(106 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental restorative, with no mention of AI or ML technologies.
No
The device is a restorative material used for dental fillings and sealants, not a therapeutic device designed to treat or cure a disease or condition.
No
Explanation: The device is described as a flowable nanocomposite used for dental restorations, fillings, and sealants. Its function is to treat and repair, not to diagnose conditions.
No
The device description clearly states it is a "low viscosity, visible-light activated, radiopaque, flowable nanocomposite" and lists its chemical composition and physical properties. This indicates 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 uses listed are all related to the direct restoration and repair of tooth structure. These are clinical procedures performed directly on the patient's tooth.
- Device Description: The device is a flowable composite material used for filling cavities and other dental repairs. It is applied directly to the tooth.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit this description. It is not used to test bodily fluids or tissues for diagnostic information.
Therefore, Filtek Supreme Ultra Flowable Restorative is a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Class III and V restorations
- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
- Base/liner under direct restorations
- Repair of small defects in esthetic indirect restorations
- Pit and fissure sealant
- Undercut blockout
- Repair of resin and acrylic temporary materials
Product codes
EBF
Device Description
Filtek Supreme Ultra Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable nanocomposite. The restorative is packaged in capsules and syringes. It is available in a variety of toothcolored shades. The shades offered with Filtek Supreme Ultra flowable restorative were designed to coordinate with shades offered with Filtek™ Supreme Ultra Universal Restorative. Filtek Supreme Ultra flowable restorative contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non-aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Supreme Ultra Flowable Restorative compared to predicate devices 3M™ LVR System and Revolution Formula 2. Properties evaluated include Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Polymerization Shrinkage, Polish Retention and Fluorescence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3M™ LVR System, Revolution Formula 2
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
3M ESPE
510(k) Summary vi
3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
MAY 1 2 2010
Image /page/0/Picture/6 description: The image shows the logo for 3M ESPE. The logo is in black and white and features the text "3M ESPE" in a bold, sans-serif font. The letters are evenly spaced and the overall design is simple and clean.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter................ | 3M Company
3M ESPE Dental Products
3M Center, Bldg. 275-2W-08
St. Paul, MN 55144-1000 USA
Establishment Registration Number
2110898 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person................ | Scott Erickson
Regulatory Affairs Specialist
Phone: (651) 736-9883
Fax: (651) 736-1599
sterickson@mmm.com |
| Date Summary was Prepared...... | January 25, 2010 |
| Trade Name................ | FiltekTM Supreme Ultra Flowable
Restorative |
| Common Name(s)................. | Tooth shade resin material |
| Recommended Classification...... | Tooth shade resin material
(21 CFR 872.3690,
Product Code: EBF) |
Predicate Devices: 3M™ LVR System, Revolution Formula 2
1
3M ESPE
Indications for Use:
- · Class III and V restorations
- · Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
- · Base/liner under direct restorations
- · Repair of small defects in esthetic indirect restorations
- Pit and fissure sealant
- Undercut blockout
- · Repair of resin and acrylic temporary materials
Description of Device:
Filtek Supreme Ultra Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable nanocomposite. The restorative is packaged in capsules and syringes. It is available in a variety of toothcolored shades. The shades offered with Filtek Supreme Ultra flowable restorative were designed to coordinate with shades offered with Filtek™ Supreme Ultra Universal Restorative. Filtek Supreme Ultra flowable restorative contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non-aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
Filtek™ Supreme Ultra Flowable Restorative is a minor modification of predicate device 3M™ LVR System. The formulation was modified to improve physical properties, such as fluorescence and polish retention and to provide additional tooth colored shades of the restorative material.
When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
Technological Characteristics:
Filtek Supreme Ultra flowable restorative contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a nonagglomerated/non-aggregated surface modified 20nm silica filler, a nonagglomerated/non-aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average
2
3M ESPE
cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
Filtek™ Supreme Ultra Flowable Restorative is a minor modification of predicate device 3M™ LVR System. The formulation was modified to improve physical properties, such as fluorescence and polish retention and to provide additional tooth colored shades of the restorative material. As a result of the reformulation, a biocompatibility assessment was developed for FiltekTM Supreme Ultra Flowable Restorative using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11. The conclusion of the assessment is that Filtek™ Supreme Ultra Flowable Restorative is safe for its intended use.
Summary of Physical Tests:
This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Supreme Ultra Flowable Restorative compared to predicate devices 3M™ LVR System and Revolution Formula 2. Properties evaluated include Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Polymerization Shrinkage, Polish Retention and Fluorescence.
Substantial Equivalence:
Information provided in this 510(k) submission shows that Filtek™ Supreme Ultra Flowable Restorative is substantially equivalent to the predicate device 3M™ LVR System in terms of intended use, indications for use, composition, physical properties and technological characteristics. Filtek™ Supreme Ultra Flowable Restorative is substantially equivalent to the predicate device Revolution Formula 2 in terms of intended use, indications for use, physical properties and technological characteristics. Physical properties evaluated include Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Polymerization Shrinkage, Polish Retention and Fluorescence. A comparison of technological characteristics is provided below:
3
ЗМ ESPE
| Technological property | Filtek™
Supreme
Ultra
Flowable | 3M™
LVR | Revolution
Formula 2 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------------|-------------------------|
| Camphorquinone/amine photoinitiator system | X | X | - |
| Methacrylate-based resin matrix | X | X | X |
| Silane treated fillers | X | X | - |
| Bonded with a permanent dental adhesive | X | X | X |
| When irradiated by light, the methacrylate
functionalities of the resins and surface-treated
fillers undergo, in conjunction with the
photoinitiator system, a light-induced
polymerization to form a hard composite that is
bonded to the tooth structure with a permanent
dental adhesive. | X | X | X |
:
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or abstract human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
3M Company Mr. Scott Erickson, RAC Regulatory Affairs 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul. Minnesota 55144-1000
MAY 1 2 2010
Re: K100235
Trade/Device Name: Filtek TM Supreme Ultra Flowable Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 23, 2010 Received: April 27, 2010
Dear Mr. Scott Erickson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2- Mr. Scott Erickson
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
6
3M ESPE
Indications for Use Statement 4.
Indications for Use
510(k) Number (if known): K |00235
Device Name: Filtek™ Supreme Ultra Flowable Restorative
Indications for Use:
- · Class III and V restorations
- · Restoration of minimally invasive cavity preparations (including small, non stressbearing occlusal restorations)
- · Base/liner under direct restorations
- · Repair of small defects in esthetic indirect restorations
- Pit and fissure sealant
- Undercut blockout
- · Repair of resin and acrylic temporary materials
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Kein Nule for HSR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page _ of _
510(k) Number: K100235
Filtek™ Supreme Ultra Flowable Restorative 510(k)
Page 13 of 111