Cleared Traditional

IMPLANTMED SI-915 (115V VERSION) (K052741) - FDA 510(k) Clearance

Also marketed or referenced as:
IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES

Class I Dental device.

K052741 · W&H Dentalwerk Buermoos GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
105d
Days
Class 1
Risk

K052741 is an FDA 510(k) clearance for the IMPLANTMED SI-915 (115V VERSION). Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on January 13, 2006 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 W&H Dentalwerk Buermoos GmbH devices

Submission Details

510(k) Number K052741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2005
Decision Date January 13, 2006
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.