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HI-WAVE - Hi-Wave

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011762

by Denplus Inc

Identifiers

510(k) Number
K011762 FDA 510(k)
FDA Product Code
EBI FDA 510(k)
Models / Variants
Hi-Wave FDA 510(k)
Pour-Plus FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3760 FDA 510(k)
Regulation Number
872.3760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

HI-WAVE; POUR-PLUS is a denture base acrylic resin system used by dental professionals in laboratory settings. Hi-Wave is a microwave heat-curing acrylic and Pour-Plus is an auto-curing (self-curing) acrylic. Both materials are used to fabricate complete or partial removable dentures.

The device is supplied as a dental material for laboratory use by dental professionals. It is processed to form the denture base, providing a stable and color-stable result. The device received FDA 510(k) clearance under K011762 and is classified under product code EBI with advisory committee designation DE (Dental).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HI-WAVE; POUR-PLUS (K011762) — FDA 510 (k) | Innolitics, Hi-wave; Pour-plus 510 (k) FDA Premarket Notification K011762 DENPLUS, INC., DenPlus Inc. -

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Denplus Inc
FDA Applicant
Denplus, Inc.

Sources (1)

  • FDA 510(k) K011762 24 fields · synced Sep 28, 2026