Cleared Traditional

SMARTbase Abutment System

K223535 · Implant Direct Sybron Manufacturing, LLC · Dental

Jun 2023

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K223535 is an FDA 510(k) clearance for the SMARTbase Abutment System, 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 June 20, 2023, 209 days after receiving the submission on November 23, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K223535 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2022
Decision Date	June 20, 2023
Days to Decision	209 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.