Cleared Traditional

K122424 - ISUS IMPLANT SUPRASTRUCTURES

K122424 is the FDA 510(k) clearance for ISUS IMPLANT SUPRASTRUCTURES by Dentsply International, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K122424 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
330d
Days
Class 2
Risk

K122424 is an FDA 510(k) clearance for the ISUS IMPLANT SUPRASTRUCTURES. 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 Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on July 5, 2013 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dentsply International, Inc. devices

Submission Details

510(k) Number K122424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2012
Decision Date July 05, 2013
Days to Decision 330 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
203d slower than avg
Panel avg: 127d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K122424.
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
K133377 · Nobel Biocare AB · Apr 2014
ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
K131644 · Dentsply International, Inc. · Jan 2014
ET PROSTHETIC SYSTEM
K130662 · Osstem Implant Co., Ltd. · Jan 2014
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
K130808 · Straumann USA · Jun 2013
NOBELPROCERA PEEK ABUTMENTS
K120954 · Nobel Biocare AB · Jun 2013
MULTI ANGLED ABUTMENT
K123755 · Osstem Implant Co., Ltd. · Apr 2013