Cleared Traditional

FORMA Composite (Shade A3D)

K240694 · Ultradent Products, Inc. · Dental
Mar 2024
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K240694 is an FDA 510(k) clearance for the FORMA Composite (Shade A3D), a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 15, 2024, 1 days after receiving the submission on March 14, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K240694 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2024
Decision Date March 15, 2024
Days to Decision 1 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