Cleared Traditional

K080549 - DURAFINISH ALL-CURE, MODEL S296 (FDA 510(k) Clearance)

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

K080549 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
76d
Days
Class 2
Risk

K080549 is an FDA 510(k) clearance for the DURAFINISH ALL-CURE, MODEL S296. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on May 13, 2008 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Parkell, Inc. devices

Submission Details

510(k) Number K080549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2008
Decision Date May 13, 2008
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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.