Cleared Special

LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM

K083324 · Zest Anchors, Inc. · Dental

Feb 2009

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K083324 is an FDA 510(k) clearance for the LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Zest Anchors, Inc. (Escondido, US). The FDA issued a Cleared decision on February 25, 2009, 105 days after receiving the submission on November 12, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K083324 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2008
Decision Date	February 25, 2009
Days to Decision	105 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Statement

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.