510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042828Substantially Equivalent

Obtura Gutta Percha Delivery System, Model 823-700

Young O/S, LLC, Fenton MO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042828 is the FDA 510(k) clearance record for OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700, a class I device, cleared for Young O/S, LLC on under FDA product code EKR (Plugger, Root Canal, Endodontic). FDA records list one 510(k) clearance for Young O/S, LLC. As of , FDA records show no recalls naming K042828.

Clearance record

Decision date
Received
(50 days to decision)
Product code
EKR Plugger, Root Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Young O/S, LLC 1663 Fenton Business Park Ct., Fenton MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKR

Trailing 12 months

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

FDA records show no clearances under product code EKR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKR, 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