Cleared Abbreviated

K080308 - BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD

K080308 is an FDA 510(k) clearance for BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE..., manufactured by Bioscaffold International Pte, Ltd.. The device is a Class 2 Dental device with product code LYC cleared through the Abbreviated 510(k) pathway after a 69-day FDA review.

K080308 · Bioscaffold International Pte, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
69d
Days
Class 2
Risk

K080308 is an FDA 510(k) clearance for the BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Bioscaffold International Pte, Ltd. (Rome, IT). The FDA issued a Cleared decision on April 14, 2008 after a review of 69 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080308

510(k) Number K080308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2008
Decision Date April 14, 2008
Days to Decision 69 days
Submission Type Abbreviated
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
59d faster than avg
Panel avg: 128d · This submission: 69d
Pathway characteristics
Standards-based clearance path.

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 230
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K080308.
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K073571 · Baxter Healthcare Corporation · Apr 2008
SYNOSS SYNTHETIC BONE GRAFT MATERIAL
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K080308 · BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
Download PDF FDA Summary Bioscaffold Internati…