FILTEK BULK FILL POSTERIOR RESTROATIVE by 3M ESPE DENTAL PRODUCTS

3MTM ESPETM FiltekTM Bulk Fill Posterior Restorative material is a visible-light activated, restorative composite optimized to create posterior restorations simpler and faster. This bulk fill material provides excellent strength and low wear for durability. The shades are semi-translucent and low stress curing, enabling up to a 5 mm depth-ofcure. With excellent polish retention, Filtek™ Bulk Fill Posterior Restorative is also useful for anterior restorations that call for a semi-translucent shade. All shades are radiopaque. Filtek™ Bulk Fill Posterior Restorative is offered in A.I. A2. A3. B1. and C2 shades. Filtek™ Bulk Fill Posterior Restorative is applied to the tooth following use of a methacrylate-based dental adhesive, such as manufactured by 3M™ ESPETM. which permanently bonds the restoration to the tooth structure.

Filtek™ Bulk Fill Posterior 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.

AI/ML Overview

This document is a 510(k) summary for a dental restorative material, not a medical imaging or AI-based device, so many of the requested criteria (e.g., sample size for test set, number of experts, MRMC study, training set information) are not applicable.

However, I can extract the acceptance criteria and performance as presented for the physical properties of the dental material.

Acceptance Criteria and Reported Device Performance for Filtek™ Bulk Fill Posterior Restorative:

The submission indicates that "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."

The overall "acceptance criterion" for this 510(k) submission is Substantial Equivalence to the predicate devices. The document explicitly states:

"Filtek™ Bulk Fill Posterior Restorative is substantially equivalent to the predicate devices, Filtek™ Supreme Ultra Universal Restorative, SonicFill, Sonic-Activated Bulk Fill Composite and Tetric EvoCeram Bulk Fill in terms of intended use, indications for use, physical properties, and technological characteristics. FiltekTM Bulk Fill Posterior Restorative is substantially equivalent to the predicate device, Filtek™ Supreme Ultra Universal Restorative in terms of formulation."

The study that proves the device meets the acceptance criteria (i.e., is substantially equivalent) involves a comparison of its technological characteristics and physical properties against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific numerical acceptance criteria (e.g., "Compressive Strength > X MPa") and corresponding reported performance are not detailed in this summary, the table will reflect the comparative nature of the substantial equivalence claim. The "acceptance criteria" here are essentially "similar to or better than predicate devices" for the listed properties.

Acceptance Criterion (Technological/Physical Property)	Reported Device Performance (Filtek™ Bulk Fill Posterior Restorative)	Predicate Device(s)
Photoinitiator system	X (Present)	Filtek™ Supreme Ultra Universal Restorative, Tetric EvoCeram Bulk Fill
Methacrylate-based resin matrix	X (Present)	All Predicates (Filtek™ Supreme Ultra U.R., SonicFill, Tetric EvoCeram B.F.)
Compatible with methacrylate-based dental adhesives	X (Compatible)	Filtek™ Supreme Ultra U.R., Tetric EvoCeram B.F.
Inorganic fillers	X (Present)	All Predicates
Oxide fillers are silane treated	X (Present)	Filtek™ Supreme Ultra U.R., SonicFill
Bulk fill (up to 4 mm depth of cure)	X (Achieved, for Class I from occlusal aspect)	SonicFill, Tetric EvoCeram Bulk Fill
Bulk fill (5 mm depth of cure, Class II)	X (Achieved with multi-site light-curing)	SonicFill, Tetric EvoCeram Bulk Fill
Light-induced polymerization mechanism	X (Operates via this mechanism)	All Predicates
Dispensing system: single-use capsule	X (Available)	All Predicates
Dispensing system: reusable syringe	X (Available)	Filtek™ Supreme Ultra U.R., Tetric EvoCeram Bulk Fill
Recommended for load-bearing occlusal surfaces	X (Recommended)	All Predicates
Additional Physical Properties Tested (Data not detailed but stated to be included in submission):	Performance "readily pass the ISO 6874 Depth of Cure requirement" and generally support substantial equivalence in physical properties.	Predicate devices' performance as comparative benchmark.
Compressive Strength	Data included
Diametral Tensile Strength	Data included
Flexural Strength	Data included
Flexural Modulus	Data included
Surface Hardness	Data included
Radiopacity	Data included
Water Sorption	Data included
Water Solubility	Data included
Volumetric Shrinkage	Data included
Wear	Data included
Depth of Cure (ISO 4049 & ISO 6874)	Data included, "readily pass the ISO 6874 Depth of Cure requirement."
Cusp Deflection	Data included
Polish Retention	Data included
Biocompatibility (ISO 10993 series, ISO 7405)	Assessed to be safe for intended use by a Diplomate of the American Board of Toxicology.	Filtek™ Supreme Ultra U.R. (evaluated against earlier versions of same standards).
Product Standards (ISO 4049)	Tested against ISO 4049:2009.	Filtek™ Supreme Ultra U.R. (evaluated against same standard version for this submission).

