Cleared Traditional

Legacy SMARTBase Abutments

K191458 · Implant Direct Sybron Manufacturing, LLC · Dental

Oct 2019

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K191458 is an FDA 510(k) clearance for the Legacy SMARTBase Abutments, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on October 10, 2019, 132 days after receiving the submission on May 31, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K191458 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2019
Decision Date	October 10, 2019
Days to Decision	132 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.