Cleared Traditional

TEMPFIL

K013895 · Sybron Dental Specialties, Inc. · Dental
Feb 2002
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K013895 is an FDA 510(k) clearance for the TEMPFIL, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on February 4, 2002, 73 days after receiving the submission on November 23, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K013895 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2001
Decision Date February 04, 2002
Days to Decision 73 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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