(139 days)
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No
The document describes a dental cement and does not mention any AI or ML capabilities.
No
This device is a dental luting cement used for bonding dental restorations and orthodontic appliances. It does not provide any therapeutic effect such as treating or preventing a disease, but rather acts as a bonding agent.
No
Explanation: The device is described as a permanent cement for various dental restorations, indicating it is a therapeutic or restorative device, not one used for diagnosis.
No
The device description clearly states it is a "filled composite, multi-purpose permanent cement," which is a physical material, not software.
Based on the provided information, the Prime-Dent® Dual Cure Composite Luting Cement is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the final cementation of various dental restorations (crowns, bridges, etc.) and orthodontic appliances. This is a therapeutic or restorative use, not a diagnostic one.
- Device Description: The description confirms it's a dental cement, a material used in the body or on the teeth for structural purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Prime-Dent® Dual Cure Composite Luting Cement does not fit this definition.
N/A
Intended Use / Indications for Use
The Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement. This material can be used for final cementation of crowns, bridges, inlay, onlays, veneers, posts and pins, and cementation of orthodontic bands and appliances.
Product codes
EMA
Device Description
The Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement.
Mentions image processing
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Javier Alvarez Management Representative Prime Dental Manufacturing, Incorporation 4555 West Addison Street Chicago, Illinois 60641
JAN 2 3 2012
Re: K112574
Trade/Device Name: Prime-Dent® Dual Cure Composite Luting Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 18, 2012 Received: January 19, 2012
Dear Mr. Alvarez:
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.
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Page 2 - Mr. Alvarez
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 (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.
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 ucm1 15809.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,
Wh for
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
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Image /page/2/Picture/0 description: The image shows the logo for Prime Dental Manufacturing Inc. The logo includes the company name in bold, along with the address, phone number, fax number, and website. The address is 4555 West Addison Street - Chicago, Illinois 60641. The phone number is (773) 283.2914 and the fax number is (773) 283.3085.
An ISO 13485;2003, ISO 9001:2008 & CE Ma
Indications for Use
Device Name: Prime-Dent® Dual Cure Composite Luting Cement
Indications for Use:
The Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement. This material can be used for final cementation of crowns, bridges, inlay, onlays, veneers, posts and pins, and cementation of orthodontic bands and appliances.
Susan Quases
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112574
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This document is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender and destroy all copies of the original document.