Base under Class I and II direct restorations .
Liner under direct restorative materials .
. Pit and fissure sealant
Restoration of minimally invasive cavity preparations (including small, ◆ non stress-bearing occlusal restorations)
Class III and V restorations .
. Undercut blockout
Repair of small enamel defects .
Repair of small defects in esthetic indirect restorations .
Repair of resin and acrylic temporary materials .
As a core build-up where at least half the coronal tooth structure is . remaining to provide structural support for the crown

Device Description

Filtek™ Bulk Fill Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable. This low stress flowable material is semitranslucent enabling a 4mm depth of cure. The restorative is packaged in capsules and syringes. The shades offered with Filtek™ Bulk Fill flowable are U (Universal), A1, A2, and A3. Filtek™ Bulk Fill flowable contains bisGMA, UDMA, bisEMA(6) and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 microns and zirconia/silica with a particle size range of 0.01 to 3.5 µm. The inorganic filler loading is approximately 64.5% by weight (42.5% by volume). A dental adhesive is used to permanently bond the restoration to the tooth structure.

Filtek™ Bulk Fill Flowable Restorative is a modification of predicate device Filtek™ Supreme Ultra Flowable Restorative. The formulation was modified to increase depth of cure, while decreasing polymerization shrinkage stress.

AI/ML Overview

The provided text describes a 510(k) submission for a dental restorative material, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth, MRMC study, standalone performance), and training set details for a device meeting acceptance criteria and proven by a study is not present.

The document focuses on demonstrating substantial equivalence of the Filtek™ Bulk Fill Flowable Restorative to predicate devices. This is achieved through bench testing of physical properties and an assessment of biocompatibility and risk management.

Here's an analysis of the provided text in relation to your request, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance:

Not Available directly as a table for "acceptance criteria" and "reported device performance" in the AI/ML context.
The document states: "This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Bulk Fill Flowable Restorative compared to predicate devices Filtek™ Supreme Ultra Flowable Restorative, Adaptable Composite Resin Restorative Material and Revolution™ Formula 2. Standards utilized include ISO 4049.2009 and ISO 6874:2005. Properties evaluated include Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Cusp Deflection, Volumetric Shrinkage, Wear and Depth of Cure."
The "acceptance criteria" here are implied to be meeting or being comparable to the performance of the predicate devices and relevant ISO standards for these physical properties. The reported device performance for each of these specific properties is not explicitly listed in the summary but would have been part of the full 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available. The document mentions "bench testing" but does not specify sample sizes for these tests, nor the "provenance" in terms of subject or data origin, as this is a material science evaluation, not a clinical study involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/available. This section refers to AI/ML ground truth establishment. For this dental material, "ground truth" is established by standard material science testing and adherence to ISO standards.
One "Diplomate of the American Board of Toxicology" assessed biocompatibility, which is a different type of expert review, not related to an AI/ML ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/available. Adjudication methods are relevant for expert consensus in AI/ML performance evaluation and are not described here for material property testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/available. This is a question specifically for AI/ML devices. No human reader studies are mentioned, as the device is a dental restorative material, not an AI aid for diagnosis or treatment planning.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/available. This question is also specific to AI/ML algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/available in the AI/ML sense. The "ground truth" for this device's performance is based on established scientific measurement methods for material properties (e.g., compressive strength, depth of cure) as defined by ISO standards 4049.2009 and 6874:2005. Biocompatibility "ground truth" is derived from toxicology assessments and ISO 10993 and 7405 standards.

8. The sample size for the training set:

Not applicable/available. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable/available. There is no "training set."

In summary, the provided document describes the 510(k) submission for a non-AI dental material. Therefore, most of the requested information pertaining to AI/ML device evaluation criteria and study design is not present or applicable. The document focuses on demonstrating substantial equivalence based on material properties, biocompatibility, and risk management through bench testing and adherence to established standards, rather than clinical efficacy through human evaluations or AI model performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for 3M ESPE. The logo is in black and white, with the "3M" part of the logo being larger than the "ESPE" part. The font is a sans-serif font, and the letters are all capitalized. The logo is simple and easy to read.

K120453

3.

