Cleared Traditional

K141177 - VITALA PORCINE DERIVED COLLAGEN MEMBRANE

K141177 is an FDA 510(k) clearance for VITALA PORCINE DERIVED COLLAGEN MEMBRANE, manufactured by Osteogenics Biomedical, Inc. (Formerly Obi Biologi. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 496-day FDA review.

K141177 · Osteogenics Biomedical, Inc. (Formerly Obi Biologi · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
496d
Days
Class 2
Risk

K141177 is an FDA 510(k) clearance for the VITALA PORCINE DERIVED COLLAGEN MEMBRANE. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Osteogenics Biomedical, Inc. (Formerly Obi Biologi (Lubbock, US). The FDA issued a Cleared decision on September 15, 2015 after a review of 496 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K141177

510(k) Number K141177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2014
Decision Date September 15, 2015
Days to Decision 496 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
368d slower than avg
Panel avg: 128d · This submission: 496d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPL Device Classification - Class 2, Special Controls

Product Code NPL Barrier, Animal Source, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.
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 - NPL Barrier, Animal Source, Intraoral

All 56
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K141177.
OSSIX VOLUMAX
K153549 · Datum Dental, Ltd. · Aug 2016
OSSIX PLUS
K160281 · Datum Dental, Ltd. · Aug 2016
DSM Biomedical Porcine Pericardium Dental Membrane
K160474 · Kensey Nash Corporation Dba Dsm Biomedical · Jun 2016
Collagen Dental Membrane - Conformable IIBP
K142496 · Collagen Matrix, Inc. · Nov 2014
GUIDOSS
K133507 · Nibec Co., Ltd. · Nov 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
K141909 · Collagen Matrix, Inc. · Nov 2014
K141177 · VITALA PORCINE DERIVED COLLAGEN MEMBRANE
Download PDF FDA Summary Osteogenics Biomedica…