Cleared Traditional

K951582 - ULTRADENT PORCELAIN ETCH (FDA 510(k) Clearance)

K951582 · Ultradent Products, Inc. · Dental device

May 1995

Decision

34d

Days

Class 2

Risk

K951582 is an FDA 510(k) clearance for the ULTRADENT PORCELAIN ETCH. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 10, 1995, 34 days after receiving the submission on April 6, 1995.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K951582 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 1995
Decision Date	May 10, 1995
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement