(318 days)
K053427 Fresh Bold, Impression material
Not Found
No
The device description and performance metrics relate to the physical properties and handling of a dental impression material, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to reproduce the structure of teeth and gums for diagnostic and restorative purposes, not to treat a disease or condition.
No
Explanation: The device, Dynax® Dental Impression Material, is used to reproduce the structure of a patient's teeth and gums for procedures like producing crowns or bridges. It does not provide information about a patient's health status or diagnose any disease. Its function is to create a physical mold of the teeth and gums.
No
The device is a dental impression material, which is a physical substance used to create a mold of teeth and gums. It is 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 to "reproduce the structure of a patient's teeth and gums." This is a physical reproduction for the purpose of creating dental prosthetics or appliances.
- Device Description: The description details a material that is placed in the mouth to create a physical mold. It does not involve analyzing biological samples or providing diagnostic information about a patient's health status.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical and physical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This dental impression material does not fit that definition.
N/A
Intended Use / Indications for Use
Dynax Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
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
patient's teeth and gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This is a prescription only material. The labeling and working instructions are designed for health care professionals.
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)
The Dynax® Dental Impression Materials have been designed, developed, tested and produced according to ISO 13485; CAN/CSA ISO 13485 and European Medical Device Directive 93/42/EEC. The quality system is certified by a Notified Body.
Testing has confirmed that these devices meet their product specification. A series of in-house tests have been conducted to verify the intended signals are accurate and can maintain performance over its useful life.
An assessment of the biocompatibility according to FDA Recognized Consensus Standard ISO 10993-1 is included in this application. As a result of this assessment/testing we conclude that the device is safe for its intended use and does not show any unacceptable risks for users, patients and third parties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Working / Processing time: 90 sec
Setting time / Time in the mouth: 90 sec
Hardness: 46 - 70 Shore A
Working humidity: 50 %
Dimensional accuracy: 99.9 % - 99.2 %
Stability (linear dimensional change):
§ 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).
0
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Dreve Dentamid GmbH Rilchard Keen Consultant 1151 Hope Street Stamford, Connecticut 06907-1659 April 13, 2018
Re: K171562
Trade/Device Name: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: February 22, 2018 Received: March 14, 2018
Dear Richard Keen:
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
1
801); medical device 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
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
Dreve Dentamid
510(k) Number (if known): K171562
Device Name:
Dynax Dental Impression Material:
- . Dynax clear
- Dynax putty
- Dynax heavy body
- Dynax light
- Dynax mono
Indications for Use:
Dynax Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
| Prescription Use
| (21 CFR Part 801 Subpart D) | |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
and/or
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/2/Picture/17 description: The image is a circular logo with the text "TUV NORD" at the top. Below that is the text "TUV Rheinland Group". The bottom of the logo contains the text "ISO 9001