Cleared Traditional

K071278 - EMBRACE DUAL CURE COMPOSITE MATERIALS
(FDA 510(k) Clearance)

K071278 · Pulpdent Corporation · Dental
Jun 2007
Decision
53d
Days
Class 2
Risk

K071278 is an FDA 510(k) clearance for the EMBRACE DUAL CURE COMPOSITE MATERIALS. This device is classified as a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF).

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on June 29, 2007, 53 days after receiving the submission on May 7, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K071278 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2007
Decision Date June 29, 2007
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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