510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843901Substantially Equivalent

Isostatic Condenser

Shofu Dental Corp., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843901 is the FDA 510(k) clearance record for ISOSTATIC CONDENSER, a class I device, cleared for Shofu Dental Corp. on under FDA product code EKG (Condenser, Amalgam And Foil, Operative). FDA records list 97 510(k) clearances for Shofu Dental Corp., from to . As of , FDA records show no recalls naming K843901.

Clearance record

Decision date
Received
(61 days to decision)
Product code
EKG Condenser, Amalgam And Foil, Operative
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Shofu Dental Corp. 4024 Bohannon Dr., Menlo Park CA
Third party review
No

Clearances, product code EKG

Trailing 12 months

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

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