(76 days)
Korlex-GRTM is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures when sulcus widening is needed.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Biotech One, Incorporated, regarding their device Korlex-GR™. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for the detailed table and study information based on this input. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also outlines general regulatory compliance requirements.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
Biotech One, Incorporated C/O Ms. Karen Uyesugi U.S. Regulatory Consultant Uyesugi & Associates 92 Costa Brava Laguna Niguel, California 92677
Re: K053329
Trade/Device Name: Korlex-GRTM Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: November 29, 2005 Received: December 1, 2005
Dear Ms. Uyesugi:
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 (1 mr 1), it and 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. Uyesugi
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 mean that FDA nas made a decemminations 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 regaratents, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practice and listing (21 CFR Pat 607), laoolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality byotsing (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 premits the momention. THE I Drive 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 S01), IT you desire specific advice to: Jour de 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 other general meetirs. 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,
Susan Dunne
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
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510(k) Notification Korlex-GR™M
BioTech One, Inc.
510(k) number (if known): K053329
Korlex-GR™ Device Name: ™
Indications for Use:
Korlex-GRTM is intended for the temporary retraction and hemostasis of the gingival
ed for the same and mean deves when sulcus widening is needed. Korlex-GR™ is intended for the temporary rotuses.
margin during dental procedures when sulcus widening is needed.
The submit
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Runo
O faton to mynthasingy, General Hoeplic
Iraken Control. Denial Devices
K05 3339
N/A