510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853183Substantially Equivalent

Endodontic Electronic Spreader Heater

Sturgeon Engineering Co., Petrolia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853183 is the FDA 510(k) clearance record for ENDODONTIC ELECTRONIC SPREADER HEATER, a class I device, cleared for Sturgeon Engineering Co. on under FDA product code EKK (Spreader, Pulp Canal Filling Material, Endodontic). FDA records list 2 510(k) clearances for Sturgeon Engineering Co., from to . As of , FDA records show no recalls naming K853183.

Clearance record

Decision date
Received
(78 days to decision)
Product code
EKK Spreader, Pulp Canal Filling Material, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Sturgeon Engineering Co. 1 Innovation Rd., Petrolia CA
Third party review
No

Clearances, product code EKK

Trailing 12 months

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

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