(66 days)
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Not Found
No
The description focuses on the chemical properties and color-changing characteristics of the alginate material, with no mention of AI or ML.
No
The device is a dental impression material used to create copies of the oral cavity for diagnostic and planning purposes, not for treating a condition.
No
Explanation: The document describes the device as a dental impression material used for creating physical models (gypsum casts) of the oral cavity. Its purpose is for constructing models for various dental procedures (e.g., study models, orthodontic impressions), not for diagnosing medical conditions. The color changes indicate material properties and timing, not diagnostic information about the patient.
No
The device is a dental impression material, which is a physical substance, not software.
Based on the provided text, 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 for the purpose of constructing a gypsum cast. This is a physical impression of a body part, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the material properties and color-changing characteristics, which are relevant to its use as an impression material, not for diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
This device is clearly a dental material used for creating a physical model, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Simulate, Color Change Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Simulate, Color Change Alginate has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
Product codes
ELW
Device Description
Simulate, Color Change Alginate is a dental impression material based on alginate. It is a general purpose impression material. It has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2006
Mr. Richard Woortman Manager Technical Services Cavex Holland B.V. Harmaniansweg 19 P.O. Box 852 2003 RW Haarlem THE NETHERLANDS
Re: K061267
Trade/Device Name: Simulate, Color Change Alginate Impression Materials Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 5, 2006 Received: May 9, 2006
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) _ 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sujita Y. Michie Ond.
Chiu Lin, Ph.D. 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): K061267
DEVICE NAME: Simulate, Color Change Alginate Alginate Impression Materials
INDICATIONS FOR USE:
Simulate, Color Change Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Simulate, Color Change Alginate has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Cgn. Oth
on of Anestog. General Hospital,
ion Control, Dental Lavicus
: Number. K06/26/7