(57 days)
Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Crown lining material for 3M ESPE Prefabricated Temporary Crowns.
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.
The provided text is a 510(k) summary for the Protemp™ 3 Garant™ temporary crown and bridge resin. It focuses on demonstrating substantial equivalence to predicate devices, primarily through biocompatibility testing and a comparison of performance characteristics.
Based on the provided document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "tensile strength must be > X MPa"). Instead, the acceptance criteria are implied by the comparison to predicate devices, indicating that the new device should perform "at least as well as" or "comparably to" the predicates for relevant characteristics. The study presented is primarily a comparative one.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Protemp™ 3 Garant™) |
|---|---|---|
| Biocompatibility | Biocompatible (based on ISO 10993) | "Protemp 3 Garant is a safe device." |
| General Performance Characteristics (e.g., mechanical properties, handling) | Comparable to Protemp™ H and 3M™ Quik Temp | "performance characteristics of Protemp 3 Garant were compared to those of the respective predicate devices." "substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for performance characteristic comparisons. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for a dental material, these tests are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for material properties is established through standardized laboratory testing methods, not by expert consensus in the clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" in this context refers to laboratory samples evaluated for material properties, not patient data requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that involve human interpretation of medical cases. Protemp™ 3 Garant™ is a dental material, not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. Protemp™ 3 Garant™ is a material, not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is established by adherence to recognized standards like ISO 10993, which involves specific biological tests to assess safety (e.g., cytotoxicity, sensitization, irritation).
For effectiveness and performance characteristics (e.g., mechanical properties, handling), the "ground truth" is established through comparative testing against established predicate devices using validated laboratory methods (e.g., measuring tensile strength, flexural modulus, working time, setting time). The document implies that the "effectiveness" was proven by demonstrating comparable performance to the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. Protemp™ 3 Garant™ is a material and its development does not involve training a machine learning algorithm, hence there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
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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 |
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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 andBridge 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 (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
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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
Page 1 of I
510(k) Number:...
§ 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.