Cleared Traditional

CEREC Tessera Abutment Block, CEREC Tessera Abutment System

K221402 · Dentsply Sirona, Inc. · Dental

Mar 2023

Decision

310d

Days

Class 2

Risk

About This 510(k) Submission

K221402 is an FDA 510(k) clearance for the CEREC Tessera Abutment Block, CEREC Tessera Abutment System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on March 22, 2023, 310 days after receiving the submission on May 16, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K221402 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2022
Decision Date	March 22, 2023
Days to Decision	310 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — 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.