Cleared Traditional

K990381 - TOTALBOND (FDA 510(k) Clearance)

K990381 · Parkell, Inc. · Dental device

May 1999

Decision

98d

Days

Class 2

Risk

K990381 is an FDA 510(k) clearance for the TOTALBOND. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 17, 1999, 98 days after receiving the submission on February 8, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K990381 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 08, 1999
Decision Date	May 17, 1999
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF