Cleared Traditional

ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE

K132214 · Hager& Meisinger GmbH · Dental

Jul 2014

Decision

356d

Days

Class 2

Risk

About This 510(k) Submission

K132214 is an FDA 510(k) clearance for the ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on July 7, 2014, 356 days after receiving the submission on July 16, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K132214 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2013
Decision Date	July 07, 2014
Days to Decision	356 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.