Cleared Traditional

K901967 - DENDIA WERK BURS AND CUTTING DISCS

K901967 is an FDA 510(k) clearance for DENDIA WERK BURS AND CUTTING DISCS, manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K901967 · Micro-Aire Surgical Instruments, Inc. · Dental device
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Jul 1990
Decision
73d
Days
Class 1
Risk

K901967 is an FDA 510(k) clearance for the DENDIA WERK BURS AND CUTTING DISCS. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on July 13, 1990 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - 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 Micro-Aire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K901967

510(k) Number K901967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date July 13, 1990
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

DZP Device Classification - Class 1, General Controls

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
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.