Cleared Traditional

K082671 - HERCULITE ULTRA (FDA 510(k) Clearance)

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

K082671 · Sybron Dental Specialties · Dental device
Dec 2008
Decision
87d
Days
Class 2
Risk

K082671 is an FDA 510(k) clearance for the HERCULITE ULTRA. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on December 11, 2008 after a review of 87 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.

Submission Details

510(k) Number K082671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date December 11, 2008
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 158d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - EBF Material, Tooth Shade, Resin

All 27
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