Cleared Traditional

K152559 - TruAbutment DS

K152559 is an FDA 510(k) clearance for TruAbutment DS, manufactured by Truabutment. 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.

K152559 · Truabutment · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
254d
Days
Class 2
Risk

K152559 is an FDA 510(k) clearance for the TruAbutment DS. 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 Truabutment (Anaheim, US). The FDA issued a Cleared decision on May 20, 2016 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 - K152559

510(k) Number K152559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2015
Decision Date May 20, 2016
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 Consultant

Withus Group, Inc.
APRIL LEE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K152559.
VITA ENAMIC Implant Solutions (IS)
K153645 · Vita Zahnfabrik H.Rauter GmbH & Co. · Jun 2016
NobelDesign Software
K153036 · Nobel Biocare AB · Jun 2016
VARIOunite
K160244 · Thommen Medical AG · Jun 2016
Neodent Implant System
K153624 · Jjgc Industria E Comercio DE Materiais Dentarios S · Apr 2016
4plus6Line Abutment System
K151608 · Ot Medical GmbH · Apr 2016
Abutment for Bridges
K153779 · Altatec GmbH · Mar 2016