Cleared Traditional

K030036 - TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
(FDA 510(k) Clearance)

K030036 · Pulpdent Corporation · Dental

Mar 2003

Decision

68d

Days

Class 2

Risk

K030036 is an FDA 510(k) clearance for the TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH).

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 12, 2003, 68 days after receiving the submission on January 3, 2003.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number	K030036 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 2003
Decision Date	March 12, 2003
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF