(30 days)
Not Found
None
No
The summary describes a physical impression material and contains no mention of AI, ML, or image processing.
No
A therapeutic device is used for treating or curing a disease or condition. An impression material is a diagnostic tool used to create a model for diagnosis or treatment planning, not for therapy itself.
No
The device is described as an impression material for taking intra-oral impressions, which is a tool for collecting information rather than analyzing it for diagnostic purposes.
No
The device is described as a dental vinylpolysiloxane impression material, which is a physical substance used for taking impressions, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "taking intra-oral impressions of a patient's mouth." This is a physical process of creating a mold of the mouth's structures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description focuses on the material's use for creating an impression, not for analyzing a biological sample to provide diagnostic information.
The device is a dental material used for a physical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Product is a dental vinylpolysiloxane impression material intended for use of taking intra-oral impressions of a patient's mouth.
Product codes
ELW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 U.S. Department of Health and Human Services. The seal features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2004
Mr. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K041398
Trade/Device Name: GC FUSION Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 24, 2004 Received: June 1, 2004
Dear Mr. Joritz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becales by the device is substantially equivalent (for the referenced above and have determinou re) to legally marketed predicate devices marketed in multations for use stated in also 28, 1976, the enactment date of the Medical Device Interstate conmiseree prior to that have been reclassified in accordance with the provisions of Amendinents, or to do roob may in to i - Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval uppheadon (The Act. The general controls provisions of the Act include controls providents of an 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 If your device is clusified (boo as a 10 10) in a controls. Existing major regulations affecting (1 MA), it may of subjoct to back ade of Federal Regulations, Title 21, Parts 800 to 898. In your device can be round in firsther announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisod that 1 DTC isbualles of that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and reguirements, including, but not limited to: registration r ou must comply with an the Pieveg (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labeling (21 CFR Partial requirents as set form in the quality bjoksion (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) IThis letter will anow you to other and of substantial equivalence of your device to a premarket notified.com - The PDF 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), if you desire speofile at 700 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Britistics (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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
Indications for Use
510(k) Number (if known):
604139 GC FUSION
Device Name:
Indications for Use:
The Product is a dental vinylpolysiloxane impression material intended for use of taking intra-oral impressions of a patient's mouth.
Prescription Use (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runse
(Division Sian-Off) Division of Anesthesiology, General Hospits Infection Control, Dental D
510(k) Number: K041308
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