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the 510(k) summary. The document mentions "Test results for the following physical properties were included in this submission," implying laboratory testing, but does not provide specific sample quantities for each test.
Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. As these are material property tests, they are typically conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of material property testing for substantial equivalence. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO).
However, for biocompatibility, it states: "A Diplomate of the American Board of Toxicology assessed the safety of the product." This indicates at least one, highly qualified expert was involved in the safety assessment.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses or interpretations, which is not the nature of this submission. The tests are based on objective physical measurements per ISO standards.

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 device is a dental restorative material, not an AI-assisted diagnostic or imaging tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

The "ground truth" for the performance claims is based on International Standardization Organization (ISO) standards for dental materials. Specifically, ISO 4049 and ISO 6874 are mentioned for certain properties, and the ISO 10993 series and ISO 7405 for biocompatibility.

8. The sample size for the training set:

Not applicable. This is a physical material, not a machine learning model, so there is no "training set."

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

Not applicable. (See #8)

Summary

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MAY 0 8 2014

510(k) Summary 3.

3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000

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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 ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 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 ...... 15Apr2014 Trade Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Filtek™ Bulk Fill Posterior Restorative Common Name(s). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tooth shade resin material Restorative Recommended Classification ...... 21 CFR 872.3690 Tooth shade resin material Product Code: EBF

Predicate Devices:

Filtek™ Supreme Ultra Universal Restorative (K083610) Metamorphosis (K091023)

Trade name: SonicFill, Sonic-Activated Bulk Fill Composite Tetric EvoCeram Bulk Fill (K111958)

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Description of Device:

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:

FiltekTM Bulk Fill Posterior Restorative is a modification of predicate device, Filtek™ Supreme Ultra Universal Restorative. The formulation was modified to create semitranslucent shades with low polymerization shrinkage stress to enable bulk placement and cure for ease of use.

The fillers used in Filtek™ Bulk Fill Posterior Restorative are a combination of a nonagglomerated/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 agglomerated 100 nm particles. The inorganic filler loading is about 76.5% by weight (58.4% by volume). The principal resins used in Filtek™ Bulk Fill Posterior Restorative are ERGP-DMA, diurethane-DMA and 1, 12-dodecane-DMA.

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.

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Substantial Equivalence:

Technological property	Filtek™ Bulk FillPosteriorRestorative	Filtek™ SupremeUltra UniversalRestorativeK083610	SonicFill,Sonic-ActivatedBulk FillCompositeK091023	TetricEvoCeramBulk FillK111958
Photoinitiator system	X	X	NA1	X2
Methacrylate-based resin matrix	X	X	X	X
Compatible with methacrylate-baseddental adhesives	X	X	NA1	X
Inorganic fillers	X	X	X	X
Oxide fillers are silane treated so thatthey bond to the resin matrix when therestorative is cured	X	X	X3	NA1
Bulk fill (up to 4 mm depth of cure)	X	-	X	X
Bulk fill (5 mm depth of cure, Class II)	X4	-	X4	X
When irradiated by light, themethacrylate functionalities of theresins and fillers undergo, inconjunction with the photoinitiatorsystem, a light-induced polymerizationto form a hard composite that is bondedto the tooth structure with a permanentdental adhesive.	X	X	X	X
Dispensing system:
single-use capsule (intraoral)5	X	X	X	X
reusable syringe (extraoral)6	X	X	-	X
Recommended for load-bearingocclusal surfaces	X	X	X	X
FDA-Recognized Standards followed	RiskManagement:ISO 14971Biocomp stds7:ISO 10993-1ISO 10993-3ISO 10993-5ISO 10993-10ISO 10993-11ISO 7405Product stds8:ISO 4049	RiskManagement:ISO 14971Biocomp stds7:ISO 10993-1ISO 10993-3ISO 10993-5ISO 10993-10ISO 10993-11ISO 7405Product stds8:ISO 4049	NA1	NA1

1. Not available, details not disclosed by manufacturer.
1. Product also contains a second photoinitiator.

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1. Based on disclosure that product contains 3-trimethoxysily|propyl methacrylate.
1. Similarity: In order to obtain 5 mm depth of cure for Class II restorations, product is light-cured from the occlusal surface and, after the matrix band is removed, light-cured from the buccal and lingual surfaces.

