Cleared Traditional

DTX Studio design

K181932 · Nobel Biocare AB · Dental
Mar 2019
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K181932 is an FDA 510(k) clearance for the DTX Studio design, a Dental Abutment Design Software For Dental Laboratory (Class II — Special Controls, product code PNP), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on March 1, 2019, 225 days after receiving the submission on July 19, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number K181932 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2018
Decision Date March 01, 2019
Days to Decision 225 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PNP — Dental Abutment Design Software For Dental Laboratory
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3630
Definition The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And Cam Or Create That Component At A Dental Office Or Dental Laboratory Following The Directions Of The Dental Implant System. The Abutment-to-implant Interface/connection Platform Is Not A Patient-specific Component Of The Dental Abutment.