510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771120Substantially Equivalent

Impreflex Alginate Impression Material

Espe Dental Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771120 is the FDA 510(k) clearance record for IMPREFLEX ALGINATE IMPRESSION MATERIAL, a class II device, cleared for Espe Dental Products on under FDA product code LEW (Thin Layer Chromatography, Theophylline). FDA records list 8 510(k) clearances for Espe Dental Products, from to . As of , FDA records show no recalls naming K771120.

Clearance record

Decision date
Received
(42 days to decision)
Product code
LEW Thin Layer Chromatography, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Espe Dental Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LEW

Trailing 12 months

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

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