Cleared Abbreviated

K121873 - AVINENT DENTAL IMPLANT SYSTEM

K121873 is an FDA 510(k) clearance for AVINENT DENTAL IMPLANT SYSTEM, manufactured by Avinent Implant System S.L.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 532-day FDA review.

K121873 · Avinent Implant System S.L. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
532d
Days
Class 2
Risk

K121873 is an FDA 510(k) clearance for the AVINENT DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Avinent Implant System S.L. (Santpedor, ES). The FDA issued a Cleared decision on December 11, 2013 after a review of 532 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: High-complexity regulatory submission. Standards-verified equivalence. 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 - K121873

510(k) Number K121873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2012
Decision Date December 11, 2013
Days to Decision 532 days
Submission Type Abbreviated
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
404d slower than avg
Panel avg: 128d · This submission: 532d
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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K121873.
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
K130572 · Implant Direct Sybron Manufacturing, LLC · Dec 2013
TI STAR IMPLANT SYSTEM
K132992 · T-Plus Implant Tech. Co., Ltd. · Dec 2013
AIDI DENTAL IMPLANT SYSTEM
K123861 · Aidi Biomedical, LLC · Dec 2013
INNO SLA SUBMERGED IMPLANT SYSTEM
K132242 · Cowellmedi Co., Ltd. · Dec 2013
UD IMPLANT SYSTEM
K131682 · Medimecca Co., Ltd. · Dec 2013
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013
K121873 · AVINENT DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Avinent Implant Syste…