Cleared Traditional

K993932 - SOLITAIRE 2
(FDA 510(k) Clearance)

K993932 · Heraeus Kulzer, Inc. · Dental
Dec 1999
Decision
34d
Days
Class 2
Risk

K993932 is an FDA 510(k) clearance for the SOLITAIRE 2, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 22, 1999, 34 days after receiving the submission on November 18, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K993932 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1999
Decision Date December 22, 1999
Days to Decision 34 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