Cleared Traditional

MIS Ti-base abutment (K211225) - FDA 510(k) Clearance

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

K211225 · Dentsply Sirona · Dental device
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Jul 2021
Decision
96d
Days
Class 2
Risk

K211225 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 28, 2021 after a review of 96 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 Dentsply Sirona devices

Submission Details

510(k) Number K211225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date July 28, 2021
Days to Decision 96 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
31d faster than avg
Panel avg: 127d · This submission: 96d
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 K211225.
Kisses Plus Implant System
K200193 · Achimhai Medical Corporation · Aug 2021
DESS Dental Smart Solutions
K203464 · Terrats Medical SL · Aug 2021
Neodent Implant System - Mini Abutment 60°
K203542 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Aug 2021
IS Multi Unit Abutment System
K210903 · Neobiotech Co., Ltd. · Jul 2021
TruAbutment DS, TruBase
K202579 · Truabutment, Inc. · Jul 2021
Straumann CARES M-Series CAD/CAM System
K203456 · Institut Straumann AG · Jun 2021