Cleared Traditional

K033098 - OSTEOGEN SBRG

K033098 is the FDA 510(k) clearance for OSTEOGEN SBRG by Impladent , Ltd.. It is a Class 2 Dental device (product code LYC) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K033098 · Impladent , Ltd. · Dental device
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Apr 2004
Decision
211d
Days
Class 2
Risk

K033098 is an FDA 510(k) clearance for the OSTEOGEN SBRG. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Impladent , Ltd. (Hollis, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Impladent , Ltd. devices

Submission Details

510(k) Number K033098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date April 27, 2004
Days to Decision 211 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 127d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K033098.
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · Synthes (Usa) · Jan 2006
CALC-I-OSS
K042583 · Ultradent Products, Inc. · Jul 2005
OSTIM
K030052 · Heraeus Kulzer, Inc. · Dec 2004
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346 · W.L. Gore & Associates, Inc. · Dec 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