Cleared Traditional

K011032 - SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

K011032 is an FDA 510(k) clearance for SMARTJET BONE GRAFT LIQUID APPLICATOR (..., manufactured by Harvest Technologies, Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K011032 · Harvest Technologies, Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
89d
Days
Class 2
Risk

K011032 is an FDA 510(k) clearance for the SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE .... Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Harvest Technologies, Corp. (Plymouth, US). The FDA issued a Cleared decision on July 3, 2001 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Harvest Technologies, Corp. devices

FDA 510(k) Submission Details - K011032

510(k) Number K011032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYC Device Classification - Class 2, Special Controls

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LYC Bone Grafting Material, Synthetic

All 152
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K011032.
ORTHOSS RESORBABLE BONE VOID FILLER
K014289 · Geistlich-Pharma · Mar 2002
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346 · W.L. Gore & Associates, Inc. · Dec 2001
3I CALCIUM SULFATE BONE CEMENT
K012047 · Implant Innovations, Inc. · Sep 2001
BIOCELLECT
K010775 · Imtec Corp. · Jun 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · Medtronic Sofamor Danek USA, Inc. · Jun 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · Biomet, Inc. · Apr 2001