K Number
K033022
Device Name
PROTEMP 3 GARANT
Date Cleared
2003-11-21

(57 days)

Product Code
Regulation Number
872.3770
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Crown lining material for 3M ESPE Prefabricated Temporary Crowns.
Device Description
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.
More Information

K 002364, K 001114

Not Found

No
The device description and intended use are focused on a material for fabricating temporary dental prostheses, with no mention of software, algorithms, or data processing that would suggest AI/ML.

No
The device is a temporary dental restorative material used to fabricate temporary crowns, bridges, inlays, onlays, and veneers until a permanent restoration is made. It is not used for treating or curing a disease or condition, which is the primary characteristic of a therapeutic device.

No
The device is a temporary crown and bridge resin used for fabricating temporary prostheses, not for diagnosing medical conditions.

No

The device description clearly states it is a "temporary crown and bridge resin," which is a physical material, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "Fabrication of temporary crowns, bridges, inlays, onlays and veneers" and as a "Crown lining material". These are procedures performed directly on a patient's teeth, not tests performed on samples taken from the body.
  • Device Description: The description clearly states it's a "temporary crown and bridge resin intended to make a temporary prosthesis". This is a material used in a dental procedure.
  • Regulatory Classification: It is designated as a "Class II device" under 21 C.F.R § 872.3770, which is the regulation for "Temporary crown and bridge resin". This classification is for dental devices used in the mouth, not IVDs.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.

Therefore, based on the information provided, Protemp 3 Garant is a dental device used for creating temporary restorations, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

EBG

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K 002364, K 001114

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3770 Temporary crown and bridge resin.

(a)
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.(b)
Classification. Class II.

0

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,
Manager U.S. Regulatory Affairs
Phone:011-49-8152-700 1395
Fax:011-49-8152-700 1869
E-mail:andreas.petermann@mmm.com

1

Name of Device

Proprietary Name:ProtempTM 3 GarantTM
Classification NameTemporary Crown and Bridge Resin
Common Name:Composite based Temporary Crown and
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.

2

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.

3

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

4

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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