KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC

K983161 · Sabre-K , Ltd. · ELR · Sep 30, 1998 · Dental

Device Facts

• Record ID: K983161
• Device Name: KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
• Applicant: Sabre-K , Ltd.
• Product Code: ELR · Dental
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Kurer K4 Anchor System consists of prefabricated, pre-threaded dental posts; designed for passive placement into pre-tapped root canals. Posts are cemented into place to support a core for crown restoration or to prevent coronal tooth shearing. System includes titanium versions; dentist selects material. Used in dental clinics by licensed dentists. Passive placement mechanism minimizes fitting stress compared to active cutting posts. Benefits include structural support for compromised teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Prefabricated dental posts; threaded and non-threaded versions. Materials include titanium. Passive placement design; posts are cemented into pre-tapped canals. Class I device.

Indications for Use

Indicated for dental patients requiring tooth restoration via crown support or prevention of coronal tooth substance shearing. Used by dentists to support a core in a tooth canal.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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NO. 456

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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