Cleared Traditional

K141970 - DIGITEK TITANIUM ABUTMENT

K141970 is an FDA 510(k) clearance for DIGITEK TITANIUM ABUTMENT, manufactured by Digitek Dental Solutions Limited. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K141970 · Digitek Dental Solutions Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
375d
Days
Class 2
Risk

K141970 is an FDA 510(k) clearance for the DIGITEK TITANIUM 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 Digitek Dental Solutions Limited (Kowloon, Hong Kong, CN). The FDA issued a Cleared decision on July 31, 2015 after a review of 375 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 Digitek Dental Solutions Limited devices

FDA 510(k) Submission Details - K141970

510(k) Number K141970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2014
Decision Date July 31, 2015
Days to Decision 375 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 127d · This submission: 375d
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 559
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K141970.
Straumann Screw-Retained Abutment
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K151247 · Straumann USA, LLC · Aug 2015
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K151157 · Straumann USA, LLC · Aug 2015
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
K143505 · Zimmer Dental, Inc. · Jun 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528 · Zimmer Dental, Inc. · May 2015
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
K142572 · Zimmer Dental, Inc. · Jan 2015