Difference: The predicate device techniques states up to a 5mm depth of cure for Class I restorations, as well, also using the multi-site light-curing process described above. For FiltekTM Bulk Fill Posterior Restorative, 4mm Depth of Cure is stated for Class I restorations, light-curing from the occlusal aspect only, as supported by ISO 4049 Depth of Cure test results. This difference does not affect the safety or efficacy of the device.

1. Restorative material is dispensed from a single-use capsule in the mouth.
  Difference: The predicate device SonicFill, Sonic-Activated Bulk Fill Composite (K091023) is dispensed from the capsule using the air-driven SonicFill Handpiece, which, per the Instructions for Use "offers sonically activated delivery."

Similarity: FiltekTM Bulk Fill Posterior Restorative and predicates Filtek™ Supreme Ultra Universal Restorative (K083610) and Tetric EvoCeram Bulk Fill (K111958) all use a traditional manual restorative dispenser (not air-driven) for dispensing capsules. In light of this similarity, the difference mentioned above does not affect the safety or efficacy of the device.

1. Restorative material is dispensed from a reusable syringe outside the mouth (e.g., onto a pad).
1. Newer versions of several biocompatibility standards were applied to Filtek™ Bulk Fill Posterior Restorative, due to time elapsed since the predicate device was evaluated. This difference is not significant because for both Filtek™ Bulk Fill Posterior Restorative and the predicate device, Filtek™ Supreme Ultra Universal Restorative (K083610):
- a. A Diplomate of the American Board of Toxicology assessed the safety of the product.
- b. Standard risk assessment techniques and consideration of internationally recognized guidelines were used in the evaluation.
- c. The conclusion of the assessment is that the device is safe for its intended use.
1. ISO 4049 data in this submission for both Filtek™ Bulk Fill Posterior Restorative and the predicate device, Filtek™ Supreme Ultra Universal Restorative (K083610), was generated using the current version of the standard, ISO 4049:2009.

Difference: ISO 6874:2005 was not used to evaluate the predicate device, Filtek™ Supreme Ultra Universal Restorative for the 510(k) submission K083610, because it does not have a sealant indication. The only test in ISO 6874 that is applicable for a light-cure material, like Filtek™ Bulk Fill Posterior

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Restorative, is Depth of Cure. This submission includes data showing both Filtek™ Bulk Fill Posterior Restorative and predicate device, Filtek™ Supreme Ultra Universal Restorative (K083610) readily pass the ISO 6874 Depth of Cure requirement. Therefore, this difference is not significant and does not affect the safety or efficacy of the device.

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.

Conclusion:

Filtek™ Bulk Fill Posterior Restorative is substantially equivalent to the predicate devices, Filtek™ Supreme Ultra Universal Restorative, SonicFill, Sonic-Activated Bulk Fill Composite and Tetric EvoCeram Bulk Fill in terms of intended use, indications for use, physical properties, and technological characteristics. FiltekTM Bulk Fill Posterior Restorative is substantially equivalent to the predicate device. Filtek™ Supreme Ultra Universal Restorative in terms of formulation.

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Public Health Service

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

May 8, 2014

3M ESPE Dental Products Scott Erickson, RAC Senior Regulatory Affairs Specialist 2510 Conway Avenue St. Paul, MN 55144-1000

Re: K141081

Trade/Device Name: Filtek™ Bulk Fill Posterior Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 15, 2014 Received: April 25, 2014

Dear Mr. 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: CDRII 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. 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Acting Division 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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Indications for Use Statement 4.

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 befow

510(k) Number (if known) K141081

Device Name Filtek 14 Bulk Fill Posterior Restorative

Indications for Use (Describe)

· Direct anterior and posterior restorations (including occlusal surfaces)
· Base/liner under direct restorations
· Core build-ops
· 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 temporaties

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 601 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpert 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) (2002)

Sheena A. Green -S. : 2014.05.08 11:23:43-04'00

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 Realth and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRASTambida hhs cov

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FORM FDA 3881 (1/14)

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Filtek™ Bulk Fill Posterior Restorative 510(k)

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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.