Cleared Abbreviated

OSTA MAXIGRO AND REGIGRO (K091424) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K091424 · Osta Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
462d
Days
Class 2
Risk

K091424 is an FDA 510(k) clearance for the OSTA MAXIGRO AND REGIGRO. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Osta Technologies (Roswell, US). The FDA issued a Cleared decision on August 18, 2010 after a review of 462 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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.

View all Osta Technologies devices

Submission Details

510(k) Number K091424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date August 18, 2010
Days to Decision 462 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 127d · This submission: 462d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects 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 - NPM Bone Grafting Material, Animal Source

All 38
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K091424.
Geistlich Bio-Oss®
K251786 · Geistlich Pharma AG · Jul 2025
SwissGraft X
K251613 · Geistlich Pharma AG · Jun 2025
Geistlich Bio-Flow®
K242510 · Geistlich Pharma AG · Mar 2025
Xenograft Bovine Bone Particulate
K240133 · Collagen Solutions, LLC · Aug 2024
THE Graft Collagen
K230305 · Purgo Biologics, Inc. · Jul 2024
Geistlich Bio-Oss®
K240661 · Geistlich Pharma AG · Jul 2024