Cleared Traditional

HYDENT (K911259) - FDA 510(k) Clearance

Class I Dental device.

K911259 · Pascal Co., Inc. · Dental device
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Jun 1991
Decision
76d
Days
Class 1
Risk

K911259 is an FDA 510(k) clearance for the HYDENT. Classified as Paper, Articulation (product code EFH), Class I - General Controls.

Submitted by Pascal Co., Inc. (Bellevue, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6140 - 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 Pascal Co., Inc. devices

Submission Details

510(k) Number K911259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1991
Decision Date June 06, 1991
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
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.

Device Classification

Product Code EFH Paper, Articulation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.