Cleared Traditional

K101827 - OSTEOSCAF

K101827 is an FDA 510(k) clearance for OSTEOSCAF, manufactured by Texas Innovative Medical Devices (Dba) Skeletal. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K101827 · Texas Innovative Medical Devices (Dba) Skeletal · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
293d
Days
Class 2
Risk

K101827 is an FDA 510(k) clearance for the OSTEOSCAF. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Texas Innovative Medical Devices (Dba) Skeletal (San Antonio, US). The FDA issued a Cleared decision on April 20, 2011 after a review of 293 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.

FDA 510(k) Submission Details - K101827

510(k) Number K101827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date April 20, 2011
Days to Decision 293 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 128d · This submission: 293d
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 208
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K101827.
REPROBONE DENTAL GRAFTING MATERIAL
K103820 · Ceramisys, Ltd. · Nov 2011
ENDOBON XENOGRAFT GRANULES
K110449 · Biomet 3i · May 2011
NANOGEN
K102208 · Orthogen, LLC · May 2011
CERACELL DENTAL
K103709 · Curasan AG · Mar 2011
OSBONE DENTAL
K102872 · Curasan AG · Jan 2011
CARRIGEN
K100883 · Etex Corp. · Dec 2010
K101827 · OSTEOSCAF
Download PDF FDA Summary Texas Innovative Medi…