Cleared Traditional

K133884 - BIODENTA DENTAL IMPLANT SYSTEM-BONE LEV...

K133884 is an FDA 510(k) clearance for BIODENTA DENTAL IMPLANT SYSTEM-BONE LEV..., manufactured by Biodenta Swiss AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K133884 · Biodenta Swiss AG · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2014
Decision
175d
Days
Class 2
Risk

K133884 is an FDA 510(k) clearance for the BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biodenta Swiss AG (Berneck, St.Gallen, CH). The FDA issued a Cleared decision on June 13, 2014 after a review of 175 days - an extended review cycle.

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 Biodenta Swiss AG devices

FDA 510(k) Submission Details - K133884

510(k) Number K133884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date June 13, 2014
Days to Decision 175 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
48d slower than avg
Panel avg: 127d · This submission: 175d
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 837
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133884.
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K133339 · Zimmer Dental, Inc. · Mar 2014
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013