Cleared Traditional

TUF LINK SILICONE RELINER

K042931 · Dentatus USA , Ltd. · Dental
Dec 2004
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K042931 is an FDA 510(k) clearance for the TUF LINK SILICONE RELINER, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Dentatus USA , Ltd. (New York, US). The FDA issued a Cleared decision on December 8, 2004, 47 days after receiving the submission on October 22, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K042931 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2004
Decision Date December 08, 2004
Days to Decision 47 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