TEMPXN28

K073296 · 3M Espe AG Dental Products · EBG · Jan 9, 2008 · Dental

Device Facts

• Record ID: K073296
• Device Name: TEMPXN28
• Applicant: 3M Espe AG Dental Products
• Product Code: EBG · Dental
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.

Device Story

TempXN28 is a composite-based temporary crown and bridge resin. It is used by dental professionals to fabricate temporary prostheses (crowns, bridges, inlays, onlays, veneers) for use until permanent restorations are completed. The material is supplied in the Garant mixing and dispensing system for application. It functions as a restorative material to protect prepared teeth and maintain space/occlusion during the interim period before final cementation. The device benefits patients by providing functional and aesthetic temporary coverage.

Clinical Evidence

Bench testing only; biocompatibility testing was performed to demonstrate safety.

Technological Characteristics

Composite-based resin for temporary crown and bridge fabrication. Utilizes the Garant mixing and dispensing system. Class II device per 21 CFR 872.3770.

Indications for Use

Indicated for the fabrication of temporary crowns, bridges, inlays, onlays, veneers, and long-lasting temporary restorations, as well as a lining material for prefabricated composite or metal temporary crowns.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• Protemp™ 3 Garant™ (K033022)
• Luxatemp Fluorescence (K013674)
• Sinfony (K992645)

Submission Summary (Full Text)

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K073296

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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JAN - 9 2008

## Submitter

| Company: | 3M ESPE AG |
|-----------------------------------|--------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann,<br>Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | November 16, 2007 |
| Name of Device | |
| Proprietary Name: | TempXN28 |
| Classification Name: | Temporary Crown and Bridge Resin |
| Common Name: | Composite based Temporary Crown<br>and Bridge Material |

## Predicate Device

| Protemp™ 3 Garant™ by 3M ESPE | K033022 |
|----------------------------------------|---------|
| Luxatemp Fluorescence by DMG USA, Inc. | K013674 |
| Sinfony by 3M ESPE | K992645 |

:

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#### Description for the Premarket Notification

TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.

Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.

To provide evidence for safety biocompatibility testing was carried out. The results show that TempXN28 is a safe device.

The comparison for chemistry, performance data and indications for use shows that TempXN28 is substantially equivalent to the predicate devices.

In summary, it can be concluded that safety and effectiveness requirements for TempXN28 are completely met.

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JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Andreas Petermann Manager, Regulatory Affairs 3M ESPE AG Dental Products ESPE Platz Seefeld, Bavaria, GERMANY D-82229

Re: K073296

Trade/Device Name: Temp XN28 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: November 16, 2007 Received: November 23, 2007

Dear Dr. Petermann:

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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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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Sutte Y. Michaud MD

Chiu Lin, Ph.D. 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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# Indications for Use

K073296

510(k) Number (if known):

Device Name:

Indications For Use:

TempXN28

Fabrication of temporary crowns, bridges, inlays, onlays and veneers.

Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.

Prescription Use
(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 IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumsey

sion of Anesthesiology, General Hospital,
fection Control, Cumbria, Davids

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