Cleared Traditional

K253513 - MultiMatch Flow Chameleon AntiMicrobial...

K253513 is the FDA 510(k) clearance for MultiMatch Flow Chameleon AntiMicrobial... by Premier Dental Products Company. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 1-day FDA review.

K253513 · Premier Dental Products Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
1d
Days
Class 2
Risk

K253513 is an FDA 510(k) clearance for the MultiMatch Flow Chameleon AntiMicrobial Composite. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Premier Dental Products Company (Plymouth Meeting, US). The FDA issued a Cleared decision on November 7, 2025 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Premier Dental Products Company devices

Submission Details

510(k) Number K253513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2025
Decision Date November 07, 2025
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K253513.
ZAFIRA®
K254245 · New Stetic, SA · Mar 2026
LumiCera
K260170 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Jan 2026
Any-Core
K252465 · Mediclus Co., Ltd. · Dec 2025
G-BLOCK
K253236 · Graphenano Dental S.L. · Sep 2025
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K253053 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Sep 2025
G aenial Universal Injectable II
K251946 · GC America, Inc. · Aug 2025