Cleared Traditional

K252035 - DENTURE SOFT EX (Pink set) (FDA 510(k) Clearance)

Also includes:
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)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252035 · Kamemizu Chemical Industry Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
79d
Days
Class 2
Risk

K252035 is an FDA 510(k) clearance for the DENTURE SOFT EX (Pink set). Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Kamemizu Chemical Industry Co., Ltd. (Neyagawa, JP). The FDA issued a Cleared decision on September 17, 2025 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kamemizu Chemical Industry Co., Ltd. devices

Submission Details

510(k) Number K252035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2025
Decision Date September 17, 2025
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 327
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K252035.
LuxCreo Flexible Partial Denture Resin
K253365 · LuxCreo, Inc. · Nov 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · Graphy, Inc. · Nov 2025
UltraPrint-Dental Denture UV
K253324 · Guangzhou Heygears IMC., Inc. · Nov 2025
Freeprint® denture flex
K252430 · Detax GmbH · Oct 2025
Flexible Partial Resin
K250302 · Prismatik Dentalcraft, Inc. · Jun 2025
Partial Flex
K242897 · Clemde SA DE CV · Jun 2025