(84 days)
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No
The summary describes a traditional dental impression material (alginate) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a dental impression material used for diagnostic purposes (making models) and does not inherently treat a disease or condition.
No
Explanation: The device is an impression material used to create molds of the oral cavity for constructing gypsum models, not for diagnosing diseases or conditions.
No
The device is described as "dental impression materials based on alginate," which are physical substances, 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 derived from the human body. The intended use of emulate Fast Set and emulate Regular Set is to take impressions of the oral cavity to create a physical model. This is a mechanical process for creating a replica, not a diagnostic test performed on a biological sample.
- The purpose of an IVD is to provide information for diagnosis, monitoring, or screening. The purpose of these impression materials is to create a physical model for various dental procedures, not to diagnose a condition or provide diagnostic information.
The description clearly indicates the device is a dental impression material used for creating physical models, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
emulate Fast Set and emulate Regular Set are dental impression materials based on emmate Fast Set and emailate Nogains of the oral cavity with the purpose of alginate. They are are about for taxing in the situation in the mouth. They are constructing a gypoum odot that evials for making study models, first impressions for general purpose improolor. maters, situation models, orthodontic impressions etc.
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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
Mr. Richard Woortman Manager Technical Services Cavex Holland B.V. Harmenjansweg 19 P.O. Box 852 Haarlem (Holland). NETHERLANDS
Re: K020242
Trade/Device Name: Emulate Fast Set & Emulate Regular Set Regulation Number: 872.3660 Regulation Name: Alginate Impression Material Regulatory Class: II Product Code: ELW Dated: January 18, 2002 Received: January 23, 2002
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. Woortman
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Ko20242
NUMBER (IF KNOWN) : 510 (k)
DEVICE NAME : emulate Fast Set & emulate Regular Set Alginate Impression Materials
INDICATIONS FOR USE:
emulate Fast Set and emulate Regular Set are dental impression materials based on emmate Fast Set and emailate Nogains of the oral cavity with the purpose of alginate. They are are about for taxing in the situation in the mouth. They are constructing a gypoum odot that evials for making study models, first impressions for general purpose improolor. maters, situation models, orthodontic impressions etc.
(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)
Susan Rumm
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _