Cleared Traditional

SMARTBOND

K981036 · Gac Intl., Inc. · Dental
Apr 1999
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K981036 is an FDA 510(k) clearance for the SMARTBOND, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on April 5, 1999, 382 days after receiving the submission on March 19, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K981036 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1998
Decision Date April 05, 1999
Days to Decision 382 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

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