Cleared Special

STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026

K053643 · Lifecore Biomedical, Inc. · Dental

Jan 2006

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K053643 is an FDA 510(k) clearance for the STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on January 23, 2006, 24 days after receiving the submission on December 30, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K053643 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2005
Decision Date	January 23, 2006
Days to Decision	24 days
Submission Type	Special
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.