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FDA 510(k)

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

K-Number: K983161 · 1998-09-30

ApplicantSabre-K , Ltd.
Decision Date1998-09-30
Product CodeELR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC is the device name listed in this FDA 510(k) record. The listed applicant is Sabre-K , Ltd.. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K983161. The device is classified under product code ELR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Sabre-K , Ltd.. The 510(k) number is K983161.

When did KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC receive FDA 510(k) clearance?

KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC received FDA 510(k) clearance on 1998-09-30, under 510(k) number K983161.

Who is the listed applicant for KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC?

The FDA 510(k) record lists Sabre-K , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC?

The FDA product code for KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC is ELR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ELR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060075FIBER-METAL POSTForemost Dental, LLCK042848FRC POSTEC PLUSIvoclar Vivadent, Inc.K030820EVERSTICK POSTStick Tech , Ltd.K020431FIBIOCOREEst. AnthogyrK012496CARBON POSTJ. Morita USA, Inc.K013802FRC POSTECIvoclar Vivadent, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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