(84 days)
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No
The document describes a dental cement and does not mention any AI or ML components or functionalities.
No
Explanation: A therapeutic device is used to treat or manage a disease or condition. This device, TempoCem, is a temporary dental luting agent used for cementing crowns and bridges, which is a restorative or procedural function, not a therapeutic one.
No
Explanation: The device, TempoCem, is a temporary dental luting agent (cement) used for cementing provisional crowns and bridges, and semi-permanent implants. It is described as a material used to affix dental prosthetics, not to diagnose a condition or disease.
No
The device description clearly states that TempoCem is a temporary cement based on zinc oxide / eugenol, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary cementation of dental prosthetics (crowns, bridges, implants). This is a direct application within the body (or on a structure intended to be in the body), not for testing samples taken from the body.
- Device Description: The description details a dental cement for physical application, not a reagent or instrument for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. TempoCem's function is purely mechanical/adhesive within the oral cavity.
N/A
Intended Use / Indications for Use
TempoCem is a dental luting agent indicated for:
- . temporary cementation of provisional crowns and bridges
- cementing of semi-permanent implants .
Product codes (comma separated list FDA assigned to the subject device)
EMB
Device Description
TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." TempoCem meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
0
Kil0759
0 March 2011
510(k) Summary
| Trade Name: | TempoCem | |
|---|---|---|
| Sponsor: | DMG USA, Inc. | |
| 23 Frank Mossberg Drive | ||
| Attleboro, MA 02703 | ||
| Owner/Operator No. 9005969 | JUN 10 2011 | |
| Device Generic Name: | TempoCem | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class II. |
Product Description:
DMG USA. Inc.
Abbreviated 510(k) Premarket Notification
TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.
Product Indications for Use:
- temporary cementation of provisional crowns and bridges ●
- cementing of semi-permanent implants .
Predicate Devices:
Substantial equivalence is based on comparison to the dental restorative materials identified below.
| Product Name - 3 - 1 - 1 - 1 Predicate Device 610 (k) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | ||||
|---|---|---|---|---|
| TempoCem | K970775 (Foremost Dental, Inc) | |||
| S&C Provi Cem Esthetic | K091735 (S&C Polymer GmbH) |
Safetv and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." TempoCem meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate devices, TempoCem has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
JUN 1 0 2511
Re: K110759 Trade/Device Name: TempoCem Regulation Number: 21 CFR 872.3275(a) Regulation Name: Dental Cement - Zinc Oxide-Eugenol Regulatory Class: I Product Code: EMB Dated: March 9, 2011 Received: March 18, 2011
Dear Ms. Papineau:
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.
2
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
hh fcc
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
9 March 2011
TempoCem
| 510(k) Number (if known): | K110759 |
|---|---|
| --------------------------- | --------- |
Page 1 ofDevice Name: TempoCem
Product Indications for Use:
TempoCem is a dental luting agent indicated for:
- . temporary cementation of provisional crowns and bridges
- cementing of semi-permanent implants .
OR Over-the -Counter Use Prescription Use X (Per 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110759