Cleared Traditional

K150454 - Acryfree Denture Base Material and Biosens Denture Base Material

K150454 is an FDA 510(k) clearance for Acryfree Denture Base Material and Bios..., manufactured by Perflex. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K150454 · Perflex · Dental device
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May 2015
Decision
95d
Days
Class 2
Risk

K150454 is an FDA 510(k) clearance for the Acryfree Denture Base Material and Biosens Denture Base Material. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Perflex (Netanya, IL). The FDA issued a Cleared decision on May 26, 2015 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K150454

510(k) Number K150454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date May 26, 2015
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 128d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 Consultant

Licensale, Inc.
RAY KELLY

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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 293
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K150454.
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K151142 · Wieland Dental + Technik GmbH & Co. KG · Aug 2015
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K143033 · Dentca, Inc. · Jul 2015
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K150511 · Sun Medical Co., Ltd. · May 2015
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K143265 · Sun Medical Co., Ltd. · Apr 2015
TCS Blend
K142894 · Thermoplastic Comfort Systems, Inc. · Feb 2015
Ufi Gel hard C
K143486 · Voco GmbH · Jan 2015
K150454 · Acryfree Denture Base Material and Biosens Denture Base Material
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