510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K940368Substantially Equivalent

Canal King (Thin) Canal King (Thick)

Pulpdent Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940368 is the FDA 510(k) clearance record for CANAL KING (THIN) CANAL KING (THICK), a class II device, cleared for Pulpdent Corp. on under FDA product code KIF (Resin, Root Canal Filling). FDA records list 110 510(k) clearances for Pulpdent Corp., from to . As of , FDA records show no recalls naming K940368.

Clearance record

Decision date
Received
(359 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Pulpdent Corp. 80 Oakland St., Watertown MA
510(k) summary
Summary
Third party review
No

Clearances, product code KIF

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