Cleared Traditional

KAVO EVEREST C-TEMP

K063624 · Kavo America · Dental
Feb 2007
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K063624 is an FDA 510(k) clearance for the KAVO EVEREST C-TEMP, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Kavo America (Deer Field, US). The FDA issued a Cleared decision on February 8, 2007, 64 days after receiving the submission on December 6, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K063624 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2006
Decision Date February 08, 2007
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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