(57 days)
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
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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 Name | Temporary 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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