510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100653Substantially Equivalent

Jet Xr Radiopaque Acrylic Resin Powder 45 Grams, Jet Xr Radiopaque Acrylic Resin Powder 100 Grams, Jet Liquid 118 Ml Mod

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

K100653 is the FDA 510(k) clearance record for JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD, a class II device, cleared for Lang Dental Mfg. Co., Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 9 510(k) clearances for Lang Dental Mfg. Co., Inc., from to . As of , FDA records show no recalls naming K100653.

Clearance record

Decision date
Received
(214 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 Mfg. 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