Cleared Traditional

K833725 - PRE-LOADED C-R TUBES FOR SYRINGE (FDA 510(k) Clearance)

K833725 · Centrix, Inc. · Dental device

Mar 1984

Decision

158d

Days

Class 2

Risk

K833725 is an FDA 510(k) clearance for the PRE-LOADED C-R TUBES FOR SYRINGE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Centrix, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984, 158 days after receiving the submission on October 24, 1983.

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

Submission Details

510(k) Number	K833725 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 24, 1983
Decision Date	March 30, 1984
Days to Decision	158 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—