FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE

K100235 · 3M Company · EBF · May 12, 2010 · Dental

Device Facts

• Record ID: K100235
• Device Name: FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE
• Applicant: 3M Company
• Product Code: EBF · Dental
• Decision Date: May 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended 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

Device Story

Low-viscosity, visible-light activated, radiopaque, flowable nanocomposite restorative material; used by dentists in clinical settings. Input: light energy (curing light). Transformation: light-induced polymerization of methacrylate-based resins and surface-treated fillers (ytterbium trifluoride, silica, zirconia/silica clusters) to form a hard, bonded composite. Output: cured dental restorative material. Benefit: provides tooth-colored restoration, fluorescence, and polish retention for various dental defects and cavity preparations.

Clinical Evidence

Bench testing only. Performance compared to predicate devices 3M™ LVR System and Revolution Formula 2. Evaluated properties: Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Polymerization Shrinkage, Polish Retention, and Fluorescence. Biocompatibility assessment conducted per ISO 10993 Parts 3, 5, 6, 10, and 11.

Technological Characteristics

Flowable nanocomposite; contains bisGMA, TEGDMA, Procrylat resins. Fillers: ytterbium trifluoride (0.1-5.0 microns), 20nm silica, 75nm silica, and aggregated zirconia/silica clusters (0.6-10 microns). Inorganic filler loading ~65% wt (46% vol). Visible-light activated polymerization via camphorquinone/amine photoinitiator system. Radiopaque. Packaged in capsules/syringes.

Indications for Use

Indicated for dental patients requiring Class III and V restorations, minimally invasive cavity preparations, base/liner placement, repair of esthetic indirect restorations, pit and fissure sealing, undercut blockout, and repair of resin/acrylic temporary materials.

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

• 3M™ LVR System (K100235)
• Revolution Formula 2 (K100235)

Submission Summary (Full Text)

{0}------------------------------------------------

**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 Company<br>3M ESPE Dental Products<br>3M Center, Bldg. 275-2W-08<br>St. Paul, MN 55144-1000 USA<br>Establishment Registration Number<br>2110898 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person................ | Scott Erickson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Summary was Prepared...... | January 25, 2010 |
| Trade Name................ | FiltekTM Supreme Ultra 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: 3M™ LVR System, Revolution Formula 2

{1}------------------------------------------------

# 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:

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).

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.

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

{2}------------------------------------------------

# 3M ESPE

cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).

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.

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:

{3}------------------------------------------------

# ЗМ ESPE

| Technological property | Filtek™<br>Supreme<br>Ultra<br>Flowable | 3M™<br>LVR | Revolution<br>Formula 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 methacrylate<br>functionalities of the resins and surface-treated<br>fillers undergo, in conjunction with the<br>photoinitiator system, a light-induced<br>polymerization to form a hard composite that is<br>bonded to the tooth structure with a permanent<br>dental adhesive. | X | X | X |

:

{4}------------------------------------------------

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.

{5}------------------------------------------------

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 [phone] or [phone] 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

{6}------------------------------------------------

## 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