Cleared Traditional

K150454 - Acryfree Denture Base Material and Bios...

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.

View all Perflex devices

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
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · 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 Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 176
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