3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110

MAR 1 9 2012

3M ESPE

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 Company3M ESPE Dental Products3M Center, Building 260-2A-11St. Paul, MN 55144-1000 USAEstablishment Registration Number:3005174370
Contact person	Scott Erickson, RACSenior Regulatory Affairs SpecialistPhone: (651) 736-9883Fax: (651) 736-1599sterickson@mmm.com
Date Summary was Prepared	January 26, 2012
Trade Name	Filtek™ Bulk Fill FlowableRestorative
Common Name(s)	Tooth shade resin material
Recommended Classification	Tooth shade resin material(21 CFR 872.3690,Product Code: EBF)

Predicate Devices:

Filtek™ Supreme Ultra Flowable Restorative (K100235) Adaptable Composite Resin Restorative Material (K083841) Revolution™ Formula 2 (K013647) 3M™ Dent II System (K981647)

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3M ESPE

Description of Device:

Indications for Use:

Base under Class I and II direct restorations .
Liner under direct restorative materials .
. Pit and fissure sealant
Restoration of minimally invasive cavity preparations (including small, ◆ non stress-bearing occlusal restorations)
Class III and V restorations .
. Undercut blockout
Repair of small enamel defects .
Repair of small defects in esthetic indirect restorations .
Repair of resin and acrylic temporary materials .
As a core build-up where at least half the coronal tooth structure is . remaining to provide structural support for the crown

Technological Characteristics:

Filtek™ Bulk Fill Flowable Restorative contains bisGMA, UDMA, bisEMA(6) and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 microns and zirconia/silica with a particle size range of 0.01 to 3.5 µm. The inorganic filler loading is approximately 64.5% by weight (42.5% by volume). A dental adhesive is used to permanently bond 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 lightinduced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.

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3M ESP

Substantial Equivalence:

Biocompatibility:

A Diplomate of the American Board of Toxicology has assessed the safety of Filtek™ Bulk Fill Flowable Restorative. Standard risk assessment techniques and consideration of FDA General Program Memorandum G95 and internationally recognized guidelines, including ISO 10993-1:2009 along with Parts 3, 5, 6, 10, 11, 12 and ISO 7405:2008. were used in this evaluation. The conclusion of the assessment is that the product is safe for its intended use.

Risk Management:

The environmental, health and safety (EHS) risks for FiltekTM Bulk Fill Flowable Restorative were evaluated using a process compliant with ISO 14971:2007, as well as specific procedures and practices outlined by 3M ESPE Dental Products Standard Operating Procedures. After application of risk control, all risks identified in the Filtek™ Bulk Fill Flowable Restorative risk assessment were deemed to be broadly acceptable.

Summary of Physical Tests:

This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Bulk Fill Flowable Restorative compared to predicate devices Filtek™ Supreme Ultra Flowable Restorative, Adaptable Composite Resin Restorative Material and Revolution™ Formula 2. Standards utilized include ISO 4049.2009 and ISO 6874:2005. Properties evaluated include Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Cusp Deflection, Volumetric Shrinkage, Wear and Depth of Cure.

Conclusion:

Information provided in this 510(k) submission shows that Filtek™ Bulk Fill Flowable Restorative is substantially equivalent to the predicate devices, Filtek™ Supreme Ultra Flowable Restorative, Adaptable Composite Resin Restorative Material, and Revolution™ Formula 2 in terms of intended use, indications for use, physical properties and technological characteristics. FiltekTM Bulk Fill Flowable Restorative is substantially equivalent to the predicate devices Filtek™ Supreme Ultra Flowable Restorative and 3MTM Dent II System in terms of formulation.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

3M ESPE Dental Products C/O Mr. William Sammons Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

MAR 1 9 2012

Re: K120453

Trade/Device Name: Filtek™ Bulk Fill Flowable Restorative Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: EBF Dated: March 12, 2012 Received: March 14, 2012

Dear Mr. Sammons:

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 Eederal Register.

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Page 2 - Mr. Sammons

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,

Wh 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

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3M ESPE

Indications for Use Statement 4.

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ Filtek™ Bulk Fill Flowable Restorative

Indications for Use:

Base under Class I and II direct restorations .
Liner under direct restorative materials .
Pit and fissure sealant .
Restoration of minimally invasive cavity preparations (including small, non stress-. bearing occlusal restorations)
Class III and V restorations ●
Undercut blockout .
Repair of small enamel defects .
Repair of small defects in esthetic indirect restorations ・・
Repair of resin and acrylic temporary materials .
As a core build-up where at least half the coronal tooth structure is remaining to . provide structural support for the crown

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)

signature

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K 120453

Filtek™ Bulk Fill Flowable Restorative 510(k)

Page 1 of 1

Regulation Number and Section

§ 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.