510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981234Substantially Equivalent

Flare,file, Fill

Lone Star Technologies, Chatham NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981234 is the FDA 510(k) clearance record for FLARE,FILE, FILL, a class I device, cleared for Lone Star Technologies on under FDA product code EJB (Handle, Instrument, Dental). FDA records list 2 510(k) clearances for Lone Star Technologies, from to . As of , FDA records show no recalls naming K981234.

Clearance record

Decision date
Received
(62 days to decision)
Product code
EJB Handle, Instrument, Dental
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Lone Star Technologies 31 Runnymeade, Chatham NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EJB

Trailing 12 months

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

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