Cleared Traditional

FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS

K072730 · Dentsply Intl. · Dental

Mar 2008

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K072730 is an FDA 510(k) clearance for the FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 27, 2008, 183 days after receiving the submission on September 26, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K072730 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2007
Decision Date	March 27, 2008
Days to Decision	183 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.