Cleared Traditional

K072030 - IMPLANT CENTER

K072030 is an FDA 510(k) clearance for IMPLANT CENTER, manufactured by Satelec - Acteon Group. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K072030 · Satelec - Acteon Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
118d
Days
Class 2
Risk

K072030 is an FDA 510(k) clearance for the IMPLANT CENTER. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Satelec - Acteon Group (Mt. Laurel, US). The FDA issued a Cleared decision on November 19, 2007 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Satelec - Acteon Group devices

FDA 510(k) Submission Details - K072030

510(k) Number K072030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2007
Decision Date November 19, 2007
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 30
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K072030.
STRAUMANN GUIDED INSTRUMENTS
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EMS PIEZON MASTER SURGERY
K072146 · E.M.S Electro Medical Systems S.A · Dec 2007
PIEZOTOME
K060274 · Satelec · May 2006
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
K060270 · Linvatec Corp. · Apr 2006
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · Linvatec Corp. · Nov 2003