Cleared Traditional

K113738 - CREODENT SOLIDEX CUSTOM ABUTMENT

K113738 is an FDA 510(k) clearance for CREODENT SOLIDEX CUSTOM ABUTMENT, manufactured by Creodent Prosthetics, Ltd.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 637-day FDA review.

K113738 · Creodent Prosthetics, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
637d
Days
Class 2
Risk

K113738 is an FDA 510(k) clearance for the CREODENT SOLIDEX CUSTOM 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 Creodent Prosthetics, Ltd. (New York, US). The FDA issued a Cleared decision on September 17, 2013 after a review of 637 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Creodent Prosthetics, Ltd. devices

FDA 510(k) Submission Details - K113738

510(k) Number K113738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2011
Decision Date September 17, 2013
Days to Decision 637 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
509d slower than avg
Panel avg: 128d · This submission: 637d
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 712
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K113738.
IPS E.MAX CAD ABUTMENT SOLUTIONS
K132209 · Ivoclar Vivadent, AG · Oct 2013
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
K122295 · Core 3D Protech, S.L. · Oct 2013
SFI-BAR
K131526 · Cendres & Metaux SA · Sep 2013
ITERO SOFTWARE
K131101 · Cadent, Ltd. an Align Technology Company · Aug 2013
KLOCKNER DENTAL IMPLANT ABUTMENTS
K122988 · SOADCO, S.L. · Jul 2013
SFI BAR ABUTMENTS
K130183 · Sterngold Dental, LLC · Jul 2013