Cleared Traditional

Conometric Abutments

K183079 · Dentsply Sirona, Inc. · Dental

Jul 2019

Decision

247d

Days

Class 2

Risk

About This 510(k) Submission

K183079 is an FDA 510(k) clearance for the Conometric Abutments, 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 July 10, 2019, 247 days after receiving the submission on November 5, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K183079 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2018
Decision Date	July 10, 2019
Days to Decision	247 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.