Cleared Traditional

K011403 - SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE

K011403 is an FDA 510(k) clearance for SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE, manufactured by Orthogen Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K011403 · Orthogen Corp. · Dental device
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Sep 2001
Decision
127d
Days
Class 2
Risk

K011403 is an FDA 510(k) clearance for the SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Orthogen Corp. (Stillwater, US). The FDA issued a Cleared decision on September 11, 2001 after a review of 127 days - within the typical 510(k) review window.

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 Orthogen Corp. devices

FDA 510(k) Submission Details - K011403

510(k) Number K011403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date September 11, 2001
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
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 146
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K011403.
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