(13 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a dental restorative material, with no mention of AI or ML capabilities.
No
The device is a restorative composite material used for dental fillings, not a therapeutic device designed to treat a disease or condition.
No
The device description clearly states it is a "restorative composite" used for "creating fast and easy restorations" and "core build-ups," indicating it is a therapeutic material, not a diagnostic tool.
No
The device is a dental restorative material, which is a physical substance, 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. This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The description details a visible-light activated restorative composite used for filling cavities and building up tooth structure. This is consistent with a dental restorative material.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Anatomical Site: The anatomical site is "Tooth structure," which is the target of the restorative action, not a source of a diagnostic sample.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically restore damaged tooth structure.
N/A
Intended Use / Indications for Use
- · Direct anterior and posterior restorations (including occlusal surfaces)
- · Base/liner under direct restorations
- · Core build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
- · Restorations of deciduous teeth
- · Extended fissure sealing in molars and premolars
- · Repair of defects in porcelain restorations, enamel, and temporaries
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
3MTM FiltekTM One Bulk Fill Restorative, is a visible-light activated, restorative composite optimized to create fast and easy restorations. This material provides excellent strength and low wear for durability and improved esthetics. The material can be placed and cured up to 5mm deep, enabled by a stress relieving resin system and optimized optical properties. Filtek™ One Bulk Fill Restorative serves to enhance the 3M ESPE lineup of restorative materials by improving the esthetic properties of a bulk fill material to allow for broader use in both posterior and anterior restorations. Filtek™ One Bulk Fill Restorative is offered in a range of tooth-colored shades. All shades are radiopaque.
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)
Test results for the following physical properties were included in this submission: Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus. Surface Hardness. Radiopacity. Water Sorption. Water Solubility. Volumetric Shrinkage, Wear, Depth of Cure, Cusp Deflection and Polish Retention.
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.
Filtek™ Bulk Fill Posterior Restorative (K141081)
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
§ 872.3690 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human figures connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 28,2016
3M ESPE Dental Products c/o Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K163207
Trade/Device Name: 3M™ Filtek™ One Bulk Fill Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 13, 2016 Received: November 15, 2016
Dear Mark Job:
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.
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runno DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used to represent the 3M company.
Indications for Use Statement ব
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
| 510(k) Number (if known) | |
|---|---|
| -------------------------- | -- |
Device Name
3MTM FiltekTM One Bulk Fill Restorative
Indications for Use (Describe)
- · Direct anterior and posterior restorations (including occlusal surfaces)
- · Base/liner under direct restorations
- · Core build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
- · Restorations of deciduous teeth
- · Extended fissure sealing in molars and premolars
- · Repair of defects in porcelain restorations, enamel, and temporaries
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | ||||
|---|---|---|---|---|
| -- | ------------------ | -- | -- | -- |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
3
Appendix A Revised Section 3 - 510(k) Summary
510(k) Summary 3.
ЗМ ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000
Image /page/3/Picture/4 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The number "3" is larger than the letter "M". The logo is simple and recognizable.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter................................ | 3M ESPE Dental Products
2510 Conway Ave.
St. Paul, MN 55144 USA |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact person................................ | Scott Erickson, RAC
Senior Regulatory Affairs Specialist
Phone: (651) 736-9883
Fax: (651) 736-1599
sterickson@mmm.com |
| Date Summary was Prepared...... | 19Oct2016 |
| Trade Name................................ | 3MTM FiltekTM One Bulk Fill
Restorative |
| Common Name(s)............................ | Tooth shade resin material
Restorative |
| Recommended Classification...... | 21 CFR 872.3690
Tooth shade resin material
Product Code: EBF |
Predicate Device: Filtek™ Bulk Fill Posterior Restorative (K141081)
4
Image /page/4/Picture/0 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used on 3M products and marketing materials.
Description of Device:
3MTM FiltekTM One Bulk Fill Restorative, is a visible-light activated, restorative composite optimized to create fast and easy restorations. This material provides excellent strength and low wear for durability and improved esthetics. The material can be placed and cured up to 5mm deep, enabled by a stress relieving resin system and optimized optical properties. Filtek™ One Bulk Fill Restorative serves to enhance the 3M ESPE lineup of restorative materials by improving the esthetic properties of a bulk fill material to allow for broader use in both posterior and anterior restorations. Filtek™ One Bulk Fill Restorative is offered in a range of tooth-colored shades. All shades are radiopaque.
Indications for Use:
- · Direct anterior and posterior restorations (including occlusal surfaces)
- · Base/liner under direct restorations
- Core build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
- · Restorations of deciduous teeth
- · Extended fissure sealing in molars and premolars
- · Repair of defects in porcelain restorations, enamel, and temporaries
Technological Characteristics:
Filtek™ One Bulk Fill Restorative is a modification of predicate device, Filtek™ Bulk Fill Posterior Restorative, also manufactured by 3M ESPE Dental Products. The formulation was modified to improve the esthetics of the cured restorative material.
The fillers are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, a non-agglomerated/non-aggregated 4 to 11 nm zirconia filler, an aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles), and a ytterbium trifluoride filler consisting of agglomerate 100 mm particles. The inorganic filler loading is about 76.5% by weight (58.5% by volume). FiltekTM One Bulk Fill Restorative contains AUDMA. AFM. diurethane-DMA. and 1. 12dodecane-DMA. Filtek™ One Bulk Fill Restorative is applied to the tooth following use of a methacrylate-based dental adhesive, such as manufactured by 3M ESPE, which permanently bonds the restoration to the tooth structure.
When irradiated by light. the methacrylate functionalities of the resins and 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.
5
Image /page/5/Picture/0 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The logo is simple and recognizable.
Substantial Equivalence:
| Technological property | Filtek™ One
Bulk Fill
Restorative | Filtek™ Bulk
Fill Posterior
Restorative
(K141081) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photoinitiator system | X | X |
| Methacrylate-based resin matrix | X | X |
| Compatible with methacrylate-based dental adhesives | X | X |
| Inorganic fillers | X | X |
| Oxide fillers are silane treated so that they bond to the
resin matrix when the restorative is cured | X | X |
| Single-surface light-cure (up to 3 mm depth of cure) | X1 | - |
| Single-surface light-cure (up to 4 mm depth of cure) | X | X |
| Multi-surface light-cure (5 mm depth of cure, Class II) | X2 | X2 |
| Multi-surface light-cure (5 mm depth of cure, Core
Build-Up) | X3 | - |
| When irradiated by light, the methacrylate
functionalities of the resins and 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 |
| Dispensing system:
single-use capsule (intraoral)4
reusable syringe (extraoral)5 | X | X |
| Recommended for load-bearing occlusal surfaces | X | X |
| FDA-recognized standards followed | Risk Management:
ISO 14971:2007
Biocomp stds:6
ISO 10993-1:2009
ISO 10993-3:2003
ISO 10993-3:2014
ISO 10993-5:2009
ISO 10993-6:2007
ISO 10993-10:2010
ISO 10993-11:2006
ISO 10993-12:2012
ISO 7405:2008/
Amd1 2013
Product stds:7
ISO 4049:2009 | Risk Management:
ISO 14971:2007
Biocomp stds:6
ISO 10993-1:2009
ISO 10993-3:2003
ISO 10993-5:2009
ISO 10993-6:2007
ISO 10993-10:2010
ISO 10993-11:2006
ISO 10993-12:2012
ISO 7405:2008
Product stds: 7
ISO 4049:2009 |
6
Image /page/6/Picture/0 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The logo is simple and recognizable.
-
- Curing protocol for