(71 days)
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Not Found
No
The description focuses on the chemical formulation and application process of a dental bonding agent, with no mention of AI or ML technologies.
No.
Hermes Bond 3 is a tooth bonding agent used to improve the retention of restorative materials, which is a structural and restorative function rather than a therapeutic one that treats or prevents a disease.
No
Explanation: The device, Hermes Bond 3, is described as a "Resin Tooth Bonding Agent" intended to improve the retention of restorative materials by bonding between dentin/enamel and composites. Its function is to facilitate a dental restoration procedure, not to diagnose a condition or disease.
No
The device description clearly states that Hermes Bond 3 is a "Resin Tooth Bonding Agent" and is available in a "two-vial version" containing chemical components (Primer and Link). This indicates a physical, chemical-based product, not a software-only device.
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 between dentin/enamel and composite materials within the mouth of a patient. This is a direct application to the patient's 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 of a tooth." This is a dental restorative procedure performed on a living patient.
- Anatomical Site: The anatomical site is "Dentin/enamel of a tooth," which is part of the human body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
Therefore, Hermes Bond 3 is a dental device used for direct application to a patient's tooth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bonding between dentin/enamel and 3M ESPE silorane (or oxirane) based composites
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth (dentin/enamel)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 |
1
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.
2
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.
3
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
4
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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