FILTEK BULK FILL FLOWABLE RESTORATIVE

K120453 · 3M Espe Dental Products · EBF · Mar 19, 2012 · Dental

Device Facts

• Record ID: K120453
• Device Name: FILTEK BULK FILL FLOWABLE RESTORATIVE
• Applicant: 3M Espe Dental Products
• Product Code: EBF · Dental
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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

Device Story

Filtek™ Bulk Fill Flowable Restorative is a low-viscosity, visible-light-activated, radiopaque composite resin used by dentists in clinical settings. It consists of bisGMA, UDMA, bisEMA(6), and Procrylat resins combined with ytterbium trifluoride and zirconia/silica fillers. The material is applied via syringe or capsule into cavity preparations and cured using a dental light source, which triggers polymerization to form a hard, bonded restoration. It is designed to allow a 4mm depth of cure while reducing polymerization shrinkage stress compared to previous formulations. The device is used for various restorative applications, including bases, liners, sealants, and core build-ups, providing structural support and esthetic repair. It requires a dental adhesive for permanent bonding to tooth structure.

Clinical Evidence

Bench testing only. Performance evaluated against predicate devices using ISO 4049:2009 and ISO 6874:2005. Properties tested included 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. Biocompatibility assessed per ISO 10993-1:2009 and ISO 7405:2008.

Technological Characteristics

Visible-light-activated composite resin containing bisGMA, UDMA, bisEMA(6), and Procrylat resins. Fillers: ytterbium trifluoride (0.1-5.0 µm) and zirconia/silica (0.01-3.5 µm). Inorganic filler loading ~64.5% by weight (42.5% by volume). Form factor: capsules and syringes. Polymerization via light-induced methacrylate reaction. Radiopaque.

Indications for Use

Indicated for dental patients requiring restorative procedures including Class I, II, III, and V restorations, cavity liners/bases, pit and fissure sealants, undercut blockouts, repair of enamel or indirect restoration defects, repair of temporary materials, and core build-ups.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 Company<br>3M ESPE Dental Products<br>3M Center, Building 260-2A-11<br>St. Paul, MN 55144-1000 USA<br>Establishment Registration Number:<br>3005174370 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Scott Erickson, RAC<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Summary was Prepared | January 26, 2012 |
| Trade Name | Filtek™ Bulk Fill Flowable<br>Restorative |
| Common Name(s) | Tooth shade resin material |
| Recommended Classification | Tooth shade resin material<br>(21 CFR 872.3690,<br>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:

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.

#### 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 [phone] or [phone] 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)

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