(62 days)
K 010781, K 964285, K 960548, K 962440
Not Found
No
The description focuses on the material properties and chemistry of a dental filling composite, with no mention of AI or ML.
No
The device is a dental filling composite used for restorations, not a device designed to treat or prevent a disease or condition.
No.
The device description and intended use indicate that Hermes is a dental filling composite used for restorations, not for diagnosing conditions.
No
The device description clearly states "Hermes is a one component dental filling composite," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material used for direct and indirect dental restorations (fillings, veneers, inlays, onlays, etc.). This is a therapeutic or restorative application, not a diagnostic one.
- Device Description: The description focuses on the chemical composition and properties of a dental filling composite, highlighting its low shrinkage. This aligns with a material used to repair or replace tooth structure.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The anatomical site is "Teeth," which is consistent with a dental restorative material.
- Intended User/Care Setting: The intended user is a "Dental office," which is where dental procedures are performed.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a material used to treat or restore damaged teeth.
N/A
Intended Use / Indications for Use
Direct anterior restorations including: . Class III, IV, V and VI Veneers Incisal edge repair
- Direct posterior restorations including: ● Class I or II or V Sandwich technique with glass ionomer resin material Cusp buildups
- Core buildups ●
- Splinting .
- Indirect anterior and posterior restorations including: . Inlays Onlays Veneers
Product codes
EBF
Device Description
Hermes is a one component dental filling composite. Hermes uses different monomer chemistry and a different polymerization mechanism than most filling composites which are currently commercially available.
Based on its particular chemistry, Hermes reveals considerably low shrinkage properties. Thus, Hermes may lead to significant advantages in the dental office such as reduced stress to cavity walls. On the other hand, the clinician can fill the cavity in much larger increments (layers) in one stcp compared to methacrylate based composites leading to time savings and reduced stress for the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental office
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)
Comparison to the predicate devices for performance data and indications for use shows that Hermes is substantially equivalent to the predicate devices.
Biocompatibility testing for Hermes provides evidence that the device is safe for its intended use.
In summary, it can be concluded that safety and effectiveness requirements for Hermes are completely met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 010781, K 964285, K 960548, K 962440
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the date December 22, 2003. The text is written in a simple, sans-serif font. The date is written in the standard month-day-year format. The text is black and the background is white.
FEB 2 4 2004
K03346
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 |
| Date: | December 22, 2003 |
| Name of Device | |
| Proprietary Name: | Hermes |
| Classification Name: | Tooth Shade Resin Material |
| Common Name: | Epoxy-Based Universal Restorative, |
| Resin-Based Filling Material | |
| Predicate Devices | |
| 3M ESPE HAUR by 3M ESPE | K 010781 |
| Tetric Ceram by Vivadent | K 964285 |
| AH Plus by Dentsply | K 960548 |
| Pertac II by ESPE | K 962440 |
:
1
Description for the Premarket Notification
Hermes is classified as Tooth Shade Resin Material because it is a device intended to restore carious lesions or structural defects in teeth. Tooth Shade Resin Matcrial is designated at 21 C.F.R. § 872.3690 as a Class II device.
Hermes is a one component dental filling composite. Hermes uses different monomer chemistry and a different polymerization mechanism than most filling composites which are currently commercially available.
Based on its particular chemistry, Hermes reveals considerably low shrinkage properties. Thus, Hermes may lead to significant advantages in the dental office such as reduced stress to cavity walls. On the other hand, the clinician can fill the cavity in much larger increments (layers) in one stcp compared to methacrylate based composites leading to time savings and reduced stress for the patient.
Comparison to the predicate devices for performance data and indications for use shows that Hermes is substantially equivalent to the predicate devices.
Biocompatibility testing for Hermes provides evidence that the device is safe for its intended use.
In summary, it can be concluded that safety and effectiveness requirements for Hermes are completely met.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circular seal. The eagle is depicted with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2004
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY
Re: K033996
Trade/Device Name: Hermes Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: December 22, 2003 Received: December 24, 2003
Dear Dr. Petermann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your because to the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreasary of the Medical Device Amendments, or to devices that provision in May 20, 1970, in clarge with the provisions of the Federal Food, Drug, and Cosmetic nave occh tectasion of 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 thereone, manker the device, dables requirements for annual registration, listing of devices, good controls provisions of alleding, 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 of subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
3
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,
Clues
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
4
Indications for Use
510(k) Number (if known):
Hermes
Device Name:
Indications For Use:
Direct anterior restorations including: . Class III, IV, V and VI Veneers Incisal edge repair
- Direct posterior restorations including: ● Class I or II or V Sandwich technique with glass ionomer resin material Cusp buildups
- Core buildups ●
- Splinting .
- Indirect anterior and posterior restorations including: . Inlays Onlays Veneers
Prescription Use V (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 Rump
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of I
510(k) Number. K033996