Cleared Traditional

K992097 - ENDOREZ (FDA 510(k) Clearance)

K992097 · Ultradent Products, Inc. · Dental device

Oct 1999

Decision

127d

Days

Class 2

Risk

K992097 is an FDA 510(k) clearance for the ENDOREZ. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 26, 1999, 127 days after receiving the submission on June 21, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number	K992097 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 21, 1999
Decision Date	October 26, 1999
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement