Cleared Traditional

K782165 - PHASEAFILL

K782165 is an FDA 510(k) clearance for PHASEAFILL, manufactured by Phasealloy. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K782165 · Phasealloy · Dental device
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Mar 1979
Decision
85d
Days
Class 2
Risk

K782165 is an FDA 510(k) clearance for the PHASEAFILL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Phasealloy (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979 after a review of 85 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 Phasealloy devices

FDA 510(k) Submission Details - K782165

510(k) Number K782165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1978
Decision Date March 21, 1979
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 128d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 Peers - EBF Material, Tooth Shade, Resin

All 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K782165.
DENTAL COMPOSITE RESTORATIVE MATERIAL
K790594 · Wallace A. Erickson & Co. · Jun 1979
FINESSE
K790585 · L.D. Caulk Co. · May 1979
CONTACT RESIN
K790439 · Vivadent (Usa), Inc. · Apr 1979
ISOPLAST
K781787 · Vivadent (Usa), Inc. · Dec 1978
AUROFIL
K781687 · Wallace A. Erickson & Co. · Dec 1978
ZYTRON
K780796 · Premier Dental Products Co. · Jun 1978