Cleared Traditional

K911259 - HYDENT

K911259 is an FDA 510(k) clearance for HYDENT, manufactured by Pascal Co., Inc.. The device is a Class 1 Dental device with product code EFH cleared through the Traditional 510(k) pathway after a 76-day FDA review.

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.

FDA 510(k) Submission Details - K911259

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 128d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

EFH Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFH Paper, Articulation

All 8
Devices cleared under the same product code (EFH) and FDA review panel - the closest regulatory comparables to K911259.
PFINGST PRESSURE PASTE
K965026 · Pfingst & Co., Inc. · Feb 1997
OCCLUDE
K912632 · Pascal Co., Inc. · Jan 1992
FIXTECTOR
K864572 · Prodent Intl., Inc. · Feb 1987
REVISED T-SCAN SYSTEM
K870032 · Sentek, Inc. · Feb 1987
ARTICULATING PAPER
K832647 · Ardent Intl., Inc. · Feb 1984
MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY
K833132 · Myo-Tronics Research, Inc. · Feb 1984
K911259 · HYDENT
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