510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K983161Substantially Equivalent

Kurer Crown Saver K4 Anchor System-the Universal Kit, Kurer Standard K4 Anchor System- the Ready Core Kit, Kurer Fin-Loc

Sabre-K, Ltd., Cheshire Wa 15 8ah, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983161 is the FDA 510(k) clearance record for KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC, a class I device, cleared for Sabre-K , Ltd. on under FDA product code ELR (Post, Root Canal). FDA records list one 510(k) clearance for Sabre-K , Ltd. As of , FDA records show no recalls naming K983161.

Clearance record

Decision date
Received
(21 days to decision)
Product code
ELR Post, Root Canal
Regulation
21 CFR 872.3810
Device class
Class I
Review panel
Dental
Applicant
Sabre-K , Ltd. Golf Rd., Hale Altrincham, Cheshire Wa 15 8ah, GB
510(k) summary
Statement
Third party review
No

Clearances, product code ELR

Trailing 12 months

FDA records hold no clearances under product code ELR in the trailing twelve months.

FDA records show no clearances under product code ELR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260