FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE

K083610 · 3M Company · EBF · Dec 17, 2008 · Dental

Device Facts

• Record ID: K083610
• Device Name: FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
• Applicant: 3M Company
• Product Code: EBF · Dental
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Direct anterior and posterior restorations (including occlusal surfaces) Core Build-ups Splinting Indirect restorations including inlays, onlays and veneers

Device Story

Filtek Supreme Ultra Universal Restorative is a visible-light activated, radiopaque, restorative composite resin; used by dental professionals in clinical settings for direct and indirect tooth restorations. Material is applied to tooth structure and cured via light activation to restore form and function. Benefits include improved polish retention and physical strength compared to previous formulations. Device is a direct replacement for existing resin restorative materials.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated via comparative bench testing against predicate 3M ESPE HAUR across multiple physical and chemical properties including strength, hardness, radio-opacity, and polish retention.

Technological Characteristics

Visible-light activated, radiopaque, restorative composite resin. Characteristics include compressive strength, diametral tensile strength, flexural strength, flexural modulus, surface hardness, radio-opacity, water sorption, water solubility, polish retention, and fluorescence.

Indications for Use

Indicated for patients requiring direct anterior and posterior dental restorations, core build-ups, splinting, or indirect restorations such as inlays, onlays, and veneers.

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 ESPE HAUR

Submission Summary (Full Text)

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**3M ESPE**

K083610

#### 510(k) Summary 5.

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

DEC 1 7 2008

# 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, 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......... | 12/05/2008 |
| Trade Name................................ | FiltekTM Supreme Ultra Universal<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™ ESPE™ HAUR

Description of Device: Filtek™ Supreme Ultra Universal Restorative is a visible-light activated, radiopaque, restorative composite.

Filtek™ Supreme Ultra Universal Restorative 510(k)

:

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**3M ESPE**

Indications for Use:

- · Direct anterior and posterior restorations (including occlusal surfaces)
- · Core Build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers

Substantial Equivalence:

Information provided in this 510(k) submission shows that Filtek TM Supreme Ultra Universal Restorative is substantially equivalent to the predicate device 3M™ ESPETM HAUR in terms of intended use, indications for use, composition, physical properties and technological characteristics. A biocompatibility assessment was developed for FiltekTM Supreme Ultra Universal Restorative using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that Filtek™ Supreme Ultra Universal Restorative is safe for its intended use.

This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Supreme Ultra Universal Restorative compared to predicate device 3MTM ESPETM HAUR. The properties evaluated include Compressive strength, Diametral Tensile Strength, Flexural strength, Flexural Modulus, Surface hardness, Radio-opacity, Water Sorption, Water Solubility, Polish Retention and Fluorescence.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Erickson Regulatory Affairs Specialist 3M Company 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul, Minnesota 55144-1000

# DEC 1 7 2008

Re: K083610

Trade/Device Name: Filtek™ Supreme Ultra Universal Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 5, 2008 Received: December 8, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Snjite H. Michie Dmd

Chiu S. Lin. Ph. D Division 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

1.683610 510(k) Number (if known):

Device Name: Filtek™ Supreme Ultra Universal Restorative

Indications for Use:

- · Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers

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)

> Concurrence of CDRH, Office of Device Evaluation (ODE) 1000 Kunte

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

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510(k) Number: k053610

Filtek™ Supreme Ultra Universal Restorative 510(k)

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