(16 days)
Not Found
No
The device description and summary of performance studies focus on the physical and chemical properties of a dental restorative material, with no mention of AI or ML capabilities.
No
The device is a restorative material used for dental fillings, not for treating diseases or improving health through therapeutic means.
No
The device is a restorative composite material used for filling cavities and other dental restorations, not for diagnosing diseases or conditions.
No
The device description clearly indicates it is a physical restorative composite material, not software. It is packaged in syringes and capsules and has physical properties like strength, wear, and radiopacity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "restorative composite" used for "direct anterior and posterior restorations," "core build-ups," "splinting," and "indirect restorations." These are all procedures performed directly on the patient's teeth within the mouth.
- Lack of Biological Sample Testing: There is no mention of this device being used to test or analyze any biological samples taken from the patient.
Therefore, 3M™ Filtek™ Universal Restorative is a dental restorative material used for direct application to teeth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core build-ups
- Splinting
- Indirect restorations including inlays, onlays, and veneers
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
3MTM FiltekTM Universal Restorative, is a visible-light activated, restorative composite optimized to create esthetic anterior and posterior restorations. This material provides excellent strength and low wear for durability and improved esthetics with higher level of visual opacity. The shades are body like opacity enabling up to a 2mm depth-of-cure. The pink opaquer can be placed in 1mm thick increments. All shades are radiopaque. Filtek Universal Restorative is offered in the following shades: A1. A2, A3. A3.5. A4, B1. B2, D3. XW, and PO. The pink opaque shade option can be used to mask discolored or stained tooth structure.
Filtek™ Universal Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser. Capsules may be warmed up to 70°C/158°F for one hour in a commercial warmer prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/Dental
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 stability testing, biocompatibility testing, and the following physical properties were included in this submission: Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, 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.
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
January 2, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
3M ESPE Dental Products % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
Re: K183476
Trade/Device Name: 3M Filtek Universal Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: December 13, 2018 Received: December 17, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mary S. Mary S. Bunner -S3 Runner -S3 Date: 2019.01.02
For 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
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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 on 3M products and marketing materials. The logo is a registered trademark of 3M Company.
Indications for Use Statement বঁ
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
3MTM Filtek™ Universal Restorative
Indications for Use (Describe)
· Direct anterior and posterior restorations (including occlusal surfaces)
· Core build-ups
· Splinting
· Indirect restorations including inlays, onlays, and veneers
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Survices (301) 443-6740 BB
3
ЗМ ЕЅРЕ Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000
Image /page/3/Picture/2 description: The image shows the 3M logo. The logo is in red and features the number 3 followed by the letter M. The logo is simple and recognizable.
510(k) Summary
This summary of 510(k) 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 | Lam Duong
Regulatory Affairs Associate
Phone: (651) 733-5945
Fax: (651) 736-1599
lduong@mmm.com |
| Date Summary was Prepared | 12Dec2018 |
| Trade Name | 3M™ Filtek™ Universal 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
Description of Device:
3MTM FiltekTM Universal Restorative, is a visible-light activated, restorative composite optimized to create esthetic anterior and posterior restorations. This material provides excellent strength and low wear for durability and improved esthetics with higher level of visual opacity. The shades are body like opacity enabling up to a 2mm depth-of-cure. The pink opaquer can be placed in 1mm thick increments. All shades are radiopaque. Filtek Universal Restorative is offered in the following shades: A1. A2, A3. A3.5. A4, B1. B2, D3. XW, and PO. The pink opaque shade option can be used to mask discolored or stained tooth structure.
Filtek™ Universal Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser. Capsules may be warmed up to 70°C/158°F for one hour in a commercial warmer prior to use.
Indications for Use:
- · Direct anterior and posterior restorations (including occlusal surfaces)
- · Core build-ups
- Splinting
- · Indirect restorations including inlays, onlays and veneers
The proposed intended use of Filtek™ Universal Restorative is the same to that of the predicate device, Filtek™ Bulk Fill Posterior Restorative. The proposed indications for Filtek™ Universal Restorative are a subset to Filtek™ Bulk Fill Posterior Restorative indications, all of which are still covered within the intended use of a dental restorative. Filtek™ Universal Restorative is a modification of predicate device with no new ingredients introduced, thus it is expected that the performance of Filtek™ Univeral Restorative and its predicate will be equivalent. The differences do not affect the safety and effectiveness of the device. Therefore, the intended use and indications of Filtek™ Universal Restorative are not significantly different to those of FiltekTM Bulk Fill Posterior Restorative.
Technological Characteristics:
Filtek Universal Restorative is a modification of predicate device. Filtek™ Bulk Fill Posterior Restorative, also manufactured by 3M ESPE Dental Products. The formulation was modified to provide a higher level of visual opacity enhancing the final esthetics of restorations.
The fillers are a combination of a non-agglomerated 20 nm silica filler, a nonagglomerated/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 nm particles. The inorganic filler loading is about 76.5% by weight (58.4% by volume). Filtek Universal Restorative contains AUDMA, AFM. diurethane-DMA, and 1, 12-dodecane-DMA. Filtek™M Universal 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.
5
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.
6
Substantial Equivalence:
| Technological property | FiltekTM
Universal
Restorative | FiltekTM 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 2 mm depth of cure for
body shades and up to 1mm depth of cure for opaque
shade)1 | X | – |
| Single-surface light-cure (up to 4 mm depth of cure) 2 | – | X |
| Multi-surface light-cure (5 mm depth of cure, Class II) 2 | – | X |
| 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)3
reusable syringe (extraoral)4 | X | X |
| Recommended for load-bearing occlusal surfaces | X | X |
| FDA-recognized standards followed | Risk Management:
ISO 14971:2007
Biocomp stds:
ISO 10993-1:2009
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:5
ISO 4049:2009 | Risk Management:
ISO 14971:2007
Biocomp stds:
ISO 10993-1:2009
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:5
ISO 4049:2009
ISO 6874:2005 |
7
-
- Curing protocol for