Cleared Special

DS Implants abutments provided with the EV connection (K213449) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213449 · Dentsply Sirona · Dental device
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Nov 2021
Decision
20d
Days
Class 2
Risk

K213449 is an FDA 510(k) clearance for the DS Implants abutments provided with the EV connection. 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 November 15, 2021 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentsply Sirona devices

Submission Details

510(k) Number K213449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2021
Decision Date November 15, 2021
Days to Decision 20 days
Submission Type Special
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
107d faster than avg
Panel avg: 127d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 K213449.
DESS Dental Smart Solutions
K212577 · Terrats Medical SL · Dec 2021
Sherlock
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FAICO Dental Implant System and CAD/CAM Abutments
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Multi-unit Abutment, Multi-unit Angled Abutment
K203808 · Megagen Implant Co., Ltd. · Oct 2021
Straumann CARES P-Series CAD/CAM System
K203750 · Institut Straumann AG · Oct 2021
Dynamic TiBase
K212108 · Talladium Espa?a, SL · Sep 2021