(42 days)
This product is a vinylpolysiloxane impression material to be used for taking intra-oral impressions.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental impression material named "Fusion™ Fast". This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you are requesting for an AI/device performance study.
The letter simply states that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It confirms that the device can proceed to market subject to general controls.
Key points from the document relevant to your request (though not directly answering your detailed questions):
- Trade/Device Names: Fusion™ Fast
- Regulation Number: 21 CFR 872.3660
- Regulation Name: Impression Material
- Regulatory Class: II
- Product Codes: ELW
- Indications for Use: This product is a vinylpolysiloxane impression material to be used for taking intra-oral impressions.
- 510(k) Number: K043471
To answer your request, if this were an AI device, I would need a different type of document, such as a clinical study report or a 510(k) summary that includes performance data.
Since the information is not present in the provided document, I cannot fulfill your request for an acceptance criteria table and study details.
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Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol consisting of three curved lines that resemble a stylized human figure or a flowing design. The symbol is positioned in the center of the circle.
JAN 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry L. Joritz Director, Regulatory Affairs & Ouality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K043471
Trade/Device Names: Fusion™ Fast Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: December 14, 2004 Received: December 24, 2004
Dear Ms. Joritz:
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 - Ms. Terry L. Joritz
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/dsma/dsmamain.html
Sincerely yours,
Chiu S. Lin, PhD
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
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Indications for Use
510(k) Number (if known): _ K04347)
Device Name:
FUSION FAST SET
Indications for Use:
This product is a vinylpolysiloxane impression material to be used for taking intra-oral impressions.
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 Runner
ிvision Sign-Off) Unision of Anesthesiology, General Hospital, Infection Control. Dental Devices
210(k) Number: Y04347
Page 1 of 1
§ 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).