Cleared Traditional

K983285 - ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS

K983285 is an FDA 510(k) clearance for ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS, manufactured by Engle Dental Systems. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K983285 · Engle Dental Systems · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
47d
Days
Class 1
Risk

K983285 is an FDA 510(k) clearance for the ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Engle Dental Systems (Forest Grove, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 47 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 Engle Dental Systems devices

FDA 510(k) Submission Details - K983285

510(k) Number K983285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1998
Decision Date November 04, 1998
Days to Decision 47 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
80d faster than avg
Panel avg: 127d · This submission: 47d
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 171
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K983285.
ERADIC-ALL
K981171 · Theratechnologies, Inc. · Dec 1998
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
K983847 · Germiphene Corp. · Dec 1998
BIO-2000
K973765 · Micrylium Laboratories · Nov 1998
BIOCLEAR CONCENTRATE
K981565 · Waggoner Product Development · Oct 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
ULTRACAM
K973410 · W. Edward Johansen · Oct 1998