(21 days)
The K4 products fall into the general category of prefabricated (preformed) posts which comprises threaded and non-threaded versions. The K4 system is designed is designed so that the posts are cemented into canals tapped previously with a thread. This means that the K4 system is pre-threaded and therefore placement is passive (not active) as the posts themselves are not cutting into the dentine at the cementation stage. If placed in accordance with the instructions the process will largely eliminate fitting stress.
Posts are placed to support a core so that a crown can complete a tooth restoration, or to stop the coronal tooth substance from shearing off.
The introduction of titanium versions of certain of the K4 products does not change the method or the purpose of the placement. The dentist is simply to be offered a choice of post material. We will not seek to influence the dentist's decision.
Not Found
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
Here's why:
- The document is a 510(k) clearance letter. This type of document from the FDA states that a device is "substantially equivalent" to a legally marketed predicate device. It is not a clinical study report or a document detailing performance specifications and test results.
- Lack of acceptance criteria and study details. The letter explicitly states that the FDA has reviewed the 510(k) notification and determined substantial equivalence. It does not contain sections outlining specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness study results. These details would typically be found in the 510(k) submission itself, which is not provided here.
- Focus on regulatory classification. The document's primary purpose is to inform the applicant that their device (Kurer Crown Saver K4 Anchor System) can be legally marketed, subject to general controls, because it's substantially equivalent to existing devices.
Therefore, the information you requested regarding acceptance criteria, study details, and performance metrics is simply not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that could represent water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Mr. Steven R. Buckley Sabre-K Limited Golf Road, Hale, Altrincham Cheshire WA 15 8AH UNITED KINGDOM
Re : K983161 Kurer Crown Saver K4 Anchor System-The Trade Name: Universal Kit, Kurer Standard K4 Anchor Requlatory Class: I Product Code: ELR September 2, 1998 Dated: Received: September 9, 1998
Dear Mr. Buckley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Buckley
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Kane
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2 oi
Page
NO. 456
DD1 வி பயப் 3
510(k) Number (if known): K 983161
Device Name: KURER ﻴﺔ ﺍﻟﻤﻠ ANCHOR
Indications For Use:
15:52
The K4 products fall into the general category of prefabricated (preformed) posts which comprises threaded and non-threaded versions. The K4 system is designed is designed so that the posts are cemented into canals tapped previously with a thread. This means that the K4 system is pre-threaded and therefore placement is passive (not active) as the posts themselves are not cutting into the dentine at the cementation stage. If placed in accordance with the instructions the process will largely eliminate fitting stress.
Posts are placed to support a core so that a crown can complete a tooth restoration, or to stop the coronal tooth substance from shearing off.
The introduction of titanium versions of certain of the K4 products does not change the method or the purpose of the placement. The dentist is simply to be offered a choice of post material. We will not seek to influence the dentist's decision.
(PLEASE DO NOT VIRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Conc urrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Form
(Division Sign-Of
""
(Optional Formal 1-2-96)
Division of Thures, infection Cuatro),
and General Hospital Devices
510(k) Number Ra8361
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.