Cleared Special

MODIFICATION TO: LOCATOR IMPLANT ANCHOR

K072878 · Zest Anchors, Inc. · Dental

Dec 2007

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K072878 is an FDA 510(k) clearance for the MODIFICATION TO: LOCATOR IMPLANT ANCHOR, 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 December 3, 2007, 55 days after receiving the submission on October 9, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K072878 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2007
Decision Date	December 03, 2007
Days to Decision	55 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.