Cleared Traditional

IMPLANT CENTER (K072030) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 13
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K072030.
Piezosurgery White
K171326 · Mectron S.P.A. · Apr 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · Mectron S.P.A. · Jan 2018
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
STRYKER ORAL MAX SYSTEM
K954690 · Stryker Corp. · Aug 1996
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
K791326 · Sherwood Medical Co. · Oct 1979