Cleared Traditional

K150295 - LOCATOR RTx
(FDA 510(k) Clearance)

K150295 · Zest Anchors, Inc. · Dental

Jul 2015

Decision

168d

Days

Class 2

Risk

K150295 is an FDA 510(k) clearance for the LOCATOR RTx, 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 July 24, 2015, 168 days after receiving the submission on February 6, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K150295 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2015
Decision Date	July 24, 2015
Days to Decision	168 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.