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
K840113Substantially Equivalent

Silicone Splinting Material

General Dental Products, Inc., Elk Grove Village IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840113 is the FDA 510(k) clearance record for SILICONE SPLINTING MATERIAL, a class I device, cleared for General Dental Products, Inc. on under FDA product code MDA (Elastomer, Silicone, For Scar Management). FDA records list 2 510(k) clearances for General Dental Products, Inc., from to . As of , FDA records show no recalls naming K840113.

Clearance record

Decision date
Received
(462 days to decision)
Product code
MDA Elastomer, Silicone, For Scar Management
Regulation
21 CFR 878.4025
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
General Dental Products, Inc. 2281 Devon Ave., Elk Grove Village IL
Third party review
No

Clearances, product code MDA

Trailing 12 months

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

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