Cleared Traditional

PrimeTaper EV Dental Implant

K210610 · Dentsply Sirona, Inc. · Dental
Aug 2021
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K210610 is an FDA 510(k) clearance for the PrimeTaper EV Dental Implant, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on August 27, 2021, 179 days after receiving the submission on March 1, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K210610 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2021
Decision Date August 27, 2021
Days to Decision 179 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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