Cleared Traditional

CreoDent Solidex Customized Abutment and Screw (K202095) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202095 · Creodent Prosthetics, Ltd. · Dental device
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Dec 2020
Decision
140d
Days
Class 2
Risk

K202095 is an FDA 510(k) clearance for the CreoDent Solidex Customized Abutment and Screw. 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 December 16, 2020 after a review of 140 days - within the typical 510(k) review window.

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 Creodent Prosthetics, Ltd. devices

Submission Details

510(k) Number K202095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2020
Decision Date December 16, 2020
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
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 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K202095.
Straumann TLX Novaloc and Cementable Abutments
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K202282 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jan 2021
Blue Sky Bio CAD-CAM Abutments
K202026 · Blue Sky Bio, LLC · Dec 2020
CARES Screw - Retained Bars and Bridges (SRBB)
K201711 · Medentika GmbH · Dec 2020
Magic UCLA Abutment System
K202418 · Innobiosurg Co., Ltd. · Dec 2020
NobelProcera Zirconia Implant Bridge
K202452 · Nobel Biocare AB · Dec 2020