Cleared Traditional

K896361 - HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE

K896361 is an FDA 510(k) clearance for HANDPIECE FIBER OPTIC SYSTEM IMPROVEMEN..., manufactured by Dentalez Group. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K896361 · Dentalez Group · Dental device
Download Printable Device Report (PDF)
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Feb 1990
Decision
88d
Days
Class 1
Risk

K896361 is an FDA 510(k) clearance for the HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on February 2, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Dentalez Group devices

FDA 510(k) Submission Details - K896361

510(k) Number K896361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date February 02, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 114
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K896361.
OSTEOMED IB DRILL
K911937 · Osteomed Corp. · Jun 1991
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · Dentsply Intl. · Mar 1990
MICRO-AIRE HIGH SPEED DRILL (2910-000)
K894606 · Micro-Aire Surgical Instruments, Inc. · Oct 1989
PLAQUE-SWEEP
K873209 · Dentsply Intl. · Aug 1987
TUBING HANDPIECE REPLACEMENT
K854697 · Almore Intl., Inc. · Mar 1986