(241 days)
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No
The summary describes a dental impression material and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
This device is an impression material used to reproduce the structure of teeth and gums, and while it aids in retracting tissue and controlling bleeding during the impression process, its primary function is diagnostic/reconstructive rather than active treatment of a disease or condition for therapeutic benefit.
No
Explanation: The device is an impression material used to reproduce the structure of teeth and gums for indirect dental restorations. It does not diagnose any condition but rather facilitates a restorative procedure.
No
The device description clearly states it is a "low viscosity vinyl polysiloxane impression material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of NoCord is to create an impression of a patient's teeth and gums in the mouth. It's a material used directly on the patient for a physical impression, not for analyzing a biological sample.
- The description focuses on physical properties and application. The description details the material type (vinyl polysiloxane), viscosity, and how it's used in a dental impression technique. This aligns with a medical device used for a physical procedure, not a diagnostic test.
- There is no mention of analyzing biological samples or providing diagnostic information. The intended uses are gingival retraction, bleeding control, and reproducing anatomical structure – all related to the physical process of taking an impression.
Therefore, NoCord with astringent, as described, is a dental impression material used in a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord
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- Retracts the gingival tissue to expose the sub-gingival margin
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- Controls gingival bleeding
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- Reproduces the structure of a patient's teeth and gums
Product codes
ELW, MVL
Device Description
NoCord is a low viscosity vinyl polysiloxane impression material.
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
Teeth and gums
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): 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.
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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
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§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2016
Centrix, Inc. Mr. Greg Moreau Regulatory Affairs/ Ouality Assurance 770 River Road Shelton, CT 06484
Re: K152826
Trade/Device Name: NoCord Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW, MVL Dated: February 16, 2016 Received: February 29, 2016
Dear Mr. Moreau:
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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -
for Erin I. Keith, M.S. 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
510(k) Number:
Device Name: NoCord
Indications for Use:
NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord
-
- Retracts the gingival tissue to expose the sub-gingival margin
-
- Controls gingival bleeding
-
- Reproduces the structure of a patient's teeth and gums
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 subpart D) (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)
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