Cleared Special

K060270 - MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL

K060270 is an FDA 510(k) clearance for MICROPOWER HAND PIECE: ORAL MAX HIGH SP..., manufactured by Linvatec Corp.. The device is a Class 2 Dental device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K060270

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
60d faster than avg
Panel avg: 128d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

DZI Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K060270.
EMS PIEZON MASTER SURGERY
K072146 · E.M.S Electro Medical Systems S.A · Dec 2007
IMPLANT CENTER
K072030 · Satelec - Acteon Group · Nov 2007
PIEZOTOME
K060274 · Satelec · May 2006
PIEZOSURGERY DEVICE
K043408 · Piezosurgery S.R.L. · Jun 2005
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
K042434 · NOUVAG AG · Nov 2004
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · Linvatec Corp. · Nov 2003
K060270 · MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
Download PDF FDA Summary Linvatec Corp.