(44 days)
For use in the fabrication of full and partial dentures using conventional heat cured dough pack and or injection processing technique.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental resin, Nature-Cryl™ Hi Plus, used for fabricating dentures. It is not a study that proves a device meets acceptance criteria.
Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are not present in this type of regulatory correspondence.
The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. It does not contain the detailed performance study information you are asking for.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
JUL - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K051358
Trade/Device Names: Nature-Cryl™ Hi Plus Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: May 20, 2005 Received: June 01, 2005
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 Please be advised that FDA 's Issualice of a successfies with other requirements of the Act or that FDA has made a delemination mat your develop other Federal agencies. You must comply with any Federal statures and regulations acmiliated of our registration of disting (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration in t all the Act's requirements, including, but not interests as set forth in the quality.
Iabeling (21 CFR Part 801); good manufacturing practice requirements product radiation labeling (21 CFR Part 801), good manufacturing production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic pro systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin manxallig your device of your device of your device to a legally prematket notification. The IDA midnig of succanian organizations of successions of the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your as not the regulation of the regulation entitled, a contact the Office of Comphalice at (210) 210 of real 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Division of Small " Misoranding of relefence to promation is a many the Act from the Division of Small general information on your responsibilities and its toll-free number (800) 638-2041 or Manufacturers, international and Consultip://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
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): _
Device Name:
Indications for Use:
NATURE-CRYL HI PLUS
1051368
For use in the fabrication of full and partial dentures using conventional heat cured dough pack and or injection processing technique.
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)
Kein Muluy for KSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K 051358
Page 1 of 1
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.