Cleared Traditional

K043295 - VERSYO.DIRECT
(FDA 510(k) Clearance)

K043295 · Heraeus Kulzer, Inc. · Dental
Jan 2005
Decision
37d
Days
Class 2
Risk

K043295 is an FDA 510(k) clearance for the VERSYO.DIRECT, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on January 5, 2005, 37 days after receiving the submission on November 29, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K043295 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2004
Decision Date January 05, 2005
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

Similar Devices — EBI Resin, Denture, Relining, Repairing, Rebasing

All 327
LuxCreo Flexible Partial Denture Resin
K253365 · LuxCreo, Inc. · Nov 2025
TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
K253681 · Graphy, Inc. · Nov 2025
UltraPrint-Dental Denture UV
K253324 · Guangzhou Heygears IMC., Inc. · Nov 2025
Freeprint? denture flex
K252430 · Detax GmbH · Oct 2025
DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
K252035 · Kamemizu Chemical Industry Co., Ltd. · Sep 2025
Flexible Partial Resin
K250302 · Prismatik Dentalcraft, Inc. · Jun 2025