Cleared Traditional

Zipbond

K191656 · Sdi Limited · Dental
Dec 2019
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K191656 is an FDA 510(k) clearance for the Zipbond, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on December 2, 2019, 164 days after receiving the submission on June 21, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K191656 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2019
Decision Date December 02, 2019
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200