Cleared Traditional

K122559 - BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS

K122559 is an FDA 510(k) clearance for BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS, 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 254-day FDA review.

K122559 · Biodenta Swiss AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
254d
Days
Class 2
Risk

K122559 is an FDA 510(k) clearance for the BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS. 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 3, 2013 after a review of 254 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.

FDA 510(k) Submission Details - K122559

510(k) Number K122559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date May 03, 2013
Days to Decision 254 days
Submission Type Traditional
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
126d slower than avg
Panel avg: 128d · This submission: 254d
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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K122559.
CERTAIN BELLATEK PROVISIONAL ABUTMENTS
K130310 · Biomet 3i · Jun 2013
NOBELPROCERA PEEK ABUTMENTS
K120954 · Nobel Biocare AB · Jun 2013
BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT
K123491 · Biodenta Swiss AG · May 2013
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
K130216 · Dentsply Implant · May 2013
MULTI ANGLED ABUTMENT
K123755 · Osstem Implant Co., Ltd. · Apr 2013
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE
K124008 · Ivoclar Vivadent, Agin · Mar 2013