Cleared Traditional

SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

K011032 · Harvest Technologies, Corp. · Dental
Jul 2001
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K011032 is an FDA 510(k) clearance for the SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Harvest Technologies, Corp. (Plymouth, US). The FDA issued a Cleared decision on July 3, 2001, 89 days after receiving the submission on April 5, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K011032 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2001
Decision Date July 03, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LYC — Bone Grafting Material, Synthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.