510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163482Substantially Equivalent

Orthodontic Acrylic 2

Lang Dental Manufacturing Co., Inc., Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163482 is the FDA 510(k) clearance record for Orthodontic Acrylic 2, a class II device, cleared for Lang Dental Manufacturing Co., Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 2 510(k) clearances for Lang Dental Manufacturing Co., Inc., from to . As of , FDA records show no recalls naming K163482.

Clearance record

Decision date
Received
(170 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 Co., Inc. 175 Messner Dr., Wheeling IL
510(k) summary
Summary PDF
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