510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844635Substantially Equivalent

Hydroset Root Canal Sealer

Lund Manufacturing Co., Diamond Bar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844635 is the FDA 510(k) clearance record for HYDROSET ROOT CANAL SEALER, a class II device, cleared for Lund Manufacturing Co. on under FDA product code KIF (Resin, Root Canal Filling). FDA records list one 510(k) clearance for Lund Manufacturing Co. As of , FDA records show no recalls naming K844635.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Lund Manufacturing Co. 2151 Derringer Ln., Diamond Bar CA
Third party review
No

Clearances, product code KIF

Trailing 12 months
6 clearances under product code KIF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20262
October 20260