(4 days)
K11185
No
The device description and performance studies focus on the material properties and delivery system of a temporary dental cement, with no mention of AI or ML.
No
The device is a temporary dental cement used for the fixation of dental restorations, which is not considered a therapeutic device.
No
The device is a temporary dental cement used for the fixation of dental restorations, which is a therapeutic rather than a diagnostic function.
No
The device is a temporary dental cement, which is a physical material, not software. The description details its chemical composition, packaging, and physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Temporary cementation of provisional restorations. Temporary cementation of final restorations." This describes a procedure performed on a patient's teeth, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a dental cement used for fixing restorations in the mouth. It doesn't mention analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on physical properties relevant to a dental cement (working and setting times, bonding strength, etc.) and comparison to a predicate dental cement. There are no studies related to analyzing biological samples or diagnostic accuracy.
- Anatomical Site: The anatomical site is "Dental," which aligns with a device used directly in the mouth for dental procedures.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Temporary cementation of provisional restorations
- Temporary cementation of final restorations
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
3M™ Protemp™ Cement Temporary Dental Cement is a radiopaque, temporary cement used for temporary or provisional fixation of dental restorations. It is a selfcuring cement, with an option for tack light curing of any excess cement for ease of clean up. As a non-eugenol cement, Protemp™ Cement Temporary Dental Cement is suitable for use on patients with sensitivity to eugenol.
Protemp™ Cement Temporary Dental Cement consists of a base and catalyst paste packaged in a proprietary automix delivery dispenser with a self-sealing cap. The automix delivery dispenser offers convenience over traditional hand mixed cements. Compared to leading automix systems, the proprietary delivery dispenser is designed to generate less waste and also has a lower extrusion force for ease of use.
It is available in two shades. Opaque and Translucent.
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)
Bench testing consistent with the clinical application and intended use was used to evaluate the performance of Protemp™ Cement Temporary Dental Cement compared to the predicate device Temp-Bond™ NE (K003658). Properties evaluated include: working and setting times, bonding strength, optimum film thickness, compressive strength, extrusion force, radiopacity, dimensional change and fluoride release profile.
Based on the testing results, 3M ESPE Dental Products concludes that Protemp™ Cement Temporary Dental Cement is substantially equivalent to the predicate device Temp-Bond™ NE.
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.
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.
K11185
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2017
3M ESPE Dental Products c/o Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K170330
Trade/Device Name: 3M™ Protemp™ Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: January 31, 2017 Received: February 2, 2017
Dear Mark Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runno DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement এ.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
3MTM ProtempTM Cement Temporary Dental Cement
Indications for Use (Describe)
- · Temporary cementation of provisional restorations
- · Temporary cementation of final restorations
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
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- 510(k) Summary
3M ESPE Dental Products
2510 Conway Avenue St. Paul, MN 55144-1000
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter | 3M ESPE Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 USA |
| ------------------ | ------------------------------------------------------------------------------ |
|---|
| Contact person | Idalia M. Stark, MS |
|---|---|
| Regulatory Affairs Specialist | |
| Phone: (651) 733-0168 | |
| Fax: (651) 737-9665 | |
| imstark@mmm.com |
| Submission Date: | January 31, 2017 |
|---|---|
| Trade Name: | 3M™ Protemp™ Cement |
| Temporary Dental Cement | |
| Classification Name: | Dental Cement |
| Regulation Number: | 21 CFR 872.3275 |
| Product Code: | EMA |
| Classification Panel: | Dental |
| Device Classification: | Class II |
Predicate Device: Temp-Bond™ NE (K003658) Reference Device: RelyX™ Luting Plus Automix Resin Modified Glass Ionomer Cement (K11185)
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Description of Device:
3M™ Protemp™ Cement Temporary Dental Cement is a radiopaque, temporary cement used for temporary or provisional fixation of dental restorations. It is a selfcuring cement, with an option for tack light curing of any excess cement for ease of clean up. As a non-eugenol cement, Protemp™ Cement Temporary Dental Cement is suitable for use on patients with sensitivity to eugenol.
