PROTEMP 3 GARANT

K033022 · 3M Espe AG Dental Products · EBG · Nov 21, 2003 · Dental

Device Facts

• Record ID: K033022
• Device Name: PROTEMP 3 GARANT
• Applicant: 3M Espe AG Dental Products
• Product Code: EBG · Dental
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Crown lining material for 3M ESPE Prefabricated Temporary Crowns.

Device Story

Protemp 3 Garant is a composite-based temporary crown and bridge resin used by dental professionals to fabricate temporary dental prostheses. The material is supplied in the Garant mixing and dispensing system for application. It serves as a temporary solution until a permanent restoration is fabricated. The device is used in a clinical dental setting. It benefits the patient by providing a functional and aesthetic temporary restoration during the interim period before permanent placement.

Clinical Evidence

No clinical data. Safety and effectiveness were established through biocompatibility testing and bench-top performance comparisons against predicate devices.

Technological Characteristics

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

Indications for Use

Indicated for patients requiring temporary dental restorations including crowns, bridges, inlays, onlays, and veneers, or as a lining material for prefabricated 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™ H by 3M ESPE (K002364)
• 3M™ Quik Temp Temporization Material (K001114)

Submission Summary (Full Text)

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K033022

# NOV 2 1 2003

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 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 U.S. Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |

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#### Name of Device

| Proprietary Name: | ProtempTM 3 GarantTM |
|---------------------|--------------------------------------------------------|
| Classification Name | Temporary Crown and Bridge Resin |
| Common Name: | Composite based Temporary Crown and<br>Bridge Material |

#### Predicate Device:

Protemp™ H by 3M ESPE, K 002364

3MTM Quik Temp Temporization Material, K 001114

#### Description for the Premarket Notification

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

To provide evidence for safety biocompatibility testing was carried out. The results show that Protemp 3 Garant is a safe device.

To prove the effectiveness of Protemp 3 Garant, the performance characteristics of Protemp 3 Garant were compared to those of the respective predicate devices.

In summary, the temporary crown and bridge resin Protemp 3 Garant described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

NOV 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY

Re: K033022

Trade/Device Name: ProtempTM 3 GarantTM Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: September 23, 2003 Received: September 25, 2003

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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#### Page 2 - Dr. Andreas Petermann

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 (OS) 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Chin S. Lin, Ph.D.

Chiu S. Lin, PhD 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

510(k) Number (if known): K033022

Device Name:___Protemp™ 3 Garant™

Indications For Use:

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

Crown lining material for 3M ESPE Prefabricated Temporary Crowns.

**Prescription Use**
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runno

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

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