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
K152981Substantially Equivalent

Jet Set 4 Denture Repair Resin

Lang Dental Manufacturing Co., Inc., Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K152981 is the FDA 510(k) clearance record for JET SET 4 DENTURE REPAIR RESIN, a class II device, cleared for Lang Dental Manufacturing Company, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 2 510(k) clearances for Lang Dental Manufacturing Company, Inc., from to . As of , FDA records show no recalls naming K152981.

Clearance record

Decision date
Received
(329 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Lang Dental Manufacturing Company, Inc. 175 Messner Dr., Wheeling IL
510(k) summary
Statement
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260