(90 days)
Not Found
Not Found
No
The device description and the absence of mentions of AI, DNN, or ML, along with the focus on material properties and traditional restorative techniques, indicate no AI/ML technology is incorporated.
No.
The device is a restorative material used for dental fillings, veneers, and core buildups, which are procedures to restore the structure and function of teeth, not to treat or cure a disease or condition in a therapeutic sense.
No.
The device description and indicated uses clearly label it as a "restorative material" for direct and indirect restorations, core buildups, and splinting, which are all treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "visible-light activated, radiopaque restorative material," which 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/Indications for Use: The intended uses listed are all related to direct and indirect dental restorations (fillings, veneers, inlays, onlays, etc.), core buildups, and splinting. These are procedures performed directly on the patient's teeth.
- Device Description: The device is described as a "visible-light activated, radiopaque restorative material." This is a material used in the body, not on or with a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to restore the structure and function of teeth.
N/A
Intended Use / Indications for Use
Indications:
- Direct anterior restorations including:
- Class III, IV, V, and VI
- Veneers
- Incisal edge repair
- Direct posterior restorations including:
- Class I or II
- Sandwich technique with glass ionomer resin material
- Cusp Buildups
- Core Buildups
- Splinting
- Indirect anterior and posterior restoration including:
- Inlays
- Onlays
- Veneers
Product codes
EBF
Device Description
3M™ Dent II System is a visible-light activated, radiopaque restorative material. This device, as well as the predicate devices, are based on monomer chemistry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Bench tests conducted for shrinkage, diametral tensile strength, compressive strength, wear and hardness. Also, laboratory bench tests for depth of cure.
Key Metrics
Not Found
Predicate Device(s)
3M™ Z100™ Restorative, Prisma TPH™ Spectrum, XRV™ Herculite®, Alert™, SureFil™
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
K981647
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Name: | Lael J. Pickett
Regulatory Affairs Specialist |
|----------------------|----------------------------------------------------------------------------------------------|
| Address: | 3M Dental Products Laboratory
3M Center, Building 260-2B-12
St. Paul, MN 55144-1000 |
| Telephone: | 612-733-3594 |
| Fax: | 612-736-0990 |
| Trade Name: | 3MTM Dent II System |
| Common Names: | Tooth shade resin material |
| Classification Name: | Tooth shade resin material
(21 CFR §872.3690) |
| Predicate Devices: | 3MTM Z100TM Restorative
Prisma TPHTM Spectrum
XRVTM Herculite®
AlertTM
SureFilTM |
3M™ Dent II System is a visible-light activated, radiopaque restorative material. This device, as well as the predicate devices, are based on monomer chemistry.
3M™ Dent II System is used in conjunction with a dental adhesive system for both anterior and posterior restorations. The predicate devices, when taken as a whole, have the same intended uses.
3M™ Dent II System II and 3M™ Z100™ Restorative, Prisma TPH™ Spectrum and XRV™ Herculite® devices have similar technological characteristics as indicated by their TEGDMA and BISGMA monomer chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include shrinkage, diametral tensile strength, compressive strength, wear and hardness.
3M ™ Dent II System and Alert™, SureFil™ have similar depth of cure based on laboratory bench tests conducted.
Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ Dent II System is safe, effective and performs as well or better than the predicate devices mentioned above.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 1998
Ms. Rebecca L. Hannack Regulatory Affairs 3M Dental Products Laboratory 3M Center, Building 260-2B-12 St. Paul, Minnesota 55144-1000
Re : K981647 3M™ Dent II System Trade Name: Requlatory Class: II Product Code: EBF Dated: May 7, 1998 Received: May 11, 1998
Dear Ms. Hannack:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੈਂ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Ms. Hannack
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Detmer for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... ............
3
510(k) Number (if known):
Device Name: 3M Dent II System
Indications For Use:
Indications:
-
- Direct anterior restorations including:
- Class III, IV, V, and VI 1
- Veneers ー
- Incisal edge repair -
- Direct anterior restorations including:
-
- Direct posterior restorations including:
- Class I or II l
- Sandwich technique with glass ionomer resin material l
- -Cusp Buildups
- Direct posterior restorations including:
-
- Core Buildups
- ★ Splinting
- Indirect anterior and posterior restoration including: ★
- -Inlays
- Onlays -
- Veneers
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runney
(Division Sign Off) Division of Donal Infection Control, and General Hospital Devices KG XIII 4 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
:
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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