Cleared Traditional

VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS

K090976 · Whip-Mix Corp. · Dental

Jun 2009

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K090976 is an FDA 510(k) clearance for the VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Whip-Mix Corp. (Alexandria, US). The FDA issued a Cleared decision on June 25, 2009, 80 days after receiving the submission on April 6, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K090976 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2009
Decision Date	June 25, 2009
Days to Decision	80 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.