Cleared Abbreviated

els extra low shrinkage? composite & els extra low shrinkage? flow

K240823 · Saremco Dental AG · Dental

Jun 2024

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K240823 is an FDA 510(k) clearance for the els extra low shrinkage? composite & els extra low shrinkage? flow, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Saremco Dental AG (Rebstein, CH). The FDA issued a Cleared decision on June 27, 2024, 93 days after receiving the submission on March 26, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K240823 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2024
Decision Date	June 27, 2024
Days to Decision	93 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF