510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K890449Substantially Equivalent

Permagum Putty Soft & Permagum Garrant

Wacker-Chemie GmbH, East Germany, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890449 is the FDA 510(k) clearance record for PERMAGUM PUTTY SOFT & PERMAGUM GARRANT, a class II device, cleared for Wacker-Chemie GmbH on under FDA product code ELW (Material, Impression). FDA records list one 510(k) clearance for Wacker-Chemie GmbH. As of , FDA records show no recalls naming K890449.

Clearance record

Decision date
Received
(181 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Wacker-Chemie GmbH Prinzregentenstrabe 22, East Germany, MY
Third party review
No

Clearances, product code ELW

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