(83 days)
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No
The description focuses on the material properties and color-changing characteristics of a dental impression material, with no mention of AI or ML.
No
The device is a dental impression material used to create a copy of the oral situation for constructing models, not for treating a disease or condition.
No
The document describes Tulip Colorswitch as a dental impression material used to create gypsum casts, which are copies of the oral cavity. Its purpose is to construct models for study, orthodontic impressions, etc., not to diagnose a disease or condition. The color-changing feature is for workflow indication (mixing and setting times), not for diagnosis.
No
The device is a dental 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Tulip Colorswitch's Function: Tulip Colorswitch is a material used to create a physical impression of the oral cavity. It is a tool for capturing the shape and structure of the mouth, not for analyzing biological samples to diagnose or monitor a medical condition.
- Intended Use: The intended use clearly states it's for taking impressions to construct a gypsum cast, which is a physical model. This is a mechanical process, not a diagnostic test.
Therefore, Tulip Colorswitch falls under the category of a dental device, specifically a dental impression material, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Tulip Colorswitch 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.
Tulip Colorswitch 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.
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): 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2003
Mr. Richard Woortman Manager Technical Services Cavex Holland B.V. Harmanjansweg 19 P.O. Box 852 Haarlem, Holland
Re: K032116
Trade/Device Name: Tulip Colorswitch Alginate Impression Materials Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 7, 2003 Received: September 17, 2003
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.
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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 (OS) 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 vour 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
Susan Runnin
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
11032116 510(k) NUMBER (IF KNOWN):
DEVICE NAME: Tulip Colorswitch Alginate Impression Materials
INDICATIONS FOR USE:
Tulip Colorswitch 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.
Tulip Colorswitch 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.
McAdhe for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K032116
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________