510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011762Substantially Equivalent

Hi-Wave; Pour-Plus

Denplus, Inc., Longueuil, Quebec, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011762 is the FDA 510(k) clearance record for HI-WAVE; POUR-PLUS, a class II device, cleared for Denplus, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 2 510(k) clearances for Denplus, Inc., from to . As of , FDA records show no recalls naming K011762.

Clearance record

Decision date
Received
(77 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Denplus, Inc. 1221 Labadie, Suite 205, Longueuil, Quebec, CA
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