Cleared Traditional

K013970 - PRIME-DENT HEMA DESENSITIZER
(FDA 510(k) Clearance)

K013970 · Prime Dental Manufacturing, Inc. · Dental
Feb 2002
Decision
78d
Days
Class 2
Risk

K013970 is an FDA 510(k) clearance for the PRIME-DENT HEMA DESENSITIZER, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on February 19, 2002, 78 days after receiving the submission on December 3, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K013970 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2001
Decision Date February 19, 2002
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690