Cleared Special

K113042 - REVOIS IMPLANT SYSTEM

K113042 is an FDA 510(k) clearance for REVOIS IMPLANT SYSTEM, manufactured by Riemser Arzneimittel AG. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 513-day FDA review.

K113042 · Riemser Arzneimittel AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
513d
Days
Class 2
Risk

K113042 is an FDA 510(k) clearance for the REVOIS IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Riemser Arzneimittel AG (Durham, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 513 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K113042

510(k) Number K113042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2011
Decision Date March 08, 2013
Days to Decision 513 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
385d slower than avg
Panel avg: 128d · This submission: 513d
Pathway characteristics
Modification to existing cleared device.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1510
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K113042.
HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM
K130221 · Medimecca Co., Ltd. · Mar 2013
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
K123415 · Biodenta Swiss AG · Mar 2013
BIOGENESIS IMPLANT SYSTEM
K120089 · Biogenesis Co., Ltd. · Mar 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · Prismatik Dentalcraft, Inc. · Feb 2013
T3 DENTAL IMPLANT
K122300 · Biomet 3i · Jan 2013
HERO I DENTAL IMPLANT SYSTEM
K121098 · Kj Meditech Co., Ltd. · Jan 2013
K113042 · REVOIS IMPLANT SYSTEM
Download PDF FDA Summary Riemser Arzneimittel …