Cleared Traditional

K990844 - STARDENTAL AXCS STERILE WATER SYSTEM

K990844 is an FDA 510(k) clearance for STARDENTAL AXCS STERILE WATER SYSTEM, manufactured by Dentalez Group. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K990844 · Dentalez Group · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
74d
Days
Class 1
Risk

K990844 is an FDA 510(k) clearance for the STARDENTAL AXCS STERILE WATER SYSTEM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on May 28, 1999 after a review of 74 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.

FDA 510(k) Submission Details - K990844

510(k) Number K990844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date May 28, 1999
Days to Decision 74 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
54d faster than avg
Panel avg: 128d · This submission: 74d
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 261
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K990844.
DIFOTI SYSTEM
K991098 · Electro-Optical Sciences, Inc. · Jun 1999
QUANTEC-E IRRIGATION SYSTEM
K991035 · Sybron Dental Specialties, Inc. · Jun 1999
ORASCOPE
K991011 · Fiberdent Corp. · Jun 1999
HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR
K990479 · Hygenitek, Inc. · 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
K990844 · STARDENTAL AXCS STERILE WATER SYSTEM
Download PDF FDA Summary Dentalez Group