Protemp™ Cement Temporary Dental Cement consists of a base and catalyst paste packaged in a proprietary automix delivery dispenser with a self-sealing cap. The automix delivery dispenser offers convenience over traditional hand mixed cements. Compared to leading automix systems, the proprietary delivery dispenser is designed to generate less waste and also has a lower extrusion force for ease of use.
It is available in two shades. Opaque and Translucent.
| | Protemp™ Cement
Temporary Dental Cement | Temp-Bond™ NE
K003658 |
|---------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Temporary Dental Cement | Temporary Dental Cement |
| Indications for Use | Temporary cementation of provisional restorations. Temporary cementation of final restorations. | Temporary cement used for the cementation of temporary restorations.1 Temp-Bond is a temporary cement for trial cementing restorations or cementing temporary crowns and bridges.2 |
Intended Use/Indications for Use Comparison:
1 Indications from FDA 510(k) clearance letter enclosure.
2 Indications from Kerr website: https://www.kerr-restoratives/temp-bond-temporary-dental-cement
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Technological Properties Comparison:
| PROPERTIES | Protemp™ Cement
Temporary Dental
Cement | Temp-Bond™ NE
K003658 |
|------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------|
| Formulation | Non-eugenol
Methacrylate and
water based resin | Non-eugenol
Zinc oxide |
| Intended Use | Temporary dental
cement | Temporary dental cement |
| Recommended Cure
mode | Self-curing
with option for tack
light curing of excess
cement | Self-curing |
| Inorganic Fillers | Yes | Yes |
| Releases Fluoride | Yes* | No |
| Radiopaque | Yes | Yes |
| Manufacturer
Recommended
Working Time
(minutes:seconds) | 1:30 | ≥ 1:30 |
| Manufacturer
Recommended
Setting Time
(minutes:seconds) | 5:00 after seating in
the mouth | ≤ 7:00 after mixing |
| Available shades | Opaque/Translucent | Universal |
| Dispensing System | Automix/Multi-dose | Automix/Multi-dose Unidose® Tube-Tube/Multi-dose |
| Storage conditions | 2°-27° C/
35°-80° F | Ambient temperature |
-
- Fluoride release profile supplied in 510(k) per FDA Guidance Dental Cements – Premarket Notification (August 18, 1998)
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Performance Testing:
Bench testing consistent with the clinical application and intended use was used to evaluate the performance of Protemp™ Cement Temporary Dental Cement compared to the predicate device Temp-Bond™ NE (K003658). Properties evaluated include: working and setting times, bonding strength, optimum film thickness, compressive strength, extrusion force, radiopacity, dimensional change and fluoride release profile.
Based on the testing results, 3M ESPE Dental Products concludes that Protemp™ Cement Temporary Dental Cement is substantially equivalent to the predicate device Temp-Bond™ NE.
Animal and Clinical Testing
No animal or clinical testing was submitted in this 510(k).
Biocompatibility Testing
3M's biocompatibility assessment, developed for this new product using standard risk assessment techniques of ISO14971:2007 and consideration of FDA & internationally recognized guidelines including:
- ISO 10993-1;2009 ●
- ISO 10993-3:2014 ●
- ISO 10993-5:2009 ●
- ISO 10993-6:2007 ●
- ISO 10993-10:2010 ●
- ISO 10993-11:2006
- ISO 10993-12:2012 .
- ISO 7405:2008/Amd 1 2013
The assessment concluded that the product is biocompatible for its intended use.
Conclusion
Protemp™ Cement Temporary Dental Cement is substantially equivalent to the predicate device Temp-Bond™ NE in terms of intended use, indications for use, dispensing system, technological characteristics, and physical and mechanical properties. The information presented in this 510(k) submission demonstrate that
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Protemp™ Cement Temporary Dental Cement is as safe, as effective and is demonstrated to be substantially equivalent to the predicate device.