Cleared Traditional

Custom Bars

K162633 · Implant Direct Sybron Manufacturing, LLC · Dental

Jul 2017

Decision

306d

Days

Class 2

Risk

About This 510(k) Submission

K162633 is an FDA 510(k) clearance for the Custom Bars, 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 July 24, 2017, 306 days after receiving the submission on September 21, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K162633 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2016
Decision Date	July 24, 2017
Days to Decision	306 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.