510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854529Substantially Equivalent

Inlay Wax Regular

The Hygenic Company, LLC, Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854529 is the FDA 510(k) clearance record for INLAY WAX REGULAR, a class I device, cleared for The Hygenic Corp. on under FDA product code EGD (Wax, Dental, Intraoral). FDA records list 16 510(k) clearances for The Hygenic Corp., from to . As of , FDA records show no recalls naming K854529.

Clearance record

Decision date
Received
(117 days to decision)
Product code
EGD Wax, Dental, Intraoral
Regulation
21 CFR 872.6890
Device class
Class I
Review panel
Dental
Applicant
The Hygenic Corp. 1245 Home Ave., Akron OH
Third party review
No

Clearances, product code EGD

Trailing 12 months

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

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