Cleared Traditional

K113539 - REVOIS PRO IMPLANT STSYEM

K113539 is an FDA 510(k) clearance for REVOIS PRO IMPLANT STSYEM, manufactured by Riemser Arzneimittel AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 520-day FDA review.

K113539 · Riemser Arzneimittel AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
520d
Days
Class 2
Risk

K113539 is an FDA 510(k) clearance for the REVOIS PRO IMPLANT STSYEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Riemser Arzneimittel AG (Greifswald-Insel Riems, DE). The FDA issued a Cleared decision on May 3, 2013 after a review of 520 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

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 - K113539

510(k) Number K113539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date May 03, 2013
Days to Decision 520 days
Submission Type Traditional
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
392d slower than avg
Panel avg: 128d · This submission: 520d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K113539.
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
K122519 · Dio Corporation · May 2013
ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
K122804 · Intai Technology Corp. · May 2013
NEODENT IMPLANT SYSTEM
K123022 · Jjgc Industria E Comercio DE Materiais Dentarios S · May 2013
ZUGA DENTAL IMPLANT SYSTEM
K122664 · Zuga Medical, Inc. · Apr 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K130222 · Straumann USA, LLC · Apr 2013
PERIOTYPE X-PERT
K123386 · Clinical House Europe GmbH · Apr 2013
K113539 · REVOIS PRO IMPLANT STSYEM
Download PDF FDA Summary Riemser Arzneimittel …