Cleared Traditional

K994302 - RESIN TOOTH BONDING AGENT (FDA 510(k) Clearance)

K994302 · Parkell, Inc. · Dental device

Feb 2000

Decision

48d

Days

Class 2

Risk

K994302 is an FDA 510(k) clearance for the RESIN TOOTH BONDING AGENT. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on February 7, 2000, 48 days after receiving the submission on December 21, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K994302 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 1999
Decision Date	February 07, 2000
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF