(77 days)
This product is a high consistency vinylpolysiloxane impression material to be used for taking intra-oral impressions.
Not Found
The document provided is a 510(k) premarket notification letter from the FDA for a device called "FUSION PUTTY," an impression material. It determines substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided document. The document is essentially an approval letter based on equivalence, not a performance study report.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAR 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry L. Joritz Director, Customer Care Group GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K043493
Trade/Device Name: FUSION PUTTY Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 1, 2005 Received: March 2, 2005
Dear Ms. Joritz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have revealy 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 incrate commerce prior to 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 approvisions 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 cither class II (Spccial Controls) or class III If your device is classinos (so as additional controls. Existing major regulations affecting (1 Writ), it may of acress of Federal Regulations, Title 21, Parts 800 to 898. In your device earl of roundsh further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Ms. Joritz
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualles of a base our device complies with other requirements mean that FDA has made a decommance hatw Js administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal status of the Act of ally rederal statutes and reguirements, including, but not limited to: registration You must comply with an the Fee s requires (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 607), laboring (21 CFR Pat 820) regulation (21 CFR Pat 820); and if requirenents as set form in the quality Brovisions (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) This letter will anow you to begin maiing of substantial equivalence of your device to a premarket notification. The PDF mailts 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 specific at not to your ce 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 may obtain 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,
Sophie Michaud
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
KO43493 510(k) Number (if known): _
FUSION PUTTY Device Name:
Indications for Use:
This product is a high consistency vinylpolysiloxane impression material to be used for taking intra-oral impressions.
Prescription Use __ X (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 Purvis
Con Sion-Off) non of Anesthosiology, General Hospital, Scrion Control. Dental Devices
(); Rumber_
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).