Cleared Traditional

K093630 - BIODENTA DENTAL IMPLANT SYSTEM

K093630 is an FDA 510(k) clearance for BIODENTA DENTAL IMPLANT SYSTEM, 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 192-day FDA review.

K093630 · Biodenta Swiss AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
192d
Days
Class 2
Risk

K093630 is an FDA 510(k) clearance for the BIODENTA DENTAL IMPLANT SYSTEM. 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 3, 2010 after a review of 192 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.

FDA 510(k) Submission Details - K093630

510(k) Number K093630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date June 03, 2010
Days to Decision 192 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
64d slower than avg
Panel avg: 128d · This submission: 192d
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 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K093630.
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
ZIT-Z
K092507 · Ziterion · May 2010
M
K092542 · Mediscitec, Inc. · Apr 2010
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · Hiossen, Inc. · Apr 2010