Cleared Traditional

K101453 - VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE

K101453 is an FDA 510(k) clearance for VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE, manufactured by Obi Biologics, Inc.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K101453 · Obi Biologics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
422d
Days
Class 2
Risk

K101453 is an FDA 510(k) clearance for the VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Obi Biologics, Inc. (Lubbock, US). The FDA issued a Cleared decision on July 21, 2011 after a review of 422 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 - K101453

510(k) Number K101453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2010
Decision Date July 21, 2011
Days to Decision 422 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
294d slower than avg
Panel avg: 128d · This submission: 422d
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 K101453.
COLLADENTAL BARRIER
K100695 · Collamatrix, Inc. · Jan 2013
COVAMAX RESORBABLE COLLAGEN MEMBRANE
K103087 · Biom'Up Sas · Aug 2011
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600 · Collagen Matrix, Inc. · Jul 2011
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
K102307 · Genoss Co., Ltd. · May 2011
MUCOGRAFT
K102531 · Ed. Geistlich Soehne AG Fur Chemische Industrie · Nov 2010
COLLAGEN DENTAL MEMBRANE V
K100156 · Collagen Matrix, Inc. · Aug 2010
K101453 · VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
Download PDF FDA Summary Obi Biologics, Inc.