt L-Pop, RelyX Unicem, ESPE Sil, Sinfony - all by 3M ESPE). In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 3 are completely met. |
Study Details (Missing Information)
The provided text is a 510(k) summary, which focuses on establishing substantial equivalence rather than detailing a specific clinical or performance study with the requested metrics. Therefore, the following information is not present:
- Sample size used for the test set and the data provenance: Not mentioned. The document refers to "biocompatibility testing" and "comparison for chemistry, performance data," but doesn't provide details on the test set for these comparisons.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a dental adhesive, not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental adhesive, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For biocompatibility, it would typically be based on established biological tests and standards. For performance, it would likely be laboratory or in-vitro tests comparing bond strength, durability, etc., against predicate devices, but these details are not provided.
- The sample size for the training set: Not applicable, as this is a dental adhesive, not a machine learning model.
- How the ground truth for the training set was established: Not applicable, as this is a dental adhesive, not a machine learning model.
In summary: The document is a regulatory submission demonstrating substantial equivalence for a dental bonding agent. It confirms that biocompatibility testing was performed and that the device's chemistry, performance, and indications for use are comparable to legally marketed predicate devices, thereby meeting safety and effectiveness requirements. However, it does not provide the detailed study parameters, acceptance criteria, or performance data that would be typical for a clinical study report of a diagnostic device or AI algorithm.
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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,Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | Andreas.Petermann@mmm.com |
| 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 (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/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
Page 1 of
§ 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.