Cleared Traditional

K072030 - IMPLANT CENTER (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 47
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K072030.
VarioSurg 4
K254163 · Nakanishi, Inc. · Dec 2025
MT-Bone
K242432 · Mectron S.P.A. · Aug 2024
Surgical Drive System (Model: ES70, ES90, E8)
K240340 · Guangdong Jinme Medical Technology Co., Ltd. · Jul 2024
Guided Surgery Kit
K231087 · Implant Direct Sybron Manufacturing, LLC · Aug 2023
TRAUS SUS20
K192561 · Saeshin Precision Co., Ltd. · Jul 2020
Surgical Drills
K200265 · Implant Direct Sybron Manufacturing, LLC · Jun 2020