Cleared Traditional

Custom Legacy and Custom InterActive Titanium Abutments

K192218 · Implant Direct Sybron Manufacturing, LLC · Dental

May 2020

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K192218 is an FDA 510(k) clearance for the Custom Legacy and Custom InterActive Titanium 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 May 8, 2020, 267 days after receiving the submission on August 15, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K192218 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2019
Decision Date	May 08, 2020
Days to Decision	267 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.