Cleared Traditional

K971899 - ENDO-SEAL (FDA 510(k) Clearance)

K971899 · Ultradent Products, Inc. · Dental device

Jun 1997

Decision

35d

Days

Class 2

Risk

K971899 is an FDA 510(k) clearance for the ENDO-SEAL. 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 June 26, 1997, 35 days after receiving the submission on May 22, 1997.

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

Submission Details

510(k) Number	K971899 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 22, 1997
Decision Date	June 26, 1997
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement