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

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).

AI/ML Overview

The provided text describes a 510(k) submission for the "Filtek™ Supreme Ultra Flowable Restorative" dental device. However, this is a material rather than an AI-based or software device, and therefore the concepts of "acceptance criteria," "study" in the context of an AI device, "sample size for test set," "data provenance," "experts for ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set" are not applicable in this document.

Instead, the submission focuses on demonstrating the substantial equivalence of the new dental restorative material to existing predicate devices through bench testing of physical properties and an assessment of biocompatibility.

Here's a breakdown of the relevant information from the document in the format requested, with NA (Not Applicable) for AI-specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental restorative material), "acceptance criteria" are typically defined by comparing physical properties to predicate devices or established standards. The document states that the formulation was modified to improve certain physical properties. The "performance" is demonstrated by showing substantial equivalence in several properties.

Property Evaluated	Predicate Device(s) (Baseline/Reference)	Filtek™ Supreme Ultra Flowable Restorative (Reported Performance - Implied equivalent or improved)
Compressive Strength	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Diametral Tensile Strength	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Flexural Strength	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Flexural Modulus	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Surface Hardness	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Radiopacity	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Water Sorption	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Water Solubility	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Polymerization Shrinkage	3M™ LVR System, Revolution Formula 2	Demonstrated equivalence/improvement
Polish Retention	3M™ LVR System, Revolution Formula 2	Improved compared to predicate
Fluorescence	3M™ LVR System, Revolution Formula 2	Improved compared to predicate
Biocompatibility	N/A (Assessed against ISO 10993)	Safe for intended use

2. Sample Size Used for the Test Set and the Data Provenance

This refers to bench testing samples, not patient data for an algorithm. The document does not specify the exact sample sizes for each physical property test.

Sample Size: Not specified in the provided text, but implied to be sufficient for bench testing of physical properties to establish statistical relevance for comparison.
Data Provenance: The data is generated from bench testing performed by the manufacturer, 3M ESPE Dental Products. It is laboratory-generated data, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable, as this is a dental material, not an AI device requiring expert-labeled ground truth from medical images or clinical data. The "truth" is established by direct physical measurements according to standardized testing methods.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI/imaging studies. For a physical material, measurements are taken and compared.

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. This is not an AI/software device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This describes a dental material, not an algorithm.

7. The Type of Ground Truth Used

For physical properties, the "ground truth" is the measured value of the property itself, obtained through standardized laboratory tests. For biocompatibility, the ground truth is established through risk assessment techniques and adherence to international guidelines like ISO 10993.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for a physical dental material like there would be for an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set, there's no ground truth to establish for it.

Summary of Device Meeting Acceptance Criteria:

The device, Filtek™ Supreme Ultra Flowable Restorative, meets its "acceptance criteria" by demonstrating substantial equivalence to the predicate devices (3M™ LVR System and Revolution Formula 2) in its intended use, indications for use, composition (with minor modifications), physical properties, and technological characteristics. The manufacturer performed bench testing to compare a range of physical properties (Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Polymerization Shrinkage, Polish Retention, and Fluorescence). The text explicitly states the formulation was modified to improve properties like fluorescence and polish retention, and the total assessment, including biocompatibility (evaluated against ISO 10993 standards), concluded the device is safe for its intended use. This evidence of comparable or improved performance for key physical characteristics, along with biocompatibility, forms the basis for the FDA's "substantially equivalent" determination.

Summary

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3M ESPE

K100235

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 Company3M ESPE Dental Products3M Center, Bldg. 275-2W-08St. Paul, MN 55144-1000 USAEstablishment Registration Number2110898
Contact person................	Scott EricksonRegulatory Affairs SpecialistPhone: (651) 736-9883Fax: (651) 736-1599sterickson@mmm.com
Date Summary was Prepared......	January 25, 2010
Trade Name................	FiltekTM Supreme Ultra FlowableRestorative
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

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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:

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

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3M ESPE

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. 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:

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ЗМ ESPE

Technological property	Filtek™SupremeUltraFlowable	3M™LVR	RevolutionFormula 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 methacrylatefunctionalities of the resins and surface-treatedfillers undergo, in conjunction with thephotoinitiator system, a light-inducedpolymerization to form a hard composite that isbonded to the tooth structure with a permanentdental adhesive.	X	X	X

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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.

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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

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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

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.