Cleared Traditional

K014138 - PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
(FDA 510(k) Clearance)

K014138 · Pulpdent Corp. · Dental

Mar 2002

Decision

87d

Days

Class 2

Risk

K014138 is an FDA 510(k) clearance for the PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on March 14, 2002, 87 days after receiving the submission on December 17, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number	K014138 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2001
Decision Date	March 14, 2002
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF