Cleared Traditional

K911068 - 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM

K911068 is an FDA 510(k) clearance for 29540 DYNASURG ELECTRIC HANDPIECE AND I..., manufactured by Micro Motors, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K911068 · Micro Motors, Inc. · Dental device
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May 1991
Decision
65d
Days
Class 1
Risk

K911068 is an FDA 510(k) clearance for the 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Micro Motors, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 65 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.

FDA 510(k) Submission Details - K911068

510(k) Number K911068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date May 15, 1991
Days to Decision 65 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
63d faster than avg
Panel avg: 128d · This submission: 65d
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 237
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K911068.
ORALSAFE
K923469 · Oralsafe, Inc. · Oct 1992
W-H TOPAIR DENTAL HANDPIECE
K912786 · Sabra-The Dental Products Group · Jul 1991
OSTEOMED IB DRILL
K911937 · Osteomed Corp. · Jun 1991
LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS
K905542 · Lares Research, Inc. · Mar 1991
LARES 757 WORKHORSE HIGHSPEED HANDPIECE
K905541 · Lares Research, Inc. · Mar 1991
HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES
K905155 · Star Dental Mfg. Co. · Feb 1991
K911068 · 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM
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