Cleared Traditional

K981596 - ULTRAPAK E (FDA 510(k) Clearance)

K981596 · Ultradent Products, Inc. · Dental device
Jul 1998
Decision
88d
Days
—
Risk

K981596 is an FDA 510(k) clearance for the ULTRAPAK E. This device is classified as a Cord, Retraction.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 31, 1998, 88 days after receiving the submission on May 4, 1998.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K981596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date July 31, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MVL — Cord, Retraction
Device Class —