Cleared Abbreviated

K092261 - DEFCON TSA/TSH DENTAL IMPLANT SYSTEM

K092261 is an FDA 510(k) clearance for DEFCON TSA/TSH DENTAL IMPLANT SYSTEM, manufactured by Impladent, S.L.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 360-day FDA review.

K092261 · Impladent, S.L. · Dental device
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Jul 2010
Decision
360d
Days
Class 2
Risk

K092261 is an FDA 510(k) clearance for the DEFCON TSA/TSH DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Impladent, S.L. (Sentmenat, Barcelona, ES). The FDA issued a Cleared decision on July 23, 2010 after a review of 360 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 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.

FDA 510(k) Submission Details - K092261

510(k) Number K092261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2009
Decision Date July 23, 2010
Days to Decision 360 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 128d · This submission: 360d
Pathway characteristics
Standards-based clearance path.

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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K092261.
STAR/VENT INTERNAL HEX SCREW IMPLANT
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NEODENT IMPLANT SYSTEM
K101207 · Jjgc Industria E Comercio DE Materiais Dentarios S · Aug 2010
VARIOUS DENTAL IMPLANTS
K100411 · Grundy Advanced Biomedical Systems, LLC · Jul 2010
SARGON NON-EXPANDABLE DENTAL IMPLANT
K082573 · Sargon Ent., Inc. · Jul 2010
COTEC DENTAL IMPLANT SYSTEM
K100511 · Cotec Implant Co., Ltd. · Jul 2010
AEDIS(TM)
K100902 · Embed Technology, LLC · Jun 2010
K092261 · DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
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