Cleared Special

K060270 - MICROPOWER HAND PIECE: ORAL MAX HIGH SP...

K060270 is the FDA 510(k) clearance for MICROPOWER HAND PIECE: ORAL MAX HIGH SP... by Linvatec Corp.. It is a Class 2 Dental device (product code DZI) cleared through the Special 510(k) pathway after a 68-day FDA review.

K060270 · Linvatec Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
68d
Days
Class 2
Risk

K060270 is an FDA 510(k) clearance for the MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on April 10, 2006 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Linvatec Corp. devices

Submission Details

510(k) Number K060270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2006
Decision Date April 10, 2006
Days to Decision 68 days
Submission Type Special
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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZI Drill, Bone, Powered

All 23
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K060270.
SYNTHES 90 DEGREE SCREWDRIVER
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VARIOSURG
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K032607 · Linvatec Corp. · Nov 2003
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
K032117 · Stryker Instruments · Aug 2003
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991696 · Stryker Instruments · Oct 1999