Cleared Traditional

K851722 - 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS
(FDA 510(k) Clearance)

K851722 · Artiberia · Dental
Jul 1985
Decision
68d
Days
Class 1
Risk

K851722 is an FDA 510(k) clearance for the 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS. This device is classified as a Excavator, Dental, Operative (Class I — General Controls, product code EKC).

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 K851722 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 EKC — Excavator, Dental, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565