Cleared Traditional

NobelDesign, DTX Studio Design

K171466 · Nobel Biocare AB · Dental

Nov 2017

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K171466 is an FDA 510(k) clearance for the NobelDesign, DTX Studio Design, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on November 29, 2017, 195 days after receiving the submission on May 18, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K171466 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2017
Decision Date	November 29, 2017
Days to Decision	195 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.