Cleared Traditional

K151375 - Inclusive Titanium Abutments compatible with: Hiossen HG Implant System

K151375 is an FDA 510(k) clearance for Inclusive Titanium Abutments compatible..., manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K151375 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
138d
Days
Class 2
Risk

K151375 is an FDA 510(k) clearance for the Inclusive Titanium Abutments compatible with: Hiossen HG Implant System. 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 Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on October 7, 2015 after a review of 138 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.

FDA 510(k) Submission Details - K151375

510(k) Number K151375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2015
Decision Date October 07, 2015
Days to Decision 138 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
10d slower than avg
Panel avg: 128d · This submission: 138d
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 K151375.
Medentika CAD/CAM Abutments
K150203 · Medentika GmbH · Oct 2015
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
K150669 · Neoss, Ltd. · Oct 2015
OsteoReady ZircoSeal Abutments
K151169 · Osteoready, LLC · Oct 2015
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
K143515 · Prismatik Dentalcraft, Inc. · Oct 2015
Telio CAD Abutment Solutions
K151564 · Ivoclar Vivadent, AG · Sep 2015
ArgenIS Titanium Abutments
K143051 · The Argen Corporation · Sep 2015
K151375 · Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
Download PDF FDA Summary Prismatik Dentalcraft…