Cleared Traditional

VERICORE IMPLANT ABUTMENTS

K082299 · Whip-Mix Corp. · Dental

Nov 2008

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K082299 is an FDA 510(k) clearance for the VERICORE IMPLANT ABUTMENTS, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Whip-Mix Corp. (Louisville, US). The FDA issued a Cleared decision on November 20, 2008, 100 days after receiving the submission on August 12, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K082299 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2008
Decision Date	November 20, 2008
Days to Decision	100 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.