Cleared Traditional

K082200 - KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM

K082200 is an FDA 510(k) clearance for KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, manufactured by SOADCO, S.L.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K082200 · SOADCO, S.L. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2008
Decision
113d
Days
Class 2
Risk

K082200 is an FDA 510(k) clearance for the KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by SOADCO, S.L. (Escaldes-Engordany, AD). The FDA issued a Cleared decision on November 25, 2008 after a review of 113 days - within the typical 510(k) review window.

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. 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 SOADCO, S.L. devices

FDA 510(k) Submission Details - K082200

510(k) Number K082200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2008
Decision Date November 25, 2008
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K082200.
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