Cleared Traditional

K123491 - BIODENTA DENTAL IMPLANT SYSTEM - MULTI-...

K123491 is an FDA 510(k) clearance for BIODENTA DENTAL IMPLANT SYSTEM - MULTI-..., manufactured by Biodenta Swiss AG. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K123491 · Biodenta Swiss AG · Dental device
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May 2013
Decision
198d
Days
Class 2
Risk

K123491 is an FDA 510(k) clearance for the BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT. 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 Biodenta Swiss AG (Berneck, St.Gallen, CH). The FDA issued a Cleared decision on May 30, 2013 after a review of 198 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 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 - K123491

510(k) Number K123491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date May 30, 2013
Days to Decision 198 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
71d slower than avg
Panel avg: 127d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 559
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