Cleared Traditional

K010070 - ULTRAPAK NEHA (FDA 510(k) Clearance)

K010070 · Ultradent Products, Inc. · Dental device
Mar 2001
Decision
66d
Days
—
Risk

K010070 is an FDA 510(k) clearance for the ULTRAPAK NEHA. This device is classified as a Cord, Retraction.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 15, 2001, 66 days after receiving the submission on January 8, 2001.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K010070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date March 15, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MVL — Cord, Retraction
Device Class —