510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850014Substantially Equivalent

Hit Kit (Hydrodynamic Impression Technique

Medi-Dent American, Inc., Niagara Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850014 is the FDA 510(k) clearance record for HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE, a class I device, cleared for Medi-Dent American, Inc. on under FDA product code EBH (Material, Impression Tray, Resin). FDA records list one 510(k) clearance for Medi-Dent American, Inc. As of , FDA records show no recalls naming K850014.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EBH Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Applicant
Medi-Dent American, Inc. 110 24th St., Niagara Falls NY
Third party review
No

Clearances, product code EBH

Trailing 12 months

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

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