Cleared Traditional

K851726 - 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN
(FDA 510(k) Clearance)

K851726 · Artiberia · Dental
Jul 1985
Decision
68d
Days
Class 1
Risk

K851726 is an FDA 510(k) clearance for the 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN. This device is classified as a Instrument, Filling, Plastic, Dental (Class I — General Controls, product code EIY).

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on July 2, 1985, 68 days after receiving the submission on April 25, 1985.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K851726 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1985
Decision Date July 02, 1985
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIY — Instrument, Filling, Plastic, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565