Cleared Abbreviated

K151194 - KLOCKNER DENTAL IMPLANT ABUTMENTS (II)

K151194 is an FDA 510(k) clearance for KLOCKNER DENTAL IMPLANT ABUTMENTS (II), manufactured by SOADCO, S.L.. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 270-day FDA review.

K151194 · SOADCO, S.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
270d
Days
Class 2
Risk

K151194 is an FDA 510(k) clearance for the KLOCKNER DENTAL IMPLANT ABUTMENTS (II). Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by SOADCO, S.L. (Escaldes-Engordany, AD). The FDA issued a Cleared decision on January 29, 2016 after a review of 270 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all SOADCO, S.L. devices

FDA 510(k) Submission Details - K151194

510(k) Number K151194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2015
Decision Date January 29, 2016
Days to Decision 270 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 127d · This submission: 270d
Pathway characteristics
Standards-based clearance path.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 534
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K151194.
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