Cleared Traditional

K113779 - CONELOG IMPLANT SYSTEM

K113779 is the FDA 510(k) clearance for CONELOG IMPLANT SYSTEM by Altatec GmbH. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K113779 · Altatec GmbH · Dental device
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Dec 2012
Decision
358d
Days
Class 2
Risk

K113779 is an FDA 510(k) clearance for the CONELOG IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Altatec GmbH (San Diego, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 358 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Altatec GmbH devices

Submission Details

510(k) Number K113779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date December 14, 2012
Days to Decision 358 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
231d slower than avg
Panel avg: 127d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 589
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K113779.
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · Prismatik Dentalcraft, Inc. · Feb 2013
TS IMPLANT SYSTEM
K121585 · Osstem Implant Co., Ltd. · Jan 2013
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
K122855 · Straumann USA · Dec 2012
TS FIXTURE SYSTEM
K121995 · Osstem Implant Co., Ltd. · Nov 2012
MS SA IMPLANT SYSTEM
K122171 · Osstem Implant Co., Ltd. · Nov 2012