(182 days)
Not Found
Not Found
No
The 510(k) summary describes a dental cement and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The devices are cements used for dental restorations, which are used to attach or temporarily hold dental prostheses, not to treat or cure a disease or condition.
No
Explanation: The provided text describes the intended use of "Dimer Dual Cure Temporary Resin Cement" and "Dimer Dual Cure Permanent Resin Cement" for the cementation of dental restorations. These are materials used in dental procedures, not devices designed to diagnose diseases or conditions. There is no mention of diagnosis, screening, or interpretation of medical data.
No
The device description is not found, but the intended use clearly describes a "resin cement," which is a physical material used in dentistry. This indicates it is a hardware/material device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental cement used for the temporary or permanent cementation of dental restorations. This is a direct application within the patient's mouth (or on dental prosthetics intended for the mouth), not a test performed on samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
- Measuring analytes.
Therefore, the "Dimer Dual Cure Temporary Resin Cement" and "Dimer Dual Cure Permanent Resin Cement" are classified as dental devices, specifically dental cements, and not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
"Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.
"Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.
Product codes
EMA
Device Description
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Cora Breacho-Trosonis Director of Scientific and Regulatory Affairs Novocol, Incorporated 416 South Taylor Avenue Louisville, Colorado 80027
JUL 3 1 2012
Re: K120283
Trade/Device Name: Dimmer Dual Cure Permanent Resin Cement, Dimer Dual Cure Temporary Resin Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 11, 2012 Received: July 12, 2012
Dear Ms. Breacho-Trosonis:
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.
1
Page 2- Ms. Breacho-Trosonis
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 /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 vours.
Nh 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
2
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: "Dimer Dual Cure Temporary Resin Cement"
Indications for Use:
"Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
h
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology. General Hospital
Division of Anesthesiology. Dental Devices Division of Antonicental Devices
510(k) Number:
3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: "Dimer Dual Cure Permanent Resin Cement"
Indications for Use:
. : " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
"Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ﺴﺴ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wh for
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120283