Cleared Traditional

K990479 - HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR

K990479 is an FDA 510(k) clearance for HYGENICLEAR WKR 1, manufactured by Hygenitek, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K990479 · Hygenitek, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
86d
Days
Class 1
Risk

K990479 is an FDA 510(k) clearance for the HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Hygenitek, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on May 13, 1999 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Hygenitek, Inc. devices

FDA 510(k) Submission Details - K990479

510(k) Number K990479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1999
Decision Date May 13, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 154
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K990479.
QUANTEC-E IRRIGATION SYSTEM
K991035 · Sybron Dental Specialties, Inc. · Jun 1999
ORASCOPE
K991011 · Fiberdent Corp. · Jun 1999
STARDENTAL AXCS STERILE WATER SYSTEM
K990844 · Dentalez Group · May 1999
SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,
K984332 · International Technology Concepts · Apr 1999
HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
K991161 · Kay See Dental Mfg. Co. · Apr 1999
S575 INTRAORAL DOCKING DENTAL CAMERA
K990948 · Sopro · Apr 1999