Cleared Traditional

K020115 - PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
(FDA 510(k) Clearance)

K020115 · Pulpdent Corp. · Dental

Feb 2002

Decision

48d

Days

Class 2

Risk

K020115 is an FDA 510(k) clearance for the PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM, 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 February 28, 2002, 48 days after receiving the submission on January 11, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number	K020115 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 2002
Decision Date	February 28, 2002
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF