(41 days)
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No
The summary describes a traditional alginate impression material and does not mention any AI or ML components.
No
The device is an impression material used to create a gypsum cast of the oral cavity, which is a diagnostic or preparatory step, not a therapeutic intervention.
No
Explanation: The device description states its purpose is to take impressions for creating gypsm casts, which are copies of the oral cavity. This is a material used for physical modeling, not for diagnosing conditions or diseases.
No
The device is described as an "alginate impression material," which is a physical substance used to take dental impressions. This is a hardware component, 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 take impressions of the oral cavity to create a gypsum cast. This cast is a physical model of the mouth, used for purposes like orthodontics.
- Nature of the Device: It's an alginate impression material, a substance used to physically capture the shape of the oral cavity.
- Lack of Diagnostic Purpose: The material itself is not used to diagnose any condition or disease. It's a tool for creating a model that might be used in the process of diagnosis or treatment planning, but the material itself doesn't perform a diagnostic function.
- No Analysis of Biological Samples: IVDs are typically used to examine biological samples (blood, urine, tissue, etc.) to provide information about a patient's health. This device does not interact with or analyze biological samples in this way.
Therefore, Cavex Orthotrace alginate impression material falls under the category of a dental device used for creating physical models, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is about constituting a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting, high elasticity, high tear resistance, can be poured twice with gypsum, and is proven to be dimensionally stable. Cavex Orthotrace is particularly suited for orthodontics
Product codes
ELW
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
oral cavity
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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§ 872.3660 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 Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2005
Mr. Richard Woortman Manager, Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem THE NETHERLANDS
Re: K051207
Trade/Device Name: Cavex Orthotrace Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 02, 2005 Received: May 11, 2005
Dear Mr. Woortman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -- Mr. Richard Woortman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1727 s issualled of a subscription with other requirements of the Act or that FDA nas made a decemination allar your as your Federal agencies. You must comply with any Pederal Statutes and regulations administered of taxistration and listing (21 CFR Part 807); all the Act s requirements, merading, but virus ments as set forth in the quality labeling (21 CFR 1 art 801); good manazations of applicable, the electronic product radiation systems (QB) rogalisons 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maing of substantial equivalence of your device to a legally premarked notheation: "The PDF mining sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite int 70% (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other Misoranianing of relerence to promobilities under the Act from the Division of Small general international on your consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oction http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) NUMBER (IF KNOWN):
DEVICE NAME: Cavex Orthotrace Alginate impression material
INDICATIONS FOR USE:
Cavex Orthotrace alginate impression material is a dental impression material based Gavex Ofthotraos alginate inity impressions of the oral cavity with the purpose of on algmate. It is aboution that is a copy of the situation in the mouth. Cavex constitucing a gypoum oact that is atisf, high elasticity, high tear resistance, can be Orthotrace has an oxtra fact betting and in a attractive fuchsia-coloured powder pource twice with gypount and is proven Orthotrace is particularly suited for orthodontics
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Koin Muluy for MSR
Division of Anesthesiology. Gene
510(k) Number: