Cleared Traditional

K191152 - MIS Ti-base Abutment

K191152 is the FDA 510(k) clearance for MIS Ti-base Abutment by Dentsply Sirona. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 432-day FDA review.

K191152 · Dentsply Sirona · Dental device
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Jul 2020
Decision
432d
Days
Class 2
Risk

K191152 is an FDA 510(k) clearance for the MIS Ti-base 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 Dentsply Sirona (York, US). The FDA issued a Cleared decision on July 6, 2020 after a review of 432 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 Dentsply Sirona devices

Submission Details

510(k) Number K191152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date July 06, 2020
Days to Decision 432 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
305d slower than avg
Panel avg: 127d · This submission: 432d
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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K191152.
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K193404 · Dio Corporation · May 2020